BiondVax Pharmaceuticals Ltd. (Nasdaq:BVXV), a Jerusalem based biopharmaceutical company focused on developing, manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, has signed definitive agreements with the Max Planck Society, the parent organization of the Max Planck Institute for Multidisciplinary Sciences (MPI), and the University Medical Center Gottingen (UMG), both in Germany, to enter into a strategic collaboration for the development of innovative nanosized antibodies (NanoAbs). BiondVax has entered a broader collaboration with the same team at Max Planck, based on the same NanoAb platform technology, to develop additional NanoAbs with the potential to treat a range of illnesses such as asthma, psoriasis, psoriatic arthritis, and macular degeneration. BiondVax will have an option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated Nano-Ab.
The Nano-Abs 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 shares, such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. As with the 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 probability of 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 will be mass-produced through recombinant protein manufacturing at 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 trial results in 2023.
BiondVax has initiated preparations for the manufacturing of NanoAbs at the Company’s GMP biologics manufacturing facility, including acquiring and installing additional equipment and hiring talent highly experienced in the field. Owning a biological GMP manufacturing site provides BiondVax with a competitive edge compared to other development-stage biotechnology companies as it reduces its dependency on contract manufacturers, allows direct control over the manufacturing of the entire NanoAb pipeline during development, and enhances preparedness for seamless clinical supplies and future commercial launch. It also provides the opportunity to create additional intellectual property.
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 Gorlich 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 Gorlich, Director at the MPI with supporting bioassay development by Professor Matthias Dobblestein, Professor of Molecular Oncology at the UMG. Professor Gorlich commented, “We believe that the innovative platform developed by the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center of Gottigen 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.”
Monoclonal antibodies (mAbs) have demonstrated promising clinical efficacy in various therapeutic fields over the past decades. However, their size (over 150 kD) has emerged as the most restricting factor limiting their application in antibody-drug conjugate platforms or antibody-redirected delivery systems. Alpacas, llamas, and other camelids produce heavy chain-only antibodies, also named single-chain Abs or heavy-chain Abs (HcAbs). They harbor the smallest antigen binding domain in nature, the VHH Fragment. The discovery of such naturally occurring heavy chain camelid antibodies (hcAbs, two polypeptide chains, 75 kD) containing a highly stable and soluble single antigen-binding V-domain—designated VHH or nanobody (15 kDa) —represents a promising alternative strategy to develop novel interventions not only for COVID-19 but also for other emerging pathogens. VHHs or NanoAbs demonstrate the ability to interfere with bacterial pathogenesis by preventing adhesion to host tissue and sequestering disease-causing bacterial toxins. To protect from viral infections, VHHs may be employed as inhibitors of viral entry by binding to viral coat proteins or blocking interactions with cell-surface receptors. The hyper thermostable COVID-19 VHH antibody candidates or Nanoabs, have been shown in MPG and UMG labs to neutralize all known major variants of COVID-19 at picomolar concentrations, at around 100-times lower drug concentrations than current COVID-19 monoclonal antibodies and all other reported COVID-19 VHH antibodies. Their administration could be suitable for inhalation. VHH antibodies or NanoAbs, have the potential to serve as therapeutics and diagnostics for many diseases.
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 Gorlich and his team at the Max Planck Institute for Multidisciplinary Sciences, together with the University Medical Center Gottingen, 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 VHHs 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 the potential to serve as highly attractive therapies for diseases including COVID-19 as described in Gorlich 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/embi.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.
Jay Green, former Senior Vice President of Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccines business joined BiondVax’s Board of Directors in December 2021.
The European Investment Bank (EIB) has indicated that it supports BiondVax’s strategic turnaround plans. In March 2022, the EIB agreed in principle to extend the maturity of its loan until December 2027 with additional terms that provide continued long-term support for BiondVax.
BiondVaBiondVax 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.
Company: Joshua E. Phillipson 972-8-930-2529, j.phillipson AT biondvax,com
Investor Relations: Kenny Green 1-212-378-8040, kgreen AT edisongroup.com
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