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, today announced new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon’s COVID-19 drug FYB207. These show that FYB207 is even more efficient against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.

The study, which builds on previous published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443) will be presented today at the “30th Annual Meeting of the Society for Virology” and is titled “Singular ACE2-IgG4-Fc fusion protein efficiently inhibits SARS-CoV-2 entry”. The presentation will be available soon on our website https://www.formycon.com/en/pipeline/fyb207/.

In the current study, a series of SARS-CoV-2 variants with increasing infectivity were tested: (I) SARS-CoV-2-Jan, isolated from a COVID-19 patient from the earliest documented COVID-19 outbreak in Germany in January 2020, which was directly related to the first outbreak in Wuhan, China, (II) SARS-CoV-2-April, which was isolated when the virus first spread massively in Europe in April 2020, and (III) SARS-CoV-2 variant B.1.1.7, which was first detected in the United Kingdom in September 2020, is associated with increased infectivity and mortality, and soon became the predominant SARS-CoV-2 variant in Europe.

The FYB207 concentration required for 50% inhibition in vitro (IC50 value) is in the low nanomolar range and decreased with each variant: (I) 4.7 nM, (II) 1.3 nM, (III) 0.6 nM, clearly showing that the neutralizing activity of FYB207 increased the more infectious and harmful the SARS-CoV-2 variant was. The IC50 values for FYB207 suggest a high neutralizing activity against SARS-CoV-2 B.1.1.7. The in vitro neutralization assay is considered a surrogate for potential therapeutic efficacy in SARS-CoV-2 infected patients.

“Health authorities around the world are increasingly concerned that neutralizing antibodies or vaccines may lose their activity against emerging SARS-CoV-2 mutants. While studies with neutralizing antibodies and sera from vaccinated individuals in vitro have indicated a reduction in neutralizing activity against B.1.1.7 and further SARS-CoV-2 mutants, our new in vitro data show that FYB207 neutralizes SARS-CoV-2 mutant B.1.1.7 even more. These results support our strategy to develop FYB207 as a treatment option for COVID-19 patients, but also to contribute to the preparedness for the outbreak of new coronavirus mutants”, says Dr. Carsten Brockmeyer, CEO of Formycon AG.

SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory tract infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.

Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against escape of the virus by mutation. The risk of infection amplification by vaccines and IgG1 antibodies, described for coronaviruses, is minimized by using the IgG4 portion in the fusion. FYB207 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all coronaviruses that use ACE2 as a portal of entry.

The preclinical activities as well as the preparations for the entry into clinical trials with FYB207 are proceeding according to plan. In addition, Formycon had a successful Scientific Advice Meeting with the Paul-Ehrlich-Institute and has already secured GMP manufacturing capacity for FYB207.

Formycon, together with its academic research partners, is receiving funding from the Bavarian Research Foundation for the initial development steps of this project.