BioVaxys DPX-Based Vaccines Exhibit Robust Efficacy Across Multiple Infectious Diseases

BioVaxys Technology Corp. highlights the potential of its novel lipid-in-oil delivery platform, DPX™, across multiple infectious disease studies and announces its plans for partnering and further development.

BioVaxys’ DPX™ technology is a patented delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease.

Key findings demonstrated in completed infectious disease studies, which are discussed in more detail below include:

• In a phase 1 human study for respiratory syncytial virus, DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects, with 100% of responders in the 25μg dose cohort maintaining antigen-specific immunity one year post vaccination.
  Animal challenge studies with DPX-Based Anthrax vaccine demonstrated 100% immunity following a single injection compared to current vaccines which require more than one dose.
• In a pre-clinical murine model, DPX-rHA for influenza achieves higher antibody levels than standard Alum rHA Vaccine and protects against multiple flu strains.

BioVaxys President and Chief Operating Officer Kenneth Kovan says “With data so compelling and supportive of the value of DPX-based vaccines for infectious diseases, we are seeking various off-balance sheet avenues to support development. The significant cargo capacity of DPX and the proven ability to package diverse antigens such as that shown with our DPX-SurMAGE multi-antigen cancer vaccine, could also greatly benefit potential partnerships for developing more effective viral vaccines, such as a multivalent mRNA DTP vaccine to address the recognized problem of immunity to the Bordetella pertussis waning over time, or for emerging global diseases such as MPox, where a DPX-mRNA formulation could have significant advantage. This fits well with our strategy of expanding development partnerships with DPX beyond oncology.”

100% of Subjects in a Phase 1 Study Treated with a DPX-based RSV Vaccine Developed Antibodies with Persistent Immune Response

DPX™+RSV(A) “DPX-RSV” is BioVaxys’ vaccine candidate targeting the respiratory syncytial virus (RSV) based on a DPX formulation of the SHe peptide of group A RSV. Results of a Phase 1 study showed that more than nine months after the last vaccination, 15 of 16 participants (93%) who received DPX-RSV demonstrated antigen-specific immune responses. This study evaluated the safety and immune response profile of two doses of DPX-RSV in 40 healthy older adult volunteers (aged 50-64 years) and was well tolerated amongst all study participants, with no SAEs reported. One of the two doses of DPX+RSV(A) was tested out to one year and 100% of older adults (7/7 immune responders) maintained antigen-specific immune responses one year after receiving a booster dose. After one year, their antibody levels measured were still at peak with no sign of decrease.

RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.

Currently available RSV vaccines including GSK’s Arexvy, Moderna’s mResvia, and Pfizer’s Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently; it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy infected cells. BioVaxys has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV.