On November 17, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved "liraltagene autoleucel" for the non-proprietary name of the Company’s novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The INN nomenclature scheme for CAR-T cell therapies follows a two-word structure describing the gene and cell component.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of our CAR-T therapy. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN approval, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy," said Dr. Amit Kumar, Chairman and CEO of Anixa. "Looking ahead, we remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel for the treatment of ovarian cancer, and look forward to commencing the 5th dose cohort in the coming weeks. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."
Each INN name is unique and is used to identify active pharmaceutical ingredients. Each active substance that is to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the clear identification, safe prescription and dispensing of medicines to patients. Anixa will transition to the use of liraltagene autoleucel, or lira-cel, in future communications.
Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine and the co-inventor of Anixa’s CAR-T technology, stated, "It is gratifying to see this technology advance under Anixa’s guidance and through the work being performed at Moffitt Cancer Center. Receiving its non-proprietary name from the WHO is an exciting step in the process toward commercialization of this technology."
About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.
(Press release, Anixa Biosciences, NOV 17, 2025, View Source [SID1234660038])