BioVaxys’s immunotherapeutic approach is based on the established immunological concept that modifying proteins with simple chemicals called haptens makes them more visible to the immune system. Haptens were first identified by Karl Landsteiner, one of the founders of modern immunology and winner of the Nobel Prize for his discovery of ABO blood groups.
The Company’s vaccines are created by extracting a patient’s own (e.g. ‘autologous’) cancer cells, chemically treating them with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptens used by BioVaxys include dinitrophenyl (DNP) and sulfanilic acid (SA); this process of haptenization is a well-known and well-studied immunotherapeutic approach which “teaches” a patient’s immune system to recognize and make target cancer cells more ‘visible’ as foreign.
Besides having no observed toxicity over years of clinical use, this platform can be used for any resectable solid tumor, and has been evaluated in both regional and disseminated metastatic tumors
BioVaxys’ technology is supported by strong scientific principle, a well-understood mechanism of action, and extensive promising clinical data. In previous stage III and IV melanoma cancer studies conducted at Thomas Jefferson University in Philadelphia PA, a vaccine produced by modification of autologous cancer cells by a single hapten was proven to be safe and appeared to be efficacious in phase II trials. Follow-up studies suggested that using multiple haptens---which were ultimately developed into BioVaxys’s multi-haptenized autologous vaccine---provided modification of both hydrophilic and hydrophobic amino acids and a more robust immune response.
Although our proprietary autologous, haptenized, tumor vaccine technology has clinical data in different solid tumor types that are extremely encouraging for development on its own as a monotherapy, BioVaxys’ commercial strategy will be to develop the autologous bihaptenized vaccine together with an anti-CTLA4 or anti-PDA checkpoint antibodies.
BioVaxys is is developing highly-targeted, patient-specific, immunotherapeutic vaccines to treat various solid tumor types. The Company’s lead clinical program is a multihaptenized autologous vaccine that will initially be developed and marketed for melanoma and ovarian cancer.
Biovaxys is targeting an IND submission for a Phase I/II study in the upcoming months.
Earlier stage internal drug discovery efforts are focused on identifying new cancer antigens which may lead to the development of novel next-generation cancer vaccines.