ANIX News & Events

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.

Anixa Biosciences provided an update on patient outcomes observed in its ongoing Phase 1 ovarian cancer CAR-T clinical trial, following regulatory approval of a protocol amendment that enables substantial dose escalation. The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer, who have failed standard of care chemotherapy, and progressed after two or more prior therapies. To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately 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 and three patients have survived 11, 8 and 8 months, respectively. Three patients that have reached 15, 14 and 8 months remain alive, and one additional patient who was treated more recently, is also currently alive. Under the amended protocol, dosing may increase from the original range of 110 to 110 CAR-positive cells per kilogram of body weight to as high as 110 cells/kg, representing a two-order-of-magnitude increase. If no DLTs are observed at this level, additional escalation may be pursued at the discretion of the principal investigator. Anixa and Moffitt believe the favorable safety profile observed to date is partially attributable to the direct intra-peritoneal delivery of CAR-T cells, which differs from conventional intravenous administration and may reduce systemic toxicity while enhancing localized tumor targeting.

Anixa Biosciences announced that the U.S. Adopted Names, or USAN, Council approved "liraltagene autoleucel" for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. This U.S. approval follows the earlier approval for international use of the name by the International Nonproprietary Names, or INN, Expert Committee of the World Health Organization, WHO. The USAN and INN nomenclature schemes for CAR-T cell therapies follow a two-word structure describing the gene and cell component. A USAN is a non-proprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names of U.S. medications.