NEW YORK – Gritstone Bio on Tuesday said that it will work with the National Cancer Institute on a Phase I trial of a KRAS-directed combination regimen comprising an investigational neoantigen vaccine and an autologous T-cell receptor (TCR) therapy.
The trial will enroll patients who have metastatic cancers harboring a KRAS G12V or G12D mutation and are eligible for adoptive cell transfer. The trial will be led by Steven Rosenberg, chief of the surgery branch at the NCI's Center for Cancer Research, who developed the autologous KRAS mutation-specific TCR-transduced T-cell (TCR-T) therapy. Gritstone will provide its neoantigen vaccine candidate, SLATE-KRAS, for the study.
Adding SLATE-KRAS to the TCR-T could deepen responses and improve outcomes in patients with solid tumors, according to Karin Jooss, head of R&D at Gritstone Bio. "Our KRAS-directed vaccine has demonstrated the ability to induce and expand KRASmut-specific T cells and drive them into solid tumors in multiple clinical studies," Jooss said in a statement. "Combining this modality with autologous KRAS mutant-specific TCR transduced T-cells, as delivered by Dr. Rosenberg in his clinical program at the NCI, is a rational approach to augmenting therapeutic efficacy."
Gritstone, based in Emeryville, California, is also evaluating SLATE-KRAS in a Phase II trial in KRAS-mutant solid tumors including colorectal and non-small cell lung cancers. The firm is also developing another neoantigen cancer vaccine, called GRANITE, in microsatellite-stable colorectal cancers.