Anixa Biosciences, Inc. (NASDAQ:ANIX) on Monday provided an update on patient outcomes observed in its ongoing Phase 1 ovarian cancer CAR-T clinical trial, following regulatory approval of a protocol amendment that enables substantial dose escalation.
Trial Overview
Liraltagene autoleucel, or lira-cel, targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue.
The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer who have failed standard-of-care chemotherapy and progressed after two or more prior therapies.
To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately three to four months, based on disease stage and prior therapy history.
Patients Surviving Over Two Years
One patient survived 28 months following treatment, three patients have survived greater than one year following treatment (17, 15, and 14 months, respectively), and three patients have survived 11, 8, and 8 months, respectively.
Three patients who have reached 15, 14, and 8 months remain alive, and one additional patient who was treated more recently is also currently alive.
No dose-limiting toxicities (DLTs) have been observed to date, prompting Anixa's partner, Moffitt Cancer Center, to obtain Institutional Review Board (IRB) approval for a protocol amendment that permits significant dose escalation.
If no DLTs are observed at this level, additional escalation may be pursued at the discretion of the principal investigator.
Anixa and Moffitt believe the favorable safety profile observed to date is partially attributable to the direct intra-peritoneal delivery of CAR-T cells, which differs from conventional intravenous administration and may reduce systemic toxicity while enhancing localized tumor targeting.
Amendment
Under the amended protocol, dosing may increase from the original range of 1×10⁵ to 1×10⁷ CAR-positive cells per kilogram of body weight (cells/kg) to as high as 1×10⁹ cells/kg, representing a two-order-of-magnitude increase.
As part of the amended study design, the next patient cohort will receive 1×10⁷ cells/kg following treatment with cyclophosphamide and fludarabine, a preparatory regimen known as lymphodepletion.
Lymphodepletion reduces competing immune cells, creating a more favorable environment for CAR-T expansion, persistence, and activity. While lymphodepletion is routinely used in CAR-T therapies for hematologic cancers, its role in solid tumors remains investigational.
Price Action: Anixa Biosciences shares were up 1.69% at $3.01 during premarket trading on Monday, according to Benzinga Pro data.
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