Gritstone Oncology announced that following feedback from the FDA the SLATE Phase 1 clinical study may be accelerated by up to six months from the company’s prior expectations by leveraging pre-clinical data generated for the original GRANITE investigational new drug, or IND, application. Based on the similarities in the two investigational therapies, the common patient populations and the consistency in manufacturing that has led to comparable drug products, the FDA has in principle agreed to accept previously conducted GRANITE IND-enabling toxicology studies in support of the SLATE IND, which brings the anticipated IND filing date closer. The Phase 1 study will evaluate SLATE in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including metastatic lung cancer, pancreatic cancer and colorectal cancer. There will also be a cohort of patients with other solid tumor types who possess appropriate mutation/HLA combinations. Clinical acceleration is also enabled by early identification of eligible patients using a screening protocol which is currently running at multiple trial sites. The company expects to present preliminary data from the first part of both the SLATE and GRANITE Phase 1 trials in Q4.
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