Eisbach Bio Begins Dosing in Phase 1/2 Trial for EIS-12656 in Advanced Solid Tumors

MARTINSRIED, Germany I September 16, 2024 I Eisbach Bio GmbH, a clinical-stage biotechnology company focused on developing cancer therapies through synthetic lethality, has announced the dosing of the first patient in Module 1 of its Phase 1/2 MATCH clinical trial (NCT06525298). This study investigates the small molecule ALC1 inhibitor EIS-12656 in patients with solid tumors. The primary objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of EIS-12656 when used as monotherapy. This trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) and is co-funded by the Cancer Focus Fund, which collaborates with MD Anderson to support promising cancer therapies.

EIS-12656 represents a novel, first-in-class small molecule that selectively inhibits the chromatin helicase ALC1 (CHD1L), a critical player in DNA damage response and genome repair. The inhibitor functions through allosteric mechanisms, disrupting the genome reorganization processes driven by DNA damage, which are relevant to cancer development. Preclinical in vivo studies have demonstrated that EIS-12656 can quickly inhibit tumor growth while showing high bioavailability and tolerability.

Adrian Schomburg, Ph.D., Founder and CEO of Eisbach, highlighted the significance of this milestone, stating, “This marks Eisbach’s entry into the cancer clinic with a transformative target and a unique allosteric approach. ALC1 is an exceptional target in tumors with DNA damage and repair deficiencies. EIS-12656 exemplifies our capacity to target the powerful genome-reorganizing mechanisms precisely.” Schomburg emphasized that the clinical study aims to assess EIS-12656’s ability to address genetic and molecular vulnerabilities in cancer, potentially paving the way for a well-tolerated and effective drug.

The Phase 1/2 clinical trial is an open-label study that will investigate the safety, tolerability, and efficacy of EIS-12656 in patients with advanced solid tumors characterized by specific genetic profiles. The trial is led by Principal Investigator Timothy A. Yap, M.B.B.S., Ph.D., who serves as Vice President and Head of Clinical Development in the Therapeutics Discovery Division at MD Anderson. The trial design includes dose escalation of EIS-12656 as monotherapy, followed by dose expansion modules targeting patients with gynecological, pancreatic, and prostate cancers, particularly those who have progressed despite PARP inhibitor treatments. Eisbach has partnered with CTI Clinical Trial & Consulting, a global Contract Research Organization, to manage the regulatory and clinical trial aspects of this study.

Eisbach Bio GmbH is a leader in precision oncology, focusing on developing allosteric drugs that selectively inhibit molecular machines essential for tumor genome reorganization. The company's proprietary ALLOS platform targets genetic vulnerabilities in cancer, enabling the development of first-in-class therapies that promise fewer side effects.