Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company dedicated to advancing cancer treatment and prevention, has initiated the treatment of the third participant in collaboration with Moffitt Cancer Center as part of an ongoing clinical trial for its innovative chimeric antigen receptor T-cell (CAR-T) therapy designed for ovarian cancer.

The clinical trial (NCT05316129) is currently underway at Moffitt Cancer Center and represents a Phase 1 dose-escalation study aimed at assessing the safety of Anixa's CAR-T therapy. The primary objectives include determining the maximum tolerated dose of T-cells that target the follicle-stimulating hormone receptor (FSHR) and conducting a preliminary evaluation of the therapy's clinical activity. Eligible patients for this trial are those with progressive disease who have previously undergone two or more therapeutic interventions, often without success.

The third patient in the trial received the same engineered T-cell dose as the first two patients. If the safety profile remains consistent with the previous cases, Anixa anticipates the initiation of treatment for the second cohort in the fourth quarter of 2023. The second cohort will receive a cell dose approximately three times higher than that of the initial cohort.

Anixa's CAR-T therapy employs a novel approach termed chimeric endocrine receptor T-cell (CER-T), named for its focus on an endocrine receptor target. Although CAR-T therapy has demonstrated effectiveness in certain hematological malignancies, its application to solid tumors like ovarian cancer has posed challenges. Successful CAR-T therapy requires the precise targeting of antigens exclusive to the intended cells to avoid harming healthy ones. Anixa's Phase 1 trial distinguishes itself by targeting the FSHR, a receptor primarily expressed in ovarian cells of healthy adult females.

Principal Investigator of the trial and Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, Dr. Robert Wenham, expressed optimism about the trial's progression and the prospect of advancing to higher dose cohorts. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, acknowledged the slower pace of patient enrollment often observed in clinical studies of this nature. Nonetheless, he emphasized the company's satisfaction in completing the first cohort and the anticipation of proceeding to higher doses contingent on the third patient's safety outcomes.