LAEKNA-B (02105) announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for LAE118. LAE118 is a novel, pan-mutant selective PI3Kα inhibitor intended for the treatment of patients with solid tumors harboring PIK3CA mutations. The company will work closely with regulatory authorities to complete the relevant application process. Building on its strong and proven track record in clinical development and the out-licensing of LAE002 (afuresertib), the company is committed to providing this precision therapy for cancer patients in need of novel treatment options. LAE118 is a novel, pan-mutant selective PI3Kα inhibitor. As a new therapeutic approach targeting PIK3CA-mutated solid tumors, the group is actively advancing this candidate drug into clinical research.