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.

FDA已批准EIS-12656的研究性新药（IND）申请，EIS-12656是一流的口服生物利用度和血脑屏障渗透性变构抑制剂ALC1（CHD1L），是DNA修复的关键分子机器。

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.

EIS-12656靶向同源重组修复缺陷型癌症。其预期的优越安全性应该有助于在难以治疗的癌症中使用PARP抑制剂或超越PARP抑制剂的新型联合疗法。

Eisbach Bio expects to start enrolling patients in the second quarter of 2024.

Eisbach Bio预计将于2024年第二季度开始招募患者。

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).

MARTINSRIED，Germany，2024年5月6日/PRNewswire/--Eisbach Bio GmbH（“Eisbach”或“公司”）是一家私营的临床阶段生物技术公司，开创了利用合成致死率的癌症药物，已宣布美国食品和药物管理局（FDA）批准其针对EIS-12656（一种抑制染色质解旋酶ALC1（CHD1L）的小分子）的研究性新药（IND）申请。

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通过变构机制靶向ALC1，抑制由DNA损伤诱导的癌症相关基因组重组。这导致ALC1染色质捕获和癌细胞杀伤。。

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影响DNA修复途径缺陷的肿瘤。它在临床前模型中表现出显着的肿瘤生长抑制，包括与标准护理疗法相结合。与相关的合成致死靶标相比，其变构作用机制应具有选择性，有助于在所有相关的临床前模型中观察到异常的安全性。。

'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.'

“EIS-12656选择性靶向肿瘤，对正常组织没有明显影响。”艾斯巴赫创始人兼首席执行官阿德里安·肖姆伯格博士说我们的临床研究还将探索过去受到组合毒性阻碍的组合疗法。”

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..

EIS-12656的发现建立在Eisbach创始人Andreas Ladurner教授的开创性研究的基础上，他的团队发现癌细胞中的PARP效应依赖于ALC1的染色质重塑。艾斯巴赫（Eisbach）基于这一知识，设计了一种一流的、每天一次的小分子疗法，直接针对DNA损伤引起的癌症基因组重组，即PARP激活的解旋酶ALC1。。

About the Phase 1/2 Clinical Trial

关于1/2期临床试验

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..

EIS-12656的开放标签研究将评估其在遗传定义的晚期实体瘤患者中的安全性，耐受性和有效性。由首席研究员Timothy A.Yap，M.B.B.S.，博士，德克萨斯大学MD安德森癌症中心研究性癌症治疗学教授领导，该试验包括EIS-12656单一疗法的剂量递增，随后是剂量扩展模块和PARP抑制剂治疗进展患者的评估。。

About Eisbach

关于艾斯巴赫

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.

艾斯巴赫处于精准肿瘤学的前沿，开发了选择性破坏对肿瘤基因组重组至关重要的分子机器的变构药物。Eisbach将遗传脆弱性与其专有的ALLOS平台相结合，该平台可以打击其癌症靶标的分子脆弱性，开创了副作用较少的一流疗法。

For more information, visit http://www.eisbach.bio/ and follow us on LinkedIn..

有关更多信息，请访问http://www.eisbach.bio/并在LinkedIn上关注我们。。

Contacts:

联系人：

Eisbach Bio GmbH

艾斯巴赫生物股份有限公司

Adrian Schomburg, CEO

首席执行官Adrian Schomburg

+49 89 2153 7900

+49 89 2153 7900

Jonathan Iorio

Jonathan Iorio

+49 89 2153 79013

+49 89 2153 79013

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SOURCE Eisbach Bio

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