Anixa Biosciences' Breast Cancer Vaccine Shows 74% Immune Response Rate in Phase 1 Trial
核心洞察
Anixa Biosciences reported positive final Phase 1 clinical trial results for its investigational α-lactalbumin (搜索) breast cancer (搜索) vaccine, showing protocol-defined immune responses in 74% of participants.
The trial, conducted with Cleveland Clinic and funded by the U.S. Department of Defense (搜索), enrolled 35 participants across three cohorts and demonstrated the vaccine was safe and well-tolerated at the maximum tolerated dose.
The company plans to advance to Phase 2 studies, including a potential combination trial with Keytruda in the neoadjuvant setting for newly diagnosed breast cancer (搜索) patients.
Anixa Biosciences Inc. (NASDAQ:ANIX) announced positive final Phase 1 clinical trial results for its investigational breast cancer (搜索) vaccine at the 2025 San Antonio Breast Cancer Symposium on December 11, 2025. The trial demonstrated that the α-lactalbumin vaccine met all major primary endpoints and generated protocol-defined immune responses in 74% of participants.
Trial Design and Results
The Phase 1 trial was conducted in collaboration with the Cleveland Clinic and funded by a U.S. Department of Defense (搜索) grant. The study enrolled 35 participants across three cohorts to evaluate the safety and immunogenicity of the investigational vaccine.
Dr. G. Thomas Budd, principal investigator at the Cleveland Clinic, stated, "The investigational α-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."
The trial findings showed the vaccine was safe and well-tolerated at the maximum tolerated dose, meeting the study's primary safety objectives while demonstrating encouraging immunological activity.
Development Strategy and Next Steps
Based on the Phase 1 results, Anixa Biosciences plans to advance the program to Phase 2 clinical development. The company is considering a combination trial design that would evaluate the vaccine in combination with Keytruda (pembrolizumab) in the neoadjuvant setting for newly diagnosed breast cancer (搜索) patients.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "We look forward to engaging with regulators and advancing plans for a Phase 2 study." The final Phase 1 data will inform the design of the upcoming Phase 2 study.
Market Response and Company Profile
Following the announcement, Anixa Biosciences shares surged 15.21% in after-hours trading on Thursday, reaching $5.53. The stock had closed regular trading at $4.80, down 6.43% for the day. Year-to-date, the clinical-stage biotech company's stock has gained 106.90%.
Anixa Biosciences maintains a market capitalization of approximately $158-169 million, with a 52-week trading range of $2.07 to $5.46. The company operates as a clinical-stage biotechnology firm focused on cancer treatment and prevention, with a therapeutic portfolio that includes ovarian cancer (搜索) immunotherapy programs and cancer vaccines developed through collaborations with research institutions like Cleveland Clinic.