One patient in Anixa Biosciences' Phase 1 CAR-T trial for ovarian cancer has now gone three months without disease progression. This is the first time the company has seen stable disease last this long in its program. The result came in the highest dose group of the ongoing study. For women with recurrent ovarian cancer, that matters. Few options exist.
The patient got treatment at Moffitt Cancer Center. She received 1×10⁷ CAR-positive cells per kilogram after lymphodepletion. No dose-limiting toxicities have turned up at any dose so far. That is a key safety sign as Anixa moves to higher doses in this first-in-human trial. Researchers are now running correlative studies to see how long the CAR-T cells last in the body. According to a recent RTTNews update, a second patient has also received the highest dose as of October 2026. This expands the safety and efficacy data for this group.
Four patients in the trial have survived more than one year after treatment, with one patient reaching approximately 28 months of survival.
FSHR-targeted CAR-T platform and trial design
Anixa’s therapy, liraltagene autoleucel (lira-cel), targets the follicle-stimulating hormone receptor (FSHR). This marker shows up on ovarian cancer cells but is mostly missing from healthy tissue. The Phase 1 trial (ClinicalTrials.gov NCT05316129) is open to adult women with recurrent ovarian cancer who have failed at least two prior treatments. This is a late-line setting, as confirmed by independent coverage. The main goals are to check safety and tolerability. Secondary endpoints look for early signs of efficacy, like disease stabilization and survival.
Dr. Amit Kumar, Chairman and CEO of Anixa, said the study is focused on safety. Still, seeing stable disease for 90 days and several patients living more than a year is encouraging as the company tests higher doses of lira-cel. Dr. Robert Wenham, principal investigator at Moffitt, also pointed to the lack of dose-limiting toxicities. He hopes to see future responses, from stable disease to partial or even complete remissions. As OncLive reported, this is the first time the trial has seen stable disease last 90 days. It happened in the first patient treated at the highest dose.
Technology origins and business model
The CAR-T technology behind lira-cel was developed by Dr. Jose R. Conejo-Garcia at Duke University School of Medicine. Anixa holds an exclusive license from The Wistar Institute. Lira-cel is different from standard CAR-T therapies. Instead of using antibody fragments, it uses a chimeric endocrine receptor-T cell (CER-T) design. This approach uses the natural ligand FSH to bind FSHR on tumor cells. That could open a new path for targeting solid tumors, where CAR-T has often failed.
The Phase 1 trial is a single-center, dose-escalation study conducted at Moffitt Cancer Center, designed to assess safety, tolerability, and early efficacy signals in patients with recurrent ovarian cancer.
Anixa’s pipeline goes beyond CAR-T. The company is working with Cleveland Clinic on cancer vaccines that target “retired” proteins found in some cancers. Anixa’s business model is built on partnerships with top research centers to access and develop new immunotherapy and vaccine technologies.
Early signals and sector context
The data so far are early. Only one patient has shown sustained stable disease. Still, the lack of dose-limiting toxicities at the highest dose and this first sign of disease control are reasons for cautious hope. CAR-T therapy for solid tumors remains tough. Few lasting responses have been seen. Recent reported earlier results from other CAR-T programs show that clean safety and early efficacy can build momentum. But real proof will need more patients and longer follow-up.
With lira-cel, Anixa is trying to stand out in ovarian cancer immunotherapy. The company is pushing dose escalation and going after a new target. That sets it apart from many rivals. The real test is still ahead. Will these early signals turn into real clinical benefit as the trial moves forward? For now, safety at high doses and the first sign of disease stabilization in a patient offer a rare bit of hope. In this field, progress comes in small steps.
