Anixa Biosciences, Inc. and Moffitt Cancer Center have advanced the Phase 1 clinical trial for liraltagene autoleucel (lira-cel) to its fifth cohort, treating the first patient with the highest dose level evaluated to date. The patient received 1×10⁷ CAR-positive cells/kg following lymphodepletion. This milestone is significant for a highly pre-treated, recurrent ovarian cancer population that typically faces limited treatment options and poor prognosis. To date, no dose-limiting toxicities have been observed across any cohort up to and including the prior dose level of 3x10⁶/kg CAR-T cells.

The ongoing Phase 1 study (ClinicalTrials.gov NCT05316129) is evaluating a novel chimeric endocrine receptor-T cell (CER-T) therapy targeting the follicle-stimulating hormone receptor (FSHR). FSHR is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels.

As of July 6, 2026, five patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17, and 13 months post-treatment, respectively. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, noted that advancing to the fifth cohort without observing dose-limiting toxicities is a meaningful milestone, and the survival signals are encouraging for this patient population.

Anixa's therapeutic portfolio includes the ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center and vaccines licensed from Cleveland Clinic. The breast cancer vaccine technology is protected by Patent Number 10-2960889 issued by the Korean Ministry of Intellectual Property (MOIP), which secures the company's approach in South Korea through 2040. The breast cancer vaccine previously met all major primary endpoints in a Phase 1 clinical trial, with protocol-defined immune responses generated in 74% of participants.

Key Clinical Trial Details

Anixa Biosciences reported quarterly losses of $(0.07) per share, surpassing the analyst consensus estimate of $(0.09) by 22.22%. The performance marks a 22.22% improvement in losses compared to $(0.09) per share recorded in the same period last year.

The company's earnings per share (EPS) for the quarter exceeded analyst expectations, reflecting a narrowing of losses on a year-over-year basis. The consensus estimate projected a loss of $(0.09) per share, while the actual reported loss was $(0.07) per share.

Financial Performance

The following table outlines the key earnings metrics for the reported quarter:

Anixa Biosciences' ability to reduce its per-share loss compared to the prior year and analyst projections highlights its progress in managing operational efficiency during the quarter.