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Thursday, September 22, 2022

BiondVax Update on Strategic Research Collaboration with Max Planck and UMG

 BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today provided encouraging updates related to the strategic research collaboration between BiondVax, the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center Göttingen (UMG) towards the development of a pipeline of innovative alpaca–derived nanosized antibody (NanoAb) therapies.

As reported in March 2022, in addition to the exclusive license for the ongoing development and commercialization of an inhaled COVID-19 NanoAb therapy, the parties signed a five-year research collaboration agreement (RCA) for additional NanoAbs for the treatment of diseases such as psoriasis, psoriatic arthritis, asthma, and wet macular degeneration. Today, BiondVax reported that Professor Dirk Görlich of MPG and his team have successfully generated, identified and isolated NanoAbs addressing a number of additional biological target molecules as specified in the relevant RCA. Professor Görlich and his colleague Professor Matthias Dobbelstein of UMG verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. The academic research teams have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later this year.

Based on these promising results, the BiondVax-MPG-UMG Joint Steering Committee, established to guide the NanoAb collaboration, decided earlier this month to focus further development beginning with the following NanoAbs, targeting immune system cytokines:

  1. NanoAbs targeting IL-17A, IL-17F and IL-17A/F complex as drug candidates for the potential treatment of psoriasis and psoriatic arthritis.
  2. NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma.

Derisked strategy: This advancement is aligned with BiondVax's derisked R&D strategy as these cytokine targets are already validated to exert beneficial clinical results in human beings when treated with conventional monoclonal antibodies. Moreover, these conventional monoclonal antibodies are already approved for marketing and generate billions of dollars in annual commercial sales. The BiondVax-MPG-UMG research collaboration team aims to generate and develop NanoAbs with the potential to capture significant market share as "bio-betters" answering needs underserved by currently approved conventional monoclonal antibody therapeutics as the NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs. Pursuant to the RCA, BiondVax holds exclusive options for worldwide exclusive licenses to further develop and commercialize these NanoAbs.

Inhaled COVID-19 therapy: These new NanoAbs are in addition to the ongoing development of a previously announced COVID-19 NanoAb therapy exclusively licensed to BiondVax from Max Planck Innovation GmbH, which acts as the technology transfer agency of MPG. In the coming weeks, BiondVax intends to initiate a preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19 infected animals. The study will be conducted in collaboration with two world renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and The University of Veterinary Medicine Hannover (TiHo), Germany. Assuming successful results, a first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.

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