Quanta Therapeutics Inc. has gained IND clearance from the FDA for QTX-3544, an oral multi-KRAS inhibitor with G12V-preferring activity and dual ON/OFF state.
The existence of two approved therapies, Lumakras (sotorasib, Amgen Inc.) and Karzati (adagrasib, Mirati Therapeutics Inc.), has been a triumphant success against KRAS, a protein that was once considered undruggable.
The existence of two approved therapies, Lumakras (sotorasib, Amgen Inc.) and Karzati (adagrasib, Mirati Therapeutics Inc.), has been a triumphant success against KRAS, a protein that was once considered undruggable. KRAS is the most frequently mutated oncogene in solid tumors. KRAS driver mutations are found in about 30% of non-small-cell lung cancers (NSCLC), about half of colorectal cancers, and more than 90% of pancreatic cancers. Lumakras and Karzati both target the G12C mutation. Inhibitors that target other mutations, like G12D, are now making their way through preclinical and clinical development, while some companies are developing therapies that would target mutated KRAS more broadly, irrespective of the specific mutation that is activating the protein.
Mutations in GTPase KRAS occur in about 25% of human cancers, with the KRAS G12V mutation being one of the most frequent variants, and lead to activation of the MAPK pathway, thus promoting tumorigenesis.
Quanta Therapeutics Inc. has announced progression of its pipeline of KRAS-directed drug candidates, with the receipt of IND approval from the FDA for QTX-3034.
