Anixa Biosciences Announces Positive Data From Phase 1 Study Of Breast Cancer Vaccine; Stock Up

(RTTNews) - Anixa Biosciences Inc. (ANIX) announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine.

ANIX closed Wednesday's regular trading at $3.93 up $0.18 or 4.80%. In the after-hours trading, the stock further gained $0.57 or 14.48%.

Patients who had been curatively treated for triple negative breast cancer (TNBC) received three vaccinations given once every two weeks. IFN? 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 ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.

The data showed that 12 (75%) of the women had antigen-specific IFN? and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher.

The data also showed a statistically significant increase in IFN? over baseline (Day 0) was observed by Day 56; while a significant increase in IL-17 over baseline was observed by Day 14.

Among the doses studied, Dose Level 1 (10 mcg a-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).

The company noted that no significant side effects were observed, at the MTD, besides irritation at the sites of injection. 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's safety and immunologic effects in two additional patient cohorts.

The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.

The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies.

Anixa Biosciences noted that the data from Phase 1 trial to date has exceeded its expectations. The vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development.

The company said it looks forward to reviewing additional data as the trial continues to completion, and it is in the planning stages of the Phase 2/3 studies of this vaccine.

Anixa is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The grant from the U.S. Department of Defense was made directly to Cleveland Clinic.