Wednesday, April 19, 2023

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) CEO Discusses Positive Results from In Vivo Proof-of-Concept Study of Its Anti-COVID-19 NanoAb Therapy and Additional Pipeline Plans at BIO-Europe Spring

 

  • BiondVax Pharmaceuticals is a biotechnology company developing, manufacturing, and commercializing innovative NanoAb immunotherapeutic products, primarily for the treatment of infectious diseases and autoimmune diseases
  • Company CEO Amir Reichman recently presented at the BIO-Europe Spring conference, where he talked about BiondVax’s successful preclinical in vivo results of its innovative inhaled COVID-19 treatment and additional pipeline plans
  • The in vivo results have shown that the company’s inhaled COVID-19 therapy, formulated using alpaca-derived nanosized antibodies (“NanoAbs”), resulted in milder and shorter illness, virtually eliminated the virus from the lungs, and prophylactically protected against illness
  • Since he was appointed CEO in early 2021, Reichman has overseen the adoption of a de-risked strategy that entails developing and commercializing biobetter NanoAbs with known mechanisms of action and fully validated target molecules
  • The company aims to address diseases with underserved medical needs and attractive large market commercial opportunities

Amir Reichman, CEO of biotechnology company BiondVax Pharmaceuticals (NASDAQ: BVXV), recently presented at the 17th annual BIO-Europe Spring conference in Basel, Switzerland. Hosted by EBD Group, the three-day in-person conference, which was held March 20-22, brought together more than 2,800 executives from biotech, pharma, and finance companies. It not only featured presentations and exhibits from some of the most promising companies in the biotechnology space but also allowed these companies to engage in more than 15,000 one-on-one meetings with the attendees (https://nnw.fm/Axdg3).

As part of his presentation delivered on the morning of Tuesday, March 21, Reichman focused on BiondVax’s successful preclinical in vivo results of its innovative inhaled COVID-19 treatment. He also touched on additional pipeline plans, including the development of alpaca-derived nanosized antibodies (“NanoAbs”) or VHH-antibodies for the treatment of autoimmune diseases, such as macular degeneration, psoriatic arthritis, asthma, and psoriasis.

The results presented were generated from a preclinical in vivo proof-of-concept study evaluating BiondVax’s COVID-19 therapy formulated using the NanoAbs. The first set of statistically significant results, reported November 29 last year, showed that the group of SARS-CoV-2-infected hamsters treated with the company’s inhaled NanoAbs experienced a milder and shorter illness. This manifested in the form of a lower average decline in weight (3.80%) among the experimental group that was given the NanoAb therapy compared to a 12.01% decline among hamsters in the control group, which were served with saline as a placebo (https://nnw.fm/RfyTR). Weight loss in hamsters is the widely accepted proxy measurement of COVID-19 infection impact.

The second set of results, reported January 6, showed that the experimental group had over 30x lower SARS-CoV-2 viral titers in the lungs than the control group, with the levels below the border of detection, suggesting virtual elimination of the virus from the lungs (https://nnw.fm/UM0Ao). Finally, the third set of results, released January 23, evidenced the NanoAb COVID-19 drug’s protective prophylactic properties. Of note, the experimental group, which received a mid-sized 0.66mg dose of NanoAb three hours before infection, experienced no significant weight loss over the six-day trial. In contrast, the untreated control group’s weight reduced 12% on average, representing a statistically significant difference (p<0.0005) (https://nnw.fm/GKDCq).

These findings are the result of a renewed focus that followed the early 2021 appointment of Reichman as CEO (https://nnw.fm/0rLC8). At the time and under his guidance, BiondVax sought to maximize clinal assets and personnel and adopt a de-risked strategy centered around the elimination of four main risks typically associated with innovative drug development: (a) the identification of fully validated target molecules; (b) the mechanisms of action of the drugs on the target molecule(s); (c) composition of matter; and (d) a proven market opportunity – a disease with a large unmet need and attractive commercial opportunity. In addition to also targeting strong IP, the drug technology selected was to be derived from a platform that could generate multiple drug candidates and fit into the company’s existing manufacturing capabilities and the expertise and knowledge of its team.

Upon undertaking its due diligence and scouting many potential avenues, BiondVax entered into agreements with the prestigious Max Planck Society and its Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen (“UMG”) for the development of NanoAbs to address diseases and disorders with significant unmet medical needs and attractive large market commercial opportunities (https://nnw.fm/MARcY).

BiondVax then signed an exclusive license for the development and commercialization of the first NanoAb aimed at treatment and prophylactic prevention of COVID-19. In addition, the company signed another contract, a five-year strategic agreement, that gives it an option for an exclusive license for the development and commercialization of up to nine additional NanoAbs against selected targets, according to Reichman, who was speaking in a recent episode of theTest. Optimize. Scale. podcast (https://nnw.fm/Ap1M8).

The strategic selection of an antibody-based technology enabled the company to solve one of the risks – the mechanism of action, considering that attacking a target molecule with an human antibody is already known to generate a good clinical response. Coupled with the fact that BiondVax had already identified and selected fully validated molecules that the NanoAbs would then target, Reichman explained, this helped the company eliminate two primary risks, shaving off $200 million and seven years of drug development.

This new approach has allowed BiondVax to focus on a promising pipeline of innovative therapeutics that could potentially disrupt conventional human antibody treatments and equate into increased equity for its shareholders. This new NanoAb pipeline, recent clinical milestones, and the incredibly bright future are what the attendees at the BIO-Europe Spring heard about as Reichman delivered his presentation.

For more information, visit the company’s website at www.BiondVax.com.

NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://nnw.fm/BVXV

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