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Breast cancer vaccine final Phase 1 data shows all primary endpoints were met and protocol-defined immune responses in 74% of participants—Phase 2 preparations ongoing
Ovarian cancer CAR-T therapy, lira-cel, advances to highest dose level to date in fifth cohort with lymphodepletion—four patients surpass one year of survival, longest at approximately 28 months
Presentation to highlight Anixa's clinical progress and collaborations with leading cancer research institutions— Cleveland Clinic and Moffitt Cancer Center
Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that management will participate in the 2026 Cantor Fitzgerald Global Healthcare Conference being held September 9 11, 2026, in New York City.
Mike Catelani, President, COO & CFO of Anixa, will deliver a presentation highlighting Anixa's breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which completed a Phase 1 clinical trial that was funded by the U.S. Department of Defense. The trial met all primary endpoints, including safety, and protocol-defined immune responses were generated in 74% of participants. Preparations are underway for a Phase 2 trial.
"The recent presentation of preliminary data by Merck and Moderna for their personalized melanoma vaccine reinforces the growing potential of cancer vaccines as an important new approach to both treating and preventing cancer. Anixa is already advancing within this field with a vaccine designed to both treat and prevent breast cancer. Following the encouraging results from our Phase 1 trial, we are now preparing to advance the program into Phase 2 studies," stated Dr. Amit Kumar, Chairman and CEO of Anixa.
Mr. Catelani will also discuss Anixa's ovarian cancer CAR-T therapy, liraltagene-autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center. Participants in this trial are highly pre-treated, recurrent and resistant ovarian cancer patients, who have failed conventional therapies and are progressing. In the lira-cel trial, dosing has advanced to the fifth and highest cohort evaluated to date, which incorporates lymphodepletion for the first time. No dose-limiting toxicities have been observed in the study to date, and four patients have surpassed one year of survival following treatment, with the longest at approximately 28 months.
"This is an exciting time for Anixa, with our breast cancer vaccine advancing toward Phase 2 and our ovarian cancer CAR-T program now dosing at the highest level evaluated in the trial," said Mr. Catelani, "We look forward to sharing our progress in future."
Presentation details:
Event: 2026 Cantor Fitzgerald Global Healthcare Conference
Date: September 11, 2026
Time: 8:00 AM ET
Location: Waldorf Astoria New York (301 Park Avenue)
Management will be available for one-on-one meetings during the conference.
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 liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy 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.
