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Nested Therapeutics Obtains FDA Clearance for Investigational New Drug (IND) Application of NST-628, a Novel Pan-RAF/MEK Molecular Glue

Friday, March 29, 2024

Nested Therapeutics, a biotechnology company specializing in precision medicine for challenging cancers, has received FDA clearance for its investigational new drug (IND) application for NST-628. This drug targets patients with advanced solid tumors carrying genetic mutations in the RAS-MAPK pathway. NST-628 is a novel pan-RAF/MEK molecular glue that penetrates the brain fully and targets crucial nodes in the RAS-MAPK pathway.

Dr. Philip Komarnitsky, Chief Medical Officer of Nested, highlighted the critical need for effective treatments for KRAS-, NRAS-, and BRAF-mutant tumors, which are largely unresponsive to current therapies. He expressed confidence in NST-628's potential to offer improved efficacy and tolerability, while preventing pathway reactivation. The FDA's clearance is a significant milestone for Nested's clinical program, with plans to begin dosing patients in the first half of the year.

The Phase 1 study (NCT06326411) will investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of NST-628 in adult patients with advanced solid tumors driven by RAS-MAPK pathway mutations. The study comprises dose escalation (Part A) followed by dose expansion (Part B), aiming to establish NST-628's safety profile and determine the recommended dose for further studies.

NST-628 is known for its ability to penetrate the brain fully and its innovative mechanism of action, addressing shortcomings observed in other MAPK-targeted compounds. Preclinical data demonstrate promising anti-tumor activity and tolerability, particularly in RAS and central nervous system-implanted tumor models, positioning NST-628 as a leading candidate for RAS and RAF-driven cancers. Its optimized half-life, metabolic profile, and blood-brain barrier penetrance further support its potential as a superior treatment option.



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