ANIX News & Events

Anixa Biosciences announced that the Korean Ministry of Intellectual Property has issued Patent Number 10-2960889 related to Anixa's breast cancer vaccine technology. This composition-of-matter patent, exclusively licensed from Cleveland Clinic, protects the company's novel approach to breast cancer prevention and treatment in South Korea through 2040, addressing a disease for which no preventive vaccine is currently approved anywhere in the world.

Anixa Biosciences 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. "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 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.

Anixa Biosciences announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent covering key aspects of Anixa's ovarian cancer vaccine technology. The allowed patent, exclusively licensed from Cleveland Clinic, includes methods of administering an immunogenic composition comprising a nucleic acid encoding the anti-Mullerian hormone receptor 2 polypeptide to elicit an AMHR2-specific immune response to prevent or treat ovarian cancer.

Anixa Biosciences announced updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the company's follicle-stimulating hormone receptor-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer. Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive. No dose-limiting toxicities have been encountered in the first three dose cohorts. All significant adverse events observed to date have been unrelated to lira-cel administration. The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.