ANIX News & Events

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.

Anixa Biosciences announced that the Mexican Institute of Industrial Property, or IMPI, has issued Patent Number 432748, covering key aspects of the Company's breast cancer vaccine technology. Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. Anixa's vaccine is based on immunizing against human alpha-lactalbumin, a protein associated with lactation that is aberrantly 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. The vaccine was invented at Cleveland Clinic, and this patent-along with others related to this technology-has been exclusively licensed to Anixa Biosciences. Positive Phase 1 results showed that the vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and elicited protocol-defined immune responses in 74% of participants across all doses tested. Based on these findings, Anixa is moving forward with preparations for a Phase 2 clinical trial.

Anixa Biosciences announced that it has entered into a development and manufacturing agreement with Cytovance Biologics, a leading full-service contract development and manufacturing organization, or CDMO, specializing in mammalian and microbially expressed biologics, to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine. The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial. Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets alpha-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 generating an immune response against alpha-lactalbumin-expressing cells, the vaccine is designed to potentially provide both therapeutic and preventive benefits for patients with tumors expressing this protein.