BioVaxys is planning to request that its investigational vaccine for ovarian cancer, BVX-0918A, be approved for compassionate use in people with advanced ovarian cancer in Europe.
The company also plans to file requests to U.S. and European regulatory health authorities requesting authorization to pursue clinical trials of BVX-0918A in the coming months.
As part of its plan to accelerate the development of BVX-0918A, BioVaxys is already having discussions with its designated contract manufacturing organization, and expects to enter a contract in the coming months, the company announced in a press release.
BVX-0918A is the company’s lead haptenized cancer cell vaccine. It uses a patient’s own (autologous) cancer cells, which are modified with simple chemicals called haptens, to make them more recognizable as a threat by the body’s immune system. Once the process of haptenization is complete, modified cancer cells are re-introduced back into the patient, where they are expected to trigger a stronger immune response against cancer.
“Because autologous tumor cells by definition have the patient’s unique set of antigens already on them, the challenge is to increase the immune system’s ability to recognize the ovarian tumor cells as foreign, breaking the “self-tolerance,”” said Ken Kovan, founder, president and CEO of BioVaxys.
Antigens are molecules found on the surface of different types of cells that work as identifiers, signaling to the immune system what should be considered foreign and potentially dangerous, and what should not be viewed as a threat.
“A way to achieve this is by the use of a hapten, which is the foundation for the BioVaxys’ haptenized protein vaccine platform,” Kovan said.
Data from previous Phase 1/2 clinical trials of the company’s first generation of haptenized cancer cell vaccines, which were based on the use of a single hapten, demonstrated these vaccines had promising clinical activity in patients with melanoma and ovarian cancer.
BVX-0918A is part of a second generation of haptenized tumor cell vaccines, which combines the use of two different haptens to chemically alter protein antigens on patient cancer cells. According to the company, the addition of a second hapten allows for a higher number of cancer killing T-cells to be primed to attack cancer cells, leading to a stronger anti-tumor immune response.
The company announced it also is planning to explore the therapeutic potential of combining BVX-0918A with immune checkpoint inhibitors for treating ovarian cancer and other types of solid tumors.
Checkpoint inhibitors are medications that target certain proteins, such as CTLA-4, PD-1, and PD-L1, involved in mechanisms that shut down the body’s immune system. Cancer cells often exploit this natural mechanism to avoid being targeted and eliminated by immune cells. That’s how the medications increase the effectiveness of immune cells to correctly identify and destroy malignant cancer cells.
BioVaxys expects its haptenized cancer cell vaccine to be able to change the tumor’s microenvironment and render cancer cells more vulnerable to checkpoint inhibitors. Both are expected to work together to trigger a strong anti-tumor immune response.
The company is using the same haptenization approach to develop new SARS-CoV-2 vaccines that aim to increase immune responses against viral proteins to prevent people from contracting COVID-19.
BioVaxys already completed the preclinical program for BVX-0320, its lead SARS-CoV-2 vaccine, and now is considering development of additional vaccines based on its design to tackle the new viral strains that recently emerged in the U.K. and South Africa.