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BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) Leverages Top-Tier Leadership and GMP Facility to Advance Rapid Development of New Therapeutic and Prophylactic Technologies for Multiple Diseases and Disorders

  • BiondVax is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products, primarily for the treatment of infectious and autoimmune diseases
  • The company is led by CEO Amir Reichman, with over 20 years of international experience as a biopharma expert
  • Amir took company reins in 2021 and pivoted the mission and vision including diversifying risks
  • With new focus and opportunity, BiondVax now developing an innovative alpaca-derived nanosized antibody (“NanoAb”) pipeline
  • BiondVax is aggressively advancing new NanoAb therapeutic and prophylactic technologies owing to exclusive collaborations, previous pharma development experience and a state-of-the-art GMP manufacturing facility

Leveraging top-tier pharmaceutical industry leadership, extensive drug development expertise, a GMP biologics manufacturing facility, and strategic collaborations with Max Planck Institute for Multidisciplinary Sciences (“MPI”) and the University Medical Center Göttingen (“UMG”), BiondVax Pharmaceuticals (NASDAQ: BVXV) is aggressively advancing development of a pipeline of diversified, commercially viable “NanoAb” products and platforms. The Jerusalem, Israel-headquartered biopharmaceutical company is initially focused on an innovative inhaled nanosized antibody treatment for COVID.

“Overall, the NanoAb platform is an incredible opportunity for BiondVax,” said BiondVax CEO Amir Reichman following the late 2021 signing of definitive agreements with MPI and UMG to develop and commercialize the innovative anti-COVID-19 NanoAb therapy (https://ibn.fm/ZlrYX). “It will serve as a basis for an exciting new pipeline of commercially attractive products to address unmet therapeutic needs of diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration.”

The definitive agreements came only a few months after Amir’s appointment as CEO. Amir had previously served as Head of Global Vaccines Engineering, Core Technologies, and Asset Management at GSK Vaccines, headquartered in Belgium. Prior to taking up this role, he had served as Senior Director of Global Supply Chain Performance and Capabilities at the same company. Collectively, Amir has more than 20 years of international hands-on experience as a bio-pharma expert (https://ibn.fm/3XzzO). Leveraging this expertise, he made a few strategic changes to BiondVax when he took over as CEO on March 2, 2021.

“The first thing I have done as the new CEO, together with our Board of Directors, was to define a new mission and vision for BiondVax. Our new mission reflects an aspiration to focus on infectious diseases, which leverages BiondVax’s core competencies, while ensuring diversification of our corporate risks through the establishment of a new, broad product and platform pipeline,” Amir wrote in his first letter to shareholders (https://ibn.fm/JdTFq).

Although Amir and the board sought to diversify and mitigate risk by implementing strategic changes, the company still benefitted from its previous focus on developing the M-001 universal influenza vaccine candidate. Up until that point seven Phase 1/2 and 2 clinical trials conducted in Europe, Israel, and the USA, were completed, each with promising results. The success of these trials had guided the company’s execution of a pivotal phase 3 clinical trial in seven countries. Conducted between 2018 and 2020, the trial involved 12,400 participants and was completed on time and within budget (https://ibn.fm/tIbbo).

In many compelling ways, BiondVax punches well above its weight compared to biopharma companies of similar market cap: BiondVax gained extensive drug development expertise in these trials which is expected to be invaluable in the development and commercialization of the NanoAb pipeline. The company plans to undertake the first-in-human phase 1/2a clinical trial evaluating its inhaled anti-COVID-19 NanoAb therapy later this year. This rapid development path hinges not only on the expertise of its workforce and experience gained from the development of M-001 but also on its capabilities in biological drug development and manufacturing.

In 2018, BiondVax completed a 20,000-square-foot campus in Jerusalem that includes offices, laboratories, and a GMP biologics manufacturing facility, according to Amir (https://ibn.fm/7fdYz). The facility provides BiondVax with state-of-the-art GMP-ready manufacturing capabilities, enabling the company to handle pharmaceutical product development and manufacturing. As a result and following the closing of the agreements with its strategic collaborators, MPI and UMG, BiondVax’s strong team is putting the facility to use, mass producing the NanoAbs through recombinant protein manufacturing. These early batches have been used in a highly successful preclinical test of its inhaled COVID-19 NanoAb (https://ibn.fm/u5I73 and https://ibn.fm/ImvSC), and future batches are planned for the first-in-human phase 1/2a clinical trial planned for later this year.

BiondVax believes that its extensive drug development experience, experienced leadership, manufacturing capabilities, and product and platform pipeline ideally position it for in-licensing, acquisitions, and joint ventures, as well as rapid clinical development and manufacturing of new therapeutic and prophylactic technologies, beginning with the inhaled anti-COVID-19 NanoAb candidate.

By leveraging expertise, experience and collaborations, BiondVax aims to disrupt high value large market opportunities with its pipeline of innovative NanoAb therapeutics.

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://ibn.fm/BVXV

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