- Kite Pharma, one of the hot biotech pioneers in T-cell cancer therapies, announced on Saturday that new patient enrollment in certain clinical trials will be halted pending a review of manufacturing facilities by the National Institutes of Health (NIH).
- The NIH review will affect cell therapy manufacturing facilities at the National Cancer Institute (NCI), a R&D partner with Kite. Kite and NCI are cooperating on several ongoing trials studying T-cell approaches against hematological and solid tumors. For those trials, patients who are currently enrolled will continue to receive treatment, but no new patients can join.
- Kite said the review is not related to KTE-C19, its CAR-T lymphoma therapy, or the biotech's manufacturing capabilities. The four ongoing KTE-C19 trials will continue.
Kite said the NIH review was voluntary and tied to a review of all NCI facilities involving sterile material. According to EP Vantage, enrollment had been halted on April 12 but Kite did not release details until Saturday.
One NCI trial of a fully human anti-CD19 CAR-T treatment will not be affected by the review. Requests for comment were not returned by press time.
Separately, the NCI gave an update on a small early-stage trial of a T-cell receptor therapy licensed by Kite. Presented at the American Association for Cancer Research's conference in New Orleans, the data showed three patients continued to have sustained responses against solid tumors after receiving the therapy, reports Bloomberg. An initial presentation last November had first revealed the partial responses experienced by the three patients.
However, no new responses were recorded among the other eleven patients who received doses.
The therapy in question targets an antigen known as MAGE-A3, which is expressed in some solid tumors. Kite expects to file an investigational new drug application with the FDA for a MAGE-A3 product by the end of the year.