Developing Hapentized
Haptenization is based on proven science, a well-understood mechanism of action, and extensive clinical data, with evidence that it can be used to treat multiple viral infections and any resectable solid tumor.
Inducing Targeted T-Cell
and Antibody Response
The BioVaxys vaccine platform is based on the concept of haptenization. This idea has a long history, beginning with the work of the immunologist and Nobel laureate Dr. Karl Landsteiner,
Simply put, the process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating a more intense immune response. We now understand that T-cells (or T-lymphocytes, which are white blood cells that are crucial in tumor rejection) react against the haptenized material and that the T-cells also then react against the unmodified target protein. At BioVaxys, we believe that tumor and viral antigens, which are proteins, are similarly affected by haptenization which stimulates a T-cell mediated immune response.
Besides having no observed toxicity in multiple clinical trials, haptenization is based on proven science, a well-understood mechanism of action, and extensive clinical data, with evidence that it can be used to treat multiple viral infections and any resectable solid tumor.
SARS-CoV-2
Vaccine Development
BVX-0320:
Our lead IND-stage vaccine candidate for SARS-CoV-2.
In vivo studies have demonstrated that BVX-0320, BioVaxys’ monovalent haptenized s-spike protein vaccine, stimulated a 96.4% antibody response, activation of CD4+ helper T cells and CD8+ killer T cells, and stimulation of T cells that produce the cytokine, gamma interferon. Helper CD4+ T-cells are memory cells that retain information about the virus, enabling them to respond rapidly after viral exposure. CD8+ T cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells. Furthermore, our clinical experience with haptenization and safety data from prior clinical development of haptenized vaccines may prove advantageous from a regulatory perspective and lead to an accelerated development process.
BioVaxys is assessing steps to develop a multivalent version of BVX-0320 to address newly emerging SARS-CoV-2 variants such as the highly transmissible United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage) that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.
