1. Phase 1 trial results showed vaccine met all primary endpoints. 2. 74% immune response observed; vaccine was well tolerated. 3. Plans for Phase 2 trials in combination with Keytruda announced. 4. No major side effects reported, only injection-site irritation noted. 5. Study funded by U.S. Department of Defense, indicating governmental support.
FAQ
Why Bullish?
The results indicate strong efficacy and safety, boosting investor confidence, similar to past biotech successes post-phase results.
How important is it?
The outcomes of this trial directly affect future studies and potential revenue; high relevance due to anticipated next steps.
Why Short Term?
Positive developments from clinical trials typically lead to immediate market reactions; historical precedents show short-term boosts in stock price.
Anixa Biosciences Reports Promising Phase 1 Data for Breast Cancer Vaccine
Anixa Biosciences, Inc. (NASDAQ: ANIX), a leading biotechnology firm dedicated to cancer treatment and prevention, has announced positive findings from its Phase 1 clinical trial of an investigational breast cancer vaccine. The final data was presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), demonstrating that the vaccine not only met all primary endpoints but also elicited immune responses in 74% of participants.
Key Findings from the Phase 1 Trial
The Phase 1 clinical trial (NCT04674306), conducted in partnership with the Cleveland Clinic and funded by the U.S. Department of Defense, yielded significant results:
- All major primary endpoints were successfully met.
- 74% of participants exhibited protocol-defined immune responses, confirming the vaccine's efficacy.
- The vaccine was safe and well tolerated at the maximum tolerated dose (MTD), with minor side effects primarily limited to injection-site irritation.
- Preliminary immunohistochemistry (IHC) analyses indicated varying levels of α-lactalbumin (aLA) expression in primary tumors.
- Participants will continue to be monitored for five years following the trial's conclusion.
Combination with Pembrolizumab
The trial also explored the vaccine's effectiveness when combined with Keytruda (pembrolizumab). This combination successfully generated antigen-specific T cell responses without significant additional side effects, laying the groundwork for a planned Phase 2 neoadjuvant study in newly diagnosed breast cancer patients.
Study Cohorts and Safety Profile
The Phase 1 trial involved 35 participants divided into three distinct cohorts:
- Cohort Ia: 26 women who had completed standard cancer treatments.
- Cohort Ib: 4 cancer-free women with genetic mutations opting for preventive surgery.
- Cohort Ic: 5 women with triple-negative breast cancer (TNBC) receiving pembrolizumab as part of the adjuvant therapy.
Participants in Cohort Ia reported safe tolerability during the trial, with no incidences of flu-like symptoms or unusual clinical laboratory outcomes. Cohort Ib’s safety profile mirrored that of Cohort Ia, while Cohort Ic successfully evaluated the combination therapy without intolerable side effects.
The Mechanism of the Vaccine
Anixa's investigational vaccine targets α-lactalbumin, a protein typically present during lactation but expressed in many breast cancers. The vaccine is designed to elicit an immune response that directs cytotoxic T cells towards malignant cells expressing this protein, potentially providing a preemptive defense against developing tumors.
Statements from Key Figures
Dr. G. Thomas Budd from Cleveland Clinic highlighted the significance of this trial, stating, “Triple-negative breast cancer remains one of the most challenging subtypes to address...the investigational α-lactalbumin vaccine generated compelling results that support continued clinical evaluation.”
Dr. Amit Kumar, Chairman and CEO of Anixa, expressed optimism about the trial outcomes: “We are very encouraged that the final Phase 1 data met all major primary endpoints...and we look forward to advancing plans for a Phase 2 study.”
About Anixa Biosciences, Inc.
Anixa Biosciences is a clinical-stage biotechnology company focused on innovative cancer treatments. Besides its breast cancer vaccine, the company is working on an ovarian cancer immunotherapy in partnership with Moffitt Cancer Center, alongside various other cancer vaccine developments targeting multiple malignancies. Anixa's collaborative approach allows it to leverage cutting-edge research and improve clinical outcomes for cancer patients.