Data Demonstrate Activity in HER2-Low and ADC-Resistant Tumor Models, Supporting Advancement Toward IND

数据表明在HER2低表达和ADC耐药肿瘤模型中具有活性，支持向IND推进。

SHANGHAI and SUZHOU, China

中国上海和苏州

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April 14, 2026

2026年4月14日

/PRNewswire/ -- Phrontline Biopharma today announced the presentation of preclinical data for TJ106, a next-generation biparatopic HER2-targeting antibody-drug conjugate (ADC) with a dual-payload platform, at the American Association for Cancer Research Annual Meeting 2026.

/PRNewswire/ -- Phrontline Biopharma 今日宣布，在美国癌症研究协会 2026 年年会上展示了 TJ106 的临床前数据，TJ106 是一种采用双载荷平台的下一代双表位 HER2 靶向抗体药物偶联物 (ADC)。

The data demonstrate robust antitumor activity across HER2-expressing tumor models, including those with low or heterogeneous HER2 expression and models resistant to prior HER2-targeted therapies and antibody-drug conjugates, including Trastuzumab deruxtecan. These findings support the continued development of TJ106 as a potential treatment option for patients with HER2-expressing cancers who have progressed on existing therapies..

数据表明，在HER2表达的肿瘤模型中，包括那些低表达或异质性HER2表达以及对先前HER2靶向治疗和抗体药物偶联物（包括Trastuzumab deruxtecan）耐药的模型中，均显示出强大的抗肿瘤活性。这些发现支持继续开发TJ106，作为接受现有治疗后病情进展的HER2表达癌症患者的潜在治疗选择。

TJ106 is engineered with a biparatopic HER2 antibody designed to bind two distinct epitopes, promoting receptor clustering and enhancing internalization. This approach is intended to improve intracellular delivery of cytotoxic payloads and address limitations associated with heterogeneous HER2 expression and suboptimal uptake observed with earlier HER2-targeted therapies..

TJ106 工程设计采用了一种双表位 HER2 抗体，旨在结合两个不同的表位，促进受体聚集并增强内化。这种方法旨在改善细胞毒性载荷的胞内递送，并解决与早期 HER2 靶向疗法中观察到的 HER2 表达异质性和吸收不足相关的局限性。

The molecule incorporates a dual-payload design combining a topoisomerase I inhibitor and a microtubule inhibitor. These payloads provide complementary and non-overlapping mechanisms of action, enabling sustained cytotoxic activity and the potential to overcome resistance associated with single-payload ADCs.

该分子采用双重有效载荷设计，结合了拓扑异构酶 I 抑制剂和微管抑制剂。这些有效载荷提供了互补且无重叠的作用机制，能够实现持续的细胞毒活性，并有潜力克服与单有效载荷 ADC 相关的耐药性。

In preclinical studies, TJ106 demonstrated consistent tumor growth inhibition across multiple models, including those previously exposed to HER2-directed therapies..

在临床前研究中，TJ106在多个模型中展示了持续的肿瘤生长抑制作用，包括那些先前接受过HER2靶向治疗的模型。

TJ106 also incorporates an optimized linker system designed to balance plasma stability with efficient intracellular payload release, supporting a favorable therapeutic window in preclinical evaluations.

TJ106还引入了优化的连接子系统，旨在平衡血浆稳定性与高效的细胞内载荷释放，在临床前评估中展现出良好的治疗窗口。

'The data presented at AACR highlight the potential of TJ106 to address key challenges in HER2-targeted therapy, including resistance and tumor heterogeneity,' said Martin S. Olivo, M.D., M.Sc., Chief Medical Officer of Phrontline Biopharma. 'By combining biparatopic targeting with a dual-payload approach, TJ106 is designed to enhance tumor delivery and provide durable antitumor activity while maintaining an acceptable safety profile.'.

“在AACR上展示的数据突显了TJ106在应对HER2靶向治疗中的关键挑战（包括耐药性和肿瘤异质性）方面的潜力，”Phrontline Biopharma首席医学官Martin S. Olivo博士、理学硕士表示。“通过结合双位点靶向和双重载荷方法，TJ106旨在增强肿瘤递送能力，提供持久的抗肿瘤活性，同时保持可接受的安全性。”

Phrontline plans to advance TJ106 into IND-enabling studies with an anticipated Investigational New Drug (IND) submission in early 2027. A global Phase I clinical trial is expected to evaluate TJ106 in patients with HER2-expressing solid tumors, including breast and gastric cancers, with a focus on patients previously treated with HER2-targeted therapies, including ADCs.

Phrontline计划将TJ106推进到支持新药临床试验（IND）的研究阶段，预计于2027年初提交IND申请。一项全球I期临床试验预计将评估TJ106在HER2表达的实体瘤患者中的效果，包括乳腺癌和胃癌，重点关注曾接受过HER2靶向治疗（包括ADC药物）的患者。

The clinical program is expected to incorporate dose optimization principles aligned with U.S. Food and Drug Administration Project Optimus, including evaluation of exposure–response relationships and multi-cycle tolerability..

预计该临床项目将结合美国食品药品监督管理局Project Optimus的剂量优化原则，包括对暴露-反应关系和多周期耐受性的评估。

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About TJ106

关于TJ106

TJ106 is an investigational biparatopic HER2-targeting antibody-drug conjugate (ADC) incorporating a dual-payload platform consisting of a topoisomerase I inhibitor and an eribulin-based microtubule inhibitor. The molecule is designed to enhance tumor targeting, internalization, and intracellular drug delivery to address resistance mechanisms in HER2-expressing cancers..

TJ106 是一种研究性的双表位 HER2 靶向抗体药物偶联物 (ADC)，结合了包含拓扑异构酶 I 抑制剂和基于艾日布林的微管抑制剂的双载荷平台。该分子旨在增强肿瘤靶向、内化和细胞内药物递送，以应对 HER2 表达癌症中的耐药机制。

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About Phrontline Biopharma

关于Phrontline生物制药公司

Phrontline Biopharma is a clinical-stage oncology company focused on the development of next-generation antibody-drug conjugates (ADCs), including bispecific and dual-payload platforms, to address unmet needs in solid tumors.

Phrontline Biopharma是一家临床阶段的肿瘤学公司，专注于开发下一代抗体药物偶联物（ADC），包括双特异性和双载荷平台，以解决实体瘤中未满足的需求。

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Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements regarding TJ106, including anticipated IND timing, clinical development plans, and therapeutic potential. These statements are subject to risks and uncertainties that may cause actual results to differ materially.

本新闻稿包含关于TJ106的前瞻性声明，包括预期的IND时间表、临床开发计划和治疗潜力。这些声明受到可能导致实际结果存在重大差异的风险和不确定性的影响。

SOURCE Phrontline Biopharma

来源：Phrontline Biopharma

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