San Jose, California, U.S., October 5, 2026
Anixa Biosciences, Inc. has announced an important clinical development update from its ongoing Phase 1 trial of lira-cel, an investigational FSHR-targeted CAR-T therapy being evaluated in patients with recurrent ovarian cancer. The company reported the first case of stable disease maintained for 90 days following treatment in its ovarian cancer cell therapy program. The patient was treated in the fifth dose cohort with the highest dose evaluated so far, while no dose-limiting toxicities have been observed across patients treated to date. The findings provide an early clinical signal as Anixa and its collaborators continue evaluating the safety, tolerability, and preliminary activity of the novel cell therapy.
Lira-cel Shows 90-Day Stable Disease
The patient who achieved stable disease received 1×10⁷ CAR-positive cells per kilogram following lymphodepletion, representing the highest dose level evaluated in the study at the time of the announcement. According to Anixa, the patient’s cancer showed no progression for three months after treatment, marking the first stable-disease response reported in the ongoing trial. The Phase 1 study is designed primarily to evaluate safety and determine appropriate dose levels, while researchers are also monitoring preliminary signs of therapeutic activity. Anixa said multiple patients have survived for more than one year following treatment, including one patient who has survived beyond two years. These observations remain early and anecdotal because the trial is primarily designed as a safety and dose-escalation study. Correlative studies are also continuing to evaluate the presence and durability of CAR-positive cells following treatment, which could provide additional information about the persistence of the investigational therapy.
FSHR-Targeted CAR-T Approach for Ovarian Cancer
Lira-cel, or liraltagene autoleucel, is an investigational CAR-T therapy designed to target the follicle-stimulating hormone receptor (FSHR). FSHR is expressed on ovarian cancer cells, while having limited expression in healthy tissues, providing the biological rationale for selectively directing engineered immune cells toward tumor-associated targets. The Phase 1 trial, registered as NCT05316129, is evaluating lira-cel in adult women with recurrent ovarian cancer whose disease has progressed following at least two prior therapies. The study is being conducted at Moffitt Cancer Center, with researchers assessing safety, tolerability, dose escalation, and preliminary efficacy. Anixa’s technology uses a differentiated chimeric endocrine receptor-T cell (CER-T) approach. Rather than using an antibody fragment as the targeting component, the technology uses the natural ligand of the FSHR receptor, follicle-stimulating hormone, to recognize the target on tumor cells.
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Early Clinical Findings Support Further Evaluation
The latest findings add to the company’s ongoing evaluation of lira-cel as a potential cell therapy for recurrent ovarian cancer, an area where additional treatment options remain an important research priority. Anixa Chairman and CEO Amit Kumar said the company is encouraged by the early observations of overall survival and the emergence of stable disease among treated patients. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and principal investigator of the trial, noted that investigators hope to observe increasingly stronger clinical outcomes as dose escalation continues, including progression from stable disease toward partial and complete responses. Importantly, no dose-limiting toxicities have been observed to date, according to the company. The trial will continue evaluating patients at current and future dose levels to establish the safety profile and determine whether higher exposure can translate into stronger antitumor activity. Because the program remains in Phase 1 clinical development, the reported stable disease finding should be considered an early clinical observation rather than evidence of confirmed efficacy. Further patient follow-up, additional enrollment, and subsequent clinical studies will be needed to determine the potential of lira-cel in recurrent ovarian cancer.
Source: Anixa Biosciences press release
