Biovaxys Signs Binding Letter to Develop DPX™-Based Vaccines for Severe Food Allergies

VANCOUVER, BC, July 29, 2024 -- BioVaxys Technology Corp., a clinical-stage biopharmaceutical company, has entered into a binding Letter of Intent with Ontario-based AP Visionaries, Inc. (APVI). Together, they aim to develop a proprietary DPX™ formulation to address urgent therapeutic needs for severe food allergies, particularly those caused by peanuts, tree nuts, and eggs.

APVI was co-founded by Asha Parekh, CEO of Frontline Medical Technologies, Inc., and Adam Power, MD, a vascular surgeon at London Health Sciences Centre and an Associate Professor at Western University's Schulich School of Medicine & Dentistry. BioVaxys and APVI will collaborate with The Schroeder Allergy and Immunology Research Institute (SAIRI) at McMaster University in Ontario. SAIRI is an institute dedicated to researching life-threatening allergies and developing new treatments.

The agreement stipulates that BioVaxys will fund the study, and APVI will utilize its partnership with SAIRI to evaluate the effectiveness of the DPX™ platform in animal models. The study aims to assess whether DPX™ can transform the underlying immunopathology of food allergies. All intellectual property resulting from this research will belong to BioVaxys, while APVI will receive royalties from any gross sales of resulting products and a milestone payment upon first regulatory approval.

Peanut allergies provoke an Immunoglobulin E (IgE)-mediated type I hypersensitivity reaction. Upon exposure, peanut-specific IgE antibodies bind to receptors on mast cells and basophils, releasing histamine and other mediators. This can lead to severe symptoms such as angioedema, facial swelling, rhinitis, vomiting, diarrhea, and even anaphylaxis and cardiac arrest. BioVaxys and APVI believe that the DPX™ + peanut antigen formulation will be unable to trigger an anaphylactic response. Part of their collaboration with SAIRI will involve challenging allergic mice with the DPX™ + antigen formulation and comparing clinical and immunological outcomes to those from whole allergen challenges.

Kenneth Kovan, President & COO of BioVaxys, emphasized the potential of the DPX™ platform, which is already the foundation for multiple BioVaxys clinical programs in oncology and infectious disease. The company sees significant opportunities for expanding into novel formulations incorporating polynucleotides, peptides, proteins, virus-like particles, and small molecules.

Peanut and tree nut allergies are among the most severe food allergies due to their prevalence, persistence, and potential severity of reactions. The global peanut allergy treatment market is projected to reach USD 1.01 billion by 2030, growing at a compound annual growth rate (CAGR) of 11.82% from 2024 to 2030. Peanut allergies are responsible for the majority of severe food-related allergic reactions and typically manifest early in life, often persisting into adulthood. In highly sensitized individuals, even trace exposure can lead to life-threatening anaphylactic reactions. Peanut allergies affect about 1.2% of the overall US population and approximately 2.5% of the pediatric population. Many children with food allergies often experience accidental exposure, with studies showing high rates of such incidents.

The economic and personal costs of food allergies are substantial. A 2012 survey estimated the annual economic cost of food allergies in US children at $24.8 billion, including $4.3 billion in direct medical costs. Despite most children having health insurance, families still faced significant out-of-pocket expenses and loss of productivity, with many caregivers reporting job changes or job losses.

While there have been advances in peanut allergy treatments, a definitive cure remains elusive. Current treatment strategies focus on avoidance and carrying an epinephrine autoinjector for accidental exposure. Oral immunotherapy (OIT) and monoclonal antibody treatments have shown promise but come with their own risks and high costs.

James Passin, CEO of BioVaxys, highlighted the challenges with existing desensitization treatments and the high costs of monoclonal antibody treatments, which can be prohibitive. Passin expressed optimism about completing preclinical studies with development partners and the potential for a single-dose, long-duration product aligned with other DPX formulations.

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