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Breast cancer vaccine presentation includes final Phase 1 data showing all major primary endpoints were met and protocol-defined immune responses in 74% of participants
Ovarian cancer CAR-T therapy, lira-cel, presentation highlights positive survival observations from ongoing Phase 1 clinical trial
Presentations highlight Anixa's clinical progress and collaborations with leading cancer research institutions, including 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 its two clinical-stage immunotherapy programs were presented at the New York Academy of Sciences' Frontiers in Cancer Immunotherapy symposium this week.
The presentations highlighted Anixa's breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which recently completed a Phase 1 clinical trial in which all major primary endpoints were met and protocol-defined immune responses were generated in 74% of participants, and 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.
Both presentations may be accessed on the Events page of Anixa Biosciences' website: https://ir.anixa.com/events.
"Presenting both of our clinical-stage immunotherapy programs at this symposium was an important opportunity to highlight the progress of our pipeline and the strength of the collaborations supporting these programs," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Our breast cancer vaccine and ovarian cancer CAR-T therapy are being advanced with leading clinical and scientific institutions, and we believe these presentations underscore the potential of Anixa's approach to treating and preventing cancer."
The Company's breast cancer vaccine presentation, titled "Phase I Trial of an Alpha-Lactalbumin (aLA) Vaccine for Breast Cancer," was given by Dr. Emily Esakov Rhoades, FDA/IND Trial Program Manager, Cleveland Clinic Cancer Institute. The presentation reported final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants.
The Company's lira-cel presentation, titled "A Phase I Clinical Trial of an Infusion of Autologous T cells Genetically Engineered with a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients with Recurrent Ovarian Cancer," was given by Dr. Pamela D. Garzone, Chief Development Officer of Anixa Biosciences. The presentation reported the clinical trial design and objectives, as well as the current status of Anixa's ongoing Phase 1 clinical trial of lira-cel, including survival observations of multiple patients living over one year past treatment.
About Anixa's Breast Cancer Vaccine
Anixa's breast cancer vaccine represents a novel approach to the prevention and treatment of breast cancer. The vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is highly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.
About Lira-cel, Anixa's CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian and testis cells, tumor vasculature, and certain cancer cells, but not in other healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who are platinum resistant and have progressed after at least two prior therapies.
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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