WHO grants nonproprietary name to ovarian cancer cell therapy
Anixa Biosciences' experimental treatment being evaluated in Phase 1 trial
A committee of the World Health Organization (WHO) has approved an international nonproprietary name (INN) for Anixa Biosciences’ experimental cell therapy for ovarian cancer.
The therapy, which is already in clinical testing, will now carry the INN liraltagene autoleucel, or lira-cel for short. An INN — sometimes referred to as a generic name — is a designation given to a specific pharmacological product for use worldwide.
“The assignment of the nonproprietary name represents an important step in the development and potential future commercialization of our CAR-T therapy,” Amit Kumar, PhD, chairman and CEO of Anixa, said in a company press release. “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.”
A look at how lira-cel targets ovarian cancer
CAR T-cell therapies are a newer form of cancer treatment designed to harness the immune system to attack cancer cells. They work by taking T-cells — immune cells capable of killing other cells in the body — and equipping them with a chimeric antigen receptor (CAR), which is essentially a molecular weapon that targets a specific protein.
In the case of lira-cel, T-cells target follicle stimulating hormone receptor (FSHR), a molecule found on normal ovarian cells, as well as on tumor vasculature and various cancer cell types. Ovarian cancer is a form of gynecological cancer that develops when cells in or near the ovaries begin to grow uncontrollably. While CAR T-cell therapies have proven effective in several blood cancers, there is currently no CAR T therapy that is proven safe and effective for ovarian cancer in late-stage trials.
Lira-cel is being evaluated in a Phase 1 clinical trial (NCT05316129) that is testing its safety and preliminary efficacy when administered either intravenously (into the vein) or intraperitoneally (into the abdomen). The study is assessing five dose levels in about 10 women with recurrent ovarian cancer that has progressed after at least one platinum-based chemotherapy and at least two prior chemotherapy regimens. The trial is recruiting participants at the Moffitt Cancer Center in Florida.
“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,” Kumar said.
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