BiondVax Pharmaceuticals Ltd (BVXV)

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BiondVax signs definitive collaboration agreement for the development of a pipeline of innovative nanosized antibody (NanoAb) therapies

https://finance.yahoo.com/news/biondvax-signs-definitive-collaboration-agreement-110500067.html

JERUSALEM, March 24, 2022 /PRNewswire/ -- 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, the parent organization of the Max Planck Institute for Multidisciplinary Sciences (MPI), and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development of innovative nanosized antibodies (NanoAbs). BiondVax will have an exclusive option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated NanoAb.

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The NanoAbs previously developed by BiondVax's collaborators exhibit several valuable competitive advantages over existing therapies including uniquely strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. The collaboration targets indications with large and growing market sizes where the NanoAb advantages have the potential to capture significant market share such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. As with the parallel and previously announced exclusive license agreement for development of an inhaled COVID-19 therapeutic NanoAb, these are all diseases with known and validated antibody drug targets, which should shorten development timelines while increasing probability for drug approval.

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. Development of NanoAbs covered under today's agreement has already begun, and initial preclinical results are expected in 2023. BiondVax anticipates conducting a preclinical proof of concept study of inhaled COVID-19 NanoAbs in 2022 with initial human clinical trials results in 2023.

Mr. Amir Reichman, BiondVax's CEO, commented, "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 large and growing markets significantly underserved by existing biological treatments. We are going after targets already validated, but with a proprietary NanoAb that we expect will have meaningful advantages in efficacy, cost and ease of use and treatment; a true 'biobetter' capable of capturing significant market share and expanding the market. The technology is also a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I would like to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation's technology transfer team including Dr. Dieter Link and Florian Beilhack for their assistance in developing this innovative collaboration."

The NanoAb platform underlying this agreement was developed by the teams of Professor Dirk Görlich, Director at the MPI, with supporting bioassay development by Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG. Professor Görlich commented, "We believe that the innovative platform developed at the Max Planck Institute for Multidisciplinary Sciences 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 nanosized antibodies through additional development towards marketing approvals."

Prof. Dr. Martin Stratmann, President of the Max Planck Society, stated, "I am pleased that with BiondVax we have succeeded not only in finding a licensee but also a cooperation partner for the promising technology of nano-antibodies. Dirk Görlich and his team at the Max Planck Institute for Multidisciplinary Sciences, together with the University Medical Center Göttingen, have developed an innovative therapeutic approach within less than two years, which could also be used against COVID-19, among other things. Additional targets in other clinical settings are now pursued under a broader collaboration agreement. In this respect, we all hope that BiondVax will succeed in bringing these approaches to market."

The initial NanoAb blueprints are extracted from small blood samples of immunized alpacas, then selected and optimized in laboratories before being used for NanoAb production in large fermenters. The NanoAbs exhibit potential to serve as highly attractive therapies for diseases including COVID-19, as described in Görlich and Dobbelstein's paper titled "Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies," published in The EMBO Journal and available at https://doi.org/10.15252/embj.2021107985. NanoAbs are also known as VHH-antibodies or nanobodies. Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.

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