SCHLIEREN, Switzerland, Oct. 16, 2019 /PRNewswire/ -- AL-S Pharma AG, a biotech company jointly founded and financed by Neurimmune and TVM Capital Life Science, announced today enrollment of the first patient in a multicenter Phase 1 clinical trial to evaluate AP-101 in patients with amyotrophic lateral sclerosis (ALS). AP-101 is a human antibody directed against misfolded superoxide dismutase 1 (SOD1). The antibody has been discovered by translating genetic information of human memory B cells through Neurimmune's Reverse Translational Medicine™ technology.
"Promising preclinical data with the antibody warrant clinical development of AP-101, and we hope to provide therapeutic benefit to patients suffering from ALS," said Michael Salzmann, AL-S Pharma's CEO and Neurimmune's COO. He added: "We highly value our unique partnership with TVM Capital Life Science and Eli Lilly's Chorus. This collaboration allows us to leverage significant clinical development know-how as well as venture capital expertise to develop our promising molecule."
AP-101 has Orphan Drug Designation from FDA, EMA and Swissmedic. In the initiated study, safety, tolerability and pharmacokinetics of AP-101 will be assessed in patients with ALS.
Dr. Angela Genge, Director of the Clinical Research Unit at McGill University in Montreal, and AL-S Pharma's Global PI & Head of the Clinical Advisory Board, said: "The science behind AP-101 is very intriguing and we are excited to see AP-101 advance to the clinic. Our goal is to develop the molecule into a novel therapeutic option for ALS patients."
In 2016, Neurimmune and TVM Capital Life Science created AL-S Pharma AG to develop AP-101 to human proof-of-concept. AL-S Pharma engages with Chorus, an autonomous unit of Eli Lilly and Company, to execute on an innovative clinical plan in collaboration with an international network of ALS experts.
Hubert Birner, Managing Partner at TVM Capital Life Science and Chairman of the Board of AL-S Pharma said: "We are very thankful for the work accomplished by the AL-S Pharma executive management and the Chorus team, as well as to our partner Neurimmune and our ALS experts at the Montreal Neurological Institute led by Dr. Angela Genge and Prof. Guy Rouleau."
Neurimmune is a biopharmaceutical company translating human immune memory into novel therapeutics. Neurimmune's pipeline comprises high-potential drug candidates at both clinical and advanced preclinical development stages for Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, fronto-temporal dementia as well cardiomyopathy and type 2 diabetes. Neurimmune collaborates with Biogen and Ono Pharmaceutical on programs for neurodegenerative diseases and Biogen acquired rights in antibodies BIIB054 for Parkinson's disease and BIIB076 for Alzheimer's disease. Neurimmune partnered with TVM and Eli Lilly's Chorus unit to advance an antibody for the treatment of amyotrophic lateral sclerosis.
About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 30-years of transatlantic investment track record and in excess of US$1.4bn raised and under management. With its advisory, corporate finance and investment teams located in Munich and Montreal, the TVM Capital Life Science team provides investors as well as entrepreneurs and innovation-seeking biopharmaceutical companies access to global life science innovation and provides paths for successful tech transfer and commercialization for the benefit of patients and investors alike.
The TVM Capital Life Science international team looks back on more than 130 investments and over 90 exits, including more than 45 initial public offerings on all major U.S. and European stock exchanges and has gained unrivalled international investment experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development and a direct knowledge of the local markets.
About AL-S Pharma AG
AL-S Pharma AG is a special purpose company created to develop AP-101 to proof-of-concept. The project is fully financed by TVM Life Science Ventures VII and Neurimmune. AL-S Pharma is led by an experienced management team and the Board of Directors comprises Guy Rouleau, director of McGill University's Montreal Neurological Institute (MNI) and Hospital, Chair Department of Neurology and Neurosurgery, McGill University, Hubert Birner, Managing Partner, TVM Capital Life Science, Munich, Marc Riviere, General Partner, TVM Capital Life Science, Montreal, Christoph Hock (CMO of Neurimmune AG and Professor at University of Zurich, Institute for Regenerative Medicine) and Jan Grimm (CSO and Managing Director of Neurimmune AG).
This press release contains forward-looking statements about TVM Life Science Ventures VII and Lilly's investment in a pre-clinical stage compound for the treatment of ALS that is being developed by AL-S Pharma AG. It reflects Lilly's and TVM's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development. There is no guarantee Lilly will realize the expected benefits of the transaction, that the product will receive regulatory approval, or if approved, would be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The companies undertake no duty to update forward-looking statements.