Anixa Biosciences Reveals Updated Data From Breast Cancer Vaccine Trial, Says 'Exceeded Expectations'

Anixa Biosciences Inc ANIX announced new and updated results from the Phase 1 trial of its breast cancer vaccine. 

The trial is being conducted in collaboration with Cleveland Clinic with funding from a U.S. Department of Defense grant.

Patients who had been curatively treated for triple-negative breast cancer (TNBC) received three vaccinations given once every two weeks. 

Most patients developed ELISpot (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 the women had antigen-specific IFNγ and/or IL-17 ELISpot responses at all doses, while ELISA antibody responses at Dose Level 2 and higher.

A statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) 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 and the maximum tolerated dose (MTD).

No significant side effects were observed 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.

Price Action: ANIX shares are up 5.60% at $4.15 on the last check Thursday.