FDA approves clinical trials under IND application for FMC-242 in solid tumors
“FDA allowance of our IND for FMC-242 represents an important milestone as we advance FMC-242, a differentiated medicine discovered through our AI-powered CovalentAI™ platform, into clinical development,” said Chris Varma, Ph.D., Co-founder and Chief Executive Officer of Frontier Medicines. “PI3Kα is the second most frequently mutated oncogene in human cancer and plays an essential role in both PI3Kα and RAS-driven cancers. We rationally designed FMC-242 to selectively disrupt the interaction between PI3Kα and RAS, a critical driver of oncogenic signaling, while leaving normal metabolic signaling intact. By potentially addressing the dose-limiting toxicities and resistance mechanisms associated with existing PI3Kα inhibitors, we believe FMC-242 could offer a differentiated treatment approach both as monotherapy and in combination with other targeted agents. Moreover, FMC-242’s starting dose is at the high end of the predicted therapeutic dose range, reflecting the CovalentAI™ platform’s ability to generate highly selective medicines resulting in expedited drug development. We look forward to beginning patient enrollment in the monotherapy dose-escalation cohorts in the coming months.”
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