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Anixa Biosciences Reports Encouraging Phase 1 Trial Results for Lira-cel

Anixa Biosciences, Inc. (NASDAQ: ANIX), a company focused on innovative cancer therapies, recently shared new survival data from its ongoing Phase 1 clinical trial for lira-cel, a treatment aimed at recurrent ovarian cancer. The findings were presented on May 7, 2026, at the International Society for Cell & Gene Therapy’s annual meeting by Cheryl Cox, Director of Operations at Moffitt Cancer Center.

The trial, which employs CAR-T cell therapy targeting follicle-stimulating hormone receptor (FSHR), has observed some patients surviving substantially longer than the expected median survival rate of three to four months following treatment. Remarkably, one participant has survived for 28 months post-therapy, while three others have surpassed the one-year milestone with survival rates of 18, 17, and 17 months respectively. Furthermore, four additional patients have survived between 7 to 11 months, indicating a positive trend in outcomes.

Safety Profile and Administration
The preliminary safety data shared during the presentation is encouraging, with no dose-limiting toxicities (DLTs) reported across the initial dose cohorts. All dosing has been successfully administered via the intraperitoneal (IP) route, an approach that may enhance the therapy's effectiveness by allowing for direct delivery to the site of the tumor.

Notably, the absence of significant Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious reactions related to Cytokine Release Syndrome (CRS) has been observed. Furthermore, all adverse events recorded so far have been deemed unrelated to the administration of lira-cel.

Dr. Amit Kumar, the CEO of Anixa, emphasized the significance of these results given the limited treatment options available for patients suffering from recurrent ovarian cancer. The findings underscore the potential of lira-cel as a viable treatment, demonstrating not only safety but promising clinical outcomes that warrant further investigation.

Next Steps in the Trial
Looking ahead, the company plans to escalate the dosage in the next cohort. This phase will involve a dose approximately three times higher than that used previously, along with a lymphodepletion regimen that includes cyclophosphamide and fludarabine to create a more conducive environment for CAR-T cell expansion and longevity. The objective is to sustain the treatment's efficacy and potentially improve overall survival for participating patients.

About Lira-cel
Lira-cel represents a cutting-edge approach in cell-based therapy, making it noteworthy within the landscape of cancer treatments. By uniquely targeting FSHR, which is predominantly expressed in ovarian tissues and certain tumor cells, this immunotherapy has the potential to spare healthy cells from damage. With a clinical identifier of ClinicalTrials.gov Identifier NCT05316129, the ongoing trial is focusing on adult women who have not responded to at least two prior treatment modalities. Its primary aims include assessing safety and tolerability, identifying the maximum tolerated dose and evaluating early clinical efficacy.

About Anixa Biosciences, Inc.
Anixa is dedicated to the development of effective therapies and vaccines to tackle cancer, collaborating closely with esteemed institutions such as Moffitt Cancer Center and Cleveland Clinic. Their innovative approach includes not only CAR-T therapies like lira-cel but also a range of vaccines intended to prevent and treat various forms of cancer. With a commitment to advancing research, Anixa aims to provide cutting-edge solutions to patients with the hope of better outcomes in the fight against cancer.

To stay updated on Anixa's progress and to learn more about their portfolio, visit Anixa's website or follow them on LinkedIn, X, Facebook, and YouTube.