From the "HALT NR" About BioVaxys
BioVaxys' vaccine platform is based on the established immunological concept that modifying proteins---whether they are viral or tumor antigens---with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization "teaches" a patient's immune system to recognize and make target proteins more 'visible' as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys antiviral approach entails haptenizing those SAR-CoV-2 viral proteins that are critical to the virus' ability to bind to and enter human cells. For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.
The SARS-CoV-2 virus that emerged in December 2019 has aggressively spread around the world, with 5.89 million infections and over 363,000 deaths. In the US alone, there have been 1.78 million confirmed infections in the US and 104,000 deaths, making COVID-19 the leading cause of death in the US. There are no vaccines or therapies available to treat SARS-CoV-2.
Many of the vaccines currently in development are either unproven approaches or focus on antibody approaches to the virus. Antibodies are made by B cells and ideally would latch onto SARS-CoV-2 and prevent it from entering human cells. However, a T-cell response, which is induced by the BioVaxys cancer vaccines, may be necessary for effective antibody production; moreover, T cells can directly battle infections by targeting and destroying infected cells. A study published in the May 14 issue of Cell demonstrated that in a sample of patients who recovered from SARS-CoV-2 infection, all of the patients carried helper T-cells that recognized the SARS-CoV-2 S-spike protein, and virus-specific killer T-cells were detected in 70% of the test subjects. Dr. David Berd, co-founder and scientific director of the BioVaxys research program, commented that, "haptenized proteins are known to induce potent T cell responses as well as antibody, so our approach could have an advantage over other developing SARS-Cov-2 vaccines."
BioVaxys is in the process of launching a preclinical study to evaluate the immunogenicity of its SARS-CoV-2 vaccine approach in a controlled murine model at various dosages, with serology screening evaluating an immune response to SARS-CoV-2, or the protein that binds the virus to human cells (the "Murine Model Study"), which will be funded by the Bridge Loan. No regulatory approval is required for completion of the Murine Model Study, which is anticipated to commence within the next seven to ten days, conditional on BioVaxys signing a proposal with the supplier who will produce the non-GMP vaccine material to be used in Murine Model Study. The results of the Murine Model Study are anticipated to be available in October, 2020.