- Citing quality and safety concerns, the National Institutes of Health has suspended production at two facilities which manufacture sterile or infused products for use in clinical studies. No new patients will be enrolled in the affected clinical trials, the NIH said in a statement Tuesday.
- One of the facilities, a National Cancer Institute laboratory, had been working with Kite Pharma to manufacture T-cell therapies for multiple collaborative trials. The company announced the NIH review over the weekend, saying patients currently enrolled in NCI trials will continue to receive therapy.
- The NIH does not believe any patients have been harmed by the compliance violations, but will conduct a "rigorous clinical review."
Last year the NIH halted sterile operations at the Clinical Center Pharmaceutical Development Section, which supplies the NIH Clinical Center, after finding fungal contamination in two vials of a drug called albumin. As part of its response, the NIH hired two companies to assess its facilities which produce sterile or infused products for patients enrolled in clinical trials.
Preliminary findings concluded some facilities were noncompliant with quality and safety standards, leading to the shutdown of the NCI lab and another National Institute of Mental Health facility which produces positron emission tomography materials.
In December, NIH Director Francis Collins had brought together a working group to "examine structural and cultural issues" and make recommendations on ways to improve the organization and management of the Clinical Center. That working group is scheduled to deliver its report Thursday afternoon to an advisory committee for Collins.
The halt on enrollment sets back work the NCI was doing in collaboration with Kite Pharma. The biotech originally entered into a cooperative R&D agreement with the NCI in 2012. Under principal investigator Dr. Steven Rosenberg, the NCI lab began multiple trials of CAR-T and T-cell receptor therapies. Kite expanded its partnership with a second agreement in January 2016.
So far, the NCI has studied T-cell therapies against both hematological and solid tumors. As part of the agreements, Kite has exclusive option to negotiate commercial licenses from the NCI's research, and has done so with several TCR candidates, according to its annual report.
The NIH review will not affect Kite's development of its lead candidate KTE-C19, the company said. It is also still on track to submit an investigational new drug application with the FDA for its TCR product targeting a MAGE antigen.