• Consideration of FYB207 in the funding call “BayTherapie2020”
  • Funded project includes development activities of FYB207 through to completion of Phase IIa clinical trials
  • Requested funding amount of approximately Euro 11 million

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the approval of early action for its COVID-19 drug (FYB207) by the Bavarian Ministry of Economic Affairs, Regional Development and Energy (StMWi). The requested grant is expected to support the further development of FYB207 until the completion of clinical phase IIa and has an anticipated volume of approximately Euro 11 million. The total amount of funding will be determined upon receipt of the formal notice of approval.

The early start of the project enables Formycon to implement the preclinical development activities as planned and to manufacture the test product under GMP conditions before the final approval is granted. FYB207 is expected to move into Phase I/IIa clinical testing in the fourth quarter of 2021.

As part of the Bavarian therapy strategy to combat the COVID-19 pandemic, the Free State of Bavaria has created the conditions for funding development and innovation projects aimed at opening up new therapy options for treating the infectious disease induced by the SARS-CoV-2 coronavirus with the funding call "BayTherapie 2020" and the provision of a total of up to Euro 50 million.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design and created FYB207, a highly 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 viral escape 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 lung and cardiovascular protection. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.

Recently, Formycon AG, together with its academic partners Prof. Ulrike Protzer, Chair of Virology, and Prof. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, published new results on the in vitro neutralization of SARS-CoV-2 variants by Formycon's COVID-19 drug FYB207. These showed that FYB207 had an even stronger effect against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants.

"We are pleased that the Bavarian State Ministry of Economic Affairs, Regional Development and Energy has granted an early start to our funding application. Our project prevailed in a highly competitive process and, in addition to the associated scientific and technological recognition of our development approach by renowned reviewers, the support of public funding is a key component of project financing. We want FYB207 to be an important treatment option for COVID-19 patients that saves lives. At the same time, we also want to contribute to the prevention of outbreaks of new coronaviruses in the future," comments Formycon CFO Dr. Nicolas Combé.