BVXV BiondVax Pharmaceuticals Ltd

via InvestorWire -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today announces that as part of its ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen (UMG), it has signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

“The license of the IL-17 NanoAb from Max Planck is not only an exciting opportunity to develop a unique treatment for psoriasis and other autoimmune diseases, but another validation of the productivity of our collaboration with Max Planck and UMG and portends additional significant developments to follow,” said Mr. Amir Reichman, BiondVax’s CEO. “Psoriasis affects millions of people worldwide, and we believe our NanoAbs have the potential to provide a much-needed and vastly improved treatment option.”

“I wish to thank Professor Dirk Görlich of the Max Planck Institute for Multidisciplinary Sciences and Professor Matthias Dobbelstein of the University Medical Center Göttingen for their valued research collaboration, and Dr. Dieter Link of Max Planck Innovation and his team for their continued support. Our recent experience with tech-transfer, in-house process development, scale-up and manufacturing of the COVID NanoAb, leading to a highly successful preclinical study, attests to the strong potential of this unique collaboration to develop bio-better NanoAbs addressing underserved medical needs for millions of patients,” Reichman continued.

“We are very pleased that the next VHH antibody candidates out of a larger group pursued by the collaborators have successfully been generated, discovered and characterized by the Max Planck Institute of Multidisciplinary Sciences. BiondVax is well positioned to move this closer to and into clinical application,” commented Dr. Dieter Link, patent and licensing manager at Max Planck Innovation, the technology transfer organization of the Max Planck Society (MPG).

IL-17’s Role in Disease

The IL-17 family of cytokines consists of six isoforms. Among these, IL-17A, IL-17F, and the IL-17A/F complex are particularly important in immune regulation and inflammation. Excess presence of IL‑17 is implicated in a wide range of autoimmune and inflammatory diseases including psoriasis, and therefore is the molecular target for several commercially available therapeutics.

Psoriasis is a chronic autoimmune disease that causes inflammation and scaling of the skin. The National Psoriasis Foundation notes that the disease affects more than 7.5 million adults in the U.S. and an estimated 125 million people worldwide. The most common form of psoriasis, representing 80%-90% of cases, is plaque psoriasis. Current plaque psoriasis treatments include topical steroid creams, phototherapy, oral drugs and several injectable biologicals. According to industry sources, the current biologics treatment market for psoriasis is over $9 billion per year and the anti-17 antibody market is growing at 9% CAGR.

Of the biological treatments, monoclonal antibodies (mAbs) targeting IL-17A were the first mAbs to be approved for treatment of plaque psoriasis. The latest and most effective mAbs for the treatment of plaque psoriasis that are currently marketed, as well as those that, to BiondVax’s knowledge, are under clinical development by other companies, target not only IL-17A but also IL-17F and IL-17A/F complex. It has been demonstrated in clinical trials that targeting both IL‑17A and IL-17F generates superior clinical efficacy in treatment of plaque psoriasis, as IL‑17F is the most abundant IL-17 isoform in the psoriatic lesions. Currently available mAb therapies for psoriasis require inconvenient systemic injection every four to eight weeks, are approved only for treatment of moderate to severe plaque psoriasis (representing only 25% of plaque psoriasis patients) and are associated with adverse side effects including exacerbation of IBD.

Bio-Better NanoAbs

In contrast to mAb therapies, the single-monomer NanoAb licensed by BiondVax may be effective even at extremely low concentrations, against all three key isoforms of IL-17. This potential multi‑target effect by a single NanoAb creates an opportunity for a significantly more effective therapeutic, at lower doses and with fewer side effects, for a broader range of disease conditions in addition to plaque psoriasis such as psoriatic arthritis and hidradenitis suppurativa. BiondVax’s NanoAbs, which are approximately one tenth the size of a standard mAb, are expected to have better tissue penetration thanks to their small size, and in lab experiments have demonstrated superior thermostability, which could translate to superior shelf life, easier transportation, and more convenient routes of administration.

Development Pathway

Under the BiondVax-MPG-UMG research collaboration agreement, NanoAb candidates must satisfy rigorous criteria relating to binding affinity, neutralization of the target and other attributes prior to being in-licensed by BiondVax. An ex vivo proof-of-concept for psoriasis using the anti-IL-17 NanoAb in a psoriatic human skin model is expected later this year. BiondVax plans to initiate a preclinical in vivo efficacy study in 2024 followed later by human clinical trials.

As an initial target indication, BiondVax plans to test the antibody in humans with local, intradermal injections directly to psoriatic lesions to test the NanoAb’s ability to provide a safe and affordable biologic treatment for mild to moderate psoriatic patients for whom the available mAbs are not authorized, and who represent 85% of plaque psoriasis cases. BiondVax is working on plans to develop the drug also as a subcutaneous injection for systemic treatment targeting patients with moderate to severe plaque psoriasis.

Innovative NanoAb Platform and Collaboration

BiondVax’s NanoAb platform targets treatments of diseases with large unmet medical needs and attractive commercial opportunities, such as COVID-19, psoriasis, psoriatic arthritis, asthma and macular degeneration. NanoAbs exhibit several advantages over conventional antibody treatments, including improved stability, increased potency and the potential for safer and more convenient routes of administration.

The NanoAbs are being developed as part of a broad collaboration with the world-leading research institutes Max Planck Institute of Multidisciplinary Sciences and the University Medical Center Göttingen. Recent positive preclinical in vivo data indicates BiondVax’s innovative inhaled anti‑SARS‑CoV‑2 NanoAb virtually prevented COVID-19 illness when administered prophylactically to hamsters. The results also demonstrated that when administered therapeutically, the inhaled NanoAb virtually eliminated the virus in lungs and led to a significantly shorter and milder illness. BiondVax’s NanoAb platform has the potential to address a wide range of unmet medical needs, and the company is committed to developing innovative therapies that improve the lives of patients.

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About BiondVax

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. 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 beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.

About the Max Planck Institute for Multidisciplinary Sciences

The Max Planck Institute (MPI) for Multidisciplinary Sciences was founded on 1 January 2022 through the merger of two existing Göttingen institutes, the MPI for Biophysical Chemistry and the MPI for Experimental Medicine. The two locations of the institutes remained City Campus and Faßberg Campus. At the Institute, we explore scientific issues ranging from physics and chemistry to structural and cell biology, neuroscience and biomedical research. Basic research in the natural sciences can thus be linked even more effectively with medical research approaches. We are guided by the conviction that great scientific discoveries can be achieved when scientists from different disciplines and research cultures - such as physics, chemistry and biology - work together and exchange ideas in an unbiased way. https://www.mpinat.mpg.de/en.

About University Medical Center Göttingen

The University Medical Center Göttingen (UMG) is one of Germany’s leading medical centers. With funding allocated by the state of Lower Saxony and third-party funding, UMG conducts research at the very highest level and are one of the largest medical faculties in Germany, based on the number of students enrolled. The Medical Faculty is as old as the University itself, founded in 1737. The UMG is the region’s largest employer and training institution. As the only maximum care medical center in the region, UMG takes on responsibility for inpatient and outpatient care of difficult, complex, and special cases and is an integral part of the emergency medical services in Southern Lower Saxony. www.umg.eu/en/

About Max Planck Innovation

As the technology transfer organization of the Max Planck Society, Max Planck Innovation is the link between industry and basic research. With our interdisciplinary team, we advise and support scientists at the Max Planck Institutes in evaluating inventions, filing patents and starting businesses. We offer industry central access to the innovations of the Max Planck Institutes. We are therefore fulfilling an important task: The transfer of results from basic research into commercially and socially useful products. www.max-planck-innovation.com

Contact Details

BiondVax: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Forward Looking Statements

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 position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the timing of future preclinical clinical studies, and the therapeutic and commercial potential of anti-IL-17 NanoAbs. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the 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 of delay of preclinical studies for anti-IL-17 NanoAbs; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in obtaining preclinical and clinical data for NanoAbs, if any; the risk that the Company’s business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract with BiondVax; risks relating to the SARS-CoV-2 (COVID-19) virus; BiondVax's ability to acquire rights to additional product opportunities; BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 17, 2023. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.