FDA Clears IND for EIS-12656, a Novel Therapy for Multiple Solid Tumors
A clinical trial to evaluate EIS-12656 in patients with specific types of advanced solid tumors will begin following the clearance of an investigational new drug application from the FDA.
- The FDA has cleared the investigational new drug (IND) application for EIS-12656.
- EIS-12656 is a first-in-class allosteric inhibitor of ALC1 being developed for the treatment of patients with hard to treat cancers.
- A phase 1/2 study plans to evaluate the safety, tolerability, and efficacy of EIS-12656 in patients with genetically-defined advanced solid tumors.
The FDA has cleared the IND application for EIS-12656, a first-in-class allosteric inhibitor of ALC1, for the treatment of patients with various solid tumors, according to Eisbach Bio GmbH.1
EIS-12656, a small molecule, is being designed to treat tumors that are refractory or resistant to PARP inhibitors.2
With the clearance of the IND, a phase 1/2, open-label study assessing the safety, tolerability, and efficacy of EIS-12656 in patients with genetically-defined advanced solid tumors will begin.1 The trial will consist of a dose-escalation portion where EIS-12656 monotherapy will be given to those enrolled, as well as dose-expansion modules which will evaluate the agent in patients progressing under treatment with a PARP inhibitor.
"EIS-12656 selectively targets tumors with no apparent effects on normal tissues." said Adrian Schomburg, PhD, founder and chief executive officer of Eisbach, in a press release. "Our clinical study will also explore combination therapies that were hindered by combinatorial toxicity in the past."
Investigators on the study aim to establish safety and determine the maximum tolerated dose and recommended phase 2 dose of EIS-12656. Additional modules included in the study will involve patients with hard-to-treat cancers who are progressing under PARP inhibitor treatment.
The study is being led by Timothy A. Yap, MBBS, PhD, professor of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center, who will serve as the principal investigator.
Cancer cells on scientific background, Generative AI: © tonstock - stock.adobe.com
The trial is expected to begin enrolling patients in the second quarter of 2024.
About EIS-12656
EIS-12656 is a small molecule which works by inhibiting the chromatin helicase ALC1 (CHD1L). In addition to targeting ALC1 through allosteric mechanisms, the agent suppresses the cancer-relevant genome reorganization induced by DNA damage, which then leads to ALC1 chromatin trapping and cancer cell killing.1
Preclinical studies have shown EIS-12656 to impact tumors deficient in DNA repair pathways, as well as demonstrate substantial tumor growth inhibition. In such preclinical models, EIS-12656 was shown to overcome PARP inhibitor resistance and demonstrated a benign toxicity profile and blood-brain-barrier penetrance.2
EIS-12656 has also shown potential when given in combination with standard-of-care therapies. In addition, its allosteric mechanism of action plays a role in its exceptional safety demonstrated in preclinical models.
REFERENCES:
1. Eisbach Bio announces FDA clearance of IND application for EIS-12656, a first-in-class allosteric inhibitor of ALC1. News release. Eisbach Bio GmbH. May 6, 2024. Accessed May 6, 2024. https://tinyurl.com/ykbfyxxs
2. Eisbach Bio. Accessed May 6, 2024. https://tinyurl.com/ythv6uw7
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