First clinical program built on Phrontline's DLP1 branched dual-payload linker platform

首个基于Phrontline公司DLP1分支型双载荷连接子平台构建的临床项目

HANGZHOU, China and SHANGHAI

中国杭州和上海

,

，

Sept. 30, 2026

2026年9月30日

/PRNewswire/ -- Phrontline Biopharma, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs), today announced that the first patient has been dosed in its global, first-in-human Phase I/II study of TJ102, an investigational FRα (FOLR1) × CDH6 bispecific dual-payload ADC, in patients with advanced or metastatic ovarian cancer and other solid tumors.

/美通社/ -- 临床阶段生物科技公司Phrontline Biopharma致力于开发下一代抗体药物偶联物（ADC），今日宣布，其针对TJ102的全球首个首次人体I/II期临床试验已完成首例患者给药。TJ102是一种在研的FRα（FOLR1）× CDH6双特异性双载荷ADC，用于治疗晚期或转移性卵巢癌及其他实体瘤患者。

The study is being conducted under an IND cleared by the U.S. FDA and a clinical trial application approved by China's NMPA..

该研究正在根据美国食品药品监督管理局（FDA）批准的IND和中国国家药品监督管理局（NMPA）批准的临床试验申请进行。

'Dosing the first patient with TJ102 is an important milestone for Phrontline,' said Zhaoyuan 'Tony' Chen, Ph.D., Chief Executive Officer of Phrontline Biopharma. 'TJ102 combines dual tumor targeting with two mechanistically distinct, potency-balanced payloads in a single, defined molecule. Our DLP1 platform attaches a pre-assembled dual-payload linker to the antibody in one step, supporting scalable manufacturing and consistent product quality.'.

“为首位患者给予TJ102给药是Phrontline的一个重要里程碑，”Phrontline Biopharma首席执行官陈兆元（Tony）博士表示。“TJ102将双重肿瘤靶向与两种机制不同、效力平衡的有效载荷结合于单一、明确的分子中。我们的DLP1平台通过一步法将预组装的双有效载荷连接子连接到抗体上，从而支持可规模化的生产并确保产品质量的一致性。”

The open-label, multicenter study (TJ102-I/II-001-G; NCT07778498) will assess safety, tolerability, pharmacokinetics, immunogenicity and preliminary antitumor activity, with dose escalation followed by dose-optimization and expansion cohorts to select recommended dose(s) for further development.

这项开放标签、多中心研究（TJ102-I/II-001-G；NCT07778498）将评估安全性、耐受性、药代动力学、免疫原性和初步抗肿瘤活性，通过剂量递增阶段，随后进行剂量优化和扩展队列研究，以选择推荐剂量用于进一步开发。

'This trial tests the central hypothesis behind TJ102: that targeting both FRα and CDH6 while co-delivering two distinct payloads may overcome the antigen heterogeneity and resistance that limit single-target, single-payload ADCs,' said Martín Sebastian Olivo, MD, MSc, Chief Medical Officer of Phrontline Biopharma.

“这项试验验证了TJ102背后的核心假设：在同时递送两种不同载荷的同时靶向FRα和CDH6，或许能够克服限制单靶点、单载荷抗体偶联药物（ADC）的抗原异质性和耐药性。”Phrontline Biopharma首席医学官Martín Sebastian Olivo博士表示。

'Our immediate priority is to rigorously characterize safety, pharmacokinetics and early signs of clinical activity.'.

“我们的首要任务是严格评估安全性、药代动力学以及临床活性的早期迹象。”

About TJ102

关于 TJ102

TJ102 is an investigational IgG1 bispecific ADC targeting FRα and CDH6, two antigens expressed in ovarian and other solid tumors. Its DLP1 linker-payload is a branched, protease-cleavable linker carrying a topoisomerase I inhibitor and a potency-balanced microtubule inhibitor. Four DLP1 units are conjugated to each antibody in a single step, yielding a defined 4 + 4 payload composition (drug-to-antibody ratio of 8).

TJ102 是一种在研的 IgG1 双特异性抗体偶联药物（ADC），靶向 FRα 和 CDH6，这两种抗原在卵巢癌及其他实体瘤中表达。其 DLP1 连接子-载荷体系采用分支型、可被蛋白酶切割的连接子，携带拓扑异构酶 I 抑制剂和效力平衡的微管蛋白抑制剂。每个抗体分子通过一步反应偶联四个 DLP1 单元，形成确定的 4 + 4 载荷组成（药物-抗体比为 8）。

TJ102 has not been approved by any regulatory authority, and its safety and efficacy have not been established..

TJ102尚未获得任何监管机构的批准，其安全性和有效性尚未确立。

About Phrontline Biopharma

关于Phrontline生物制药公司

Phrontline Biopharma is a clinical-stage biotechnology company headquartered in Hangzhou, China, developing next-generation antibody-drug conjugates (ADCs) for solid tumors. The company combines bispecific antibody engineering with a proprietary toolbox of payloads spanning multiple mechanisms of action, including topoisomerase I, microtubule, NMT, ATR and pan-RAS inhibitors, and a branched dual-payload linker platform that pairs complementary payloads in a single, defined molecule.

Phrontline Biopharma 是一家总部位于中国杭州的临床阶段生物技术公司，致力于开发用于实体瘤的下一代抗体偶联药物（ADC）。该公司将双特异性抗体工程技术与专有的载荷工具箱相结合，该工具箱涵盖多种作用机制，包括拓扑异构酶 I 抑制剂、微管抑制剂、NMT 抑制剂、ATR 抑制剂和泛 RAS 抑制剂；同时采用分支型双载荷连接子平台，将互补的载荷配对整合于单一、结构明确的分子中。

Phrontline's pipeline of bispecific and dual-payload ADCs is designed to address tumor heterogeneity, treatment resistance and unmet medical need. For more information, visit .

Phrontline 的双特异性抗体和双载荷抗体药物偶联物（ADC）产品管线旨在解决肿瘤异质性、治疗耐药性以及未满足的医疗需求。欲了解更多信息，请访问。

www.phrontlinebio.com

www.phrontlinebio.com

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。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements, including statements regarding the clinical development, potential benefits and manufacturability of TJ102 and the DLP1 platform. These statements are based on current expectations and are subject to risks and uncertainties, including those inherent in drug development, that could cause actual results to differ materially.

本新闻稿包含前瞻性陈述，包括关于TJ102和DLP1平台的临床开发、潜在益处及可生产性的陈述。这些陈述基于当前预期，并受风险和不确定性的影响，包括药物开发中固有的风险和不确定性，可能导致实际结果与预期存在重大差异。

Phrontline undertakes no obligation to update any forward-looking statement except as required by law..

除非法律另有要求，Phrontline 不承担更新任何前瞻性陈述的义务。

SOURCE Phrontline Biopharma

来源：Phrontline Biopharma

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