Anixa Biosciences Completes Enrollment in Phase 1 Trial of Breast Cancer Vaccine
Anixa Biosciences, Inc. (NASDAQ: ANIX), a promising player in the biotechnology sector, has officially wrapped up enrollment for its Phase 1 clinical trial of an innovative breast cancer vaccine. This significant milestone marks a pivotal step forward in the ongoing mission to enhance cancer prevention and treatment strategies. The vaccine under development is the result of collaboration with the esteemed Cleveland Clinic and is financed entirely through a grant from the U.S. Department of Defense (DoD).
The vaccine's primary purpose is to stimulate the immune system, enabling it to target breast cancer proactively, thereby preventing its recurrence. In total, 35 women have taken part in this trial, categorized into three distinct groups: 26 individuals in the triple-negative breast cancer (TNBC) cohort, four in the prevention group, and five receiving pembrolizumab concurrently with the vaccine.
Diverse Patient Cohorts
- - TNBC Group: Comprising women who have concluded treatment for triple-negative breast cancer and are currently cancer-free but at risk of relapse.
- - Prevention Group: This group consists of women who are cancer-free yet carry genetic mutations that elevate their breast cancer risk and have opted for preventative mastectomy.
- - Pembrolizumab Group: These participants are currently undergoing treatment with the immunotherapy drug pembrolizumab (Keytruda) in a post-operative context while receiving the vaccine.
The last patient visits are slated for August 2025. Following these visits, a comprehensive study report will be generated for submission to the Department of Defense, after which a Clinical Study Report (CSR) will be prepared for the U.S. Food and Drug Administration (FDA). Anixa will also transition the Investigational New Drug (IND) application from the Cleveland Clinic to its own entity as part of this important developmental journey.
Encouraging Preliminary Results
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, has expressed optimism regarding the findings thus far, noting that preliminary outcomes indicate the vaccine is well tolerated among participants. Over 70% of the patients exhibited protocol-defined immune responses, a promising sign that could shape the future of this treatment.
As the company prepares for Phase 2 trials, which will involve strategic discussions with the FDA, as well as protocol development and clinical site selection, it remains focused on addressing the substantial unmet needs within the breast cancer market—particularly for those with triple-negative breast cancer and genetically predisposed populations. This intriguing vaccine offers a unique immunologic pathway that could redefine cancer prevention and treatment strategies in immuno-oncology.
About Anixa Biosciences
Anixa is a biotechnology firm entrenched in the development of cancer treatments aimed at revolutionizing how we combat this global epidemic. Alongside its breast cancer research, Anixa is also innovating in the area of ovarian cancer immunotherapy in collaboration with the Moffitt Cancer Center, employing novel CAR-T technology. Their portfolio includes vaccines for both breast and ovarian cancers, fulfilling a crucial role in addressing various hard-to-treat malignancies such as those affecting the lung, colon, and prostate. The company's synergistic partnerships with leading research institutions empower it to integrate advanced technologies in the fight against cancer. For more information, you can visit
www.anixa.com or follow Anixa on social media platforms.
Conclusion
As we stand on the brink of what could be a revolutionary approach to breast cancer treatment, the forthcoming data from this trial is anticipated with great interest. The advancements made by Anixa Biosciences exemplify the proactive steps being taken to combat breast cancer, illustrating hope for patients and families affected by this disease.