BiondVax signed an agreement for a broad-based strategic collaboration with the Max Planck Society (MPG) and University Medical Center Göttingen (UMG), Germany. This 5-year strategic research collaboration will include an option for BiondVax to have the option to receive an exclusive worldwide license for the identified candidates of VHH antibodies (Abs) to lead their development to commercialization.
The hyper thermostable COVID-19 VHH antibody candidates 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 potentially be suitable for inhalation. VHH antibodies have the potential to serve as therapeutics and diagnostics for many diseases.
The research at the MPG and UMG labs cumulate 30 years of research following the discovery that alpacas have a unique type of antibody against disease with the potential of application for humans!
Status with BiondVax
BiondVax anticipates completing preclinical proof-of-concept inhalation studies in 2022 and initiating human clinical trials in 2023. To accelerate development timelines, BiondVax has initiated preparations for the manufacturing of VHH-Abs at the Company’s GMP biologics manufacturing facility in Jerusalem. Furthermore, BiondVax‘s current and 2022 planned activities, such as setting up equipment, developing analytical methods, and training staff, will be oriented toward all VHH-antibody production arising out of the collaboration.
The European Investment Bank (EIB) has indicated that it supports BiondVax‘s new strategic turnaround plans. The parties are currently in discussions to renegotiate the terms of the EIB‘s €24 million loan to BiondVax in a manner that would serve both parties’ long-term interests.
BiondVax also announced that Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccine business will join its Board of Directors, pending a shareholders vote at the end of the month.
Cooperation of BiondVax with the Max Planck Society and University Medical Center Göttingen
The VHH antibodies were developed by Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry, and Professor Matthias Dobbelstein, Professor of Molecular Oncology at the University Medical Center Göttingen, exhibit key advantages over current industry-standard human monoclonal antibodies (mAbs). These include:
- The ability to bind to smaller target sites; significantly higher affinity to the target;
- Higher stability which supports novel routes of administration such as inhalation;
- Ease and lower cost of manufacturing; and potential for improved patient safety.
Görlich and Dobbelstein will also conduct research on additional molecular targets for which the parties believe VHH antibodies have clear advantages over existing drugs used against various diseases. These targets are the basis for validated and currently marketed mAbs including for autoimmune conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis.
BiondVax will have an exclusive option for an exclusive worldwide license to advance these additional VHH antibodies through preclinical and clinical development, manufacturing, and commercialization. Notably, these VHH antibodies can be mass-produced through recombinant protein manufacturing in sites such as BiondVax’s state-of-the-art facility in Jerusalem.
Mr. Amir Reichman, BiondVax‘s CEO, commented, “We are thrilled to embark on this new direction for BiondVax. The VHH antibody platform will serve as a basis for a new pipeline of commercially attractive products. We see enormous potential for the COVID-19 VHH antibodies and we’re ready to hit the ground running to bring them into the clinic. In addition, this collaboration aims to address the unmet therapeutic needs of many common diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. The technology is a great fit for our manufacturing site in Jerusalem and our experience and expertise in 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.”
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 has great potential. In this respect, we are looking forward to the agreement with BiondVax that will leverage their CMC, manufacturing, regulatory and clinical development expertise to advance this technology into clinical applications.”
Mr. Mark Germain, Chairman of of the entire Board of Directors, BiondVax stated, “This collaboration is the start of an exciting new era for BiondVax, with multiple opportunities to create significant shareholder value. Professors Görlich and Dobbelstein are world-class scientists with a unique talent to develop highly differentiated VHH antibodies, and it’s been a pleasure working with them and their colleagues at Max Planck and the University Medical Center Göttingen. Since coming on board in March 2021, Amir has worked tirelessly to help identify the right opportunity around which to relaunch BiondVax and to negotiate the transaction being announced today. He and the BiondVax team have done an outstanding job researching the value proposition represented by the collaboration and the development path forward. On behalf of the entire Board of Directors, kudos and appreciation to all involved in making this happen.”
The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
More about the VHH antibodies
VHH antibodies are naturally produced by camelids such as alpacas, llamas, and camels. These antibodies, often referred to as nanobodies, are about half the size of the antibodies produced by humans. They’re also remarkably stable and easy for scientists to manipulate.
This genetic quirk, which causes camelids such as llamas to produce these smaller antibodies with single protein chains, was discovered by accident in the late 1980s by scientists in Belgium. Since then, scientists have worked with camelid nanobodies to create treatments against several diseases with great success. Their small size allows them to bind to areas of viral proteins that larger antibodies cannot fit into, blocking those proteins from connecting with cells.
Amir Reichman, BiondVax‘s CEO, stated, “The innovative VHH-antibody platform, combined with our agile manufacturing capabilities and planned ongoing collaboration with Max Planck, will enable us to respond quickly to new COVID variants of concern, including Omicron. By preparing now to manufacture batches in-house for preclinical studies, we are streamlining manufacturing for clinical and commercial batches of therapies for known and emerging COVID-19 variants, as well as for anticipated psoriasis, asthma, macular degeneration, and psoriatic arthritis VHH-antibody therapies. BiondVax is in the process of a transformative turnaround, and we are working with urgency to bring VHH-antibody therapies with compelling commercial potential that address important healthcare needs to the market.”
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. www.biondvax.com.
Contact Details
BiondVax: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson AT biondvax.com
Source: Oct. 19, 2021, PRNewswire
Nov 30, 2021 BiondVax site
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