/PRNewswire/ -- K36 Therapeutics, Inc. ('K36'), a privately held clinical-stage biotechnology company developing novel, targeted therapies for cancers with unmet medical need, today announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) Application for KTX-2001, a selective, oral inhibitor of NSD2 (nuclear receptor-binding SET domain protein 2), a histone methyltransferase and oncogene that activates gene expression in some cancers..

/PRNewswire/ -- K36 Therapeutics, Inc.（简称“K36”），一家私有的临床阶段生物技术公司，专注于为存在未满足医疗需求的癌症开发新型靶向疗法，今日宣布美国食品药品监督管理局（FDA）已批准其研究性新药（IND）申请，涉及KTX-2001——一种选择性口服NSD2（核受体结合SET结构域蛋白2）抑制剂。NSD2是一种组蛋白甲基转移酶和致癌基因，在某些癌症中激活基因表达。

With this clearance, KTX-2001 becomes the second NSD2 inhibitor from K36 to advance into clinical development. This Phase 1 program will evaluate KTX-2001 both as a monotherapy and in combination with Bayer's androgen receptor inhibitor, darolutamide, for metastatic castration-resistant prostate cancer (mCRPC) .

通过此项批准，KTX-2001成为K36公司第二个进入临床开发阶段的NSD2抑制剂。这项1期项目将评估KTX-2001作为单药疗法以及与拜耳的雄激素受体抑制剂达洛鲁胺联合使用，用于治疗转移性去势抵抗性前列腺癌（mCRPC）。

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'We are proud to announce the FDA cleared the IND for our second clinical program, KTX-2001, on

“我们自豪地宣布，FDA已批准我们第二个临床项目KTX-2001的IND，

July 3rd

7月3日

. This achievement demonstrates our team's efficiency and focus on advancing KTX-2001 and positively impacting the lives of patients with mCRPC,' said

“这一成就展示了我们团队的效率和对推进KTX-2001的关注，并积极影响mCRPC患者的生活，”表示。

Terry Connolly

特里·康诺利

, Ph.D., President and Chief Executive Officer of K36. 'Along with this significant milestone, I am delighted to announce the Company has entered into a clinical trial collaboration agreement with Bayer for supply of darolutamide for the combination with KTX-2001 in our trial.'

博士，K36总裁兼首席执行官。“随着这一重要里程碑的达成，我很高兴地宣布公司已与拜耳达成临床试验合作协议，拜耳将为我们的试验提供达洛鲁胺与KTX-2001联合用药。”

Under the terms of the agreement, K36 will conduct and sponsor the trial and Bayer will supply darolutamide. K36 maintains development and commercial rights to KTX-2001. KTX-2001 is a highly potent and selective inhibitor of NSD2 that is being developed for the treatment of solid tumors, initially mCRPC, and compliments K36's first clinical candidate, KTX-1001, that is being developed for the treatment of relapsed and/or refractory multiple myeloma patients with genetic translocation t(4;14)..

根据协议条款，K36将负责开展并赞助试验，拜耳将提供达洛鲁胺。K36保留KTX-2001的开发和商业化权利。KTX-2001是一种高效且选择性的NSD2抑制剂，正在被开发用于治疗实体瘤，最初是mCRPC，并补充了K36的第一个临床候选药物KTX-1001，该药物正在被开发用于治疗具有t(4;14)遗传易位的复发和/或难治性多发性骨髓瘤患者。

Separately, K36 announced it has selected the Prostate Cancer Clinical Trials Consortium (PCCTC) as the Contract Research Organization (CRO) who will operationalize the KTX-2001 clinical program, STRIKE-001. 'We are pleased to partner with K36 as its CRO. PCCTC has established a robust network of academic and community sites, and has significant expertise in managing innovative, multisite prostate cancer clinical trials and are uniquely positioned to support the efficient launch and execution of the STRIKE-001 trial,' said .

此外，K36宣布已选择前列腺癌临床试验联盟（PCCTC）作为合同研究组织（CRO），该组织将负责实施KTX-2001临床项目STRIKE-001。 “我们很高兴与K36合作成为其CRO。PCCTC建立了强大的学术和社区站点网络，并在管理创新的多中心前列腺癌临床试验方面具有深厚的专业知识，能够为STRIKE-001试验的高效启动和执行提供独特支持，”他表示。

Jake Vinson

杰克·文森特

, CEO of the PCCTC.

，PCCTC首席执行官。

Jason Redman

杰森·雷德曼

, MD, Senior Medical Director at K36 Therapeutics and leader of the KTX-2001 prostate cancer program stated, 'Targeting NSD2 inhibition as a first-in-class, oral therapy represents a fundamentally new approach to treating prostate cancer by modulating the epigenetic drivers of tumor progression. This novel mechanism is distinct from other epigenetic therapies and addresses the underlying biology in a new way.

K36治疗公司高级医学总监、KTX-2001前列腺癌项目负责人医学博士表示：“将NSD2抑制作为首创的口服疗法，通过调节肿瘤进展的表观遗传驱动因素，代表了一种治疗前列腺癌的根本新方法。这种新颖的机制与其他表观遗传疗法不同，并以一种新的方式解决了潜在的生物学问题。”

The STRIKE-001 Phase 1 trial marks an important step forward, bringing a promising new option to patients with limited treatment alternatives.'.

STRIKE-001一期试验标志着一个重要进展，为治疗选择有限的患者带来了充满希望的新选项。

About KTX-2001

关于KTX-2001

KTX-2001 is a small molecule, specific inhibitor of the nuclear receptor binding SET domain protein 2 (NSD2) (also known as multiple myeloma [MM] SET domain-containing protein [MMSET]/Wolf-Hirschhorn syndrome candidate 1 protein [WHSC1]). Both KTX-1001 and KTX-2001 specifically inhibit NSD2 methylation of histone H3 at lysine 36 (H3K36) and disrupts aberrant NSD2-dependent oncogenic pathways..

KTX-2001是一种小分子，是核受体结合SET结构域蛋白2（NSD2）（也称为多发性骨髓瘤[MM]含SET结构域蛋白[MMSET]/ Wolf-Hirschhorn综合征候选蛋白1 [WHSC1]）的特异性抑制剂。 KTX-1001和KTX-2001均特异性抑制组蛋白H3在赖氨酸36（H3K36）的NSD2甲基化，并破坏异常的NSD2依赖性致癌途径。

About the KTX-2001 Phase 1 Clinical Trial

关于KTX-2001一期临床试验

The Phase 1 clinical trial STRIKE-001

第一阶段临床试验STRIKE-001

NCT07103018

NCT07103018

is a multi-center, open label dose escalation of KTX-2001 single agent (Part A) and KTX-2001 combination with darolutamide (Part B). Part A will evaluate the safety and tolerability, maximum tolerated dose and recommended phase 2 dose(s) of KTX-2001 monotherapy in participants with mCRPC. Part B will study the safety and tolerability of KTX-2001+darolutamide to determine the recommended Phase 2 dose(s) of KTX-2001+darolutamide in participants with mCRPC.

是一个多中心、开放标签的KTX-2001单药（A部分）和KTX-2001与达洛鲁胺联合使用（B部分）的剂量递增研究。A部分将评估KTX-2001单药治疗在mCRPC患者中的安全性、耐受性、最大耐受剂量以及推荐的二期剂量。B部分将研究KTX-2001+达洛鲁胺的安全性和耐受性，以确定该组合在mCRPC患者中的推荐二期剂量。

Additionally, objectives for Parts A and B include pharmacokinetics, pharmacodynamics and preliminary clinical activity. K36 expects to enroll approximately 140 participants with mCRPC who have progressed on a second generation or later androgen receptor inhibitor (AR) targeted therapy/androgen biosynthesis inhibitor starting in 2H2025..

此外，A部分和B部分的目标包括药代动力学、药效学和初步临床活性。K36预计将在2025年下半年开始招募大约140名在接受第二代或更新的雄激素受体抑制剂（AR）靶向治疗/雄激素生物合成抑制剂后病情进展的mCRPC患者。

About K36 Therapeutics, Inc.

关于K36治疗公司

Founded in

成立于

February 2021

2021年2月

, K36 Therapeutics is a privately held biotechnology company backed by

，K36治疗公司是一家由以下机构支持的私营生物技术公司

Atlas Venture

阿特拉斯风险投资公司

. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide. For more information, please visit

我们的使命是将致癌途径的表观遗传调控转化为首创的小分子治疗药物，以造福全球癌症患者。欲了解更多信息，请访问

About The Prostate Cancer Clinical Trials Consortium (PCCTC)

关于前列腺癌临床试验联盟 (PCCTC)

The

The

Prostate Cancer Clinical Trials Consortium

前列腺癌临床试验联盟

(PCCTC) was initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. To fulfill their mission, the PCCTC developed a unique infrastructure which has fostered a culture of transparent project co-development between investigators, research sites and industry partners.

前列腺癌临床试验联盟 (PCCTC) 于2005年由前列腺癌基金会 (PCF) 与美国国防部 (DOD) 前列腺癌研究计划 (PCRP) 共同发起，旨在应对医生研究者和患者倡导者提出的前列腺癌临床研究中亟待解决的关键需求。为实现其使命，PCCTC建立了一个独特的基础设施，促进了研究者、研究机构和行业合作伙伴之间透明的项目共同开发文化。

Established as an independent entity in 2014, the PCCTC, LLC is now the nation's premier multicenter clinical research organization specializing in cutting-edge prostate cancer research. Through the collaborative nature and intellectual synergy of its leadership, the PCCTC remains poised to make a significant impact on the lives of patients by keeping the pipeline primed with the most promising novel agents and validated biomarkers.

PCCTC有限责任公司于2014年成立为独立实体，现已成为全国领先的多中心临床研究组织，专注于前沿的前列腺癌研究。通过其领导层的协作性质和智慧协同，PCCTC致力于通过确保研发管道中充满最具潜力的新药和经过验证的生物标志物，对患者的生活产生重大影响。