Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific Advice, the Federal Institute for Vaccines and Biomedicines supports Formycon’s approach in the further development of FYB207. In particular, analytics, process development, manufacturing (so-called CMC-part: Chemistry-Manufacturing and Control), the preclinical development as well as the clinical concept of phases I and II, including the associated bioanalytical strategy, have been aligned. The review of the applications for the clinical trials is expected to be conducted in an accelerated process. All preclinical activities as well as preparations for entering clinical trials with FYB207 are progressing according to plan. In addition, Formycon is preparing a Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced German manufacturer.
With FYB207, Formycon, together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, is developing an efficient antiviral SARS-CoV-2 blocker based on a long-acting ACE2-immunoglobulin fusion protein. SARS-CoV-2 and other corona viruses use ACE2 on the surface of human cells as an entry point for respiratory tract infections. Formycon has therefore fused the human ACE2 protein to the constant part of human Immunoglobulin G4 (IgG4) by using computer-aided structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.
The risk of infection enhancement by vaccines and antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has a natural enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. Because ACE2 is the human receptor for the spike protein of SARS-CoV-2, FYB207 is protected against virus escape by mutation. In addition, FYB207 can potentially be used for all corona viruses that use ACE2 as an entry portal.
“We are delighted about the positive feedback from the Paul-Ehrlich-Institute and feel confirmed in the development approach of FYB207. Especially in terms of virus mutations, an effective drug becomes an indispensable cornerstone in the fight against the corona pandemic. With FYB207, we are developing an important treatment option for COVID-19 patients while also contributing to the prevention of outbreaks of future corona viruses”, says Dr. Carsten Brockmeyer, CEO of Formycon AG.
Dr. Stefan Glombitza, COO of Formycon AG adds: “The consultation with the Paul-Ehrlich-Institute has provided us with clarity for our approach in the development of FYB207. The speed with which we are advancing this program from initial laboratory studies to entry into clinical trials reflects the high level of commitment of all parties involved. People infected with SARS-CoV-2 and at risk of severe illness or even death urgently need effective medicines.”
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.