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STORM Therapeutics宣布在临床合作中首位患者接受STC-15与LOQTORZI®联合治疗,并任命Atif Abbas博士为首席医学官

STORM Therapeutics Announces First Patient Dosed in Clinical Collaboration to Evaluate STC-15 in Combination with LOQTORZI® and Appointment of Atif Abbas, M.D., as Chief Medical Officer

CISION 等信源发布 2025-05-27 20:29

可切换为仅中文


STC-15 has demonstrated durable clinical activity and tolerability to progress into a combination study with a checkpoint inhibitor

STC-15 已展现出持久的临床活性和耐受性,可进一步进入与检查点抑制剂的联合研究。

Collaboration enables

协作使能

Phase

阶段

1b

1b

/2 study with

/2 与...一起学习

STORM's lead product, STC-15 in combination with Coherus's next generation PD-1 inhibitor, LOQTORZI® (toripalimab) in patients with NSCLC, HNSCC, melanoma, and endometrial cancer

STORM的主要产品STC-15与Coherus的下一代PD-1抑制剂LOQTORZI®(特瑞普利单抗)联合用于非小细胞肺癌、头颈部鳞状细胞癌、黑色素瘤和子宫内膜癌患者。

Atif Abbas

阿提夫·阿巴斯

, M.D. joins as Chief Medical Officer

,医学博士加入担任首席医疗官

CAMBRIDGE, England

剑桥,英格兰

,

May 27, 2025

2025年5月27日

/PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announced dosing of its first patient in a collaboration with

/PRNewswire/ -- STORM Therapeutics Ltd.(STORM),一家通过RNA修饰进行细胞重编程以治疗疾病的临床阶段公司,今天宣布在其与合作伙伴的协作中首次对患者进行给药。

Coherus BioSciences

科赫勒斯生物科学公司

, Inc., commencing a Phase

公司开始了一项阶段性的计划,

1b

1b

/2 study evaluating STC-15, its first-in-class lead program, in combination with LOQTORZI (toripalimab-tpzi), the anti-PD-1 antibody, for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer, and the appointment of

/2期研究评估STC-15,其首创新药先导项目,与LOQTORZI(toripalimab-tpzi)抗PD-1抗体联合用于治疗非小细胞肺癌(NSCLC)、头颈部鳞状细胞癌(HNSCC)、黑色素瘤和子宫内膜癌,以及任命

Atif Abbas

阿提夫·阿巴斯

, M.D. as Chief Medical Officer.

,医学博士担任首席医疗官。

Under the terms of the agreement with Coherus, a Phase

根据与Coherus的协议条款,一个阶段

1b

1b

study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI in a dose escalation study to determine the safety of the combination and recommended dose for STC-15. Further to this, the Phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, melanoma, and endometrial cancer, in up to 188 patients in .

研究将评估STC-15(一种METTL3抑制剂)与LOQTORZI联合使用的剂量递增研究,以确定该组合的安全性及STC-15的推荐剂量。除此之外,研究的第2阶段部分将在非小细胞肺癌、头颈部鳞状细胞癌、黑色素瘤和子宫内膜癌中评估扩展队列,涵盖多达188名患者。

the United States

美国

.

During his two-decade career, Dr. Abbas has played key roles in immuno-oncology drug development, encompassing IND to NDA/BLA submissions, product launches and life cycle management. Atif received his medical degree from King Edward Medical University in

在长达二十年的职业生涯中,阿巴斯博士在免疫肿瘤药物开发方面发挥了关键作用,涵盖从新药临床试验申请(IND)到新药申请(NDA)/生物制品许可申请(BLA)的提交、产品上市以及生命周期管理。阿提夫毕业于爱德华国王医科大学。

Pakistan

巴基斯坦

, with additional postdoctoral training at

,并在以下机构接受额外的博士后培训

Yale University

耶鲁大学

and

Harvard Medical School

哈佛医学院

. He has held roles of increasing responsibility in clinical development at Merck KGaA, Abbvie, Astellas and Boehringer Ingelheim, most recently as VP at Servier Pharmaceuticals.

他在默克KGaA、艾伯维、安斯泰来和勃林格殷格翰的临床开发领域担任过责任越来越重的职位,最近一次是在施维雅制药担任副总裁。

Jerry McMahon

杰里·麦克马洪

, Chief Executive Officer of STORM Therapeutics, said:

STORM Therapeutics首席执行官表示:

'We are excited that the first patient is receiving treatment on our collaborative clinical study, evaluating the potential of STC-15 to enhance responses to immune checkpoint inhibitors. Our clinical data has demonstrated that STC-15 can achieve durable responses for patients who are refractory to immune checkpoint inhibitors, therefore combining it with LOQTORZI may further validate our hypothesis of treating cancer through cellular reprogramming and RNA modifications.  We are thrilled that Atif has joined Storm as Chief Medical Officer to lead this effort, and to chart the development strategy for STC-15 with future studies.'.

“我们很高兴首位患者正在我们的合作临床研究中接受治疗,评估STC-15增强免疫检查点抑制剂反应的潜力。我们的临床数据已表明,STC-15可为对免疫检查点抑制剂无反应的患者带来持久的疗效,因此将其与LOQTORZI联合使用可能会进一步验证我们通过细胞重编程和RNA修饰治疗癌症的假设。我们非常激动Atif加入Storm担任首席医学官,领导这一工作,并为STC-15制定未来研究的开发策略。”

Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase

根据临床试验合作和供应协议的条款,Coherus将向STORM提供LOQTORZI,STORM将是该阶段的赞助商。

1b

1b

/2 clinical combination trial. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies.

/2 临床联合试验。STORM 和 Coherus 各自保留其各自化合物的所有商业权利,包括作为单一疗法或联合疗法。

Final clinical results from a Phase 1 study of STC-15 in patients with advanced malignancies demonstrated that it is well tolerated and achieved tumor regressions at all dose levels evaluated, with an overall response rate of 9% and disease control rate of 67%. Pharmacokinetic simulations and safety data support advancing STC-15 into combination studies with checkpoint inhibitors, such as LOQTORZI..

STC-15在晚期恶性肿瘤患者中的I期临床研究最终结果表明,该药物耐受性良好,在所有评估剂量水平上均实现了肿瘤缩小,总体缓解率为9%,疾病控制率为67%。药代动力学模拟和安全性数据支持将STC-15推进到与检查点抑制剂(如LOQTORZI)联合使用的相关研究。

About STORM Therapeutics

关于STORM Therapeutics

STORM Therapeutics is a clinical-stage biotechnology company pioneering cellular reprogramming through RNA modifications to treat disease. Its world leading understanding of RNA modifying enzymes (RME) has led to the discovery of breakthrough small molecule drugs that precisely reprogram cells through RNA biology for the treatment of cancer, inflammation, viruses and CNS diseases..

STORM Therapeutics是一家临床阶段的生物技术公司,通过RNA修饰开创细胞重编程以治疗疾病。其在RNA修饰酶(RME)领域的世界领先理解促成了突破性小分子药物的发现,这些药物通过RNA生物学精确重编程细胞,用于治疗癌症、炎症、病毒和中枢神经系统疾病。

STORM's lead product, STC-15, is the first RNA modifying enzyme inhibitor to enter human clinical development. STC-15 is currently being evaluated in a Phase

STORM的主打产品STC-15是首个进入人体临床开发的RNA修饰酶抑制剂。STC-15目前正在一期临床试验中评估。

1b

1b

/2 study in combination with LOQTORZI®, (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, in patients with NSCLC, HNSCC, melanoma, and endometrial cancer.  Further information is available at

/2 与 LOQTORZI®(托瑞帕利单抗-tpzi),一种新型的下一代 PD-1 抑制剂,联合用于非小细胞肺癌、头颈部鳞状细胞癌、黑色素瘤和子宫内膜癌患者的研究。更多信息可访问以下网站:

www.clinicaltrials.gov

www.clinicaltrials.gov

NCT identifier: NCT06975293.

NCT标识符:NCT06975293。

For more information, please visit

更多信息,请访问

www.stormtherapeutics.com

www.stormtherapeutics.com

SOURCE STORM Therapeutics

来源:STORM Therapeutics

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