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Anixa Biosciences Reports Promising Survival Rates in Ovarian Cancer CAR-T Trial

Anixa Biosciences, Inc. (NASDAQ: ANIX), a leading biotechnology company focused on innovative cancer treatments, has shared an update regarding its Phase 1 clinical trial involving CAR-T therapy for ovarian cancer. This therapy aims to provide hope for patients battling recurrent ovarian cancer who have had limited treatment options.

The recent findings are particularly encouraging: multiple patients have exhibited survival times significantly exceeding expected benchmarks, even at lower dosage levels of CAR-T therapy. Specifically, among the twelve patients treated so far, seven have surpassed their projected median survival of just three to four months. One patient remarkably survived 28 months post-treatment, while others have survived for periods ranging from 14 to 17 months. The results suggest that Anixa's CAR-T therapy could be offering substantial benefits to this hard-to-treat patient population.

The ongoing trial is specifically targeting adult women diagnosed with recurrent ovarian cancer who have previously failed standard chemotherapy treatments. So far, the trial has been administered across four dosage levels, with no observed dose-limiting toxicities (DLTs), which are adverse effects that limit the increase in dose. This clean safety profile prompted Anixa in partnership with Moffitt Cancer Center to seek and receive regulatory approval for a protocol amendment, allowing for a significant increase in the dosing levels of the CAR-T cells.

Under the new protocol, doses will rise from the previous range of 1×10⁵ to 1×10⁷ CAR-positive cells per kilogram of body weight to a substantial maximum of 1×10⁹ cells/kg. This increase, equating to a twenty-fold escalation, is a significant step in exploring the therapy's potential efficacy. Moffitt's review board has approved this modification, demonstrating a strong commitment to advancing potentially life-saving treatments.

Dr. Amit Kumar, Chairman and CEO of Anixa, expressed optimism, stating, "Despite these patients receiving doses we believe are below the optimal therapeutic level, the survival rates observed thus far inspire confidence. The absence of any dose-limiting toxicities emphasizes the feasibility of exploring higher doses safely."

The trial's design has also incorporated a preparatory regimen called lymphodepletion, which involves the administration of cyclophosphamide and fludarabine. This treatment aims to reduce competing immune cells, making the environment more favorable for the CAR-T cells, thus potentially enhancing their effectiveness against ovarian tumors that are notoriously challenging to treat.

While lymphodepletion is a standard practice in CAR-T therapies aimed at hematological cancers, its application in solid tumors remains experimental. Nevertheless, both Anixa and Moffitt, in conjunction with the U.S. FDA, view this addition as a critical opportunity to investigate whether lymphodepletion can further improve CAR-T therapy's performance in treating localized tumors.

Dr. Robert Wenham, from Moffitt’s Gynecologic Oncology Program and principal investigator for the trial, remarked on the trial's potential, noting that the absence of DLTs has afforded them the flexibility to explore higher dosage levels safely. His confidence in the study's future direction was evident, emphasizing the hope that these explorations will lead to better therapeutic outcomes for participating patients.

In conjunction with these updates, Dr. Kumar is set to elaborate on the trial findings and discuss Anixa's strategic plans in a forthcoming fireside chat hosted by Water Tower Research on February 10, 2026.

About Lira-cel, Anixa's CAR-T Therapy

Lira-cel, or liraltagene autoleucel, is a pioneering CAR-T therapy that selectively targets the follicle-stimulating hormone receptor (FSHR), predominantly expressed in ovarian tissues and certain cancer cells. This specificity aims to minimize damage to healthy tissues, representing a significant advancement over conventional treatments.

About Anixa Biosciences

Anixa is at the forefront of developing novel cancer treatments, collaborating with esteemed institutions like Moffitt Cancer Center for trials and cutting-edge therapies. Its approach encompasses a mix of innovative biotechnological strategies aimed at both treatment and prevention, with ongoing developments in various vaccine platforms for different cancers.

Through this multifaceted approach, Anixa continues to pursue advancements in oncology, with the hope of transforming cancer care for patients worldwide. For more details on Anixa and its initiatives, please visit www.anixa.com.