This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.

开始日期2025-07-16

申办/合作机构

MOMA Therapeutics, Inc.

100 项与 MOMA-341 相关的临床结果

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100 项与 MOMA-341 相关的转化医学

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100 项与 MOMA-341 相关的专利（医药）

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项与 MOMA-341 相关的新闻（医药）

2025-07-21

·药明康德

使癌症患者总生存期延长近20个月的免疫组合疗法；创新口服免疫疗法进入临床…… | 一周盘点

▎药明康德本期看点1. CUE-101联用pembrolizumab一线治疗HPV阳性复发性转移性头颈鳞状细胞癌（HNSCC）的1期试验结果积极，与单用pembrolizumab的历史研究数据相比，患者的中位总生存期（OS）延长近20个月。2. 新型口服小分子白细胞介素-2（IL-2）调节剂GL-IL2-138获FDA批准开展临床试验，该药物通过调控内源性IL-2 mRNA表达，促进产生天然IL-2蛋白。CUE-101：公布1期联合治疗试验数据Cue Biopharma公司公布了CUE-101治疗头颈鳞状细胞癌的1期联合治疗试验的积极新数据。CUE-101是该公司开发的一款基于IL-2的T细胞诱导剂，旨在选择性调节和激活HPV阳性T细胞，以提高疗效，同时减少传统免疫疗法的副作用。截至2025年7月14日的数据，接受CUE-101联用PD-1抑制剂pembrolizumab一线治疗的HPV阳性复发性转移性HNSCC患者的客观缓解率（ORR）为50%，12个月时的总生存率为88%，中位OS为32个月。在历史研究KEYNOTE-048中，pembrolizumab单药治疗的ORR为19%，12个月时的总生存率为57%，中位OS为12.3个月。在肿瘤PD-L1表达综合阳性评分（CPS）≥1的患者中，2例患者达到完全缓解（CR），10例患者达到部分缓解（PR）。此外，接受该一线联合治疗的PD-L1低表达患者的ORR也达到了50%。GL-IL2-138：IND申请获得FDA许可Genetic Leap宣布，其新型小分子IL-2调节剂GL-IL2-138的IND申请已获得美国FDA许可。GL-IL2-138是一种小分子药物，通过结合内源性的IL-2 mRNA，促使免疫细胞系统性地产生天然IL-2蛋白。传统的重组IL-2蛋白（rIL-2）在临床上有重要地位，但由于毒副作用大、改良困难，IL-2曾一度被视为是“难以成药”的靶点。相比之下，GL-IL2-138具有更强的效力和持久性，并可通过口服方式给药，耐受性更高。此外，它具备广泛的应用潜力，涵盖肿瘤、自身免疫疾病及神经退行性疾病等多个领域。该药物即将进入一项随机、双盲、安慰剂对照的1期临床试验，以评估其在人体中的安全性、药代动力学和药效学特性。MOMA-341：1期临床试验完成首例患者给药MOMA Therapeutics公司宣布，其旨在评估MOMA-341的1期临床试验已完成首例患者给药。MOMA-341是一种高度差异化、潜在“best-in-class”的口服共价Werner解旋酶抑制剂，具有新型化学支架。MOMA-341正在被开发为单药疗法，或与化疗或免疫治疗联合使用，用于治疗微卫星不稳定性高（MSI-H）和/或DNA错配修复缺陷（dMMR）的晚期或转移性实体瘤，包括结直肠癌、胃癌和子宫内膜癌等。由于Werner解旋酶是MSI-H/dMMR肿瘤细胞存活所必需的，这使其成为一个有前景的新兴药物靶点。MOMA公司预计在2026年年中初步公布单药治疗数据。参考资料（可上下滑动查看）[1] Imugene公布异体CAR-T疗法Azer-cel治疗三线以上DLBCL的1b期试验优异缓解率数据. Retrieved July 15, 2025, from https://www.prnasia.com/story/496465-1.shtml[2] Hipp, J.F., Bacino, C.A., Bird, L.M. et al. The UBE3A-ATS antisense oligonucleotide rugonersen in children with Angelman syndrome: a phase 1 trial. Nat Med (2025). https://doi.org/10.1038/s41591-025-03784-7[3] AAVantgarde Receives FDA Clearance to Progress Stargardt Disease Asset, AAVB-039, into CELESTE, a Phase 1/2 Clinical Trial. Retrieved July 15, 2025, from https://www.globenewswire.com/news-release/2025/07/15/3115443/0/en/AAVantgarde-Receives-FDA-Clearance-to-Progress-Stargardt-Disease-Asset-AAVB-039-into-CELESTE-a-Phase-1-2-Clinical-Trial.html[4] Garmezy, B., Grossman, J.E., Buell, J. et al. Salvage therapy with allogeneic invariant natural killer cells in a heavily pre-treated germ cell tumor. Oncogene (2025). https://doi.org/10.1038/s41388-025-03491-0[5] Earendil Labs announces initiation of a phase 1 study of a half-life extended novel anti-TL1A antibody. Retrieved July 18, 2025, from https://www.prnewswire.com/news-releases/earendil-labs-announces-initiation-of-a-phase-1-study-of-a-half-life-extended-novel-anti-tl1a-antibody-302502297.html[6] Genetic Leap receives FDA IND clearance for first-in-class, oral natural IL-2 modulator. Retrieved July 18, 2025, from https://www.prnewswire.com/news-releases/genetic-leap-receives-fda-ind-clearance-for-first-in-class-oral-natural-il-2-modulator-302506647.html[7] Medera and University of Kansas Medical Center Announce First Patient Treated in Pioneering Gene Therapy Trial for Duchenne Muscular Dystrophy Associated Cardiomyopathy. Retrieved July 18, 2025, from https://www.medera.bio/medera-biopharm-s-sardocor-showcases-positive-interim-data-from-heref-gene-therapy-phase-1/medera-and-university-of-kansas-medical-center-announce-pioneering-gene-therapy-trial[8] Lisata Therapeutics and WARPNINE Announce iLSTA Trial Enrollment Completion and Provide Preliminary Data Update. Retrieved July 18, 2025, from https://www.globenewswire.com/news-release/2025/07/17/3117132/18623/en/index.html[9] MOMA Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial for MOMA-341, a Highly Potent and Selective Werner Helicase Inhibitor. Retrieved July 18, 2025, from https://momatx.com/posts/moma-therapeutics-announces-first-patient-dosed-in-phase-1-clinical-trial-for-moma-341/[10] Cue Biopharma Reports New Complete Response and Confirmed 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer. Retrieved July 18, 2025, from https://www.cuebiopharma.com/news/#news-section免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

免疫疗法临床1期临床申请临床结果信使RNA

2025-07-17

·Business Wire

MOMA Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial for MOMA-341, a Highly Potent and Selective Werner Helicase Inhibitor

CAMBRIDGE, Mass.--(BUSINESS WIRE)--MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, today announced that the first patient has been dosed in its Phase 1 clinical trial to assess the safety and tolerability of MOMA-341, a potent and selective Werner helicase inhibitor with a novel chemical scaffold. MOMA-341 is being developed as a monotherapy and in combination with chemotherapy or immunotherapy for the treatment of advanced or metastatic solid tumors that exhibit high microsatellite instability (MSI-H) and/or DNA mismatch repair deficiency (dMMR), including colorectal, gastric and endometrial cancers. The fact that Werner helicase is required for survival of MSI-H/dMMR tumor cells makes it a promising emerging drug target. MOMA anticipates an initial readout of monotherapy data in mid-2026. “We are proud to enter the clinic for the second time in less than a year, with initial readouts for both MOMA-341 and MOMA-313, our novel Polθ helicase inhibitor, expected in early-to- mid 2026,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. “Given that MOMA-341’s novel chemical scaffold confers excellent target coverage, we are eager to evaluate its best-in-class potential for patients through this Phase 1 study.” About the MOMA-341 Phase 1 Trial The Phase 1 clinical trial is a global multi-center, open-label dose escalation and dose optimization study (NCT06974110) designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical activity of MOMA-341 as an orally administered single agent or combination therapy with either the chemotherapy agent irinotecan or immunotherapy. Adult participants must have unresectable advanced or metastatic microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors. About the KNOMATIC™ platform MOMA-341 and MOMA-313, were discovered and developed through the application of MOMA’s KNOMATIC platform. The KNOMATIC platform integrates deep structural insights, advanced hit-finding technologies and computation-enabled lead optimization to accelerate discovery of novel therapeutics targeting families of highly dynamic proteins, such as ATPases and GTPases. About MOMA Therapeutics MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATIC™ platform. The platform was designed to exploit key vulnerabilities inherent to all dynamic proteins, namely their dependence on well-coordinated, stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. MOMA has existing discovery partnerships with Roche and Bayer, as well as a wholly owned discovery pipeline. For more information on MOMA, go to www.momatx.com.

临床1期免疫疗法

2025-07-17

·momatx.com

MOMA Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial for MOMA-341,a Highly Potent and Selective Werner Helicase Inhibitor

Share – First-in-human study of MOMA-341 focuses on advanced or metastatic solid tumors with high microsatellite instability – – MOMA-341 is a highly differentiated, potentially best-in-class oral covalent Werner helicase inhibitor with a novel chemical scaffold identified via the KNOMATIC™ platform – CAMBRIDGE, Mass., July 17, 2025— MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, today announced that the first patient has been dosed in its Phase 1 clinical trial to assess the safety and tolerability of MOMA-341, a potent and selective Werner helicase inhibitor with a novel chemical scaffold. MOMA-341 is being developed as a monotherapy and in combination with chemotherapy or immunotherapy for the treatment of advanced or metastatic solid tumors that exhibit high microsatellite instability (MSI-H) and/or DNA mismatch repair deficiency (dMMR), including colorectal, gastric and endometrial cancers. The fact that Werner helicase is required for survival of MSI-H/dMMR tumor cells makes it a promising emerging drug target. MOMA anticipates an initial readout of monotherapy data in mid-2026. “We are proud to enter the clinic for the second time in less than a year, with initial readouts for both MOMA-341 and MOMA-313, our novel Polθ helicase inhibitor, expected in early-to- mid 2026,” said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. “Given that MOMA-341’s novel chemical scaffold confers excellent target coverage, we are eager to evaluate its best-in-class potential for patients through this Phase 1 study.” About the MOMA-341 Phase 1 Trial The Phase 1 clinical trial is a global multi-center, open-label dose escalation and dose optimization study (NCT06974110) designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical activity of MOMA-341 as an orally administered single agent or combination therapy with either the chemotherapy agent irinotecan or immunotherapy. Adult participants must have unresectable advanced or metastatic microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors. About the KNOMATIC™ platform MOMA-341 and MOMA-313, were discovered and developed through the application of MOMA’s KNOMATIC platform. The KNOMATIC platform integrates deep structural insights, advanced hit-finding technologies and computation-enabled lead optimization to accelerate discovery of novel therapeutics targeting families of highly dynamic proteins, such as ATPases and GTPases. About MOMA Therapeutics MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATIC™ platform. The platform was designed to exploit key vulnerabilities inherent to all dynamic proteins, namely their dependence on well-coordinated, stepwise changes in protein conformation. By focusing on genetically validated targets with high translation potential, MOMA is rapidly advancing its pipeline toward responses in the clinic. MOMA has existing discovery partnerships with Roche and Bayer, as well as a wholly owned discovery pipeline. For more information on MOMA, go to www.momatx.com. Media Contact Katie Engleman katie@1abmedia.com

临床1期免疫疗法

100 项与 MOMA-341 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	美国	MOMA Therapeutics, Inc.	2025-07-16
晚期恶性实体瘤	临床1期	澳大利亚	MOMA Therapeutics, Inc.	2025-07-16
结直肠癌	临床1期	美国	MOMA Therapeutics, Inc.	2025-07-16
结直肠癌	临床1期	澳大利亚	MOMA Therapeutics, Inc.	2025-07-16
子宫内膜癌	临床1期	美国	MOMA Therapeutics, Inc.	2025-07-16
子宫内膜癌	临床1期	澳大利亚	MOMA Therapeutics, Inc.	2025-07-16
转移性实体瘤	临床1期	美国	MOMA Therapeutics, Inc.	2025-07-16
转移性实体瘤	临床1期	澳大利亚	MOMA Therapeutics, Inc.	2025-07-16
MSI-H 癌症	临床1期	美国	MOMA Therapeutics, Inc.	2025-07-16
MSI-H 癌症	临床1期	澳大利亚	MOMA Therapeutics, Inc.	2025-07-16