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Anixa Biosciences, Inc. (Anixa), a biotechnology company focused on the treatment and prevention of cancer, announced updated positive survival observations from its ongoing phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the company's follicle-stimulating hormone receptor (FSHR)-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer.
Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting by Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center. The presentation, titled "A phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer," reviewed the trial design, objectives and current clinical status of Anixa's ongoing phase 1 trial of lira-cel.
Several trial participants have lived significantly beyond their median expected survival of 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, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive.
Preliminary safety observations presented at ISCT include:
- No dose-limiting toxicities ("DLTs") have been encountered in the first three dose cohorts.
- All doses have been administered successfully by the intraperitoneal ("IP") route.
- There have been no observations of Immune Effector Cell-Associated Neurotoxicity Syndrome ("ICANS") or significant Cytokine Release Syndrome ("CRS").
- All significant adverse events observed to date have been unrelated to lira-cel administration.
Dr. Amit Kumar, chairman and chief executive officer of Anixa, stated, "The updated survival observations from this ongoing phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer. While this remains an early-stage study, lira-cel has continued to demonstrate a favourable preliminary safety profile, with no dose-limiting toxicities, ICANS or CRS observed in the first three dose cohorts. We believe these findings support continued dose escalation and clinical evaluation."
Dr Kumar continued, "We look forward to treating patients in the next dose cohort, which is expected to evaluate a dose approximately three times higher than the previous cohort and to include lymphodepletion with cyclophosphamide and fludarabine. This approach may create a more favourable environment for CAR-T cell expansion, persistence and activity."
Liraltagene autoleucel, or lira-cel, is Anixa's investigational autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor ("FSHR"), which Anixa believes represents a unique CAR-T target in ovarian cancer. FSHR is selectively expressed on ovarian cells, tumour vasculature and certain cancer cells, but not in most healthy tissue. The ongoing phase 1 trial (ClinicalTrials.gov Identifier: NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.
The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.
Anixa Biosciences, Inc. is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology.
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