WHO Approves International Name for Anixa's Novel CAR-T Therapy Targeting Ovarian Cancer
核心洞察
The World Health Organization's International Nonproprietary Names Expert Committee approved "liraltagene autoleucel (搜索)" as the official name for Anixa Biosciences' FSHR (搜索)-targeted CAR-T therapy for recurrent ovarian cancer.
The therapy represents a novel CER-T (chimeric endocrine receptor-T cell) technology that uses the natural FSH ligand instead of antibody fragments to target the FSHR (搜索) receptor on tumor cells.
Anixa is currently conducting a Phase 1 first-in-human trial in partnership with Moffitt Cancer Center, with plans to commence the 5th dose cohort in the coming weeks.
Anixa Biosciences announced that the World Health Organization's International Nonproprietary Names (INN) Expert Committee has approved "liraltagene autoleucel (搜索)" as the official non-proprietary name for the company's novel CAR-T therapy targeting recurrent ovarian cancer. The approval represents a significant regulatory milestone in the development pathway toward potential commercialization of this innovative immunotherapy.
The INN nomenclature scheme for CAR-T cell therapies follows a two-word structure describing the gene and cell component. According to Dr. Amit Kumar, Chairman and CEO of Anixa, "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."
Novel CER-T Technology Platform
Liraltagene autoleucel (搜索), also known as lira-cel (搜索), employs a follicle stimulating hormone receptor (FSHR (搜索))-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. The therapy represents a new class of CAR-T known as CER-T (chimeric endocrine receptor-T cell) therapy.
The technology is differentiated from conventional cell therapies because the natural ligand of the FSHR (搜索) receptor, FSH, binds to the FSHR receptor on the tumor cell instead of using an antibody fragment. This approach leverages the natural hormone-receptor interaction to direct T-cell activity against cancer cells.
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 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."
Ongoing Clinical Development
Liraltagene autoleucel (搜索) is currently being evaluated in a first-in-human Phase 1 trial (NCT05316129) conducted in partnership with Moffitt Cancer Center. The study is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The trial is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity.
Kumar noted that the company remains focused on the successful execution of the ongoing Phase 1 trial and looks forward to commencing the 5th dose cohort in the coming weeks. The technology is based on intellectual property exclusively licensed to Anixa by The Wistar Institute.
Regulatory Significance
Each INN name is unique and used to identify active pharmaceutical ingredients. Each active substance intended for pharmaceutical marketing must receive a unique name of worldwide acceptability to ensure clear identification, safe prescription, and dispensing of medicines to patients. With this approval, Anixa will transition to using liraltagene autoleucel (搜索), or lira-cel (搜索), in future communications.
The company's broader therapeutic portfolio includes collaborations with world-renowned institutions. Beyond the ovarian cancer program, Anixa is developing vaccines in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines targeting high-incidence malignancies in lung, colon, and prostate cancers.