Anixa Biosciences, Inc. (Anixa), a biotech firm dedicated to cancer treatment and prevention, revealed its initiation of patient treatment in the third cohort of its ongoing Phase 1 clinical trial. This trial explores their innovative chimeric antigen receptor-T cell (CAR-T) therapy tailored for treating recurrent ovarian cancer. This research effort is carried out in collaboration with Moffitt Cancer Center (Moffitt).
In earlier stages, no dose-limiting side effects were encountered in the initial cohort of three patients nor in the subsequent trio, where the CAR-T cell dose was tripled from the first group. After a mandated observation period of one month to ensure safety and collect data, trial advancements have led to dosing the first patient in the third group, with a tenfold increase from the original dose.
Anixa’s CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), a receptor identified as exclusively present on specific ovarian cells, tumor vasculature, and particular malignant cells. The first-of-its-kind study (NCT05316129) targets adult women with recurrent ovarian tumors that have shown progression despite at least two previous treatments. It intends to assess safety and establish the maximum tolerable dose, alongside observing treatment efficacy.
According to Dr. Robert Wenham, the study’s principal investigator and Head of the Department of Gynecologic Oncology at Moffitt, “Given the absence of dose-limiting safety challenges in prior patient groups, we have proceeded to assess a tenfold higher dosage than initially administered. As the trial advances, we aim to confirm the tolerability of our CAR-T approach and are hopeful about demonstrating effectiveness in solid tumors—a domain where traditional CAR-T therapies primarily excel in hematological malignancies and lymphoma treatment. Trial progress is encouraging, especially observing one patient from the first cohort showing a stable condition and improvements lasting over a year post-therapy. An intriguing tumor biopsy detailed necrosis and T cell presence. These outcomes prompted us to submit a protocol amendment enabling patients with more potential improvement to receive another dose. Higher cell doses might enhance effectiveness, and an additional dose could further promote response rates and duration. We hold pride in our achievements thus far and anticipate enrolling more patients in the third cohort.”
Anixa, operating at the clinical stage, devotes its focus to cancer treatment and preventive strategies. Their therapeutic initiatives include a collaborative ovarian cancer immunotherapy program with Moffitt Cancer Center. This program utilizes a groundbreaking CAR-T approach, specifically the chimeric endocrine receptor-T cell (CER-T) technology.