In this update of small molecules in the news for February 2023, we will cover recent:
– Molecules in Motion: clinical trial updates and FDA filings
– Negative Readouts: halted, discontinued or altered clinical trials
– Million-Dollar Molecules: recent M&A’s, IPOs, and other fundraising
– Potential Approvals: recent NDA filings and upcoming PDUFA dates
– Where Are They Now? updates on past Molecules of the Month
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Molecules in Motion
Roche has added RG6330 to the Ph. III B-FAST study investigating multiple therapies as single agents or in combination for non-small cell lung cancer (NSCLC, NCT03178552), adding another late-stage contender to this competitive field. The new arm will compare RG6330 monotherapy (QD) against docetaxel in second-line KRASG12C-mutant disease. Like approved covalent molecules sotorasib and adagrasib, the compound shuts down oncogenic signaling by locking KRASG12C into the inactive GDP-bound state. KRASG12C is a hotly pursued target that we have covered in depth previously, including articles on sotorasib (Lumakras, Amgen), MRTX849 (Krazati, Mirati), Revolution Medicines’ RM-018, AstraZeneca’s compound 25, Novartis’s JDQ443, and Boehringer Ingelheim’s BI-0474, among others. This recent article discusses how new inhibitors could differentiate.
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