- Five of the National Cancer Institute's (NCI) thirteen suspended cell therapy studies resumed new patient enrollment as of July 4, reports EP Vantage.
- The National Institutes of Health, which oversees the NCI, halted new patient enrollment in April due to safety and quality concerns at the NCI's cell therapy manufacturing facilities. Seven of the suspended studies were part of research affiliated with either Lion or Kite Pharmaceuticals.
- So far, Lion Biotechnology's three affiliated studies have resumed enrollment, but Kite Pharma still has four affiliated studies halted, EP Vantage said. An NCI spokesperson told the publication that all studies should resume within three months.
When the NIH announced on April 19 it would halt new patient enrollment for trials reliant upon the NCI's cell therapy laboratory, some worried about the indefinite timeline and potential setback for Lion and Kite's research agreements with the NCI.
While the two companies never expressed much concern regarding the halts given their own manufacturing abilities, investors can breathe easy now that all of Lion's trials have resumed enrollment and Kite's projects look set to follow suit within the next three months.
Lion's three projects with the NCI involve research on tumor-infiltrating lymphocyte therapy, a treatment designed to overcome cancer's immunosuppressive effects in treating solid tumors. The trials are evaluating the treatment for Stage IV metastatic melanoma.
Meanwhile, the projects affiliated with Kite focused on testing engineered T-cell receptors' efficacy against various antigens, including the MAGE-A3 and NY-ESO which appear in various solid tumors. Kite is expected to file an investigational new drug application with the FDA for a MAGE-A3 product by the end of the year.
Also suspended is one of Kite's CAR-T investigations, but the company claims the suspended project does not affect the development of its main CAR-T project, KTE-C19, which it hopes to get approved next year.