Anixa Biosciences received the World Health Organization’s approval of the international non‑proprietary name (INN) “liraltagene autoleucel” for its follicle‑stimulating hormone receptor‑targeted CAR‑T therapy aimed at recurrent ovarian cancer. The approval, granted on November 17 2025, establishes a globally recognized, conflict‑free name that will be used in all future regulatory filings, scientific publications, and marketing materials.
The therapy, licensed from The Wistar Institute and developed in partnership with Moffitt Cancer Center, is currently in a Phase 1 clinical trial (NCT05316129). The INN designation is a critical milestone that signals regulatory progress, facilitates international collaboration, and positions the product for eventual commercialization.
Dr. Amit Kumar, Chairman and CEO, emphasized that the INN approval “represents an important step in the development and potential future commercialization of our CAR‑T therapy.” He added that the company remains focused on advancing the Phase 1 program and anticipates initiating the fifth dose cohort in the coming weeks.
The approval also strengthens Anixa’s portfolio of differentiated oncology products and enhances its attractiveness to larger pharmaceutical partners. By securing a unique, conflict‑free name, the company can more effectively pursue licensing or partnership discussions, potentially accelerating market entry and revenue generation.
While the INN approval does not directly impact current financial results, it is a key regulatory milestone that supports the company’s long‑term growth strategy. The therapy’s ongoing clinical development, combined with the INN designation, positions Anixa to advance toward regulatory approval and commercial launch, thereby expanding its pipeline and reinforcing its focus on innovative cancer immunotherapies.
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