Here's more on the NIH story -
Fierce BioTech
by John Carroll | Apr 20, 2016
The NIH has put a crimp in the clinical trial work of Steven Rosenberg, Kite Pharma’s star collaborator at the National Cancer Institute. The feds slammed the brakes on the production of experimental drugs at two of its facilities--including cell therapies that Rosenberg works with--after an internal inspection found they weren’t in compliance with safety and quality regulations.
The NIH put out a statement on Tuesday saying that work at an NCI lab and a facility run by the National Institute of Mental Health, which produces positron emission tomography (PET) materials, was suspended after an inspection uncovered the compliance issues.
“There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken,” the NIH noted in its statement. “NIH will not enroll new patients in affected trials until the issues are resolved.”
The NIH’s statement follows a release from Kite--one of the leading biotechs involved in CAR-T work--over the weekend saying only that the NIH facilities were undergoing a “voluntary internal review” that required a halt in new patient enrollment for the NCI’s cell therapy trials until the review is completed. Lion Biotechnologies used the same reference to explain a suspension of its NCI studies on tumor-infiltrating lymphocytes.
The problems at the facilities were uncovered after a fungal infection was discovered last summer in vials of albumin that were manufactured for the NIH Clinical Center. That embarrassment triggered a wide ranging probe into NIH facilities that led to the recent suspension, though the feds provided no details on exactly what they found.
Rosenberg has played a central role for Kite--which is routinely spotlighted by the biotech as a distinct competitive edge--working on reengineering T cells extracted from patients with chimeric antigen receptors that turn them into weapons aimed at cancer cells. The biotech is involved in a fast-paced rivalry with Juno, Novartis and others who are all racing to develop the first approved cell therapies for patients.
Fierce BioTech
by John Carroll | Apr 20, 2016
The NIH has put a crimp in the clinical trial work of Steven Rosenberg, Kite Pharma’s star collaborator at the National Cancer Institute. The feds slammed the brakes on the production of experimental drugs at two of its facilities--including cell therapies that Rosenberg works with--after an internal inspection found they weren’t in compliance with safety and quality regulations.
The NIH put out a statement on Tuesday saying that work at an NCI lab and a facility run by the National Institute of Mental Health, which produces positron emission tomography (PET) materials, was suspended after an inspection uncovered the compliance issues.
“There is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken,” the NIH noted in its statement. “NIH will not enroll new patients in affected trials until the issues are resolved.”
The NIH’s statement follows a release from Kite--one of the leading biotechs involved in CAR-T work--over the weekend saying only that the NIH facilities were undergoing a “voluntary internal review” that required a halt in new patient enrollment for the NCI’s cell therapy trials until the review is completed. Lion Biotechnologies used the same reference to explain a suspension of its NCI studies on tumor-infiltrating lymphocytes.
The problems at the facilities were uncovered after a fungal infection was discovered last summer in vials of albumin that were manufactured for the NIH Clinical Center. That embarrassment triggered a wide ranging probe into NIH facilities that led to the recent suspension, though the feds provided no details on exactly what they found.
Rosenberg has played a central role for Kite--which is routinely spotlighted by the biotech as a distinct competitive edge--working on reengineering T cells extracted from patients with chimeric antigen receptors that turn them into weapons aimed at cancer cells. The biotech is involved in a fast-paced rivalry with Juno, Novartis and others who are all racing to develop the first approved cell therapies for patients.