Formycon's COVID-19 Drug FYB207 even more efficient against SARS-CoV-2 Mutant B.1.1.7
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.
Formycon and Leukocare cooperate in the development of high-quality biopharmaceuticals
- Companies combine leading development expertise in high-quality biopharmaceuticals with profound knowhow in biopharmaceutical formulation development
- Master Service Agreement stipulates potential development of stable Leukocare formulations for additional Formycon projects in upcoming years
- First project covers formulation development for a biosimilar of a blockbuster therapeutic antibody
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Leukocare AG today announced a collaboration in the area of high-quality biopharmaceuticals. Under the terms of this agreement, Leukocare will apply its formulation development technologies combining state-of-the art protein analytics, bioinformatics and artificial intelligence to develop stable formulations potentially for several candidates in Formycon´s product pipeline. The first project has been started and covers the formulation development for a biosimilar of a blockbuster therapeutic antibody.
By applying Leukocare’s formulation and bioinformatics expertise to Formycon’s comprehensive development knowhow, the partners want to achieve superior stability profiles overall leading to additional value propositions for development projects.
Stefan Glombitza, Chief Operating Officer at Formycon, stated, “Suitable Drug Product formulations are an essential success factor in the development of biopharmaceutical drugs and are getting increasingly important in the competitive IP landscape. We are convinced that Leukocare’s technology platform can successfully complement our development expertise and look very much forward to our collaboration.”
“Michael Scholl, Chief Executive Officer at Leukocare, commented, “We are very proud of this partnership with Formycon, a world-leading developer of high-quality biosimilars and biopharmaceuticals. This collaboration is a perfect fit for both companies to drive the development of high-quality products.”
“Andreas Seidl, Chief Operating Officer of Leukocare, added, “Our algorithm-based formulation development expertise will allow Formycon to make use of a large formulation design space, thereby gaining manifold options for freedom to operate in a competitive environment. This will strongly support Formycon in providing high-quality medicines to as many patients as possible.”
Formycon confirms BLA-Submission Strategy and Timeline for its Lucentis(R)* Biosimilar-Candidate FYB201 following consultation with the FDA
- Pre-BLA-interaction with U.S. Food and Drug Administration (FDA) confirms planned resubmission in first half of 2021
- Submission of the marketing authorization to the European Medicines Agency (EMA) in immediate consequence
- Submission for other highly regulated territories in preparation
As announced in November 2020, the initial submission strategy of the Lucentis(R) biosimilar candidate FYB201 has been adjusted as part of a simplification of the approval procedure. With the optimization of the commercial supply chain, the approval for FYB201 will directly occur in a large commercial scale. In the context of the interaction with the FDA, the data requested by the authorities have been reviewed and the further procedure has been aligned. The BLA-submission is expected to be filed with the U.S. Food and Drug Administration on schedule during the first half of 2021. Submission to the European Medicines Agency (EMA) is expected to follow-up.
In addition to the approval in the United States of America and the countries of the European Union, Formycon and Bioeq are seeking approval of the biosimilar candidate to Lucentis(R) (ranibizumab) in other highly regulated territories such as Canada, Australia, the United Kingdom and Switzerland.
* Lucentis(R) is a registered Trademark of Genentech Inc.
Formycon receives positive Scientific Advice from Paul-Ehrlich-Institute for the COVID-19 Drug FYB207 and assures GMP Manufacturing Capacities
- Process development, preclinical as well as concepts for clinical phase I and phase II aligned
- Accelerated review of applications for clinical trials
- Manufacturing capacities for FYB207 assured at experienced German GMP manufacturer
- Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) in preparation
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received the consent from the Paul-Ehrlich-Institute (PEI) regarding the proposed development concept for its innovative SARS-CoV-2 blocker FYB207. As result of the Scientific Advice, the Federal Institute for Vaccines and Biomedicines supports Formycon's approach in the further development of FYB207. In particular, analytics, process development, manufacturing (so-called CMC-part: Chemistry-Manufacturing and Control), the preclinical development as well as the clinical concept of phases I and II, including the associated bioanalytical strategy, have been aligned. The review of the applications for the clinical trials is expected to be conducted in an accelerated process. All preclinical activities as well as preparations for entering clinical trials with FYB207 are progressing according to plan. In addition, Formycon is preparing a Scientific Advice Meeting with the U.S. Food and Drug Administration (FDA) and has assured GMP manufacturing capacity for FYB207 with an experienced German manufacturer.
With FYB207, Formycon, together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich, is developing an efficient antiviral SARS-CoV-2 blocker based on a long-acting ACE2-immunoglobulin fusion protein. 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 fused the human ACE2 protein to the constant part of human Immunoglobulin G4 (IgG4) by using computer-aided structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.
The risk of infection enhancement by vaccines and antibodies described for corona viruses is minimized by using the IgG4 portion in the fusion. FYB207 also has a natural enzymatic activity that may provide additional protection for the lungs and cardiovascular system in symptomatic patients. Because ACE2 is the human receptor for the spike protein of SARS-CoV-2, FYB207 is protected against virus escape by mutation. In addition, FYB207 can potentially be used for all corona viruses that use ACE2 as an entry portal.
"We are delighted about the positive feedback from the Paul-Ehrlich-Institute and feel confirmed in the development approach of FYB207. Especially in terms of virus mutations, an effective drug becomes an indispensable cornerstone in the fight against the corona pandemic. With FYB207, we are developing an important treatment option for COVID-19 patients while also contributing to the prevention of outbreaks of future corona viruses", says Dr. Carsten Brockmeyer, CEO of Formycon AG.
Dr. Stefan Glombitza, COO of Formycon AG adds: "The consultation with the Paul-Ehrlich-Institute has provided us with clarity for our approach in the development of FYB207. The speed with which we are advancing this program from initial laboratory studies to entry into clinical trials reflects the high level of commitment of all parties involved. People infected with SARS-CoV-2 and at risk of severe illness or even death urgently need effective medicines."
Formycon's Scientific Collaboration Partners present FYB207 Results at International Keystone Symposium
Munich - Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that its academic partners of the Technical University of Munich, present results on Formycon's COVID-19 drug (FYB207).
The results of the publication (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443) were approved for an E-Poster presentation at the international "Keystone Symposia - Antibodies and Vaccines as Drugs for COVID-19" on today's date titled "Highly efficient inhibition of SARS-CoV-2 entry by a biologically unique ACE2-IgG4-Fc fusion protein with a stabilized hinge region." The poster will be available soon on our website: https://www.formycon.com/en/pipeline/fyb207.
Formycon's innovative SARS-CoV-2-Blocker completely prevents in-vitro infection of cells. Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc 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 for treatment of all corona viruses that use ACE2 as an entry portal.
Formycon is currently preparing documents for a Scientific Advice at the Paul-Ehrlich-Institute on the preclinical and clinical studies for FYB207, which is planned to be conducted within the next weeks. The clinical trial is expected to start during the second half of 2021.
Formycon Reports on Virtual Annual General Meeting 2020
- Shareholders approve all items on the agenda
- Ratification of the actions of the Management Board and Supervisory Board by a large majority
- Dr. Olaf Stiller, Peter Wendeln and Klaus Röhrig elected to the Supervisory Board
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on December 10, 2020 – for the protection of all persons involved – in virtual form.
The shareholders were able to follow the virtual Annual General Meeting live in picture and sound via the Company’s AGM portal. They followed the proposals of the Board of Management and Supervisory Board and approved all the resolutions proposed by the management with large majorities. Both the members of the Board of Management and the Supervisory Board were given a vote of confidence with majorities of more than 96 percent each. The candidates proposed for election to the Supervisory Board, Dr. Olaf Stiller, Mr. Peter Wendeln and Mr. Klaus Röhrig, were elected to the Supervisory Board with large majorities. In a subsequent constituent meeting, the Supervisory Board re-elected Dr. Olaf Stiller as Chairman and Mr. Peter Wendeln as Deputy Chairman. Both enter their third term of office in the Supervisory Board of Formycon AG. Hermann Vogt, who had served the Company as Deputy Chairman of the Supervisory Board since 2013, did not reapply for election. Dr. Stiller expressed his thanks to Mr. Vogt for his many years of membership in the Supervisory Board and for his consistently good cooperation.
Voting rights could be executed before and during the virtual Annual General Meeting by postal vote or by authorizing the Company’s proxies. A total of around 7.14 million no-par value shares were submitted to the vote, corresponding to 64.9 % of the share capital.
Detailed voting results and further information on the 2020 virtual Annual General Meeting can be found at https://www.formycon.com/en/investor-relations/annual-general-meeting/.
Innovative SARS-CoV-2 Blocker from Formycon Completely Prevents Infection of Cells
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.
Chief Operating Officer Dr. Stefan Glombitza appointed to Formycon AG's Management Board for another Four Years
Munich - The Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has extended the appointment of Management Board member Dr. Stefan Glombitza as Chief Operating Officer (COO) until December 31, 2024. With this decision, the supervisory committee is honoring the Formycon manager's successful work over recent years, and providing the continuity needed at the head of the company.
Since October 1, 2016, Dr. Glombitza has been the COO of Formycon AG in charge of operational development activities and has since then played a leading role in the progress of Formycon AG's development projects. The initiatives for operational excellence, which were also initiated and successfully implemented under his responsibility, were and continue to be central building blocks of organizational development, making Formycon an outstanding and scalable development organization.
"In light of his outstanding achievements for the company, we are particularly pleased to extend Stefan Glombitza's appointment to the Management Board until the end of 2024. Thanks to his comprehensive expertise and his particular commitment, Mr. Glombitza has successfully advanced the further development of the individual biosimilar projects as well as the entire development organization in recent years. We are convinced that with Dr. Brockmeyer (CEO), Dr. Combé (CFO) and Dr. Glombitza (COO) we have established a strong leadership team at Formycon and look forward to continuing to work together," commented Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG.
Formycon Reports its Nine-month Figures for 2020
- Group turnover and other earnings total EUR 23.5 million
- EBITDA is EUR -2.0 million and corresponds to expectations
- Group revenues for 2020 remain forecast to be EUR 35.0 to 40.0 million
Sales and other income of the Formycon Group totaled EUR 23.5 million as of September 30 of this year (prior year period: EUR 26.8 million). Earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to EUR -2.0 million (previous year: balanced at EUR 0.0 million). The operating result (EBIT) as well as the net result amounted to a rounded EUR -2.7 million (previous year: EUR -0.7 million each) and were thus in line with the forecasts. Formycon is consistently working on building and developing its own pipeline and is investing in organizational development, such as the expansion of internal capacities and far-reaching measures to further digitalize processes.
The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership (FYB201, FYB202 and FYB203). For the 2020 fiscal year, revenues of between EUR 35.0 and 40.0 million are still anticipated at Group level.
The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 19.2 million as of September 30, 2020. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 4.3 million, the Formycon Group held liquid assets totaling EUR 23.6 million on the day of reporting. The cash capital increase announced in October 2020 with gross proceeds of EUR 25.75 million, which was fully subscribed by the strategic investor the Active Ownership Group, has now been fully implemented. The company's liquid assets have increased accordingly to almost EUR 50 million.
In the first nine months of the year, Formycon AG - as the company's actual operational unit - achieved a turnover of EUR 18.0 million (same period last year: EUR 16.2 million). The company's nine-month result was EUR -2.8 million compared to EUR -0.8 million in the previous year.
"The figures for the first nine months meet our expectations. By consistently developing our pipeline and our organization, we believe we are well positioned for the future. In addition, with the Active Ownership Group, we have been able to gain a strategic and long-term oriented investor and at the same time strengthen our liquidity base for the further projects and the development of our company," comments CFO Dr. Nicolas Combé.
Formycon and Bioeq announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara(R)* (Ustekinumab)
- Vespucci study examines comparable efficacy, safety and immunogenicity of FYB202 and the reference product Stelara(R) in patients with moderate to severe psoriasis vulgaris (plaque psoriasis)
- Successful transfer of the third (late-stage) biosimilar candidate into a Phase III clinical trial
The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara(R) has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were expanded to treat Crohn's disease and in 2019 it was also approved for the treatment of ulcerative colitis. Both of these conditions are chronic inflammatory bowel diseases. The drug is also used to treat psoriatic arthritis. In 2019, the reference market for Stelara(R) was over USD 6 billion worldwide.
FYB202 is being developed as part of a joint venture between Aristo Pharma GmbH and Formycon AG, as well as in cooperation with bioeq GmbH. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US Food and Drug Administration (FDA) and the European regulatory authority (EMA).
Formycon's COO Dr. Stefan Glombitza is pleased: "With the start of what is now our third clinical Phase III study, we have reached another milestone in the development of our (late-stage) biosimilar candidates. With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. We would also like to thank our partners for their constructive cooperation and look forward to further joint steps towards the approval of our high-quality Stelara(R) biosimilar."
* Stelara(R) is a registered Trademark of Johnson & Johnson