Anixa Biosciences Announces Execution of Data Transfer Agreement with Cleveland Clinic

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) executed a data transfer agreement (DTA) with Cleveland Clinic on Nov. 5, 2025 to move Phase 1 breast cancer vaccine clinical data and support transfer of the IND sponsorship to Anixa.

The company says Phase 1 enrollment is complete and showed encouraging immune response signals; Anixa plans to assume full IND sponsorship and advance the vaccine into a Phase 2 trial. Final Phase 1 data will be presented at the San Antonio Breast Cancer Symposium on Dec. 11, 2025.

Positive

• Executed DTA enabling transfer of Phase 1 clinical data
• Phase 1 enrollment completed for the breast cancer vaccine
• Plan to assume full IND sponsorship and run Phase 2
• Final Phase 1 data scheduled for Dec 11, 2025 presentation

Negative

• IND transfer remains in process and is not yet complete

Insights

Clinical Development Strategist

DTA execution clears a major administrative hurdle so Anixa can receive Phase 1 data and pursue a Phase 2 IND transfer and trial sponsorship.

Anixa secured a data transfer agreement with Cleveland Clinic allowing the transfer of Phase 1 trial data and related information. Enrollment for the Phase 1 study is complete and the sponsor transfer of the IND is underway, enabling Anixa to assume full sponsorship and plan a Phase 2 breast cancer vaccine trial targeting α-lactalbumin.

The key dependencies remain the completeness and integrity of the transferred data and the remaining regulatory steps for the IND transfer. The company cites "encouraging immune response data" but the final dataset and any regulatory correspondence are still pending. Regulatory timelines and the quality of the Phase 1 dataset will determine how quickly a Phase 2 can start.

Watch for the final Phase 1 data presentation on December 11 and subsequent IND transfer milestones and FDA communications within the coming months. Track the Phase 2 trial protocol, safety details in the final data, and the formal IND transfer confirmation as near-term, monitorable items.

Completion of key step in IND transfer for upcoming Phase 2 breast cancer vaccine clinical trial

SAN JOSE, Calif., Nov. 5, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development.

With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa.

Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.

"Execution of the DTA represents a significant step in the transfer of IND sponsorship to Anixa. We look forward to completing the remaining steps with Cleveland Clinic, and eventually advancing to a Phase 2 trial under our sponsorship," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, and are excited about the presentation of the final Phase 1 data, by Cleveland Clinic, at the San Antonio Breast Cancer Symposium on December 11."

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 LinkedIn, X, 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

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SOURCE Anixa Biosciences, Inc.

FAQ

What did Anixa (ANIX) announce on Nov. 5, 2025 about the Cleveland Clinic DTA?

Anixa announced execution of a data transfer agreement to receive Phase 1 clinical trial data and support transfer of the IND sponsorship.

How does the DTA affect ANIX's plan for the breast cancer vaccine Phase 2 trial?

The DTA permits transfer of Phase 1 data so Anixa can assume IND sponsorship and advance the vaccine into a Phase 2 trial.

What is the status of the Phase 1 trial for Anixa's α-lactalbumin vaccine (ANIX)?

Phase 1 enrollment is reported as complete with encouraging immune response data observed.

When will ANIX-related Phase 1 data be presented publicly?

Final Phase 1 data will be presented at the San Antonio Breast Cancer Symposium on Dec. 11, 2025.

What target does Anixa's breast cancer vaccine use and why is it relevant?

The vaccine targets α-lactalbumin, a lactation-associated protein that re-emerges in many breast cancers and may enable immune targeting.

Has the IND for the breast cancer vaccine already transferred to Anixa (ANIX)?

No; the IND is currently sponsored by Cleveland Clinic and is described as being in the process of transfer to Anixa.