Lantern Pharma secures FDA clearance for planned Phase 1b/2 trial of LP-184

Lantern Pharma (LTRN) announced that the U.S. Food and Drug Administration, FDA, has cleared the amendment to its Investigational New Drug, IND, application to initiate a Phase 1b/2 clinical trial of LP-184 in a genomically defined patient population of non-small cell lung cancer, NSCLC, where there is a need to improve patient outcomes. Outcomes: The FDA has cleared the LP-184 investigational new drug application amendment for the treatment of a biomarker defined patient population of non-small cell lung cancer. The planned phase 1b/2 clinical trial plans to evaluate LP-184 in advanced NSCLC patients with KEAP1 and/or STK11 mutations and low expression of PD-L1 in combination with the immune checkpoint inhibitor therapies, nivolumab and ipilimumab. LP-184 is a synthetically lethal, novel small molecule advanced and developed with Lantern’s AI platform, RADR. The median overall survival for newly diagnosed, advanced NSCLC with KEAP1 and/or STK11 mutations treated with checkpoint inhibitors and chemotherapy is estimated to be 15 months and this population presents an annual market opportunity in excess of $2 billion USD.