DGAP-News: Formycon and Scientists from TUM publish new Data on broadly effective SARS-CoV-2 antiviral Drug FYB207

Press Release // December 9, 2021

Formycon and Scientists from TUM publish new Data on broadly effective SARS-CoV-2 antiviral Drug FYB207

- Joint study describes optimized ACE2-IgG4-Fc fusion proteins

- Picomolar Neutralization of the SARS-CoV-2 variants of concern

- Neutralizing effect of SARS-CoV-2 delta variant confirmed

- High efficacy against omicron expected

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 (TUM), today announced the publication of new in vitro data on the development of the COVID-19 drug FYB207 following peer review in the journal Antiviral Research.

The study, titled "Picomolar inhibition of SARS-CoV-2 variants of concern by an engineered ACE2-IgG4-Fc fusion protein" (https://doi.org/10.1016/j.antiviral.2021.105197), which builds on previously published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443), describes optimized ACE2-IgG4-Fc fusion constructs that exhibit broad neutralizing activity against SARS-CoV-2 viruses, retain ACE2 enzyme activity, and show promising pharmaceutical properties. The ACE2-IgG4-Fc fusion proteins neutralize the original SARS-CoV, the January and April 2020 SARS-CoV-2, and the rapidly spreading alpha, beta and delta variants. Importantly, the neutralizing effect is maintained even with the SARS-CoV-2 delta variant at picomolar concentrations, demonstrating that the lead candidate ACE2-IgG4-Fc (FYB207), unlike vaccines and neutralizing antibodies, retains its full antiviral potential even with the SARS-CoV-2 variants of concern currently circulating worldwide.

SARS-CoV-2 and other coronaviruses use the ACE2 protein 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 (Fc) of human immunoglobulin G (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro. The fusion with the Fc moiety stabilizes ACE2 and prolongs its in vivo efficacy. ACE2 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all other coronaviruses that utilize ACE2 as a portal of entry.

As part of the ongoing in vivo preclinical studies, pharmacokinetics data are being collected in two different models and efficacy data on different variants of the ACE2-Fc fusion proteins are being collected in another model to select the most appropriate candidate for clinical testing. The clinical trial is scheduled to begin in the first half of 2022.

"New variants of concern, such as the omicron variant, demonstrate once again that vaccines and antibodies alone are not sufficient in the SARS-CoV-2 pandemic. Because ACE2 is the entry point for cell infection, SARS-CoV-2 cannot escape the ACE2-Fc fusion proteins. Our ACE2-Fc fusion proteins show consistently strong neutralization in cell cultures of all SARS-CoV-2 viral variants tested to date. Testing of omicron is underway, and we expect high efficacy here as well. Thus, with FYB207, we are developing a highly potent, long-lasting COVID-19 drug directed against all variants. Our ongoing preclinical program is designed to select the best FYB207 drug candidate and thus increase the probability of success for clinical testing," states Dr. Carsten Brockmeyer, CEO of Formycon AG.

"ACE2-IgG4-Fc is a promising antiviral drug candidate for COVID-19 that retains its full antiviral potential against the rapidly spreading SARS-CoV-2 variants. Against the background of further emerging variants of concern, there is a great need for a broadly acting SARS-CoV-2 antiviral agent", says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology at the Technical University of Munich and Helmholtz Center Munich and senior author of the study.

Formycon, together with its academic research partners, receives funding from the Bavarian Research Foundation for the basic research of this project. In July 2021, Formycon also received a commitment from the Bavarian State Ministry of Economic Affairs, Regional Development and Energy (StMWi) of up to €12.7 million to support further development of the COVID-19 drug FYB207.

In October 2021, Formycon and SCG Cell Therapy Pte Ltd ("SCG") entered into a collaboration and license agreement to develop and commercialize Formycon's COVID-19 drug FYB207 in the Asia Pacific (APAC) region, excluding Japan.

About Formycon:
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 a COVID-19 drug FYB207.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

Disclaimer:
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