FDA has cleared Eisbach Bio GmbH’s investigational new drug (IND) application for EIS-12656, a first-in-class drug designed to target the chromatin helicase ALC1 (CHD1L) in treating solid tumors.
This clearance underscored the potential of EIS-12656 and is expected to generate interest among healthcare professionals and investors.
EIS-12656 works through an allosteric mechanism to suppress ALC1 activity, which is thought to be a critical factor in DNA repair.
Adrian Schomburg, CEO of Eisbach, expressed his confidence in EIS-12656’s selectivity by highlighting that the drug selectively targets tumors without apparent effects on normal tissues, a crucial aspect that instills confidence in its potential.
He acknowledged the promising characteristics that supported the advancement of their clinical study and emphasized the combination therapies, overcoming past hurdles of combinatorial toxicity.
This milestone in Eisbach’s research marked a significant step forward in developing innovative cancer treatments.
Eisbach Bio expects to begin enrolling patients in a phase 1/2 clinical trial to evaluate the safety, tolerability, and efficacy of EIS-12656 in patients with genetically defined advanced solid tumors.
This trial for EIS-12656, led by Dr. Timothy Yap at MD Anderson Cancer Center, will start in the second quarter of 2024.
Source: Eisbach Bio announces FDA clearance of IND application for EIS-12656, a first-in-class allosteric inhibitor of ALC1
