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FDA解除对 YL202/BNT326临床试验的Partial Hold

苏州宜联生物

2024/08/19

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HER3 BNT326 FDA

中国苏州，2024年8月19日 - 苏州宜联生物医药有限公司（以下简称“宜联生物”），一家临床阶段的生物科技公司，宣布已于2024年8月15日获美国食品药品管理局（FDA）通知正式解除了对 YL202/BNT326临床I期试验（NCT05653752）的Partial Hold。YL202/BNT326是一款靶向HER3（Human Epidermal Growth Factor Receptor 3）的在研抗体偶联药物，目前由宜联生物和BioNTech SE（Nasdaq: BNTX, 以下简称“BioNTech”）合作进行开发。该临床试验将会继续受试者招募，并将集中在表现出优异有效性及可控安全性的3.0 mg/kg及以下的剂量水平进行开发。

宜联生物成立于2020年，是一家专注于开发创新型偶联药物的临床阶段生物科技公司。公司开发的新一代具有自主知识产权的肿瘤微环境可激活的新型毒素连接子平台技术（TMALIN®）可实现高DAR值高均一性的稳定偶联，有助于提高ADC药物在实体瘤适应症上的治疗窗。公司致力于以未满足的临床需求为目标，为全球肿瘤患者带来更好的治疗方案。宜联生物位于中国苏州，并在中国上海、美国波士顿建立研发分支机构。

YL202/BNT326是一款靶向人表皮生长因子受体3（HER3）的下一代抗体偶联药物（ADC）产品，基于宜联生物的TMALIN®技术所开发。HER3靶点在包括非小细胞肺癌、乳腺癌等在内的多个癌种中呈现高表达状态，并与肿瘤转移和疾病进展密切相关；此外 HER3的表达会在前线药物治疗后进一步上调，因此是极具潜力的肿瘤治疗靶点。宜联生物已就YL202/BNT326与BioNTech达成海外合作授权，目前正处于临床I/II期开发阶段。

MediLink Therapeutics Announces Lift of Partial Clinical Hold for YL202/BNT326

Suzhou, China, Aug 19th, 2024 - MediLink Therapeutics (Suzhou) Co., Ltd. (MediLink), a clinical-stage biotech company, announced that on Aug 15th, 2024, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold that was placed on the Phase I trial evaluating YL202/BNT326 (NCT05653752). YL202/BNT326 is a Human Epidermal Growth Factor Receptor 3 (HER3) targeting antibody-drug conjugate candidate that is being developed in collaboration between BioNTech SE (Nasdaq:BNTX, BioNTech) and MediLink. The trial recruitment will be re-initiated. Clinical development will focus on dose levels no higher than 3.0 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed.

MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs with global competitiveness. MediLink has developed its proprietary TMALIN® ADC technology platform, enabling the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. MediLink aims to provide improved treatment options for global patients and address unmet medical needs. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US.

YL202/BNT326 is a next-generation antibody-drug conjugate (ADC) targeting Human Epidermal Growth Factor Receptor 3 (HER3), utilizing MediLink's TMALIN® technology. HER3 is a target that is overexpressed in various cancer types, such as non-small cell lung cancer and breast cancer and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment. MediLink and BioNtech have entered a global collaboration partnership on the development of YL202/BNT326, and the molecule is currently undergoing clinical evaluation in phase I/II studies.