Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich, have published results on Formycon’s COVID-19-drug (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443).
Based on Formycon’s clinically validated experience with antibodies and antibody fusion proteins, the Company initiated the development of an ACE2 antibody fusion protein (FYB207) in March 2020, shortly after the COVID-19 pandemic broke out in Europe.
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 combined the human ACE2 protein to the constant part of human antibodies by using computer-aided structural design, creating a very effective SARS-CoV-2 blocker called ACE2-IgG-Fc. Different variants of the virus blocker were investigated in laboratory scale for manufacturability, stability and virus inhibition. In vitro tests with isolates of SARS-CoV-2 as well as the original SARS-CoV from 2003 show that Formycon’s ACE2 antibody fusion protein effectively binds to SARS corona viruses and completely prevents infection of the cells.
Compared to vaccines and therapeutic antibodies, the ACE2 antibody fusion protein is maximally protected against virus escape by mutation. The risk of infection enhancement by vaccines and IgG1 antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. In addition, FYB207 can potentially be used in all corona viruses that use ACE2 as an entry portal.
“Vaccines and antibodies alone will not be sufficient in the SARS-CoV-2 pandemic. Infected people need medication, especially if they are at risk of becoming more seriously ill or even dying. For symptomatic COVID-19 patients, there is currently no sufficiently effective drug available. As SARS-CoV-2 mutates, the virus may become resistant to vaccines and drugs. FYB207 has excellent protection against mutation and shows in vitro complete neutralization of different SARS-CoV-2 and SARS-CoV variants. With FYB207, we are thus creating a treatment option for COVID-19 patients, but also contributing to the prevention of outbreaks of new corona viruses,” says Dr. Carsten Brockmeyer, CEO of Formycon AG.
Dr. Stefan Glombitza (COO) adds: “We are very pleased with the encouraging results from our compound. Based on the results of our laboratory studies, we expect FYB207 to have advantages in efficacy, safety and convenience compared to antibodies and chemical active ingredients. The implementation of this innovative project will have no impact on our ongoing biosimilar programs.”
Formycon, together with its research partners, will receive 290,000 euros in funding from the Bavarian Research Foundation for this project. In order to accelerate further development and clinical trials, Formycon is considering options for financial and strategic partnerships. It is planned to spin off the project into a separate subsidiary. The aim is to achieve rapid approval of the COVID-19 drug for emergency use. In the search for partners, Formycon is supported by the independent corporate finance firm goetzpartners.