标新生物两项里程碑:(1)分子胶管线GT919完成首例患者入组;(2)分子胶管线GT929默许获得CDE临床批件

发布日期:2023-07-24 文章来源:标新生物

 里程碑一:
     今日,标新生物(Gluetacs Therapeutics)GlueTacs®平台开发的分子胶管线GT919成功入组首例患者,用于复发或难治性多发性骨髓瘤的治疗,该试验为旨在评估GT919在患者中的安全性、耐受性、药代动力学特征及初步疗效。
里程碑二:

     同日,标新生物(Gluetacs Therapeutics)GlueTacs®平台开发的分子胶管线GT929获得CDE临床批件,用于恶性血液肿瘤的治疗。

     标新生物基于两项里程碑的进展,标志着标新生物正式成为了蛋白降解小分子药物领域的临床阶段的生物医药创新型科技公司;标新生物期待与研究机构、监管部门和临床专家等各方面共同努力,一起推动GT919和GT929临床研究,希望给患者带来福音。

PRESS RELEASE

Shanghai, China – 24 July 2023

Two Milestones: (1) Gluetacs Therapeutics Announces First Patient Dosed in First-In-Human Phase 1 Trial to Evaluate GT919; (2) Gluetacs Therapeutics Announces IND Approval of GT929 from China CDE 

Milestone 1:

Gluetacs Therapeutics announced today that the first patient has been dosed in the first-in-human phase 1 trial to evaluate GT919, a glue degrader pipeline of the company, in relapsed or refractory multiple myeloma. The primary purpose of the clinical study is to access the safety, tolerability, pharmacokinetics and efficacy of GT919 in Chinese subjects.

Milestone 2:

Gluetacs Therapeutics announced today the Center for Drug Evaluation (CDE) of China has approved the Investigational New Drug (IND) application of GT929 to treat liquid tumors.

With these two milestones, Gluetacs Therapeutics has officially become a clinical-stage innovative biotech company in the field of small molecule target protein degradation. We are eager to promote the clinical trial of GT919 and GT929 to deliver new treatment to patients with clinically unmet needs under the joint efforts of research institutions, supervision departments and clinical experts to benefit the patients with liquid tumors.