Anixa Biosciences has treated the first patient in the fifth cohort of its Phase I clinical trial evaluating a new chimeric antigen receptor T-cell (CAR-T) therapy for recurrent ovarian cancer.
Liraltagene autoleucel (lira-cel), the CAR-T candidate under investigation, is designed to target follicle-stimulating hormone receptor (FSHR), which is found on ovarian tumour cells, tumour vasculature, and selected other cancer cells, but with little presence in normal tissue.
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The ongoing dose-escalation trial will assess the tolerability, early efficacy signals, and safety of the therapy. It is being carried out at Moffitt Cancer Center in the US.
The patient received a 1×10⁷/kg CAR-positive cells dose following lymphodepletion.
Five participants in the study have so far each survived at least one year following treatment. Their individual survival times post-treatment are reported as approximately 28, 20, 17, 17 and 13 months.
The study population consists of patients with recurrent ovarian cancer who have previously received multiple lines of therapy.
Anixa Biosciences chairman and CEO Dr Amit Kumar said: “Advancing to the fifth cohort and highest dose level while observing no dose-limiting toxicities across the study to date is a meaningful milestone for the programme.
“Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes.
“While this Phase I study is primarily designed to evaluate safety, we are highly encouraged that five patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter of weeks.
“These are precisely the kinds of signals we hoped to see at this stage. We look forward to further evaluating this novel solid tumour-specific CAR-T therapy as enrolment progresses.”
The trial is enrolling adult women with recurrent ovarian cancer after at least two previous therapies.
In October 2024, Anixa Biosciences administered the second dose of its CAR-T therapy to a patient in a Phase I clinical trial for ovarian cancer.
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