Anixa, Cleveland Clinic Announce FDA Clearance to Initiate Breast Cancer Vaccine Trial

Anixa Biosciences announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its breast cancer vaccine. This breast cancer vaccine technology was invented and developed by Cleveland Clinic immunologist Dr. Vincent Tuohy, and his research team.

Oncologist, Dr. Thomas Budd, also of Cleveland Clinic, will lead the clinical trial. Anixa Biosciences has an exclusive worldwide license to the technology.

The technology immunizes against a protein called alpha-lactalbumin that is expressed in the mammary glands of women, only during the latter part of gestation and during lactation. After lactation ceases, this protein is no longer expressed until a woman develops breast cancer. In a vaccinated woman, the researchers anticipate that these cancer cells will be destroyed by the immune system before they have the opportunity to grow into a mature cancer.

The initial focus is Triple Negative Beast Cancer, but this technology is expected to potentially prevent other types of breast cancer.

"We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial," Dr. Amit Kumar, President and CEO of Anixa said.