Anixa Biosciences Announces Completion of Enrollment in Phase 1 Trial of Breast Cancer Vaccine

Rhea-AI Summary

Anixa Biosciences has completed enrollment in its Phase 1 breast cancer vaccine trial, developed in partnership with Cleveland Clinic and funded by the Department of Defense. The trial enrolled 35 participants across three cohorts: 26 triple-negative breast cancer survivors at risk of recurrence, 4 high-risk individuals undergoing preventative mastectomy, and 5 patients receiving pembrolizumab treatment. Preliminary results show over 70% of patients demonstrating protocol-defined immune responses, with the vaccine being well-tolerated. The final patient visits are scheduled for August 2025, after which results will be submitted to the DoD and FDA. The vaccine targets a novel pathway in immuno-oncology and aims to address unmet needs in breast cancer prevention and treatment, particularly for TNBC and genetically high-risk populations.

Positive

• Over 70% of patients demonstrated protocol-defined immune responses in preliminary results
• Vaccine shows good tolerability in Phase 1 trial
• Trial fully funded by Department of Defense grant
• Successfully completed enrollment of 35 patients across three distinct cohorts

Negative

• Final results not yet available - patient visits continue until August 2025
• Phase 2 trials still require FDA discussions, protocol development, and manufacturing planning

Insights

Oncology and Clinical Trial Expert

Anixa's breast cancer vaccine shows promising immune response in 70% of Phase 1 participants, advancing a novel approach for prevention and treatment.

The completion of enrollment in Anixa's Phase 1 breast cancer vaccine trial represents a significant milestone in the company's clinical development program. With 35 total participants across three distinct cohorts, the trial has targeted key high-need populations: triple-negative breast cancer survivors at risk of recurrence, genetic mutation carriers at high risk, and patients receiving pembrolizumab post-operatively.

The preliminary efficacy signal is particularly noteworthy - 70% of patients have demonstrated protocol-defined immune responses, suggesting the vaccine is successfully triggering the intended immunological activity. This response rate exceeds typical expectations for early-stage cancer vaccines, which historically have struggled to generate robust immune activation.

The safety profile appears favorable with the vaccine being "well tolerated," though specific adverse event data isn't provided. For a preventive intervention, safety is paramount, so this initial tolerability signal is crucial.

The trial's DoD funding is strategically valuable, allowing Anixa to advance through Phase 1 without diluting shareholders or depleting corporate resources. The planned IND transfer from Cleveland Clinic to Anixa signals the company's increasing control over the asset as it progresses toward Phase 2.

Triple-negative breast cancer represents approximately 10-15% of all breast cancers and has limited treatment options compared to hormone-positive variants. A preventive vaccine targeting this aggressive subtype addresses a significant unmet medical need. Similarly, high-risk genetic mutation carriers currently face difficult choices like prophylactic mastectomy, making a vaccine alternative potentially transformative.

The novel target approach mentioned by the CEO could differentiate this vaccine from previous unsuccessful cancer vaccine attempts, though specific antigen details aren't disclosed in this release.

SAN JOSE, Calif., June 2, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine. This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded by a grant from the U.S. Department of Defense (DoD).

The vaccine is designed to stimulate the immune system to target breast cancer before it can recur or develop. A total of 35 women have received the vaccine in the trial, including 26 in the triple-negative breast cancer ("TNBC") group, four in the prevention group, and five in the pembrolizumab group. These participants represent three distinct patient cohorts:

• TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.
• Prevention Group: Women who are cancer-free but carry genetic mutations that place them at high risk of developing breast cancer and have elected to undergo preventative mastectomy to lower their risk.
• Pembrolizumab (Keytruda) Group: Women who are receiving pembrolizumab in a post-operative setting. These women are receiving the vaccine concurrently with pembrolizumab.

The final patient visits are scheduled for August 2025. Once completed, the final study report will be submitted to the Department of Defense. A Clinical Study Report (CSR) will then be prepared for submission to the U.S. Food and Drug Administration. As part of the continued development process, the Investigational New Drug (IND) application will be transferred from Cleveland Clinic to Anixa.

Anixa and Cleveland Clinic plan to submit for presentation all trial data at a major upcoming scientific meeting.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "We are very encouraged by the data we are seeing from this trial. Preliminary results show that our breast cancer vaccine is well tolerated, with more than 70% of patients demonstrating protocol-defined immune responses. These encouraging findings are guiding our planning for Phase 2 trials, which will include discussions with the FDA, protocol development, manufacturing, and clinical site selection. While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context. We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need. Our vaccine may offer a unique, immunologic pathway for both prevention and treatment."

About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

View original content to download multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-announces-completion-of-enrollment-in-phase-1-trial-of-breast-cancer-vaccine-302469508.html

SOURCE Anixa Biosciences, Inc.

FAQ

What are the preliminary results of Anixa's (ANIX) breast cancer vaccine Phase 1 trial?

Preliminary results show the vaccine is well-tolerated with over 70% of patients demonstrating protocol-defined immune responses.

How many patients were enrolled in Anixa's breast cancer vaccine trial?

The trial enrolled 35 total patients: 26 in the triple-negative breast cancer group, 4 in the prevention group, and 5 in the pembrolizumab group.

When will Anixa Biosciences (ANIX) complete the Phase 1 breast cancer vaccine trial?

The final patient visits are scheduled for August 2025, after which results will be submitted to the Department of Defense and FDA.

What are the three patient groups in Anixa's breast cancer vaccine trial?

The trial includes TNBC survivors at risk of recurrence, high-risk individuals undergoing preventative mastectomy, and patients receiving pembrolizumab treatment.

What is unique about Anixa's breast cancer vaccine approach?

The vaccine targets a novel target that has not been previously explored in immuno-oncology, potentially representing a new paradigm for both prevention and treatment.