Investor Relations

We are a clinical-stage biotechnology company that strives to go beyond the accepted management of debilitating neurodegenerative diseases to improve the lives of patients. On the path to achieving this, we have developed SAIT, a novel therapy that stimulates the body to find and fight proteins that are central to the development and progression of these diseases.

SAIT not only benefits patients, but the technology behind it allows for fast candidate selection and the generation of new intellectual property. In addition to its lead candidate AFFITOPE® PD01 for Parkinson’s disease, AFFiRiS has programs against multiple system atrophy, dementia with Lewy bodies, and Huntington’s disease which are in pre-clinical development.

Press releases

11 September 2020 AFFiRiS announces late-breaking presentation of clinical PD01 data in Parkinson’s disease patients at the MDS Virtual Congress

Vienna, Austria, September 11, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), presents  clinical data for its PD01 lead candidate in Parkinson’s disease at the MDS Virtual Congress 2020 taking place on September 12 – 16. The late-breaking presentation (pre-recorded video presentation, Guided Poster Tour 14) by Günther Staffler, PhD, Chief Technology Officer of AFFiRIS, shows additional clinical data from AFFiRiS’ phase I clinical trial program, providing  further details on the encouraging phase I results recently published by The Lancet Neurology (https://doi.org/10.1016/S1474-4422(20)30136-8).

The presentation titled “Long term safety and immunogenicity of the alpha synuclein active immunotherapeutic PD01A in patients with Parkinson’s disease: a Phase I study series” reports on a first-in-man study with a novel immunotherapeutic aimed to modify disease progression in early stage PD patients. This study provides valuable data on the safety and immunogenicity of this immunotherapeutic over an extended series of studies over four years. It also reports on exploratory analyses aimed at development of a biomarker for disease progression.

The abstract of the presentation can be found at https://virtual.mdscongress.org/2020/MDS2020/fsPopup.asp?Mode=posterinfo&PosterID=305488 (Guided Poster Tour 14: Late-Breaking Abstracts 1).

About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01, AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.                       

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services AG

E cornelia.kutzer@affiris.com                     Julia Hofmann, Europe:  P +49 89 210228 0

W https://www.affiris.com                           Dr. Erica Fiorini, USA: +1 391 310 8172

E affiris@mc-services.eu

About SAIT:
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases:
https://affiris.com/neurodegenerative-diseases

About Parkinson’s disease:
https://affiris.com/neurodegenerative-diseases/#parkinsons-disease

10 September 2020 AFFiRiS announces publication in Movement Disorders Journal of positive clinical results of a Phase 1 trial in early Multiple System Atrophy

  • Specific active immunotherapies (SAITs) PD01A and PD03A targeting aSyn assessed in randomised, double-blind, placebo-controlled phase 1 trial with 30 patients.
  • Treatment with PD01A and PD03A was safe and well tolerated and triggered a rapid and long-lasting antibody response that specifically targeted the aSyn protein.
  • AFFiRiS has begun further clinical development planning activities for SAIT candidates in this indication.

Vienna, Austria, September 10, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), today announced the publication of positive results of a phase 1 randomized, double-blind, placebo-controlled trial in Multiple System Atrophy (MSA) in the peer-reviewed Movement Disorders Journal (https://doi.org/10.1002/mds.28218).

MSA is a rare and fatal neurodegenerative disease that is caused by the progressive loss of nerve cells in the brain and spinal cord. Only very limited and symptomatic treatment options are available for patients with MSA. Symptoms worsen continuously with rapid progression after the onset of disease and a mean survival time of 6-10 years.

To address this urgent unmet medical need, AFFiRiS has developed AFFITOPE®s PD01A and PD03A, two novel immunotherapy candidates designed to induce a sustained antibody response following immunization by specifically targeting the alpha-synuclein (aSyn) epitope. The accumulation of aSyn in oligodendrocytes in the brain is believed to play a central role in the neurodegenerative process in MSA.

The results of this 52-week phase 1 trial in 30 patients with early MSA showed that both immunotherapies, PD01A and PD03A, were safe and well tolerated after five subcutaneous injections. Treatment-related adverse events were similar to site reactions typically observed in vaccination trials. Immunization with PD01A resulted in a significant increase in IgG titers against the immunizing PD01 peptide, and 89% of treated patients developed a PD01-specific antibody response after receiving all injections. Induced antibodies displayed clear reactivity to the aSyn target epitope. Moreover, the antibody response increased rapidly following a booster injection, suggesting that the priming immunizations produced a significant memory effect, and antibody levels persisted until the end of the study. Titers and antibody responder rate (58%) were lower in the PD03A treated group. No significant changes were found in clinical rating scale scores during the study period in all groups. However, the study was not designed to determine efficacy effects.

“Current treatment options for MSA are limited and provide only some symptomatic relief. Disease modifying therapies remain therefore an urgent unmet need,” says Wassilios Meissner, Professor of Neurology and Chairman of the French Reference Center for MSA at the University Hospital Bordeaux, principal investigator of the trial. “The results of this trial in terms of safety, tolerability and immune reaction following repeated administrations of two active immunotherapies, PD01A and PD03A, warrant further investigation of SAITs in MSA patients.”

“We are encouraged by these clinical results which support aSyn targeting therapies as a promising approach to modify disease progression in MSA. Planning activities are currently ongoing for future clinical studies in MSA,” adds Noel Barrett, Ph.D., CEO of AFFiRiS AG. “With our Specific Active Immunotherapies, we aim to harness the power of the body’s own immune system to target and fight the root causes of neurodegenerative diseases, rather than just treating symptoms. Based on our AFFITOME® Technology, AFFiRiS has developed a pipeline of preclinical and clinical stage immunotherapy candidates designed to effectively treat neurodegenerative diseases such as MSA, Parkinson’s and dementia with Lewy bodies, in order to improve the lives of severely ill patients.”

 About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01, AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.                       

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services AG

E cornelia.kutzer@affiris.com                     Julia Hofmann, Europe:  P +49 89 210228 0

W https://www.affiris.com                           Dr. Erica Fiorini, USA: +1 391 310 8172

E affiris@mc-services.eu

About SAIT:
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases:
https://affiris.com/neurodegenerative-diseases

About Multiple system atrophy (MSA):
https://affiris.com/neurodegenerative-diseases/#multiple-system-atrophy

18 June 2020 The Lancet Neurology publishes positive results of AFFiRiS’ Phase 1 trial with PD01A in Parkinson’s disease patients

The Lancet Neurology publishes positive results of AFFiRiS’ Phase 1 trial with PD01A in Parkinson’s disease patients

  • Repeated immunisation with PD01A is safe and well-tolerated over an extended time period
  • Active immunisation with PD01A resulted in a substantial aSyn-specific antibody response and memory effect
  • This antibody response was associated with a substantial reduction in CSF oligomeric aSyn protein
  • Results represent long-term data from a first-in-human study series using specific active immunotherapy (SAIT) AFFITOPE® PD01A

Vienna, Austria, June  18, 2020 – AFFiRiS AG, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), today announced that detailed results of the phase 1 clinical program with its lead candidate PD01 in early Parkinson’s disease (PD) patients were published in the peer-reviewed journal The Lancet Neurology (https://doi.org/10.1016/S1474-4422(20)30136-8). The results of the long-term phase 1 trial series demonstrated that repeated immunisation with PD01A is safe and well-tolerated over an extended period of time. The data showed that active immunisation with PD01A leads to a positive antibody response specific for alpha-synuclein (aSyn), a protein that is believed to contribute to the pathogenesis of Parkinson’s disease. Active immunisation also resulted in a substantial reduction (mean of 51%) in the levels of aSyn oligomers in the CSF of patients who received the high dose therapy, which is interpreted as a sign of in vivo target engagement.

Extensive evidences support the role of soluble aSyn oligomers as a causative factor in the development of Parkinson’s disease and reducing the levels of aSyn oligomers could potentially have disease-modifying benefit in PD patients.

In the trial, the patients were randomised to receive four immunisations with two different doses of AFFiRiS’ drug candidate and were followed for at least 3.5 years to assess the safety of the PD01A immunotherapeutic. In particular, this was the first study to assess the feasibility and safety of a specific active immunotherapy against aSyn.

The results of this phase 1 study demonstrated that immunisation with PD01A is safe when repeatedly administered and was well-tolerated over an extended time period. With the exception of expected local injection site reactions, most AEs were considered unrelated to study treatment. No patient discontinued due to treatment emergent adverse events. Immunisation resulted in a significant increase in IgG antibody against the immunizing AFFITOPE® PD01 peptide already after three priming injections with a maximum titre being achieved at Week 12. This led to a specific humoral immune response against the aSyn target epitope. Moreover, the priming immunisations resulted in a substantial memory effect for the aSyn target epitope as evidenced by the reactivation and augmentation of the antibody response following booster immunizations. This resulted in the persistence of the immune response until study end.

Although the study was not designed and not powered to evaluate clinical efficacy, clinical signals of efficacy were observed. In particular, MDS-UPDRS motor scores were generally stable across the study series, in contrast to published data which reports a worsening in MDS-UPDRS scores in a similar patient population.

“The PD01A safety profile and the substantial sustained aSyn antibody response targeting both the toxic oligomeric and fibrillar form of aSyn, which are believed to contribute to the pathology of PD, may offer a promising strategy for long-term management of PD, addressing an urgent medical need,” said Dieter Volc MD, principal investigator of the study series and Head of the Parkinson Center at the Privatklinik Confraternitaet, Vienna.

“The encouraging results, including signals for clinical efficacy, warrant the further development of our drug for the treatment of PD in a phase 2 clinical trial,” commented Noel Barrett, Ph.D., AFFiRiS’s Chief Executive Officer. “Potentially, specific active immunization approaches such as with PD01A might overcome the limitations of passive antibody infusion approaches for PD, caused by their short in vivo half-lives, and circumvent frequent and high treatment costs by stimulating a self-produced, long-lasting immune reaction.”

The data published in Lancet Neurology is the first report of an active anti-aSyn immunotherapy associated with reduction of CSF aSyn oligomers in PD patients and points to the possible development of this protein as a potential biomarker for disease progression.

The phase 1 trial was supported by The Michael J. Fox Foundation for Parkinson’s Research. A phase 2 trial in early-stage Parkinson’s disease patients is in preparation and expected to start in the second half of 2020, depending on the emerging COVID-19 situation.

About the Phase 1 clinical trial study:

The study was a patient-blinded, single-centre, randomised, first-in-human study followed by three consecutive extensions. 24 Parkinson’s disease patients were randomised to receive four immunisations with either 15μg or 75μg PD01A and were followed for at least 3.5 years. For the first booster injection, patients were re-randomised to receive PD01A doses of 15μg or 75μg. All patients received a second booster injection of 75μg. The primary objective was to assess the safety of the PD01A immunotherapeutic. These studies were registered at EudraCT (2011-002650-31, 2013-001774-20, 2014-002489-54 and 2015-004854-16).

About AFFITOPE® PD01:

AFFITOPE® PD01 is AFFiRiS’ novel immunotherapy candidate for the treatment of early-stage Parkinson’s disease patients. PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide-based specific active immunotherapy (SAIT), identified by the AFFiRiS’ AFFITOME® technology, that targets the protein aSyn. This protein has been identified as playing a key role in the onset and progression of Parkinson’s disease.

About Parkinson’s disease:

Parkinson´s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease and the most common neurodegenerative movement disease.  It affects approximately 1% of the population above the age of 60, about 7-10 million people worldwide. PD is a chronic progressive disorder, defined by a combination of motoric and non-motoric syndromes. The hallmark of the disease is a substantial loss of dopaminergic neurons in the brain accompanied by accumulations of filamentous protein inclusions predominantly composed of alpha Synuclein (aSyn). Evidence suggests that the misfolding of the aSyn protein causes inflammation, synaptic dysfunction and finally neuronal cell death. Current therapies target symptoms but fail to modify the underlying neurodegeneration. In addition, these therapies result in varying degrees of side effects, and their beneficial effects diminish over time.

About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01, AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. AFFiRiS’ programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development.

For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.                               

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services

E cornelia.kutzer@affiris.com                     Julia Hofmann

W https://www.affiris.com                            P +49 89 210228 0, E affiris@mc-services.eu

About SAIT
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases
https://affiris.com/neurodegenerative-diseases/

03 June 2020 Neurobiology of Disease publishes encouraging preclinical results of AFFiRiS’ antibody mAB C6-17 to treat Huntington’s disease

Neurobiology of Disease publishes encouraging preclinical results of AFFiRiS’ antibody mAB C6-17 to treat Huntington’s disease

  • Monoclonal antibody mAB C6-17 targeting human/mutant huntingtin protein (HTT/mutHTT) was developed and characterized
  • In vitro assay for testing cell-to-cell transmission of mutHTT was established
  • For the first time, capability of antibody to block mutHTT transmission in vitro was demonstrated
  • Results support potential of AFFiRiS’ antibody-based concept for a new therapeutic targeting circulating extracellular mutHTT

Vienna, Austria, June 3, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), today announced that detailed preclinical results with its monoclonal antibody mAB C6-17 to treat Huntington’s Disease (HD) were published in the peer-reviewed journal Neurobiology of Disease (https://doi.org/10.1016/j.nbd.2020.104943).

Huntington’s disease (HD) is a hereditary neurodegenerative disorder characterized by changes in personality, impairments in cognition and loss of motor function, leading to death over a period of 10 to 30 years. The disease is caused by a highly polymorphic CAG trinucleotide expansion in the gene encoding for the huntingtin protein (HTT). The resulting mutant huntingtin protein (mutHTT) is ubiquitously expressed but also exhibits the ability to propagate from cell-to-cell to disseminate pathology; a property, which may serve as a new therapeutic focus and suggest that immunotherapy may provide a viable approach to neutralize mutHTT in the extracellular space.

Accordingly, AFFiRiS set out to develop a monoclonal antibody (mAB) targeting a particularly exposed region of the HTT protein. The results published in Neurobiology of Disease show that this monoclonal antibody, designated C6-17 effectively binds mutHTT and is able to deplete the protein from cell culture supernatants. Using cell-based assays, AFFiRiS demonstrated that extracellular secretion of mutHTT into cell culture media and its subsequent uptake in recipient HeLa cells can be almost entirely blocked by mAB C6-17. Immunohistochemical stainings of post-mortem HD brain tissue confirmed the specificity of mAB C6-17 to human mutHTT aggregates.

Günther Staffler, PhD, Chief Technology Officer of AFFiRiS AG, comments: “New therapies for Huntington’s disease are urgently needed to address the root cause of this debilitating disease. Our findings demonstrate that mAB C6-17 not only successfully engages with its target, mutHTT, but also inhibits cell uptake. This suggests that the antibody could interfere with the pathological processes of mutHTT spreading in vivo. These results validate our HTT/mutHTT targeting monoclonal antibody that could ultimately be used as passive immunotherapy to treat features of Huntington’s disease.”

The majority of current preclinical and clinical mutHTT lowering strategies are based on gene silencing such as micro ribonucleic acids (miRNA) and anti-sense oligonucleotides (ASOs). These strategies are geared towards targeting mutHTT expression in the brain to interfere with the abnormal protein directly within neurons. However, mutHTT is ubiquitously expressed and antibodies would allow targeting of extracellular mutHTT throughout the body (brain and peripheral organs, tissues and plasma). This would be one of the most attractive features of this therapeutic approach.

“Previous reports indicate that the ability of peripheral antibodies to enter the brain is limited. However, considering that the peripheral nervous system can impact the central nervous system, our antibody may have the capacity to exert some beneficial effect on the brain as well, by influencing mutHTT levels in the periphery”, says Noel Barrett, PhD, CEO of AFFiRiS AG. “Additionally, combining our antibodies with intracellularly acting ASO or miRNA could provide us with a two-pronged therapy that can simultaneously tackle both intra and extracellular mutHTT. Antibody-based interventions have been demonstrated to be safe and straightforward in application and handling. As such we foresee that antibodies, such as our lead antibody C6-17, could pioneer a new therapeutic strategy for reducing extracellular mutHTT, giving hope to patients suffering from this extremely serious and difficult to treat disease.”

 

About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01, AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. AFFiRiS’ programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development.

For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.

 

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services

E cornelia.kutzer@affiris.com                     Julia Hofmann

W https://www.affiris.com                            P +49 89 210228 0, E affiris@mc-services.eu

About SAIT
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases
https://affiris.com/neurodegenerative-diseases/

About Huntington disease:
https://affiris.com/neurodegenerative-diseases/#huntingtons-disease

09 April 2020 World Parkinson’s Day: AFFiRiS developing PD01 to treat Parkinson's disease, a major unmet medical need

World Parkinson’s Day: AFFiRiS developing PD01 to treat Parkinson’s disease, a major unmet medical need

Vienna, Austria, April 9, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, joins people around the world to raise awareness of Parkinson’s disease and the need to increase the efforts in the development of innovative treatment options.

Parkinson’s disease is a neurodegenerative disease that results from a progressive loss of nerve cells in the brain. A diagnosis of PD is life-changing for patients, as increasingly debilitating and distressing problems with movement and mental function can develop. As the disease progresses, patients may require assistance for most activities of daily living, which places a profound emotional and physical strain on family members. An estimated 7–10 million people worldwide live with Parkinson’s disease.

James Parkinson first described the disease in 1817 as the “Shaking Palsy.” Since 1997, World Parkinson’s Day has been recognized annually on Parkinson’s birthday, April 11th, and April has been designated as Parkinson’s Awareness Month.

“There is a tremendous medical need for therapies that effectively treat and not just manage the symptoms of this increasingly prevalent disease,” said Noel Barrett, Ph.D., AFFiRiS’s Chief Executive Officer. “Medical innovation requires significant funding, and it is in the interest of the healthcare community and society as a whole that the development of various therapeutic approaches be financially supported by industry partners, financial investors and the public sector to achieve real progress in this field.“

Currently available treatments aim to control the symptoms, not stop or reverse disease progression. Parkinson’s disease as well as some other neurodegenerative disorders are characterized by the accumulation of the protein alpha-synuclein (aSyn) in neuronal or non-neuronal cells of the brain.

PD01, AFFiRiS’s immunotherapy candidate for the treatment of early-stage Parkinson’s disease patients, has already demonstrated early signals in a phase 1 study program that the product candidate could potentially stop or slow disease progression by inducing aSyn-specific antibodies that bind to toxic aSyn and subsequently clear it from the brain. A phase 2 trial with PD01 in early-stage Parkinson’s disease patients is expected to start in the second half of 2020.

“Never before has so much research been done to target this highly debilitating disease. We believe that we can make a real difference with AFFiRiS’ active immunotherapy PD01 by providing a powerful, patient-friendly, once-a-year, cost-effective treatment. We are confident that continuing development of our PD01 drug candidate in a phase 2 study will further confirm the clinical benefits signaled in our phase 1 study series”, added Dr. Barrett.

About AFFITOPE® PD01:

AFFITOPE® PD01 is AFFiRiS’ novel immunotherapy candidate for the treatment of early-stage Parkinson’s disease patients. PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide-based specific active immunotherapy (SAIT), identified by the AFFiRiS’ AFFITOME® technology, that targets the protein aSyn. This protein has been identified as playing a key role in the onset and progression of Parkinson’s disease. In a phase 1 study program, early-stage Parkinson’s disease patients were observed for up to 48 months with regard to long-term safety, immunological and clinical parameters. The immunotherapy candidate was demonstrated to be well tolerated. AFFITOPE® PD01 induced a long-lasting humoral immune response that could be reactivated upon booster application. Clinical scores for PD were stable during the entire study period in the PD01 treated group; however, the study was not designed and not powered to evaluate clinical efficacy. The phase 1 studies were supported by The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s disease:

Parkinson´s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease and the most common neurodegenerative movement disease.  It affects approximately 1% of the population above the age of 60, about 7-10 million people worldwide. PD is a chronic progressive disorder, defined by a combination of motoric and non-motoric syndromes. The hallmark of the disease is a substantial loss of dopaminergic neurons in the brain accompanied by accumulations of filamentous protein inclusions predominantly composed of alpha Synuclein (aSyn). Evidence suggests that the misfolding of the aSyn protein causes inflammation, synaptic dysfunction and finally neuronal cell death. Current therapies target symptoms but fail to modify the underlying neurodegeneration. In addition, these therapies result in varying degrees of side effects, and their beneficial effects diminish over time.

About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The Company’s ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01, AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. AFFiRiS’ programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development.

For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.

 

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services

E cornelia.kutzer@affiris.com                     Julia Hofmann

W https://www.affiris.com                            P +49 89 210228 0, E affiris@mc-services.eu

About SAIT
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases
https://affiris.com/neurodegenerative-diseases/

About Parkinson’s disease
https://affiris.com/neurodegenerative-diseases/#parkinsons-disease

03 March 2020 AFFiRiS granted new patent in China for treating Parkinson's disease

Patent adds to company’s robust portfolio covering clinical stage lead development candidate PD01

Vienna, Austria, March 3, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, today announces the award of a new patent by the Chinese National Intellectual Property Administration (CNIPA). The patent covers a group of AFFITOPEs, including PD01, the Company’s lead candidate for the treatment of early-stage Parkinson’s disease patients which is expected to enter clinical phase 2 in the second half of 2020.

AFFiRiS, which has already obtained patents in the United States, Europe, Australia, Canada, India, Japan and South Korea for the same application, thus further expand the geographic coverage of its intellectual property portfolio thanks to this new patent. In addition, the newly granted IP adds to AFFiRiS’ broad patent position covering the treatment of Parkinson’s disease, and its product candidate PD01, as well as to its overall body of patents and patent applications, reflecting the excellent competitive profile in the field of neurodegenerative treatments.

The new patent CN 101969989 (also published as WO 2009/103105) describes how AFFiRiS’ AFFITOPE® compounds may prevent and/or treat neurodegenerative disorders characterized by pathological accumulation of alpha-synuclein aggregates, commonly referred to as synucleinopathies, including Parkinson’s disease (PD), Parkinson’s disease with dementia (PDD) and dementia with Lewy bodies (DLB), as well as Multiple System Atrophy (MSA) or Neurodegeneration with Brain Iron Accumulation type I (NBIA Type I).

About AFFITOPE® PD01:

AFFITOPE® PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide based specific active immunotherapy (SAIT) that targets the protein aSyn, which plays a key role in the onset and progression of Parkinson’s Disease. In a phase 1 study program, early Parkinson patients were observed for up to 48 months with regard to long-term safety, immunological and clinical parameters. The immunotherapy candidate was demonstrated to be well tolerated. AFFITOPE® PD01 induced a long lasting humoral immune response that could be reactivated upon booster application. Clinical scores for PD were stable during the entire study period in the PD01 treated group, however, the study was not designed and not powered to evaluate clinical efficacy. The phase 1 studies were supported by The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s disease:

Parkinson´s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease and the most common neurodegenerative movement disease.  It affects approximately 1 % of the population above the age of 60, about 7-10 million people worldwide. PD is a chronic progressive disorder, defined by a combination of motoric and non-motoric syndromes. The hallmark of the disease is a substantial loss of dopaminergic neurons in the brain accompanied by accumulations of filamentous protein inclusions predominantly composed of alpha Synuclein (aSyn). Evidence suggests that the misfolding of the aSyn protein causes inflammation, synaptic dysfunction and finally neuronal cell death. Current therapies target symptoms but fail to modify the underlying neurodegeneration. In addition, these therapies result in varying degrees of side effects, and their beneficial effects are diminishing over time.

About AFFiRiS AG:

AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, that pursues the vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The ultimate aim is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01 AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. In addition, AFFiRiS’ programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development. For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.

Contact AFFiRiS AG:                              Media contact:

Dr. Cornelia Kutzer                                        MC Services

E cornelia.kutzer@affiris.com                     Julia Hofmann

W https://www.affiris.com                            P +49 89 210228 0, E affiris@mc-services.eu

About SAIT
https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases
https://affiris.com/neurodegenerative-diseases/

About Parkinson’s disease
https://affiris.com/neurodegenerative-diseases/#parkinsons-disease

27 January 2020 AFFiRiS Announces FDA Response to its pre-IND Submission for Phase 2 Trial with AFFITOPE® PD01 in Early Parkinson's Disease Patients

AFFiRiS Announces FDA Response to its pre-IND Submission for Phase 2 Trial with AFFITOPE® PD01 in Early Parkinson’s Disease Patients

Study start in the US and Europe confirmed for H2 2020

Vienna, Austria, January 27, 2020 — AFFiRiS AG, a clinical-stage biopharmaceutical company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, today announced it had received feedback to its pre-Investigational New Drug (”IND”) submission to the U.S. Food and Drug Administration (“FDA”) regarding the planned Phase 2 clinical trial with AFFITOPE® PD01, the Company’s lead candidate for the treatment of early-stage Parkinson’s disease patients. As an outcome to the response, AFFiRiS will proceed with the preparations for the planned phase 2 study and confirms its intended initiation in the US and Europe in the second half of 2020.

The FDA has reviewed the pre-clinical data, the CMC-package, the clinical phase 1 study results and the phase 2 study plan of AFFITOPE® PD01. In its written response, the FDA addressed AFFiRiS’ questions and provided guidance on the design of the planned phase 2 trial.

“We are pleased to have completed the pre-IND process, with the FDA providing helpful guidance for the continued advancement of AFFITOPE® PD01 for the treatment of Parkinson’s disease, an indication with an urgent and significant unmet medical need,” said Noel Barrett, Ph.D., AFFiRiS’ Chief Executive Officer. “We appreciate the FDA’s feedback as we endeavour to provide patients with a potentially disease-modifying immunotherapy utilizing our proprietary patented AFFITOME® technology.”

About AFFITOPE® PD01:

AFFITOPE® PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide based specific active immunotherapy (SAIT) that targets the protein aSyn, which plays a key role in the onset and progression of Parkinson’s Disease. In a phase 1 study program, early Parkinson patients were observed for up to 48 months with regard to long-term safety, immunological and clinical parameters. The immunotherapy candidate was demonstrated to be well tolerated. AFFITOPE® PD01 induced a long lasting humoral immune response that could be reactivated upon booster application. Clinical scores for PD were stable during the entire study period in the PD01 treated group, however, the study was not designed and not powered to evaluate clinical efficacy. The phase 1 studies were supported by The Michael J. Fox Foundation for Parkinson’s Research.

About Parkinson’s disease:

Parkinson´s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease and the most common neurodegenerative movement disease. It affects approximately 1 % of the population above the age of 60, about 7-10 million people worldwide. PD is a chronic progressive disorder, defined by a combination of motoric and non-motoric syndromes. The hallmark of the disease is a substantial loss of dopaminergic neurons in the brain accompanied by accumulations of filamentous protein inclusions predominantly composed of alpha Synuclein (aSyn). Evidence suggests that the misfolding of the aSyn protein causes inflammation, synaptic dysfunction and finally neuronal cell death. Current therapies target symptoms but fail to modify the underlying neurodegeneration. In addition, these therapies result in varying degrees of side effects, and their beneficial effects are diminishing over time.

About AFFiRiS AG:

AFFiRiS is a clinical-stage biopharmaceutical company located in Vienna, Austria, that pursues the vision of using the immune system to find and fight human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The ultimate aim is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). Besides its lead candidate AFFITOPE® PD01, AFFiRiS has programs against multiple system atrophy, Lewy body dementia, and chorea Huntington, which are in pre-clinical development. For further information, please visit www.affiris.com and follow us on LinkedIn.

About the Michael J. Fox Foundation for Parkinson’s Research:

As the world’s largest non-profit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $800 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges ground-breaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Learn more at www.michaeljfox.org.

Contact AFFiRiS AG:
Dr. Cornelia Kutzer
E cornelia.kutzer@affiris.com
W https://www.affiris.com

Media contact:
MC Services AG
Julia Hofmann
P +49 89 210228 0
E affiris@mc-services.eu

10 January 2020 AFFiRiS announces Phase 2 study in Parkinson's and new focus on neurodegenerative diseases

AFFiRiS announces Phase 2 study in Parkinson’s and new focus on neurodegenerative diseases

  • Proof of concept for AFFiRiS’ disease-modifying specific active immunotherapy (SAIT) achieved in cardiometabolic and neurodegenerative diseases
  • Long-term safety data and novel treatment approach support further clinical development in Parkinson`s disease

Vienna, Austria, January 10, 2020 – AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs), today announced a realignment of its development strategy on neurodegenerative diseases, a core area of expertise of the company. Affiris will now focus on ongoing preparations of a phase 2 clinical trial to treat patients suffering from Parkinson’s disease.

AFFiRiS has achieved proof of concept of its unique AFFITOME technology in humans for hypercholesterolemia and Parkinson’s disease with respect to safety, specific antibody production, in vivo target engagement and clinical effect, including positive long-term safety data in Parkinson’s. The company’s focusing on neurodegenerative diseases such as Parkinson´s addresses the urgent medical need and a large attractive commercial opportunity.

Noel Barrett, Chief Executive Officer at AFFiRiS commented: ‘Neurodegenerative disease has always been AFFiRiS’ strength. The company’s work with cardiometabolic and neurodegenerative diseases has been a great journey, enabling us to refine our approach and prove that the technology works in multiple settings. We have taken the strategic decision to concentrate our skills and experience, using our deep understanding of targets and pathogenesis, to progress our exciting pipeline in neurodegenerative diseases.’

Rossella Medori, Chief Medical Officer at AFFiRiS added: ‘Patients with neurodegenerative diseases such as Parkinson’s disease face an all-too-predictable future and are in urgent need of therapies that alter the course of disease progression. Although there are many treatments available to manage the devastating symptoms, sadly none of these acts on the underlying cause of the disease. However, AFFiRiS’ unique immunological approach provides a disease-modifying therapy with an excellent competitive profil in the field of neurodegenerative treatments.’

Michael Motschmann, chairman of AFFiRiS’ supervisory board, said: `We are very pleased about the significant progress of the company under new leadership. The great expertise in neurodegenerative diseases and the unique treatment approach the company is applying to Parkinson`s disease, holds a great promise for patients and care takers. ‘

About the AFFITOME technology and SAITs: AFFiRiS has devised a unique immunological approach – AFFITOME technology – which mimics the epitopes of pathologic forms of proteins. The result is a treatment modality called specific active immunotherapy (SAIT). It harnesses the power of the body’s own immune system to target rogue proteins that are involved with the development and progression of neurodegenerative diseases. It stimulates the immune system to produce antibodies against potentially pathologic forms of these proteins, helping the body to eliminate them. Via this mechanism, the aim is to inhibit disease progression and improve the lives of patients.

The AFFiRis Leadership Team:

Noel Barrett, PhD, former Vice President of Research & Development Vaccines at Baxter Healthcare took over the role as Chief Executive Officer at AFFiRiS in March 2019. Dr. Barrett has more than 30 years of experience in the vaccines and biologics industry bringing products through the development process to the market. He led the development and licensure of Baxter’s FSME tick-borne encephalitis vaccine, Meningococcal C vaccine, and cell‑culture derived H5N1, H1N1, and seasonal influenza vaccines. His contribution to the Baxter scientific community was recognized with the title of Baxter Distinguished Scientist, the most prestigious scientific recognition within the company, and the Baxter Bioscience President’s Leadership Award.

Rossella Medori, MD, has accepted the role as Chief Medical Officer in March 2019. Dr. Medori brings more than 20 years of neuroscience expertise to AFFiRiS and has an extensive track record in successful CNS drug development. Before joining AFFiRiS, she led Prexton Therapeutics to a successful early exit, had key leadership roles at Biogen (including Vice President of Translational Neurology and Vice President of Late Clinical Development) and served in European and Global Medical leadership roles at Janssen-Cilag, BMS and Lilly. Rossella practiced as a Clinical Neurologist in Italy, the United States and Germany and held various academic positions at Case Western Reserve University, Washington University and Columbia University. The identification of the DNA mutations associated with different forms of muscular dystrophy and the description of a new prion disease called Fatal Familial Insomnia are among her most important scientific contributions.

Günther Staffler, PhD, is Chief Technology Officer at AFFiRiS, where he is responsible for preclinical development and technology. Prior to his appointment to the executive board, Günther led the immunology department. Before Joining AFFiRiS, he held various positions at Intercell and Biovertis AG, which he co-founded. Günther completed his doctorate degree in biochemistry and immunology at the Institute of Immunology, University of Vienna, Austria, and has authored many publications in international journals. He was awarded the “Förderungspreis” from the Austrian Society of Chemistry in 1996 and the “Fritz and Ursula Melchers Preis” from the Austrian Societ of Immunology in 2003.

 

 

Contact:

AFFiRiS AG
Dr. Cornelia Kutzer
E cornelia.kutzer@affiris.com
W www.affiris.com


Media Contact:

MC Services AG
Julia Hofmann
P +49 89 210228 0
E affiris@mc-services.eu

Supplementary information:

About AFFiRiS

www.affiris.com
LinkedIn

About SAIT

https://affiris.com/approach/#overview-of-sait

About neurodegenerative diseases

https://affiris.com/neurodegenerative-diseases/

About Parkinson’s disease

https://affiris.com/neurodegenerative-diseases/#parkinsons-disease

 

16 September 2018 - Potential New Advances Against Huntington’s Disease

Poster presented by AFFiRiS at the 2018 European Huntington’s Disease Network Conference provides the foundation for the development of new antibody-based therapies for Huntington’s disease.

PDF-Download (Link)

27 August 2018 - A Specific Active ImmunoTherapy (SAIT) to Control Cholesterol Levels in Blood

Vienna (Austria), 27th August 2018 – Cardiovascular disease still accounts for the greatest number of deaths worldwide. PCSK9-inhibition reduces the risk of cardiovascular events by regulation of the LDL (low density lipoprotein) receptor, one of the transporters of cholesterol in blood. The protein PCSK9 binds to the LDL-cholesterol receptor and enhances its degradation, which leads to the reduced clearance of LDL-cholesterol and a higher risk of atherosclerosis.

So far, blocking PCSK9 was clinically limited by the need for frequent injections with therapeutic antibodies and economically restricted by their high cost. As a promising novel strategy, active immunotherapy that induces a long-lasting PCSK9-specific antibody response may overcome these disadvantages to reduce the burden of cardiovascular disease as the major cause of death in the developed world. On the basis of this innovative concept AFFiRiS AG. (Vienna, Austria) developed two products, AT04A and AT06A, which were tested at the Medical University of Vienna (Dept. of Clinical Pharmacology). Results of the first in-human study of this immunotherapy actively targeting PCSK9 are now available.

72 healthy individuals with slightly elevated LDL-cholesterol (75 to 200 mg/dl) were enrolled in three parallel treatment groups. Participants were randomized to receive AT04A, AT06A or placebo. Immunizations were administered as three priming immunizations at four-weekly intervals. In a second part of the study, 50 participants received a booster immunization at week 60 with a follow-up until week 90, including an interim analysis at week 70. The primary study objective was safety and tolerability of AT04A and AT06A with immunogenicity and efficacy as secondary, exploratory study objectives.

Both immunotherapies, AT04A and AT06A, were safe and well tolerated. No significant difference in the safety profile was observed between active and placebo treatment groups with the exception of injection site reactions. These local reactions – typical for vaccinations – were the most frequently reported adverse events (63.3%) and were more common in the active treatment groups. Injection site reactions were usually of mild to moderate severity, transient and not interfering with activities of daily living. More than 90% of individuals who received AT04A or AT06A developed a PCSK9-specific antibody response, which was readily reactivated after booster immunization at week 60. The mean LDL-cholesterol reduction after the booster was 13.3% at week 70 when comparing AT04A with placebo. Over the entire study period of 90 weeks, the difference in LDL-cholesterol reduction between AT04A and placebo was statistically highly significant (p<0.0001). The maximum individual reduction in LDL-cholesterol was up to 37% from baseline and was associated with a high immune response against PCSK9. LDL-cholesterol reduction persisted for at least 30 weeks after the boost immunization supporting the long-term effect of this therapy.

Prof. Martin Bauer, clinical investigator of the study and expert in clinical pharmacology, presented these results at the “Late Breaking Pharmacological Science” Session of the European Society of Cardiology (ESC) Congress on August 25th 2018 in Munich. “Specific active immunotherapy is a novel and interesting approach to target PCSK9” stated Prof. Bauer. “This was the first study to show the feasibility and safety of a specific active immunotherapy to reduce LDL-cholesterol in humans. Proof-of-concept was achieved for AT04A”.

An optimized formulation of AT04 with enhanced immunogenicity was developed and this promising candidate, called AT04B, will be tested in a next clinical trial. To fully exploit the potential of AT04B, the next study will be tested in a hyperlipidemic population in order to optimize dose, treatment schedule and efficacy. If successful, this would be the first time that an immunotherapy actively targets elevated cholesterol with long lasting efficacy to reduce the risk for coronary heart disease.

 

About AFFiRiS AG:

On the basis of its proprietary patented AFFITOME® technology, AFFiRiS develops preventative and therapeutic peptide specific active immunotherapies (SAIT) against chronic diseases. Its clinical pipeline consists of four SAIT candidates against Atherosclerosis, Parkinson´s Disease and Multiple System Atrophy. Further SAIT candidates against Alzheimer as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 165 Mio to date, half of which comes from license income and government grants. AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.

www.affiris.com

 

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Vienna, Austria
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
https://www.affiris.com

 

Distribution:
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Réka Ficsór
Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E ficsor@prd.at
http://www.prd.at/

14 May 2018 - AFFiRiS Announces Encouraging Long-term Data from a Series of First-in-Human Studies Using AFFITOPE® PD01A Targeting Oligomeric Alpha-synuclein in Early Parkinson’s Disease Patients

  • Consolidated analysis across AFF008 study series completed
  • Reevaluation of primary and secondary endpoints confirms safety and tolerability and immunogenicity profile of long-term application over 4 years of AFFITOPE® PD01A
  • Prof. Werner Poewe, Chairman of the Department of Neurology at the Medical University Innsbruck, Austria, and Leading PD Expert, Presented Results at a “Late Breaking Symposium on Treatment Strategies in PD” at the AAT-ADPD Focus Meeting in Turino, Italy on March 17

VIENNA, Austria, May 14, 2018 — AFFiRiS AG, a pharmaceutical company developing specific active immunotherapies (SAITs) for treatment of neurodegenerative diseases, announces results of their first-in-human series of studies with AFFITOPE® PD01A. In a randomized, parallel group, single-center setting, tolerability and safety of repeated subcutaneous (s.c.) administration of two doses of AFFITOPE® PD01A formulated with adjuvant to patients with early Parkinson’s disease (PD) were assessed. The studies were conducted at Confraternität by Principal Investigator Prim. Dr. Dieter Volc and were funded by a series of grants from The Michael J. Fox Foundation for Parkinson’s Research totaling nearly $3.5 million as well as a €1.4 million government-funded loan by the government agency AWS in Austria (“Austria Wirtschaftsservice”).

AFFITOPE® PD01A is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide-specific active immunotherapy. In the AFF008 study series (a series of four consecutive studies), 24 patients were randomized to either AFFITOPE® PD01A low dose (15 µg) or high dose (75µg). Patients received six injections: four for priming immunizations every four weeks, and the 5th and 6th as “boost” and “reboost” immunizations (appr. 2.2 years and 3 years, respectively after the first immunization). Key objectives were to show safety and tolerability as well as immunogenicity of AFFITOPE® PD01A in a long-term outpatient treatment setting.

Summary of Key Results:

The data presented at the AAT-ADPD Focus Meeting on March 17, 2018, by Prof. Werner Poewe are from the pilot first-in-human study series in patients with early PD treated over a period of up to four years. A total of 32 patients was enrolled, 24 of them receiving active treatment and 8 PD patients on standard of care medication, who served as an observational comparison group. 21 patients in the PD01A treatment groups and five in the observational group completed the entire series of studies. At screening, the average time of PD after the first diagnosis was 2.6 years. Patients were allowed to continue their standard of care PD medication.

Safety and Tolerability:

Both doses of AFFITOPE® PD01A were locally and systemically well tolerated. No study drug-related serious adverse events (SAE) or suspected unexpected serious adverse reactions (SUSAR) occurred. No other safety signals (including data from imaging and safety lab) were reported. Systemic adverse events (AEs), standardized by the number of observed patients, resulted in 11.1 systemic AE/subject receiving AFFITOPE® PD01A versus 10.3 systemic AE/subject in the observational arm, indicating that the systemic effects of PD01A on safety were very similar to that in patients on standard of care treatment. The majority of adverse events, approximately 55%, were local reactions (LRs), the great majority of LRs being only mild and without dose dependency.

Immunogenic Profile & Clinical Scores:

AFFITOPE® PD01A showed a clear immune response against the peptide itself and cross-reactivity against aSyn targeted epitope over time. The first boost immunization produced a significant effect on all analyzed titers, resulting in the maximum titers observed in this series of studies. The second boost immunization further stabilized the produced antibody titers. Thus, a significant increase in titers against PD01A was seen over time, which translated into a humoral immune response against aSyn, being approximately one order of magnitude lower. In addition, PD01-specific antibodies were detectable in cerebrospinal fluid. Clinical scores for PD were stable during the entire study period, however, the study was not designed and not powered to evaluate clinical efficacy.

Data from post-hoc analyses indicate that AFFITOPE® PD01-induced antibodies preferentially bind to both oligomeric and fibrillar aSynwhen compared with its monomers and showed that there was a trend in reduction of oligomeric aSYN levels in plasma as well as cerebrospinal fluid upon treatment with PD01A at week 26. “Immunogenicity results after 4 years of treatment are encouraging and support the hypothesis that long-term disease management by targeting aSyn, a protein that is believed to contribute to the pathogenesis of Parkinson’s disease, with active immunotherapy seems to be feasible,” stated Prof. Werner Poewe, Chairman of the Department of Neurology at the Medical University Innsbruck, Austria, and leading PD expert. “Future trials should focus on how to translate the immune response seen in these series of studies into clinical efficacy.”

“The results of the AFF008 study series are strong encouragement for us to continue development of PD01. We have in parallel optimized the formulation of PD01 and immunization schedule for future clinical development in order to improve immunogenicity even more. Parkinson’s is a debilitating disease which puts a significant burden on patients and caregivers. They deserve our best shot at goal to bringing a potential disease-modifying therapy for long-term disease management with our unique modality to patients.” commented Oliver Siegel, CEO of AFFiRiS AG.

About the AFF008 study series:

In the 4 consecutive studies AFFiRiS008, 008E, 008A and 008AA (“AFF008 study series”), 24 patients were randomized to receive four immunizations with either low dose (15 μg) or high dose (75 μg) AFFITOPE® PD01A in intervals of four weeks on an outpatient basis (study AFF008). To extend the observation period, an additional follow-up of twelve months was added (study AFF008E). In the third part of the study series (study AFF008A), a booster immunization was performed after rerandomizing patients from study AFF008E into two different doses of boost immunization (15 μg or 75 μg AFFITOPE® PD01A). In study AFF008AA (“reboost study”), the second booster with a fixed dose of 75 μg AFFITOPE® PD01A was applied to patients previously immunized five times. Key objectives were to show safety and tolerability as well as immunogenicity of AFFITOPE® PD01A in a long-term treatment setting.

About AFFITOPE® PD01A:

AFFITOPE® PD01A targets the protein aSyn, which plays a key role in the onset and progression of Parkinson’s Disease as well as Multiple System Atrophy (MSA), an orphan disease. AFFITOPE® PD01A is a specific active immunotherapy (SAIT) and one of two SAIT candidates currently being studied in phase I studies in both indications. So far, 98 PD and MSA patients have participated in studies investigating either AFFITOPE® PD01A or PD03A. During these phase I studies, patients were observed for up to 48 months (AFFITOPE® PD01A) or 12 months (AFFITOPE® PD03A), respectively, with regard to long-term safety, immunological and clinical parameters.

About AFFiRiS AG:

On the basis of its proprietary patented AFFITOME® technology, AFFiRiS develops preventative and therapeutic peptide-specific active immunotherapies (SAIT) against chronic diseases. Its clinical pipeline consists of four SAIT candidates against PD, MSA, and Atherosclerosis. Further SAIT candidates against Alzheimer as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 165 Mio to date, half of which comes from license income and government grants. AFFiRiS is part of a consortium receiving funding from the European Union’s 7th Framework Programme under SYMPATH Grant Agreement No. 602999 (http://www.sympath-project.eu/) and MULTISYN Grant Agreement No. 602646 (http://www.multisyn.eu/). AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria. www.affiris.com

About The Michael J. Fox Foundation for Parkinson’s Research:

As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with the active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors, and volunteers. In addition to funding more than $800 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Learn more at www.michaeljfox.org.

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Vienna, Austria
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
W https://www.affiris.com

Distribution:
PR&D – Public Relations for Research & Education
Ira Paschinger
Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E paschinger@prd.at
W http://www.prd.at

2 March 2018 - AFFiRiS Announces Results of a Phase I Clinical Study Using AFFITOPEs® PD01A and PD03A, Confirming Safety and Tolerability for both compounds as well as Immunogenicity for PD01A in early MSA patients

  • AFFITOPEs® PD01A and PD03A Safe and Well Tolerated: Primary Endpoint of Phase I Study Met
  • Immune response against AFFITOPE® PD01A and Alpha-Synuclein Seen in Patients With Early Multipe System Atrophy (MSA), an orphan disease
  • Wassilios Meissner, Principal Investigator of the Study and Leading MSA Expert, Presented Results at Today´s “Disease Modifying Treatments in the Pipeline” Session of the 6th Multiple System Atrophy Congress in New York

VIENNA, Austria, March 01, 2018 — AFFiRiS AG, a pharmaceutical company developing specific active immunotherapies (SAITs) for treatment of neurodegenerative diseases, announces results of their pilot phase 1 randomized, placebo-controlled, parallel group, patient-blinded, bi-center study, assessing the safety and exploring the immunogenicity and therapeutic activity of AFFITOPEs® PD01A and PD03A, new SAITs against alpha-synuclein (aSyn), in patients with early Multiple System Atrophy.

The study was part of SYMPATH, a collaboration of eight academic and industry partners within the 7th framework of the EU, funded by an € 6 Mio grant.

AFFITOPEs® PD01A and PD03A are synthetically produced alpha-Synuclein (aSyn)-mimicking peptide active immunotherapies. In study AFFiRiS009, 30 patients were randomized to either AFFITOPE® PD01A (75µg), AFFITOPE® PD03A (75µg) or to the placebo group treated with Alhydrogel (aluminium oxihydroxide) alone. Patients received 5 injections, 4 for priming every 4 weeks and the 5th as boost immunization 9 months after the first immunization in an outpatient setting. Key objectives were to show safety and tolerability as well as immunogenicity of AFFITOPEs® PD01A and PD03A.

Summary of key results: The data presented today by Prof. Wassilios Meissner at the 6th MSA congress in New York are from the pilot phase 1 study in patients with early MSA treated with 5 applications of either AFFITOPE® PD01A or PD03A over a period of 36 weeks. The primary endpoint of the trial was safety and tolerability of repeated s.c. administration of AFFITOPEs® PD01A or PD03A. A total of 30 patients were enrolled with 6 patients of the active treatment groups discontinuing early. At screening, the average time of MSA after first diagnosis was between 0.6-0.8 years. Patients were allowed to continue their standard of care MSA medication.

Safety and Tolerability: Both AFFITOPEs® PD01A and PD03A were locally and systemically well tolerated. Two patients died during study participation and one patient shortly afterwards. This is in line with the safety results of other MSA trials reporting a mortality rate of up to 10%. No evidence of significantly more progression of motor impairment was seen in the active treatment groups compared to the placebo group. No other safety signals (including data from imaging and safety lab) were reported. Overall, the extensive monitoring of patient’s safety during study AFF009 did not evidence any safety concern associated with AFFITOPE® PD01A and PD03A administration. The majority of adverse events (AE), appr. 30%, were local reactions (LRs), the great majority of LRs being only mild.

Immunogenic Profile: AFFITOPE® PD01A showed a clear immune response against the peptide itself and crossreactivity against aSyn targeted epitope over time, and showed antibody reactivation upon booster immunization. Regarding the immunogenicity of AFFITOPE® PD03A, no significant differences were seen compared to placebo.

Conclusions: AFFITOPEs® PD01A and PD03A were well tolerated in early MSA patients. PD01A induced a clear immune response versus the peptide itself and aSyn epitope.

“The safety profile of both compounds are in line with our expectations and similar to what we have seen in other MSA studies with a follow-up period of 52 weeks” stated Prof. Wassilios Meissner, PI of the study, Chairman of the the French Reference Center for MSA at the Bordeaux University Hospital, and leading MSA expert. “The immunogenicity profile of AFFITOPE® PD01A looks encouraging and seems to indicate that patients with early MSA elicit an antibody response specific to alpha synuclein, a protein that is believed to be contributing to the pathogenesis of the disorder.” Oliver Siegel, CEO of AFFiRiS AG explained: “Further clinical development of PD01A will focus on its pharmacodynamic and pharmacokinetic properties in synucleinopathies. The board will take a decision on the next clinical trial once we have further consulted with our key opinion leaders and after having evaluated the results of all our studies.”

About AFFITOPEs® PD01A and PD03A:

AFFITOPEs® PD01A and PD03A target the protein aSyn, which plays a key role in the onset and progression of Multiple System Atrophy (MSA) as well as Parkinson´s Disease (PD). Both AFFITOPE® PD01A and PD03A are specific active immunotherapies and have been studied in phase I studies. So far, 98 PD and MSA patients have participated in studies investigating either AFFITOPE® PD01A or PD03A. During these phase I studies patients were observed for up to 48 months (AFFITOPE® PD01A) or 12 months (AFFITOPE® PD03A), respectively, with regard to long-term safety, immunological and clinical parameters.

About SYMPATH:

AFFiRiS has launched the collaborative research project SYMPATH with funding from FP7 to forward the clinical development of the aSyn targeting vaccines AFFITOPE® PD01A and PD03A together with experts from three European countries including Austria, Germany and France. SYMPATH implemented a tandem phase I program to evaluate the safety and explore the activity of these two active immunotherapy candidates in humans. A part of the program is devoted to the identification of biomarkers with diagnostic and prognostic value. The cause of both MSA and PD are not fully understood and currently there are no treatment options available for either to alter the course of the disease.

About AFFiRiS AG:

On the basis of its AFFITOME technology, AFFiRiS develops preventative and therapeutic peptide vaccines against chronic diseases. Its clinical pipeline consists of four vaccine candidates against PD, MSA and Atherosclerosis. Further vaccine candidates against Alzheimer as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 165 Mio to date, half of which comes from license income and government grants. AFFiRiS is part of a consortium receiving funding from the European Union’s 7th Framework Programme under SYMPATH Grant Agreement No. 602999 (http://www.sympath-project.eu/) and MULTISYN Grant Agreement No. 602646 (http://www.multisyn.eu/). AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Vienna, Austria
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
W https://www.affiris.com

Distribution:
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Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E contact@prd.at
W http://www.prd.at

20 June 2017 - A vaccine to immunise people against high levels of cholesterol and the narrowing of the arteries caused by build-up of fatty material (atherosclerosis) may be possible following successful results in mice. Now, a phase I trial in patients has started to see if the findings translate to humans

The study, which is published today (Tuesday) in the European Heart Journal [1], is the first to show that it is possible to immunise genetically modified mice with a molecule that causes the body to produce antibodies against an enzyme called PCSK9 (Proprotein covertase subtilisin/kexin type 9), which plays a role in preventing the clearance of low density lipoprotein cholesterol (“bad” cholesterol) from the blood.

People with high levels of LDL cholesterol, either due to their genetic inheritance, or to poor diet and lifestyles, are at much greater risk of developing cardiovascular disease prematurely. These diseases of the heart and blood vessels, caused by atherosclerosis, have overtaken infections as the main cause of illness and death throughout the world. At present, drugs such as statins can be used to lower LDL cholesterol, but they have to be taken on a daily basis and although they are generally well-tolerated they can cause adverse side effects in some people. The most recently approved cholesterol-lowering compounds are monoclonal antibodies targeting PCSK9, which are highly effective, but their effect is short-lived, resulting in frequent re-application and high costs.

The research published today shows that the AT04A vaccine, when injected under the skin in mice that have been fed fatty, Western-style food in order to induce high cholesterol and the development of atherosclerosis, reduced the total amount of cholesterol by 53%, shrank atherosclerotic damage to blood vessels by 64%, and reduced biological markers of blood vessel inflammation by 21-28%, compared to unvaccinated mice. Furthermore, the induced antibodies remained functional over the whole study period and concentrations were still high at the end of the study.

Dr Günther Staffler, chief technology officer at AFFiRis (the company that developed AT04A) and one of the authors of the study, said: “AT04A was able to induce antibodies that specifically targeted the enzyme PCSK9 throughout the study period in the circulation of the treated mice. As a consequence, levels of cholesterol were reduced in a consistent and long-lasting way, resulting in a reduction of fatty deposits in the arteries and atherosclerotic damage, as well as reduced arterial wall inflammation.

“The reduction in total cholesterol levels was significantly correlated with induced antibody concentration, proving that induced antibodies caused the reduction in cholesterol and also are ultimately responsible for the reduction of atherosclerosis development. As antibody concentrations remained high at the end of the study, it can be assumed they would continue to reduce cholesterol levels for some time afterwards, resulting in a long-lasting effect, as has been shown in previous studies.

“If these findings translate successfully into humans, this could mean that, as the induced antibodies persist for months after a vaccination, we could develop a long-lasting therapy that, after the first vaccination, just needs an annual booster. This would result in an effective and more convenient treatment for patients, as well as higher patient compliance.”

The enzyme PCSK9 is made in the liver and it locks on to LDL cholesterol receptors, reducing their ability to get rid of LDL cholesterol from the blood. When injected, AT04A causes the body to produce antibodies that block the function of PCSK9, so that the activity of the LDL cholesterol receptors is increased.

“The way that AT04A is administered is comparable to a vaccine,” explained Dr Staffler. “However, the difference between a conventional vaccine and our approach is that a vaccine induces antibodies that are specific to bacterial or viral proteins that are foreign to the body – pathogens – whereas AT04A induces antibodies against a target protein that is produced by the body – endogenous proteins. This it is really an immunotherapeutic approach rather than a vaccine approach.”

In 2015, a phase I clinical study [2] started at the Department of Clinical Pharmacology, Medical University of Vienna, Austria, studying AT04A and another molecule AT06A in 72 healthy people to assess its safety and activity. The study is expected to complete at the end of this year.

In an accompanying editorial [3], Professor Ulrich Laufs, of Saarland University, Germany, and Professor Brian Ference, of the University of Bristol, UK, and the Wayne State University School of Medicine, Detroit, USA, write: “It appears promising to further evaluate long-term LDL cholesterol lowering by vaccination against PCSK9 for the prevention of atherosclerotic events.” However, they say that “safety, the response in humans and the very important but unknown long-term immune effects need to be very carefully addressed during the course of clinical development”. In particular, reductions in total cholesterol via statins and other drugs are associated with an increase in new onset diabetes. “Therefore, one potential safety concern for long-term lowering of LDL cholesterol with a vaccine directed against PCSK9 is the potential for an increased risk of new onset diabetes. In the short term, the LDL cholesterol lowering effect of statins and PCS9 inhibitors appears to far outweigh the risks of new onset diabetes.”

Notes:
[1] “The AT04A vaccine against proprotein convertase subtilisin/kexin type 9 reduces total cholesterol, vascular inflammation, and atherosclerosis in APOE*3Leiden. CETP mice”, by Christine Landlinger et al. European Heart Journal. doi:10.1093/eurheartj/ehx260.
[2] Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects (AFF012)”. ClinicalTrials.gov Identifier: NCT02508896
[3] “Vaccination to prevent atherosclerotic cardiovascular disease”, by Ulirich Laufs and Brian Ference. European Heart Journal. doi:10.1093/eurheartj/ehx302

The European Heart Journal is the flagship journal of the European Society of Cardiology (http://www.escardio.org). It is published on behalf of the ESC by Oxford Journals, a division of Oxford University Press. Please acknowledge the journal as a source in any articles.

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7 June 2017 - AFFiRiS Announces Top Line Results of First-in-Human Clinical Study Using AFFITOPE® PD03A, Confirming Immunogenicity and Safety Profile in Parkinson’s Disease Patients

  • AFFITOPE® PD03A Safe and Well Tolerated: Primary Endpoint of Phase I Study Met
  • Dose Dependent Immune Response Against AFFITOPE® PD03A and Alpha-Synuclein Seen in Patients With Early Parkinson’s Disease
  • Prof. Werner Poewe, PI of the Study and Leading PD Expert, Presented Results at Today´s Plenary Session of the 21 Iternational Congress of Parkinson´s Disease and Movement Disorders in Vancouver, Canada

VIENNA, Austria, June 07, 2017 — AFFiRiS AG, a pharmaceutical company developing novel active immunotherapies for treatment of neurodegenerative diseases, announces top line results of their pilot phase 1 randomized, placebo-controlled, parallel group, patient-blinded, bi-center study, assessing tolerability and safety of repeated subcutaneous (s.c.) administration of two doses of AFFITOPE® PD03A formulated with adjuvant to patients with early Parkinson’s disease (PD). The study is part of SYMPATH, a collaboration of eight academic and industry partners within the 7th framework of the EU, funded by an € 6 Mio grant. AFFITOPE® PD03A is a synthetically produced alpha-Synuclein (aSyn)-mimicking peptide vaccine. In study AFFiRiS011, 36 patients were randomized to either AFFITOPE® PD03A high dose (75μg), low dose (15 μg) or to the placebo group treated with Alhydrogel (aluminium oxihydroxide) alone. Patients received 5 injections, 4 for priming every 4 weeks and the 5th as boost immunization 9 months after the first immunization in an outpatient setting. Key objectives were to show safety and tolerability as well as immunogenicity of AFFITOPE® PD03A. Summary of key top level results: The data presented today by Prof. Werner Poewe on behalf of the SYMPATH partners at the 21st International Congress of Parkinson´s Disease and Movement Disorders in Vancouver are from the pilot phase 1 study in patients with early PD treated with 5 applications of AFFITOPE® PD03A over a period of 36 weeks. The primary endpoint of the trial was safety and tolerability of repeated s.c. administration of AFFITOPE® PD03A. A total of 39 patients were screened, 36 treated with 1 patient of the control group discontinuing early. At screening, the average time of PD after first diagnosis was between 1.6-2.3 years; Patients were allowed to continue their standard of care PD medication. Safety and Tolerability: Both doses were locally and systemically well tolerated. No study drug related serious adverse events (SAE) or suspected unexpected serious adverse reactions (SUSAR) occurred. The majority of adverse events (AE), appr. 59%, were local reactions (LRs), the great majority of LRs being only mild and without dose dependency. Immunogenic Profile: AFFITOPE® PD03A showed a clear dose dependent immune response against the peptide itself and crossreactivity against aSyn targeted epitope over time, and showed antibody reactivation upon booster immunization.

Conclusions: 15 and 75μg of AFFITOPE® PD03A were well tolerated in early PD patients. The compound induced a clear dose dependent immune response versus AFFITOPE® PD03A and aSyn epitope.

“The immunogenicity profile looks encouraging and supports the hypothesis that patients elicit an antibody response specific to alpha synuclein, a protein that is believed to be contributing to the pathogenesis of Parkinson’s” stated Prof. Werner Poewe, PI of the study, Chairman of the Department of Neurology at the Medical University Innsbruck, Austria, and leading PD expert. “Based on additional data covering alpha synuclein lowering in plasma and cerebrospinal fluid (CSF), expected in Q3 2017 we should see clearer about PD01A vs PD03A for future development in Parkinson´s patients.”

About AFFITOPE® PD03A:

AFFITOPE® PD03A targets the protein aSyn, which plays a key role in the onset and progression of PD as well as Multiple System Atrophy (MSA), an orphan disease. AFFITOPE® PD03A is one of two vaccine candidates currently being studied in phase I studies. So far, 98 PD and MSA patients have participated in studies investigating either AFFITOPE® PD01A or PD03A. During these phase I studies patients were observed for up to 48 months (AFFITOPE® PD01A) or 12 months (AFFITOPE® PD03A), respectively, with regard to long-term safety, immunological and clinical parameters. Final results of studies with both compounds are expected for Q4 2017.

About SYMPATH:

AFFiRiS has launched the collaborative research project SYMPATH with funding from FP7 to forward the clinical development of the aSyn targeting vaccines AFFITOPE® PD01A and PD03A together with experts from three European countries including Austria, Germany and France. SYMPATH implemented a tandem phase I program to evaluate the safety and explore the activity of these two active immunotherapy candidates in humans. A part of the program is devoted to the identification of biomarkers with diagnostic and prognostic value. The cause of both PD and MSA are not fully understood and currently there are no treatment options available for either to alter the course of the disease.

About AFFiRiS AG:

On the basis of its proprietary patented AFFITOME® technology, AFFiRiS develops preventative and therapeutic peptide vaccines against chronic diseases. Its clinical pipeline consists of four vaccine candidates against PD, MSA and Atherosclerosis. Further vaccine candidates against Alzheimer as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 156 Mio to date, half of which comes from license income and government grants. AFFiRiS has received grants of $ 3 Mio for its phase I studies with AFFITOPE® PD01A from The Michael J. Fox Foundation (MJFF). Furthermore, AFFiRiS is part of collaborative projects receiving funding from the European Union’s 7th Framework Programme under SYMPATH Grant Agreement No. 602999 (http://www.sympath-project.eu/) and MULTISYN Grant Agreement No. 602646 (http://www.multisyn.eu/). AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.

www.affiris.com

Contact AFFiRiS AG: Bettina Wessa Karl-Farkas-Gasse 22 1030 Vienna, Austria T +43 / (0)1 / 798 15 75 – 300 E bettina.wessa@affiris.com W https://www.affiris.com

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2 May 2017 - AFFiRiS AG successfully raises €10m equity financing

  • €10 m additional capital raised

Vienna, 2nd May 2017. AFFiRiS AG has successfully completed its capital increase and raises an additional
€ 10m from existing investors.

In an annual general meeting on 25th April 2017 the shareholders of the company have agreed to a capital
increase of € 10m. The new shares have been subscribed by the two major investors of the company, Santo
Holding – the family office of the Strüngmann family – the MIG Funds advised by MIG Verwaltungs AG and the
FCPB Affi GmbH.
AFFIRIS commenced Phase 1 clinical development of its Hypercholesterolemia and Atherosclerosis prevention
active immunotherapy candidates AT04A and AT06A and expects data from this study in Q2 2017. AT04A and
AT06A are vaccine candidates from the next generation AFFITOME technology and target PCSK9, an enzyme
which plays a role in the lipid metabolism of the liver. In addition, AFFiRiS expects to complete an exploratory
Phase 1 development program in three ongoing clinical trials with its active immunotherapy candidates PD01A
and PD03A targeting oligomeric forms of alpha synuclein in Parkinson’s and Multiple System Atrophy (MSA)
patients in Q4 2017. AFFiRiS enjoys the continous support of The Michael J. Fox Foundation, the world’s largest
nonprofit funder of Parkinson’s research.

About AFFiRiS AG:
On the basis of its AFFITOME-technolgy, AFFiRiS develops tailor-made active
immunotherapes against chronic diseases. Its clinical pipeline consists of 3 active immunotherapeutic
candidates against Parkinson’s, MSA and Hypercholesterolemia. Further candidates against diabetes, allergies,
asthma as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding
of approx. € 146m to date, half of which comes from license income and government grants. AFFiRiS currently
employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.

www.affiris.com

 

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Wien
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
W https://www.affiris.com

 

Distribution:
PR&D – Public Relations for Research & Education
Mariannengasse 8
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T +43 / (0)1 / 505 70 44
E contact@prd.at
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7 September 2016 - Boost Vaccination Data Encourage Continued Development of AFFiRiS Therapeutic Parkinson's Disease Vaccine against Alpha-Synuclein

  • PD01A was Safe and Well Tolerated: Primary Endpoint of Phase I “Boost” Study Met
  • Immune Response was Seen in 86% of Patients, Resulting in an Increase of Responder Rate after Boost Immunization
  • PD01A-induced Antibodies Preferentially Bind to Fibrilic Alpha-Synuclein (aSyn)
  • Data will be Presented at the Poster Tour of Leading Abstracts at the 4th World Parkinson Congress in Portland, Oregon, USA on September 21

VIENNA, Austria, September 07, 2016 — AFFiRiS AG announced today results of AFF008A, a Phase I clinical trial to assess boost immunizations with AFFITOPE® PD01A, an active vaccine against Parkinson´s disease (PD).The study was funded by a $1.04 million grant from The Michael J. Fox Foundation for Parkinson’s Research.

The “boost” study AFF008A was designed to assess one boost immunization with AFFITOPE® PD01A per patient with regard to safety/tolerability and immunological and clinical activity in those patients who had already received the vaccine (four “priming” vaccinations at four-week intervals) within the first-in-man clinical study AFF008. Six PD patients on best medical care, including standard symptomatic medication, served as a comparison group. In the “boost” study, two different doses of AFFITOPE® PD01A (15 μg and 75 μg) were again safe and well tolerated, meeting the primary endpoint of the trial.

Patients belonging to the low-dose group of AFF008 were randomized in two equally distributed groups receiving either 15 μg or 75 μg AFFITOPE® PD01A. The same was done with patients of the AFF008 high-dose group, in order to allow for evaluation of four different vaccination schedules.

Across all patients, no antibody concentration limiting toxicity was observed. Adverse events were similar across all five groups except injection site reactions, which only occurred in the active treatment groups, and psychiatric disorders, reported at a lower rate in the active groups. All of the 28 patients completed the study and received all planned vaccinations. Only one serious adverse event was reported, which was classified as being not related to AFFITOPE® PD01A administration.

An immune response against AFFITOPE® PD01A was seen in 19 of 22 (86%) of vaccinated patients and 12 of 19 (63%) of these responders generated aSyn-specific serum antibodies. The immune response sustained throughout the entire observation period of 24 weeks. Patients on low dose and then high dose had a clear immunological boost. This data supports that further dose and scheduling may significantly influence antibody titer/concentration and further studies need to be performed. Additionally, vaccine-induced antibodies were detectable in cerebrospinal fluid. This induction of antibodies against aSyn supports the concept of the principle of AFFiRiS’ proprietary therapeutic vaccine.

Parallel laboratory experiments using recombinant aSyn protein to assess selectivity showed that AFFITOPE® PD01A-induced antibodies preferentially bind to aSyn fibrils, which are believed to be the toxic form of the protein, as compared to the monomeric form.

Due to the limitations of the Phase I trial design (the study was not double-blind, and assignment to the comparison group was not randomized), it is not known whether effects seen in the active groups are indicative of treatment effects or due to confounding factors. Efficacy variables were evaluated in an explorative manner with regard to the small sample size. Preliminary observations showed that in eight of the 19 (42%) immunological responders, no increase of the concomitant dopaminergic PD medication was needed throughout the observational period (on average three years per subject). Among the same group, five of eight (63%) patients had stable UPDRS III scores at the end of the “boost” study.

Continuous efforts are undertaken to follow this patient cohort and to further characterize their immunological and clinical response to treatment with AFFITOPE® PD01A. The next study, AFF008AA, is focusing primarily on the long-term safety and, in addition, on the assessment of the immunological and clinical effects of a second boost vaccination (“reboost”). That study is also funded by The Michael J. Fox Foundation, as was the AFF008 trial. Recruitment of patients for AFF008AA has been completed; results are expected in Q2 2017.

About AFFITOPE® PD01A:
AFFITOPE® PD01A targets the protein alpha-Synuclein, which plays a key role in the onset and progression of Parkinson’s as well as multiple system atrophy (MSA), an orphan disease. During the first-in-man study AFF008, AFFITOPE® PD01A was safe and well tolerated, meeting the primary endpoint of the trial. PD01A is one of two vaccine candidates currently being studied in three ongoing Phase 1 studies AFF008AA, AFF009 and AFF011 in which currently 92 Parkinson’s and Multiple System Atrophy (MSA) patients are receiving either PD01A or PD03A. During these phase I studies patients are being observed for up to 48 months with regard to long-term safety, immunological and clinical parameters. Results are expected for Q4 2017.

About AFFiRiS AG:
On the basis of its AFFITOME-technology, AFFiRiS develops preventative and therapeutic peptide vaccines against chronic diseases. Its clinical pipeline consists of four vaccine candidates against Parkinson’s, MSA and Atherosclerosis prevention. Further vaccine candidates against diabetes, allergies as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 130m to date, half of which comes from license income and government grants. Furthermore, AFFiRiS is part of collaborative projects receiving funding from the European Union’s Seventh Framework Programme under SYMPATH Grant Agreement No. 60299 (http://www.sympath-project.eu/) and MULTISYN Grant Agreement No. 602646 (http://www.multisyn.eu/). AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.
www.affiris.com

About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $600 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Learn more at www.michaeljfox.org.

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Wien, Austria
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
W https://www.affiris.com

 

Distribution:
PR&D – Public Relations for Research & Education
Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E contact@prd.at
W http://www.prd.at

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23 June 2016 - AFFiRiS AG successfully raises €10m equity financing

  • €10 m additional capital raised
  • Günther Staffler appointed as Chief Technology Officer
  • Noel Barrett appointed as additional member of the supervisory board

Vienna, 23 June 2016. AFFiRiS AG has successfully completed its capital increase and raises an additional € 10m from existing investors and FCPB Affi GmbH. The Supervisory Board has appointed Günther Staffler as Chief Technology Officer. Noel Barrett has joined the Supervisory Board as of 15 June 2016.

In an extraordinary shareholders meeting on 29. April 2016 the shareholders of the company have agreed to a capital increase of € 10m. The new shares have equally been subscribed by the two major investors of the company, Santo Holding – the family office of the Strüngmann family – ,the MIG Funds advised by MIG Verwaltungs AG and new investor FCPG Affi GmbH. In the ordinary shareholders meeting on 15. June 2016 the shareholders also elected Noel Barrett as additional member of the Supervisory Board. He replaces Dr. Frank Mattner whose tenure as supervisory board member has ended on 31. December 2015.

Noel Barrett has more than 30 years’ experience in the vaccines and biotechnology industry with management responsibilities covering the complete development process required to bring vaccine products to the market. In his last position at Baxter HealthcareBaxalta Noel Barrett was Vice President, Global R&D Baxter Vaccines and has successfully overseen the development of numerous vaccine candidates through preclinical and clinical development.

Michael Motschmann, Chairman of the Supervisory Board of AFFiRiS commented: “We are excited to welcome Noel Barrett to the Supervisory Board of AFFiRiS. His product development expertise he will be tremendously valuable as the company focused on advancing its projects in clinical development.”

The company has decided to adapt its management structure to focus on development, both preclinical and clinical of its projects. All preclinical development will be led by Günther Staffler (48) whom the Supervisory Board has appointed as Chief Technology Officer and member of the executive board of AFFiRiS. Günther Staffler has previously been responsible as Head of Immunology for the preclinical development of its vaccine candidates AT04 and AT06 in Hypercholesterolemia and Atherosclerosis prevention which are currently being tested in Phase 1 clinical development. The company also announces the departure of Achim Schneeberger, previously Chief Medical Officer and Arne von Bonin, Chief Scientific Officer.

AFFIRIS commenced Phase 1 clinical development of its Hypercholesterolemia and Atherosclerosis prevention vaccine candidates AT04A and AT06A and expects data from this study in Q1 2017. AT04A and AT06A are vaccine candidates from the next generation AFFITOME technology and target PCSK9, an enzyme which plays a role in the lipid metabolism of the liver. If PCSK9 is blocked, more LDL receptors will be present on the surface of the liver and will remove more LDL cholesterol from the blood. Therefore, blocking PCSK9 can lower blood cholesterol levels.

About AFFiRiS AG:
On the basis of its AFFITOME-technolgy, AFFiRiS develops tailor-made therapeutic peptide vaccines against chronic diseases. Its clinical pipeline consists of 3 drug candidates against Parkinson’s, MSA and Hypercholesterolemia. Further vaccine candidates against diabetes, allergies, asthma as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 130m to date, half of which comes from license income and government grants. AFFiRiS currently employs 60 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.
www.affiris.com

 

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Wien
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com
W https://www.affiris.com

 

Distribution:
PR&D – Public Relations for Research & Education
Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E contact@prd.at
W http://www.prd.at

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16 June 2015 - Vaccine Specialist AFFiRiS AG successfully completes Financing Round

  • € 10m additional capital raised
  • Supervisory Board appoints Oliver Siegel as Chief Executive Officer
  • Prof. Dr. Christoph Huber elected to Supervisory Board

Vienna, 16 June 2015. AFFiRiS AG has successfully completed its capital increase and raises an additional € 10m from existing investors. The Supervisory Board has appointed Oliver Siegel as Chief Executive Officer and Dr. Arne von Bonin as Chief Scientific Officer. Prof. Dr. Christoph Huber has joined the Supervisory Board as of 18 May 2015 and replaces Dr. Walter Schmidt who has decided to leave the Supervisory Board. Mag. Vera Bürger and Claudia Juno have been appointed by the employees to join the Supervisory Board.

In an extraordinary shareholders meeting on 18 May 2015 the shareholders of the company have agreed to a capital increase of € 10m. The new shares have equally been subscribed by the two major investors of the company, Santo Holding – the family office of the Strüngmann family – and the MIG Funds represented by MIG Verwaltungs AG. The shareholders also elected Prof. Dr. Christoph Huber as member of the Supervisory Board. He will replace Dr. Walter Schmidt who has decided to leave the Supervisory Board. Walter Schmidt co-founded AFFiRiS eleven years ago and profoundly influenced the company until his resignation from operational responsibilities this past January.

Michael Motschmann, Chairman of the Supervisory Board of AFFiRiS said: “Walter Schmidt has been instrumental in shaping AFFiRiS. His business acumen and his entrepreneurship have been critical in establishing the AFFITOME-technology as a leading platform for active immune therapy in the prevention and therapy of chronic illnesses. I am pleased to welcome Prof. Christoph Huber to the Supervisory Board. His outstanding scientific achievements in the field of immunology and his entrepreneurial spirit as founder of various successful biotech companies will be of great value to the future development of AFFiRiS.” The Supervisory Board appointed Oliver Siegel (49) as Chief Executive Officer and Dr. Arne von Bonin (51) as Chief Scientific Officer (CSO).

The new capital allows the company to further advance its AFFITOME-technology for the prevention and therapy of chronic illnesses. Oliver Siegel comments these developments: “The successful capital increase demonstrates the continued support from our investors in the technology and the scientific team. The ongoing support will be essential to the successful development of our vaccine technology as platform technology in a number of indications.”
Recently, AFFIRIS presented Phase 1 data on its Parkinson’s vaccine candidate PD01. PD01A was the first α-synuclein targeting drug candidate that successfully completed a phase 1 study. α-synuclein is a protein which plays a role in the pathological processes of neurodegenerative diseases such as Parkinson’s. The program enjoys the support from The Michael J. Fox Foundation, the world’s largest nonprofit funder of Parkinson’s research.
About AFFiRiS AG:
On the basis of its proprietary patented AFFITOME-technology, AFFiRiS develops tailor-made therapeutic peptide vaccines against chronic diseases. Currently, its clinical pipeline consists of 3 drug candidates against Parkinson’s, MSA and Hypercholesterolemia. Further vaccine candidates against diabetes, allergies, asthma as well as Huntington’s disease are in preclinical development. AFFiRiS has been able to attract funding of approx. € 120m to date, half of which comes from license income and government grants. AFFiRiS currently employs 57 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.
www.affiris.com

 

Contact AFFiRiS AG:
Bettina Wessa
Karl-Farkas-Gasse 22
1030 Vienna, Austria
T +43 / (0)1 / 798 15 75 – 300
E bettina.wessa@affiris.com

 

Distribution:
PR&D – Public Relations for Research & Education
Mariannengasse 8
1090 Vienna, Austria
T +43 / (0)1 / 505 70 44
E contact@prd.at
W http://www.prd.at

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WHERE TO MEET US

International Congress of Parkinson's Disease and Movement Disorders
12-16 September 2020
Virtual
HealthTech Innovation Days
5-6 October 2020
Paris, France and Virtual