Eisbach Bio Receives FDA Clearance for IND Application of EIS-12656, a First-in-Class Allosteric Inhibitor Targeting ALC1
Tuesday, May 07, 2024
Eisbach Bio GmbH ("Eisbach"), a privately-held biotech company pioneering cancer treatment innovations, has reached a significant milestone: the United States Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for EIS-12656. This compound, a small molecule inhibitor targeting the chromatin helicase ALC1 (CHD1L), represents a promising advancement in cancer therapy.
EIS-12656 operates through allosteric mechanisms, effectively suppressing cancer-induced genome reorganization triggered by DNA damage. By targeting ALC1, the compound leads to chromatin trapping and subsequent destruction of cancer cells.
One notable aspect of EIS-12656 is its impact on tumors with deficient DNA repair pathways. Preclinical studies have shown significant inhibition of tumor growth, particularly when combined with standard-of-care therapies. Its allosteric mechanism enhances selectivity, promising exceptional safety profiles in relevant preclinical models.
Eisbach, emphasizes the selectivity of EIS-12656, highlighting its ability to target tumors while sparing normal tissues. He also notes the potential for exploring combination therapies previously hindered by toxicity concerns.
The discovery of EIS-12656 builds upon the groundbreaking research of Prof. Andreas Ladurner, founder of Eisbach. Ladurner's team identified the crucial role of ALC1 in chromatin remodeling induced by PARP effects in cancer cells. Leveraging this understanding, Eisbach developed EIS-12656 as a first-in-class, once-daily therapy directly addressing cancer genome reorganization triggered by DNA damage.
The Phase 1/2 clinical trial of EIS-12656 aims to evaluate its safety, tolerability, and efficacy in patients with genetically-defined advanced solid tumors. Led by Principal Investigator Timothy A. Yap, M.B.B.S., Ph.D., from The University of Texas MD Anderson Cancer Center, the trial encompasses dose escalation of EIS-12656 monotherapy, followed by dose expansion modules and assessment in patients progressing under PARP inhibitor treatment.
Source: prnewswire.com
