Press Release // November 3, 2022

Broad-acting antiviral SARS-CoV-2 drug FYB207 shows longer half-life and improved efficacy through optimized molecular design in preclinical studies

• Protein and glycoengineering improve pharmacokinetics and efficacy
• Half-life of more than 14 days comparable to the bioavailability of an antibody
• Reduction of viral load in the lung demonstrates neutralizing effect of FYB207 in preclinical in vivo models

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published preclinical in vivo results for the development of their COVID-19 drug FYB207.

In the course of preclinical in vivo studies, data on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein were collected in two different models, in order to select the most appropriate candidate for the human clinical trial.

The proprietary modifications of the molecular structure of the FYB207 lead candidate led to the desired effects and resulted in a significant extension of the half-life. By corresponding glyco optimizations and sequence modifications in the antibody part (Fc part), the lead candidate ACE2-IgG1-Fc (FYB207) achieved a half-life of more than 14 days, which is the order of magnitude of antibodies. As a result, FYB207 may not only have a broader application spectra for prophylaxis and treatment of COVID-19 but also in other indication areas.

Due to the high sialylation achieved within the context of glyco optimization, binding affinity to relevant receptors in the liver is reduced, which significantly slows down the elimination of the active substance and increases the bioavailability in the organism. In addition, sequence modifications have been introduced in the binding region of the antibody portion to the neonatal-receptor, enabling FYB207 to bind better to this receptor, thereby improving the recycling of the fusion protein in the body.

In the efficacy study, the in vivo preclinical models showed a significant reduction in viral load in the lungs, demonstrating the neutralizing effect of FYB207 also against the SARS-CoV-2 Delta variant in the organism. Thus, the FYB207 lead candidate, unlike vaccines and neutralizing antibodies, retains its full antiviral potential against SARS-CoV-2 variants of concern.

SARS-CoV-2 and other coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections. Biotechnologically produced ACE2 may compete for binding of the virus and thus prevent cell infection. Formycon has fused the human ACE2 protein to the constant part of human immunoglobulin G1 (IgG1) using computational structural design and thereby created FYB207, a highly effective SARS-CoV-2 blocker. By fusion with the optimized Fc part, ACE2 was stabilized and bioavailability significantly prolonged. ACE2 also has inherent enzymatic activity that may provide patients with additional protection for their lungs and cardiovascular system. In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.

The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute ("PEI") and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. Another PEI meeting to align the clinical program is scheduled this year.

The GMP production of the study medication currently takes place for the start of the clinical trials. A toxicity study with the optimized molecular construct will be conducted at the beginning of next year. Entry into clinical trials is planned for 2023. 

"The performed pre-clinical studies and the available data from the lead candidates form an important milestone in the development of our COVID-19 drug. The expanded in vivo study confirmed the intended objective - extending half-life - and showed that with FYB207 we are on track to develop a highly effective and long-lasting COVID-19 medication that is directed against all variants. In terms of efficacy, the study also showed the desired successes by demonstrating that viral load in the lungs of living organisms is significantly reduced," explains Dr. Andreas Seidl, CSO of Formycon AG.

"The threat of viral mutations will continue in the future. With each successful mutation, SARS-CoV-2 evades vaccines and therapeutic antibodies a little bit more. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19,” adds Dr. Stefan Glombitza, CEO of Formycon AG.

Formycon will present the results of the completed in vivo preclinical studies at the Festival of Biologics in Basel (Switzerland) on November 4, 2022 and the Drug Discovery Summit in Madrid (Spain) on November 16/17, 2022.


About Formycon:
Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) 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 six 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
[email protected] // www.formycon.com

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