EXCLUSIVE: FDA Approves Anixa Biosciences' Individual Patient Trial Application For Ovarian Cancer CAR-T Therapy

On Tuesday, Anixa Biosciences Inc ANIX announced that its collaborator, Moffit Cancer Center, has received FDA approval for an individual patient Investigational New Drug Application (IND) to allow a second dose of its CAR-T therapy for a patient that may be demonstrating clinical activity to the initial treatment.

Dr. Robert Wenham, the principal investigator of the trial, stated, “In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T-cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response.”

Dr. Amit Kumar, CEO of Anixa Biosciences, commented, “We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort.”

The Phase I 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.

Last week, Anixa Biosciences’ Board of Directors authorized a share repurchase program of up to $5 million.

“We believe that Anixa’s stock is currently undervalued, and this program provides an opportunity to enhance long-term shareholder value,” stated Dr. Amit Kumar, Chairman and CEO of Anixa.

Price Action: ANIX stock closed at $3.13 on Monday.

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