Anixa Biosciences’ (NASDAQ:ANIX) partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the company’s breast cancer vaccine with Keytruda.
The treatment arm is an expansion of the ongoing Phase 1 dose escalation trial of Anixa’s breast cancer vaccine and aims to determine if the vaccine/Keytruda combination increases immune response.
Anixa’s breast cancer vaccine is designed to generate T-cells that target triple negative breast cancer (TNBC). Merck’s (NYSE:MRK) Keytruda is approved for use with chemotherapy before surgery and then alone after surgery to treat both high-risk early-stage and advanced TNBC.
Keytruda is a type of immunotherapy known as a checkpoint inhibitor, which is utilized by other immune cells to modulate the activity of T-cells. Cancer cells, such as TNBC cells, have developed mechanisms to target checkpoints to inhibit the activity of T-cells, as well as other immune cells, enabling cancer cells to escape destruction by cytotoxic T-cells.
One of these key checkpoint receptors is known as PD-1 (programmed cell death protein-1). TNBC, like many other cancers, expresses a protein that binds to the PD-1 protein on T-cells and essentially turns them “off.” Keytruda is a monoclonal antibody, which blocks the ability of the cancer cells to inactivate T-cells by shielding the PD-1 receptor.
“Cleveland Clinic has demonstrated in both preclinical and clinical studies that our breast cancer vaccine induces an immune response, including, we believe, production of T-cells that can target TNBC, so, we believe that the addition of Keytruda could have a synergistic effect,” Dr. Amit Kumar, chairman and CEO of Anixa, said in a statement.
“If a vaccine induces the creation of T-cells targeting TNBC, and Keytruda generally maintains T-cell activity, the combination could be very potent,” he added.
The U.S. Department of Defense is providing funding for the vaccine/Keytruda arm of the trial. Cleveland Clinic expects to present updated data from the trial at the San Antonio Breast Cancer Symposium in December.
