Anixa Biosciences has received United States Adopted Names (USAN) approval for its follicle‑stimulating hormone receptor‑targeted CAR‑T therapy, now named liraltagene autoleucel. The approval follows a prior International Nonproprietary Names (INN) designation by WHO and confirms a unique, conflict‑free identity for the product in the U.S. market.
The therapy, internally known as lira‑cel, is a chimeric endocrine receptor‑T cell (CER‑T) product that uses the natural ligand of FSHR to target ovarian tumor cells and tumor vasculature. Anixa is conducting a first‑in‑human Phase 1 study at Moffitt Cancer Center in Tampa, Florida, enrolling patients with recurrent ovarian cancer who have progressed after at least two prior lines of therapy. The trial has completed the third dose cohort, entered the fourth cohort, and is preparing to initiate the fifth cohort, with no dose‑limiting toxicities reported to date.
Anixa’s development is under an exclusive worldwide license from The Wistar Institute, which holds U.S. Patent 12,384,826 covering the CAR‑T construct. The patent, issued in August 2025, provides protection through 2045 and underpins the company’s intellectual‑property strategy.
The U.S. market for recurrent ovarian cancer is estimated at $3.5 billion annually, and the broader solid‑tumor CAR‑T market is projected to reach $10 billion by 2030. By securing a USAN name, Anixa removes a regulatory barrier that could delay labeling, clinical trial submissions, and future licensing negotiations, thereby positioning the company to pursue partnerships with larger pharmaceutical firms seeking differentiated CAR‑T platforms for solid tumors.
Dr. Amit Kumar, Chairman and CEO, said the USAN approval is an “important step in the development and potential future commercialization” and that it “provides a universally recognized, conflict‑free non‑proprietary name that will streamline regulatory filings, labeling, and commercial agreements worldwide.” He added that the company remains focused on the successful execution of the Phase 1 trial.
Analysts noted that the naming approval, while a necessary regulatory milestone, did not deliver new clinical data, and the market reaction was muted. Investors viewed the event as a procedural step that removes a hurdle but does not immediately alter the company’s valuation or near‑term revenue prospects.
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