Anixa Biosciences and Cleveland Clinic Announce

FDA Clearance to Initiate Clinical Trial of

Breast Cancer Vaccine


DECEMBER 21, 2020

Novel technology developed by Cleveland Clinic Researchers

SAN JOSE, Calif., Dec. 21, 2020 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that 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.

  • Animal studies showed notable ability to prevent breast cancer.

  • The preclinical studies and two trials of this vaccine are being funded by the U.S. Department of Defense.


Dr. Amit Kumar, President and CEO of Anixa stated, "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."

"This is a significant milestone for our program.  Our vision has always been to prevent cancer before it arises," said Dr. Tuohy.  "We are looking forward to beginning clinical trials in patients."

About Anixa Biosciences, Inc.
Anixa is a publicly-traded biotechnology company developing a number of programs addressing cancer and infectious disease.  Anixa's therapeutics portfolio includes a cancer immunotherapy program which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology, and a Covid-19 therapeutics program focused on inhibiting certain viral protein function.  The company's vaccine portfolio includes a vaccine to prevent breast cancer, and specifically triple negative breast cancer (TNBC), the most deadly form of the disease, and a vaccine to prevent ovarian cancer.  These vaccine technologies focus on immunizing against specific proteins that have been found to be expressed in certain forms of cancer.  Anixa continually examines emerging technologies in complementary fields for further development and commercialization.  Additional information is available at