BiondVax Signs a Definitive Collaboration Agreement for the Development of a Pipeline of Innovative Nanoscale Antibody (NanoAb) Therapeutics

– Extensive collaboration with Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen (UMG), Germany, for the development of NanoAbs addressing diseases with high unmet medical needs and exciting commercial opportunities such as asthma, psoriasis, psoriatic arthritis and macular degeneration; BiondVax will have an exclusive option for an exclusive worldwide license for further development and commercialization

– NanoAbs to target disease markers validated by currently marketed antibody therapies, reducing development risks and regulatory process delays

– Unique NanoAbs previously developed by the Max Planck and UMG teams have significant competitive advantages over existing antibody therapies, including hypertherstability, patient convenience, and efficient production

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

– Results of the first human clinical trials on COVID-19 NanoAb expected in 2023; Development of a new NanoAb pipeline is already underway with preclinical results expected in 2023

JERUSALEM, March 24, 2022 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on the development, manufacturing and commercialization of 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 Society 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 nanoscale antibodies (NanoAbs). BiondVax will have an exclusive option for an exclusive worldwide license on pre-agreed commercial terms for the development and commercialization of each NanoAb generated.

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NanoAbs previously developed by BiondVax collaborators have several valuable competitive advantages over existing therapies, including high single binding affinity, high temperature stability, and the potential for more efficient and convenient routes of administration. The collaboration targets indications with large and growing market sizes where NanoAb benefits 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 the 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 the likelihood of drug approval.

BiondVax envisions a rapid development path that leverages the company’s expertise and capabilities in biologic drug development and manufacturing. In particular, NanoAbs can be mass-produced by recombinant protein manufacturing at sites such as BiondVax’s GMP biologics manufacturing facility in Jerusalem. Development of the NanoAbs covered by today’s agreement has already begun and initial preclinical results are expected in 2023. BiondVax plans to conduct a proof-of-concept preclinical study of the inhaled COVID-19 NanoAbs in 2022 with initial results human clinical trials in 2023.

Sir. Amir ReichmanCEO of BiondVax, commented: “The NanoAb platform is an incredible opportunity for BiondVax. It will serve as the foundation for an exciting new pipeline of commercially attractive products to address large and growing markets largely underserved by existing biologic treatments. We are pursuing already validated goals, but with a proprietary NanoAb that we hope will have significant advantages in terms of efficacy, cost and ease of use and treatment; a real “biobetter” capable of conquering significant market shares and expanding the market. The technology is also perfectly suited to our manufacturing site for Jerusalem and our experience and expertise in biologic drug development. I would like to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, as well as the Max Planck Innovation technology transfer team, including Dr. Dieter Link and Florian Beilhack for their help in developing this innovative collaboration.

The NanoAb platform underlying this agreement was developed by teams from Professor Dirk GorlichDirector at MPI, with support for the development of bioassays by Professor Matthias Dobbelsteinprofessor of molecular oncology at UMG. Professor Gorlich commented “We believe that the innovative platform developed at the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen has great potential to provide patients with superior therapies. We are especially pleased to team up with BiondVax to utilize their drug development and manufacturing capabilities and expertise to advance nanoscale antibodies through further development towards marketing approvals.

Teacher. dr. Martin StratmanPresident of the Max Planck Society, said: “I am happy that with BiondVax we succeeded in finding not only a licensee but also a cooperation partner for the promising nano-antibody technology. Dirk Görlich and his team at the Max Planck Institute for Multidisciplinary Sciences, in collaboration with the University Medical Center Göttingen, have developed an innovative therapeutic approach in less than two years, which could also be used against COVID-19, between others. Additional goals in other clinical settings are now being pursued as part of a broader collaborative agreement. In this regard, we all hope that BiondVax will succeed in commercializing these approaches.

Initial NanoAb blueprints are extracted from small blood samples of immunized alpacas, then screened and optimized in labs before being used for NanoAb production in large fermenters. NanoAbs show potential to serve as very attractive therapies for diseases such as 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 registered trademark of ABLYNX NV, a subsidiary of 100% Sanofi BiondVax has no affiliation with and is not endorsed by Sanofi.

The collaboration was facilitated by kENUP, a civil society organization that promotes innovative industries in Europe.

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and marketing innovative products for the prevention and treatment of infectious and other diseases. Since its inception, the company has completed eight clinical trials, including a phase 3 trial in seven countries and 12,400 participants of its candidate vaccine and has built a state-of-the-art manufacturing facility for biopharmaceuticals. With highly experienced leadership in the pharmaceutical industry, BiondVax aims to develop a pipeline of diverse and commercially viable products and platforms, starting with an innovative nanoscale antibody (NanoAb) pipeline. For more information, 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 fact, included in this press release regarding strategy, future operations, future financial condition, future revenues, projected expenditures, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the performance of a definitive amending agreement with the EIB. These forward-looking statements reflect management’s current beliefs regarding certain current and future events and are subject to various risks. es, uncertainties and assumptions that could cause actual 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 realized; the risk of delay of preclinical and clinical data of the NanoAbs, if any; the risk that BiondVax and the EIB fail to reach an agreement on the restructuring of the European Investment Bank loan; the risk that BiondVax may not be able to obtain additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate lending under its financing agreement with BiondVax; risks related 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 not at all; time of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, as appropriate or required; the risk that the manufacturing facility cannot be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development will involve a long and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company can be found 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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