Tagworks Pharmaceuticals宣布FDA已批准TGW101的IND申请，并启动I期临床试验，同时任命Keith Orford博士为首席医学官-动脉网

Tagworks Pharmaceuticals Announces FDA Clearance of IND Application and Initiation of Phase 1 Clinical Trial for TGW101 and Appoints Keith Orford, MD, PhD, as Chief Medical Officer

CISION 等信源发布 2025-04-22 19:00

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TGW101 is a next-generation, first-in-class ADC targeting TAG-72 with an MMAE payload, developed based on Tagworks proprietary Click-to-Release linker chemistry; TGW101 is the first bioorthogonal, in vivo click chemistry-activated ADC, which enables superior control of tumor payload activity

TGW101 是一种下一代、首创新药的ADC，靶向TAG-72并携带MMAE有效载荷，基于Tagworks专有的Click-to-Release连接子化学开发；TGW101是首个生物正交、体内点击化学激活的ADC，可实现对肿瘤有效载荷活性的卓越控制。

Phase 1 clinical trial of TGW101 initiated; Company plans to enroll up to 50 patients with advanced solid tumors in the U.S.

TGW101的第一阶段临床试验已启动；公司计划在美国招募多达50名晚期实体瘤患者。

Keith Orford, MD, PhD, brings over three decades of leadership in oncology research and clinical drug development and will oversee an emerging clinical pipeline of novel cancer treatments leveraging Click-to-Release technology, including ADCs and targeted radiopharmaceuticals

基思·奥福德（Keith Orford），医学博士、哲学博士，拥有超过三十年的肿瘤学研究和临床药物开发领导经验，将负责监督一条新兴的临床管线，该管线利用点击释放技术开发创新的癌症治疗方法，包括抗体药物偶联物（ADC）和靶向放射性药物。

NIJMEGEN,

尼美根，

Netherlands

荷兰

and

和

BOSTON

波士顿

，

April 22, 2025

2025年4月22日

/PRNewswire/ -- Tagworks Pharmaceuticals BV ('Tagworks'), a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors, today announced the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for a Phase 1 clinical trial evaluating TGW101, a first-in-class antibody drug-conjugate (ADC) targeting tumor associated glycoprotein 72 (TAG-72) with an monomethyl auristatin E (MMAE) payload, in patients with advanced solid tumors.

/PRNewswire/ -- Tagworks Pharmaceuticals BV（“Tagworks”），一家临床阶段的精准肿瘤学公司，利用其专有的Click-to-Release治疗平台为实体瘤患者开发新的护理标准，今天宣布美国食品药品监督管理局 (FDA) 批准了TGW101的研究性新药 (IND) 申请。TGW101是一种同类首创的抗体药物偶联物 (ADC)，靶向肿瘤相关糖蛋白72 (TAG-72)，携带单甲基澳瑞他汀E (MMAE) 毒性载荷，将用于晚期实体瘤患者的1期临床试验。

The Company also announced the appointment of Keith Orford, MD, PhD, as Chief Medical Officer (CMO)..

公司还宣布任命基思·奥福德 (Keith Orford) 医学博士为首席医疗官 (CMO)。

Tagworks initiated first-in-human Phase 1 clinical development of TGW101 in a multicenter, open-label, dose-escalation trial in patients with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of TGW101 and identify the maximum tolerated dose, recommended dose, and regiment for cohort expansion.

Tagworks 在晚期实体瘤患者中启动了TGW101的多中心、开放标签、剂量递增的首次人体1期临床试验。该研究的主要目的是评估TGW101的安全性和耐受性，并确定最大耐受剂量、推荐剂量及队列扩展方案。

The study is currently recruiting in the U.S. and plans to enroll up to 50 patients..

该研究目前正在美国招募患者，计划招募多达50名患者。

'TAG-72 is a validated target with overexpression in many high unmet need solid tumors. However, due to its non-internalizing nature, this target has remained unreachable by current ADCs and other therapies which require uptake by tumor cells to activate their anti-tumor activity. TGW101's highly differentiated profile enables controlled MMAE payload release and activation in the tumor microenvironment without internalization by tumor cells.

TAG-72 是一个在许多高未满足需求的实体瘤中过表达的已验证靶点。然而，由于其非内化特性，当前的抗体药物偶联物（ADC）和其他需要通过肿瘤细胞摄取来激活抗肿瘤活性的疗法无法作用于此靶点。TGW101 的高度差异化特性使得 MMAE 有效载荷能够在肿瘤微环境中可控释放和激活，而无需被肿瘤细胞内化。

This controlled drug release is achieved through a click reaction of the ADC linker with a trigger molecule, which is administered in a second step,' said .

这种受控的药物释放是通过ADC连接子与触发分子的点击反应实现的，触发分子是在第二步中施用的。

Marc Robillard

马克·罗比拉德

, Chief Scientific Officer and Co-Founder of Tagworks. 'TGW101 has demonstrated a favorable safety profile as well as effective and durable responses in preclinical solid tumor models. The IND clearance and initiation of our Phase 1 clinical trial is a significant milestone for our lead program and Tagworks, the pioneer of Click-to-Release chemistry.'.

Tagworks的首席科学官和联合创始人表示：“TGW101在临床前实体瘤模型中展示了良好的安全性以及有效且持久的反应。我们的1期临床试验的IND获批和启动是我们主导项目和Tagworks的重要里程碑，Tagworks是点击释放化学的先驱。”

Anthony Tolcher

安东尼·托尔彻

, MD, FRCPC, CEO, Founder, and Director of Clinical Research of NEXT Oncology San Antonio and the TGW101 Phase 1 Primary Investigator commented, 'TGW101 represents an attractive new potential treatment option in advanced solid tumors with high unmet need, overcoming certain challenges and limitations of other ADC therapies.

医学博士、FRCPC、NEXT Oncology圣安东尼奥的首席执行官、创始人兼临床研究总监，以及TGW101一期临床试验的主要研究者评论道：“TGW101代表了一种在高度未满足需求的晚期实体瘤中具有吸引力的新潜在治疗选择，克服了其他ADC疗法的一些挑战和局限性。"

TGW101 has the potential to offer an improved anti-tumor effect and safety profile which may lead to better clinical outcomes. I am excited to collaborate with Tagworks' team to evaluate TGW101 in patients with advanced solid tumors in the Phase 1 clinical trial.'.

TGW101有望提供更好的抗肿瘤效果和安全性，这可能会带来更佳的临床结果。我很高兴能与Tagworks团队合作，在1期临床试验中评估TGW101在晚期实体瘤患者中的表现。

In addition, Tagworks further strengthened its management team with the appointment of Keith Orford, MD, PhD, as CMO. Dr. Orford's proven track record as a physician, scientist, and executive leader at several biotechnology companies will support Tagworks' position as a leader and innovator in cancer drug development..

此外，Tagworks通过任命Keith Orford（医学博士、哲学博士）为首席医学官，进一步加强了其管理团队。Orford博士在多家生物技术公司担任医生、科学家和执行领导的出色履历，将支持Tagworks在癌症药物开发领域的领导地位和创新者角色。

'We are pleased to welcome Keith and look forward to his contributions to the clinical development of our pipeline of innovative ADCs and targeted radiopharmaceuticals,' said

“我们很高兴欢迎基思，并期待他对我们的创新ADC和靶向放射性药物的临床开发做出贡献，”

Ken Mills

肯·米尔斯

, Chief Executive Officer of Tagworks. 'As we enter into clinical development, Keith's development expertise, strategic insights, and leadership in the oncology community will be critical in positioning Tagworks for long-term success.'

Tagworks首席执行官表示：“随着我们进入临床开发阶段，Keith在肿瘤学领域的开发专业知识、战略洞察力和领导能力将对Tagworks的长远成功至关重要。”

'I am thrilled to join the experienced team at Tagworks to develop and expand on the transformative potential of the Click-to-Release technology with the clear goal of providing safe and efficacious new therapies for patients with cancer,' said Keith Orford, MD, PhD, CMO of Tagworks. 'I look forward to immediately working closely with all of our investigators to evaluate the therapeutic utility of TGW101 in multiple advanced solid tumor indications.'.

“我非常高兴加入Tagworks的经验丰富的团队，开发并拓展Click-to-Release技术的变革潜力，目标是为癌症患者提供安全有效的新型疗法，”Tagworks首席医学官Keith Orford博士表示，“我期待立即与所有研究人员紧密合作，评估TGW101在多种晚期实体瘤适应症中的治疗效用。”

Dr. Orford brings extensive experience in leadership and oncology development, having served as CMO at public and private cancer biotechnology companies. Most recently, he was CMO, Executive Vice President, Clinical and Translational Science at Parabilis Medicines (formerly Fog Pharma), where he oversaw translational medicine and clinical development.

奥福德博士在领导力和肿瘤学发展方面拥有丰富的经验，曾担任上市和私人癌症生物技术公司的首席医学官。最近，他担任Parabilis Medicines（前身为Fog Pharma）的首席医学官、执行副总裁，临床与转化科学部门，负责监督转化医学和临床开发。

Prior to Parabilis, he held a series of clinical development roles of increasing responsibility, including CMO of Calithera Biosciences, Clinical Development Lead and Clinical Head of Immuno-Oncology and Combinations DPU at GlaxoSmithKline, and Associate Director of Clinical Pharmacology and Experimental Medicine and Oncology at Merck.

在加入Parabilis之前，他担任过一系列临床开发职位，职责不断增加，包括Calithera Biosciences的首席医学官（CMO）、葛兰素史克（GlaxoSmithKline）的免疫肿瘤学与组合疗法部门（DPU）临床开发负责人和临床主管，以及默克（Merck）临床药理学、实验医学和肿瘤学的副主管。

Before joining industry, he held various roles as a Research Fellow and Instructor at Massachusetts General Hospital and .

在加入行业之前，他曾担任麻省总医院的研究员和讲师等职务。

Harvard Medical School

哈佛医学院

, where he trained in internal medicine and completed a postdoctoral fellowship. He received his BS, MD, and PhD from

，他在那里接受了内科培训并完成了博士后研究。他获得了学士、医学博士和哲学博士学位

Georgetown University

乔治敦大学

。

About TGW101

关于TGW101

TGW101 is an antibody-drug conjugate (ADC) targeting TAG-72, a non-internalizing marker found on the surface of many solid tumor cells. TGW101 consists of a TAG-72-binding diabody conjugated with monomethyl auristatin E (MMAE) toxin. TGW101 is administered intravenous (IV) first and allowed to bind to TAG-72 in the tumor.

TGW101是一种抗体药物偶联物（ADC），靶向TAG-72，这是一种存在于许多实体肿瘤细胞表面的非内化标志物。TGW101由与单甲基澳瑞他汀E（MMAE）毒素结合的TAG-72结合双体抗体组成。TGW101首先通过静脉注射（IV）给药，并允许其在肿瘤中与TAG-72结合。

Then a small molecule trigger is administered IV, resulting in selective chemical cleavage of the linker of the tumor-bound TGW101, release of the MMAE in the extracellular tumor microenvironment and diffusion into surrounding tumor cells. TGW101 is being studied in an open-label, multicenter, Phase 1 dose-escalation clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors..

然后通过静脉注射给予小分子触发剂，导致肿瘤结合的TGW101连接子选择性化学裂解，在细胞外肿瘤微环境中释放MMAE并扩散到周围肿瘤细胞。TGW101正在一项开放标签、多中心、I期剂量递增临床试验中进行研究，该试验旨在评估其在晚期实体瘤患者中的安全性、耐受性、药代动力学和初步疗效。

About Tagworks Pharmaceuticals

关于Tagworks Pharmaceuticals

Tagworks Pharmaceuticals is a clinical-stage precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors by targeting clinically validated tumor markers that so far have remained out of reach of current therapies.

Tagworks Pharmaceuticals是一家临床阶段的精准肿瘤学公司，利用其专有的点击释放治疗平台，通过靶向目前疗法尚未触及的经过临床验证的肿瘤标志物，为患有实体瘤的患者开发新的护理标准。

Its lead program, TGW101, is an antibody-drug conjugate (ADC) targeting TAG-72, a non-internalizing marker found on the surface of many solid tumor cells. Tagworks is developing a pipeline of novel cancer treatments leveraging its Click-to-Release technology in a range of therapeutics modalities, including ADCs and targeted radiopharmaceutical therapies.

其主导项目TGW101是一种抗体药物偶联物（ADC），靶向TAG-72，这是一种在许多实体肿瘤细胞表面发现的非内化标志物。Tagworks正在开发一系列新型癌症治疗方法，利用其Click-to-Release技术应用于多种治疗模式，包括ADC和靶向放射性药物疗法。

The Company is headquartered in .

公司总部位于。

the Netherlands

荷兰

with operations in the U.S. For more information, visit us at

在美国有运营。欲了解更多信息，请访问我们的网站

www.tagworkspharma.com

。

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