BiondVax Receives Supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for Anti-COVID-19 Nano-Antibody Development Plans, Including the First Phase 1/2a Clinical Trial on Safety and Efficacy in man
PEI supports BiondVax’s plan for the first-in-man clinical trial to be conducted in patients in a combined Phase 1/2a, testing both safety and efficacy, thereby shortening lead times. clinical development of BiondVax for its first product NanoAb, a treatment against COVID-19;
PEI is part of the German National Medicines Agency; its experts are also involved in the committees of the European Medicines Agency (EMA). As PEI’s scientific opinion is generally considered a key first step towards regulatory approval, the encouraging feedback is an important step towards the successful development of NanoAb COVID-19 by BiondVax;
Based on comments from PEI. and following proof-of-concept animal studies planned later this year to demonstrate efficacy by inhaled administration, BiondVax plans to initiate a first-in-human Phase 1/2a clinical trial in 2023.
JERUSALEM, June 7, 2022 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing a pipeline of innovative nano-abs for the prevention and treatment of infectious diseases and other illnesses, today announced that it has received the minutes of its recent scientific advisory meeting with the Paul Ehrlich Institute (PEI) in Germany. The scientific opinion covered the preclinical, clinical and manufacturing development plans for the COVID-19 NanoAb therapy that BiondVax is developing based on an exclusive license from Max-Planck-Innovation GmbH and research collaboration from support with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen.
The PEI Science Advisory Report is generally considered a key first step towards regulatory approval. It also informs germany drug regulatory authority of new pharmaceutical product developments. Although alignment with the PEI advice. is not a guarantee of marketing approval, it provides important guidance regarding scientific and regulatory principles for the development of the COVID-19 NanoAb. Therefore, a company’s alignment with the PEI guidance. is widely considered a key step in drug development.
The minutes of the science advisory meeting sent by the State of Prince Edward Island, “Generally, P.E.I. agrees with the proposed proof-of-concept study…and overall non-clinical strategy that are necessary to support further clinical development as well as eventual regulatory approval.Notably, Prince Edward Island has indicated its support for conducting a combined first-in-man Phase 1/2a clinical trial that would include patients with confirmed COVID-19 infection. This would allow BiondVax to assess safety and efficacy in a single trial rather than the typical two trials, and thereby significantly accelerate its development timeline.This combined Phase 1/2a trial would follow preclinical proof of concept and toxicology, with a target start date of 2023.
dr. Tamar Ben YedidiaBiondVax’s Chief Scientific Officer, who oversees the clinical development of BiondVax, said: “We thank the experts at the Paul Ehrlich Institute for their helpful and informative advice. BiondVax intends to align our development plans with PEI’s guidance, and I am pleased that we have a clear path through preclinical and clinical testing of the COVID-19 NanoAb therapy. As COVID-19 is expected to continue circulating for many years, its high infectivity rate poses a real challenge to vaccination campaigns due to the high costs to health systems combined with the continuously declining immunity observed. Having a safe and effective therapeutic product, which is also convenient to use, as it can be self-administered directly to the site of infection by inhalation, would provide tremendous value for both patients and our healthcare systems.“
BiondVax’s NanoAb COVID-19 is being developed as a patient-friendly primary care product that can be self-administered by inhalation directly to the site of infection. Other valuable competitive advantages over existing therapies, demonstrated in laboratory tests to date, include stability at higher temperatures, higher binding affinity and more efficient production. With the expectation that COVID-19 will continue to circulate as public interest in repeat vaccinations wanes, the Company believes these attributes position a successfully developed product to capture significant market share.
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and marketing innovative products for the prevention and treatment of infectious and other diseases. Since its inception, the company has completed eight clinical trials, including a phase 3 trial in seven countries and 12,400 participants of its candidate vaccine and has built a state-of-the-art manufacturing facility for biopharmaceuticals. With highly experienced leadership in the pharmaceutical industry, BiondVax aims to develop a pipeline of diverse and commercially viable products and platforms, starting with an innovative nanoscale antibody (NanoAb) pipeline. www.biondvax.com.
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect”, “believe”, “intend”, “plan”, “continue” , “may”, “will”, “anticipate” and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial condition, future revenues, projected expenditures, outlook, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regardingng the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execonclusion of a definitive amendment agreement with the EIB. These forward-looking statements reflect management’s current beliefs regarding certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be realized; the risk of delay of preclinical and clinical data of the NanoAbs, if any; the risk that BiondVax and the EIB fail to reach an agreement on the restructuring of the European Investment Bank loan; the risk that BiondVax may not be able to obtain additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate lending under its financing agreement with BiondVax; risks related to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or not at all; time of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, as appropriate or required; the risk that the manufacturing facility cannot be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development will involve a long and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company can be found under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
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