Anixa Biosciences, Inc. "Anixa" or the a biotechnology company focused on the treatment and prevention of cancer, announced that it has administered the second dose of its CAR-T therapy to an individual patient.This follows a positive response after the initial treatment in the ongoing Phase 1 clinical trial of its chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study is being conducted in collaboration with Moffitt Cancer Center.
Previously, Anixa and Moffitt received approval for a single-patient IND application, allowing the administration of a second dose to a patient whose tumor biopsy revealed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy.
After the first infusion, the patient remained stable, did not require alternative treatment and her quality of life was good, leading to the decision to administer a second dose to further enhance these positive results. These findings offer promising indications that the CAR-T therapy may serve as a successful long-term treatment option, highlighting its potential effectiveness in the fight against ovarian cancer.
"While this is a single patient, the positive clinical activity observed, including necrosis and T cell infiltration, is an encouraging sign of the therapy's potential effectiveness," stated Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial. "Based on these results, we recently submitted an amendment to the current trial protocol to allow patients who may benefit to receive a second dose. We are excited to continue evaluating this treatment in our ongoing trial, and we are optimistic about the potential long-term benefits it may offer to patients with ovarian cancer."
Dr. Monica Avila, the patient's treating oncologist, stated, "My patient received her first infusion in May 2023. We are now nearly 18 months from that date, and she is doing well and is now receiving this second dose. I am thrilled with her status and look forward to observing further progress."
Dr. Amit Kumar, CEO of Anixa Biosciences, stated, "We are proud to have an outstanding team, including Dr. Wenham and Dr. Avila, and we are encouraged by the positive response seen in this patient following the initial dose of our CAR-T therapy. The continued clinical improvements reinforce our confidence in the potential of this groundbreaking treatment to provide hope for patients battling ovarian cancer. We remain committed to advancing this innovative therapy and bringing new, effective treatment options to the forefront."
The Phase 1 clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.
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