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BiondVax Signs Definitive Agreements for Development and Commercialization of Innovative Nanosized COVID-19 Antibody Therapy

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BiondVax Signs Definitive Agreements for Development and Commercialization of Innovative Nanosized COVID-19 Antibody Therapy | Pharmtech Focus

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of definitive agreements with the Max Planck Society (MPG), the parent organization of the Max Planck Institute of Biophysical Chemistry, and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative COVID-19 nanosized antibodies (NanoAbs*). These agreements are part of a broader collaboration, expected to be signed in January 2022, covering development and commercialization of NanoAbs for several other disease indications with large market sizes that leverage their unique binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration.

The lead NanoAb candidates for the COVID-19 program, developed by Professor Dirk Görlich, Director at the Max Planck Institute of Biophysical Chemistry, and Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG, exhibit a strong competitive edge over existing COVID-19 therapies. For example, the NanoAbs exhibit superior affinity to the target, neutralizing the SARS-COV-2 virus, in-vitro, at drug concentrations about 100-times lower than those required by currently commercially available monoclonal antibodies. This may lead to increased efficacy, reduced side effects, and allow production at a lower cost. In addition, the NanoAbs’ small size and hyper-thermostability at 95°C (200°F) potentially enables administration through inhalation and longer shelf life, and potentially avoids the need for enhanced cold chain storage and transport. Together, these attributes are designed to create significant competitive advantages.

The NanoAbs have demonstrated strong neutralization at very low concentrations of major Variants of Concern (VoCs) including Alpha, Beta, Gamma and Delta in in-vitro studies in Görlich’s and Dobbelstein’s laboratories and based on in-silico studies, are expected to neutralize Omicron. Given the potential of additional emerging VoCs, the BiondVax-MPG-UMG collaboration covers development of new NanoAbs as needed during the evolution of COVID-19. The methodologies employed by the Görlich and Dobbelstein labs enable generation of new NanoAb candidates within weeks of acquiring the sequence for any emerging variant, and thereby positions BiondVax to stay at the forefront of COVID-19 preparedness.

In addition to the COVID-19 NanoAb collaboration and as previously announced, BiondVax, MPG and UMG have signed a term-sheet for development of NanoAbs towards other indications with major opportunities in key therapeutic areas of psoriasis, asthma, macular degeneration, and psoriatic arthritis. These are all diseases with known and validated antibody drug targets (thereby shortening development timelines and lowering risk), and where the NanoAb advantages have the potential to capture significant market share. BiondVax anticipates finalizing the collaboration agreements for these additional NanoAbs in January 2022.

BiondVax is planning a rapid development path that leverages the company’s expertise and capabilities in biological drug development and manufacturing. In particular, NanoAbs can be mass-produced through recombinant protein manufacturing in sites such as BiondVax’s GMP biologics manufacturing facility in Jerusalem. BiondVax anticipates conducting COVID-19 NanoAb preclinical studies in 2022 with initial human clinical trials results in 2023.

Mr. Amir Reichman, BiondVax’s CEO, commented, “As Omicron’s recent and rapid emergence makes clear, improved therapeutics are needed to bring COVID-19 under control. The innovative COVID-19 NanoAb candidates offer the potential for a superior therapeutic platform. Overall, the NanoAb platform is an incredible opportunity for BiondVax. It will serve as a basis for an exciting new pipeline of commercially attractive products to address unmet therapeutic needs of diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. The technology is a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I wish to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation’s technology transfer team including Dr. Dieter Link for their assistance in developing this innovative collaboration. BiondVax is in the process of a transformative turnaround, and I am highly confident that these NanoAb therapies present compelling commercial potential and will address important healthcare needs.”

Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry, commented, “We believe that the innovative platform developed at the Max Planck Institute for Biophysical Chemistry and the University Medical Center of Göttingen has great potential to provide patients with superior therapies. We are particularly pleased to team with BiondVax to use their drug development and manufacturing capabilities and expertise to advance the COVID-19 nanosized antibodies through additional development towards marketing approvals.”

The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.

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