SAN JOSE, California, July 6, 2026
Anixa Biosciences, Inc. and Moffitt Cancer Center have announced a significant milestone in the development of liraltagene autoleucel (lira-cel), their investigational FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer, with the first patient successfully treated in Cohort 5 of the ongoing Phase 1 dose-escalation clinical trial. The patient received 1×10⁷ CAR-positive cells/kg, representing the highest dose level evaluated to date following lymphodepletion. Importantly, the study has reported no dose-limiting toxicities (DLTs) across all completed dose cohorts, highlighting the encouraging safety profile of this novel solid tumor-specific CAR-T therapy. In addition to achieving a key clinical development milestone, investigators also reported promising survival outcomes, with five patients surviving beyond one year after treatment, including one patient who has exceeded two years of survival, offering encouraging early evidence of potential clinical benefit in patients with advanced ovarian cancer who had exhausted multiple prior treatment options. The latest progress strengthens Anixa’s expanding immuno-oncology pipeline and reinforces growing optimism surrounding cell and gene therapies for difficult-to-treat solid tumors.
Novel FSHR-Targeted CAR-T Therapy Shows Encouraging Safety Profile
The ongoing Phase 1 clinical trial is evaluating the safety, tolerability, and preliminary efficacy of lira-cel, an innovative CAR-T/CER-T therapy designed to target the follicle-stimulating hormone receptor (FSHR). Unlike conventional CAR-T therapies that primarily target blood cancers, lira-cel focuses on solid tumors, where treatment has historically been more challenging due to tumor complexity and limited target specificity. FSHR is highly expressed on ovarian cancer cells and tumor-associated vasculature, while showing minimal expression in healthy tissues, making it an attractive target for precision immunotherapy.
The successful dosing of the highest planned cell dose without observing dose-limiting toxicities demonstrates continued confidence in the therapy’s safety profile as investigators proceed through escalating dose levels. The study continues to enroll women with recurrent ovarian cancer who have experienced disease progression after at least two previous lines of therapy, a patient population with limited therapeutic options and generally poor prognosis.
Promising Survival Outcomes Support Continued Clinical Development
Advertisement
Although the primary objective of this early-stage trial is to evaluate safety and tolerability, the survival outcomes observed thus far have generated considerable interest within the oncology community. According to the company, five treated patients have surpassed one year of survival, with individual survival durations reaching approximately 28, 20, 17, 17, and 13 months following treatment. One participant has now survived more than two years, an encouraging outcome considering the aggressive nature of recurrent ovarian cancer and the limited life expectancy typically associated with heavily pretreated patients.
Investigators believe these preliminary observations warrant continued clinical evaluation as enrollment advances through higher-dose cohorts. If future studies confirm these encouraging signals, lira-cel could emerge as a promising new immunotherapy option capable of improving outcomes for women facing recurrent ovarian cancer, an area where substantial unmet medical need continues to exist despite advances in targeted therapies and chemotherapy.
Innovative CAR-T Platform Expands Precision Oncology Pipeline
Anixa Biosciences continues to strengthen its position in precision oncology through strategic collaborations with leading research institutions, including Moffitt Cancer Center and Cleveland Clinic. The company’s therapeutic pipeline combines next-generation cell therapies with innovative cancer vaccine programs targeting ovarian, breast, lung, colon, and prostate cancers. Unlike traditional CAR-T therapies that utilize antibody fragments to recognize tumor antigens, lira-cel employs a unique Chimeric Endocrine Receptor-T (CER-T) technology, utilizing the natural follicle-stimulating hormone (FSH) ligand to selectively bind the FSHR receptor expressed on ovarian cancer cells.
This differentiated approach has the potential to improve tumor specificity while minimizing off-target effects. As global investment in cell and gene therapy continues to accelerate, the advancement of Anixa’s ovarian cancer CAR-T program represents another important step toward expanding the application of engineered immune cell therapies beyond hematologic malignancies and into the treatment of solid tumors, where innovative immunotherapies remain one of the most promising frontiers in cancer medicine.
Source: Anixa Biosciences press release
