FDA has cleared Nested Therapeutics’ investigational new drug (IND) application for NST-628, a novel, entirely brain penetrant non-degrading pan-RAF/MEK molecular glue designed to target RAF and MEK nodes within the RAS-MAPK pathway for treating patients with advanced solid tumors.
This clearance paved the way for a phase 1 clinical trial (NCT06326411) for NST-628, offering hope to patients with advanced solid tumors.
Philip Komarnitsky, Nested’s CMO, acknowledged the pressing need for new medicines to address the significant majority of KRAS-, NRAS-, and BRAF-mutant tumors that are not treatable by current therapies.
He emphasized that NST-628 holds promise in providing superior efficacy and tolerability for these hard-to-treat solid tumors.
NST-628’s IND clearance marked a significant milestone in Nested’s clinical program, supported by activated clinical trial sites, and highlighted the company’s commitment to advancing innovative treatments for patients with solid tumors.
Preclinical data suggested NST-628’s potential as a best-in-class treatment for solid tumors, optimizing half-life, metabolic profile, and intrinsic blood-brain barrier penetrance all contribute to this promise.
Source: Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue
https://www.prnewswire.com/news-releases/nested-therapeutics-announces-fda-clearance-of-investigational-new-drug-ind-application-for-nst-628-a-novel-pan-rafmek-molecular-glue-302101827.html
