Eisbach Bio announces FDA clearance of IND application for EIS-12656, a first-in-class allosteric inhibitor of ALC1

• The FDA has cleared the investigational new drug (IND) application for EIS-12656, a first-in-class orally bioavailable and blood brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair.
• EIS-12656 targets homologous recombination repair deficient cancers. Its expected superior safety should facilitate novel combination therapies with and beyond PARP inhibitors in hard to treat cancers.
• Eisbach Bio expects to start enrolling patients in the second quarter of 2024.

MARTINSRIED, Germany, May 6, 2024 /PRNewswire/ -- Eisbach Bio GmbH ("Eisbach" or the "Company"), a privately-held clinical-stage biotechnology company pioneering cancer medicines leveraging synthetic lethality, has announced United States Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application for EIS-12656, a small molecule inhibiting the chromatin helicase ALC1 (CHD1L). EIS-12656 targets ALC1 through allosteric mechanisms, suppressing the cancer-relevant genome reorganization induced by DNA damage. This leads to ALC1 chromatin trapping and cancer cell killing.

EIS-12656 impacts tumors deficient in DNA repair pathways. It demonstrated substantial tumor growth inhibition in preclinical models, including in combination with standard-of-care therapies. Its allosteric mechanism of action should afford selectivity compared to related synthetic lethal targets, contributing to the exceptional safety observed in all relevant preclinical models.

"EIS-12656 selectively targets tumors with no apparent effects on normal tissues." said Adrian Schomburg, Ph.D., Founder and CEO of Eisbach. "Our clinical study will also explore combination therapies that were hindered by combinatorial toxicity in the past."

The discovery of EIS-12656 builds on the pioneering research of Eisbach founder Prof. Andreas Ladurner, whose team discovered that PARP effects in cancer cells are reliant on chromatin remodeling by ALC1. Eisbach built upon this knowledge and designed a first-in-class, once-daily small molecule therapy, directly targeting cancer genome reorganization induced by DNA damage at its source – the PARP-activated helicase ALC1.

About the Phase 1/2 Clinical Trial

The open label study of EIS-12656 will 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., Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, the trial includes dose escalation of EIS-12656 monotherapy, followed by dose expansion modules and evaluation in patients progressing under PARP inhibitor treatment.

About Eisbach

Eisbach is at the forefront of precision oncology, developing allosteric drugs that selectively disrupt molecular machines vital for tumor genome reorganization. Combining genetic vulnerabilities with its proprietary ALLOS platform, which hits the molecular vulnerability of its cancer targets, Eisbach pioneers first-in-class therapies with fewer side effects. For more information, visit http://www.eisbach.bio/ and follow us on LinkedIn.

Contacts:

Eisbach Bio GmbH

Adrian Schomburg, CEO
+49 89 2153 7900

Jonathan Iorio
+49 89 2153 79013

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SOURCE Eisbach Bio