Anixa Biosciences (NASDAQ:ANIX) and its partner, Cleveland Clinic, presented positive new results from the Phase 1 clinical trial of Anixa’s breast cancer vaccine at the 2023 San Antonio Breast Cancer Symposium (SABCS).
The trial is assessing three vaccine doses given once every two weeks to patients who had been curatively treated for triple-negative breast cancer (TNBC). IFNγ and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect.
Data from the 16 patients treated to date showed that:
- The majority of patients developed T-cell responses that met the protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.
- 12 (75%) of patients had antigen-specific T-cell responses at all dose levels, while antibody responses were observed at Dose Level 2 and higher.
- A statistically significant (P = 0.03) increase in IFNγ over baseline was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.
- Among the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).
- No significant side effects were observed, at the MTD, besides irritation at the sites of injection; and no myalgias, flu-like symptoms, or aberrant laboratory values were noted.
Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine in two additional patient cohorts.
“We are in the planning stages of the Phase 2/3 studies of this vaccine,” Dr. Amit Kumar, chairman and CEO of Anixa, said in a statement. “Our goal is to initially evaluate the vaccine’s ability to prevent recurrence of cancer in survivors and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC.”
Following the SABCS presentation, the company publicly released the data, and hosted a call for investors. In addition to Anixa management, guest speakers on the call included:
- Jennifer Davis, a nurse, wife, mother of three, and TNBC survivor who was the first person in the world to receive Anixa’s breast cancer vaccine in 2021 through Cleveland Clinic
- H. Michael Shepard, Ph.D., an advisor to Anixa, a key opinion leader in oncology and the inventor of Herceptin (trastuzumab)
- Brian Leyland-Jones, MBBS, M.D., Ph.D., FACP, FRCPC, an advisor to the company, key opinion leader in oncology, and a past chief of developmental therapeutics at the National Cancer Institute (NCI)
