Anixa Biosciences Presents Final Data from Breast Cancer Vaccine Trial at 2025 San Antonio Symposium
Anixa Biosciences announced the presentation of final data from the Phase 1 clinical trial of its investigational breast cancer vaccine at the 2025 San Antonio Breast Cancer Symposium. The trial was conducted in collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense. Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose, and elicited protocol-defined immune responses in 74% of participants. The presentation, titled "Final Results of a Phase I Trial of Alpha-lactalbumin Vaccine for Breast Cancer," was delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. "Triple-negative breast cancer remains one of the most challenging subtypes to address, and Phase 1 trials are an important step in determining whether a new approach can be administered safely and activate the immune system as intended," said G. Thomas Budd, M.D., of Cleveland Clinic's Cancer Institute and principal investigator of the study. "In this trial, the investigational alpha-lactalbumin vaccine was safe and well tolerated at the maximum tolerated dose and generated protocol-defined immune responses in 74% of participants-results that support continued clinical evaluation."
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Anixa Secures Mexican Patent for Breast Cancer Vaccine
- Patent Approval: Anixa Biosciences has received a patent allowance from the Mexican Institute of Industrial Property, marking an expansion of its international intellectual property coverage for breast cancer vaccine technology, thereby reinforcing its leadership in cancer immunotherapy.
- Market Opportunities: The patent complements existing patents in the U.S. and other key markets, laying the groundwork for Anixa's future regulatory and commercial efforts in regions with high breast cancer incidence like Mexico.
- Clinical Development Support: The vaccine is based on immunizing against human α-lactalbumin, aiming to selectively activate the immune system to prevent tumor formation, which is expected to improve breast cancer diagnosis and treatment outcomes for women in Mexico.
- Global Strategic Positioning: By strengthening its global patent estate, Anixa is paving the way for future international development and commercialization strategies, potentially partnering with larger pharmaceutical companies for worldwide commercialization.
Anixa Biosciences Declines Following Phase 1 Results for Breast Cancer Vaccine
Anixa Biosciences Phase 1 Trial Results: Anixa Biosciences (ANIX) reported a ~21% drop in stock after sharing phase 1 data for its breast cancer vaccine targeting α-lactalbumin, which showed that 74% of participants achieved immune responses.
Cohorts and Safety Findings: The trial involved 35 participants across three cohorts, with good safety and tolerability noted in the first two cohorts, while the third cohort experienced some Grade 3 adverse events related to injection-site irritation.
Future Trial Plans: Anixa indicated that the phase 2 trial design may include a combination study with Merck's Keytruda in the neoadjuvant setting for newly diagnosed breast cancer patients.
Market Reaction and Context: The market's reaction to the trial results has been cautious, with discussions around the justification of optimism regarding Anixa's upcoming phase 1 readout and other clinical programs.
