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

- Broad collaboration with Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen (UMG), Germany, for development of NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration; BiondVax to have exclusive option for exclusive worldwide license for further development and commercialization

- NanoAbs to target disease markers validated by currently marketed antibody therapies thereby de-risking development and regulatory process timelines

- The unique NanoAbs previously developed by the Max Planck and UMG teams exhibit significant competitive advantages over existing antibody therapies including hyper-thermostability, patient convenience, and efficient production

- Builds on existing collaboration for development of COVID-19 NanoAbs that are stable at very high temperatures and will be developed for convenient inhalation administration targeting the virus directly in the lungs and airways

- COVID-19 NanoAb initial human clinical trials results expected in 2023; New NanoAb pipeline development already initiated with preclinical results anticipated 2023

News provided by

BiondVax Pharmaceuticals Ltd.

Mar 24, 2022, 07:05 ET

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.

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.

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.

Contact Details

Company: Joshua E. Phillipson | +972 8 930 2529 | [email protected]
Investor Relations: Kenny Green | +1 212 378 8040 | [email protected]

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax's ability to acquire rights to additional product opportunities; BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

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