BioVaxys DPX Vaccines Show Strong Efficacy Against Various Diseases

VANCOUVER, Canada I August 22, 2024 I BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys” or the “Company”) has unveiled the potential of its innovative lipid-in-oil delivery platform, DPX™, for various infectious disease studies and disclosed its future plans for partnerships and further development.

The DPX™ technology is a proprietary platform that integrates a range of bioactive molecules to initiate targeted and long-lasting immune responses, facilitated by different formulated components. This delivery mechanism allows for the efficient transport of antigens to regional lymph nodes, successfully generating robust and durable T cell and B cell responses in both cancer and infectious disease contexts, as evidenced by pre-clinical and clinical studies.

Key findings from the completed infectious disease studies include:

1. RSV Vaccine Study:
DPX™+RSV(A) or “DPX-RSV” is BioVaxys’ vaccine candidate targeting respiratory syncytial virus (RSV) using a DPX formulation of the SHe peptide of group A RSV. Results from a Phase 1 study demonstrated that over nine months after the final vaccination, 93% (15 out of 16) of participants showed antigen-specific immune responses. This study involved 40 healthy older adults (aged 50-64 years) and was well tolerated with no serious adverse events reported. Additionally, 100% of older adults (7 out of 7) who received a booster dose maintained antigen-specific responses one year later, with antibody levels remaining at their peak.

RSV is a highly contagious virus affecting the lungs and respiratory passages across all age groups, with a significant impact on older adults, leading to severe lower respiratory tract diseases and sometimes death. In the U.S., RSV causes between 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths annually among adults aged 65 and older. Unlike other RSV vaccines targeting the virus's F or G proteins, DPX-RSV targets the SH viral ectodomain, enabling the immune system to recognize and eliminate infected cells. BioVaxys holds exclusive global licenses for applications targeting the SH ectodomain antigen in RSV and is exploring out-licensing opportunities.

2. Anthrax Vaccine Study:
The DPX platform's versatility is further evidenced by studies involving a DPX formulation targeting anthrax. A DPX Anthrax vaccine demonstrated 100% immunity after a single injection in animal challenge studies. In preclinical trials led by the National Institutes of Health, recombinant B. anthracis-protective antigen (rPA) formulated in DPX™ (“DPX-rPA”) induced higher immune responses compared to rPA in alum and Biothrax® (an FDA-approved vaccine needing multiple doses). Studies in rabbits and non-human primates showed that DPX-rPA provided 100% protection from a lethal anthrax challenge after a single injection, unlike the two-dose regimen required for AVA.

Anthrax, caused by Bacillus anthracis exposure, is a serious biological threat. An ideal anthrax vaccine would provide rapid protection with a single dose and a durable immune response, characteristics that the DPX-based vaccine is expected to meet. Current anthrax vaccines, like Biothrax and Cyfendus, require multiple doses and adjunctive antibiotic treatment. BioVaxys is considering advancing DPX-rPA with the support of the US Department of Defense and other organizations.

3. Influenza Vaccine Study:
Recent preclinical studies in a murine model indicated that a single dose of DPX formulated with recombinant hemagglutinin (rHA) achieved higher and more durable HA antibody levels than Alum+rHA. Additional in vivo studies compared two different influenza strains packaged in DPX (DPX+FLU) with Alum+FLU. The DPX+FLU formulation showed nearly 100% survival in mice challenged with live influenza strains one month post-vaccination, outperforming the Alum+FLU group.

BioVaxys plans to conduct further preclinical studies to evaluate a quadrivalent DPX formulation for influenza.

BioVaxys Technology Corp., based in British Columbia, Canada, focuses on developing novel immunotherapies using its DPX™ platform. The company's clinical-stage pipeline includes MVP-S for cancers and DPX™-RSV for respiratory syncytial virus. BioVaxys is also progressing with DPX™+SurMAGE for dual-targeted immunotherapy and BVX-0918 for late-stage ovarian cancer.

BioVaxys remains committed to advancing its pipeline and leveraging its DPX™ platform to address various infectious diseases through potential partnerships and further research initiatives.

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