Anixa Biosciences has administered the second dose of its chimeric antigen receptor T-cell (CAR-T) therapy to a patient in a Phase I clinical trial for ovarian cancer.
This development follows the patient’s positive response to the initial treatment. The trial is being conducted in partnership with Moffitt Cancer Centre.
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Anixa and Moffitt were previously granted approval for a single-patient investigational new drug (IND) application, which permitted the administration of a second dose to the patient.
This decision was based on a tumour biopsy that showed cellular infiltration and necrosis, suggesting biological activity of the CAR-T therapy.
The patient’s condition remained stable after the first infusion, with no need for alternative treatments, and she experienced a good quality of life. These outcomes led to the decision to administer a second dose to further enhance the positive results.
Oncologist Dr Monica Avila said: “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.”
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By GlobalDataMoffitt Department of Gynaecologic Oncology chair Dr Robert Wenham said: “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.
“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.”
The ongoing Phase I trial at Moffitt is focused on treating recurrent ovarian cancer in patients who have not responded to standard-of-care therapies.
To date, six patients have received the treatment, with three in the first cohort and another three in the second cohorts. The trial will continue to escalate doses after confirming the safety of the previous dosages.
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