达歌生物全球首个针对HuR靶点的分子胶降解剂新药DEG6498的IND申请获美国FDA批准在实体瘤中开展临床试验

达歌生物（简称“达歌”），一家致力于针对不可成药靶点开发新型分子胶降解剂药物的生物技术公司，宣布公司全球首个针对First-in-Class靶点HuR（Human antigen R）的分子胶降解剂DEG6498的美国新药临床试验申请（IND），已于2025年1月29日成功获得美国食品药品监督管理局（FDA）的批准。达歌即将启动该药物在结直肠癌、肺癌、肝癌和其他类型实体肿瘤患者中的全球临床开发。

DEG6498是针对HuR靶点开发的全球首创分子胶药物，它也是达歌在研管线中第一款进入临床开发药物。HuR是一种RNA结合蛋白，此前被业界认为是无法成药的靶点，它在癌症、炎症和代谢等疾病的进程中发挥着关键性的作用。达歌生物首席执行官邹丽晖博士表示：“FDA批准达歌第一个IND申请是公司的一个重要里程碑。它验证了达歌的GlueXplorer平台在发现和验证针对过往无法成药靶点的创新型分子胶降解剂的能力，也展示了达歌从一个“药物发现引擎”，快速成长为临床阶段公司。达歌是全球首个发现HuR分子胶降解剂并将其推进至临床开发的公司。我们对该项目的潜力充满期待，希望为患者带来全新的治疗方案，并成功验证分子胶降解剂是针对不可成药靶点的一种全新治疗方法。”

达歌自主研发的GlueXplorer®平台，目前已囊括了超过10,000个具有独特结构的分子胶化合物，以及这些化合物诱导邻近和降解靶点蛋白的数据。凭借这一基于生物学研究的化合物库，结合公司完善的分子胶药物筛选和验证体系，达歌能够发现全新的分子胶靶点并优化新型分子胶降解剂。除了HuR项目，公司还在推进多个分子胶药物项目，旨在攻克多个传统方法无法成药但被广泛研究的疾病靶点。公司的战略目标是为了改善人类健康不断提供突破性治疗方法，为全球患者带来福音。

关于**DEG6498

DEG6498是一种强效、口服生物利用度高的分子胶降解剂小分子药物，能诱导E3泛素化连接酶Cereblon（CRBN）与RNA结合蛋白HuR的相互作用，从而促进HuR蛋白的靶向降解。我们的早期临床开发计划旨在评估DEG6498在多种实体肿瘤中的安全性、耐受性、药代动力学、药效动力学和抗肿瘤活性。

关于达歌生物（Degron Therapeutics）

达歌生物是一家用全球领先的分子胶药物发现平台来开发全新的蛋白降解药物-分子胶类小分子新药的研发公司。公司独特的GlueXplorer®平台包括自研的具有特殊骨架结构和专利保护的化合物库和筛选验证系统，以发现针对重要疾病靶点的新型小分子药物，包括以前无法成药的靶点。公司的产品管线包括在癌症、炎症，神经生物学，和代谢等多个领域不断增加的管线项目，以造福人类健康为使命。欲了解更多信息，请访问 www.degrontx.com。

Degron Therapeutics Announces FDA Clearance of Investigational New Drug Application for DEG6498, a Globally First-in-Class**HuR Molecular Glue Degrader**for Clinical Development in Solid Tumors

Degron Therapeutics (“Degron”), a biotechnology company developing a new class of molecular glue degrader (MGD) medicines targeting previously undruggable proteins, announced that it has received clearance on January 29, 2025, from the U.S. Food and Drug Administration (FDA) the company’s Investigational New Drug (IND) application for DEG6498, a first-in-class HuR (Human antigen R) molecular glue degrader investigational drug. Degron is initiating clinical development globally in patients with colorectal, lung, hepatocellular and other types of solid tumors.

DEG6498 is the leading program in Degron’s pipeline of novel MGD therapeutics, targeting HuR, a previously undruggable RNA-binding protein playing critical roles in driving cancer, inflammatory and metabolic disorders. “FDA clearance of our first IND is a significant milestone for our company. It validates the ability for our GlueXplorer platform to discover and validate novel molecular glue degraders for targets that are previously undruggable, and illustrates the rapid growth of the company from a discovery engine to a clinical stage company,” said Lily Zou, Ph.D., CEO of Degron Therapeutics. “Degron is the first company to discover a molecular glue degrader for HuR, and advances it into clinical development. We are excited about the potential of this program to bring new treatment for patients and demonstrate MGD as a new therapeutic approach for undruggable targets.”

Degron’s proprietary GlueXplorer® platform has included more than 10,000 structurally differentiated MGD compounds with associated compound-induced proximity and degradation data. This biology-backed library, combined with the company’s comprehensive screening and validation systems, enables the discovery of novel targets and the optimization of new MGDs. In addition to the HuR program, the company is advancing multiple MGD programs addressing historically intractable but extensively characterized disease targets. Degron’s strategic goal is to continuously deliver breakthrough therapies that improve human health, benefiting patients worldwide.

About DEG6498

DEG6498 is a potent and orally bioavailable small molecule molecular glue degrader that induces the interaction between the E3 ubiquitin ligase component cereblon (CRBN) and the RNA binding protein Human antigen R (HuR), leading to the targeted degradation of HuR protein. Our early clinical development program aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamics, and anti-tumor activity of DEG6498 in multiple solid tumors.

About Degron Therapeutics

Degron Therapeutics is a biotechnology company advancing human health by developing novel medicines using its proprietary molecular glue-based targeted protein degradation drug discovery platform. The company’s unique GlueXplorer® platform has created a rapidly expanding IP-protected compound library and screening and validation systems to discovery a new class of small-molecule medicines that target previously undruggable disease targets. The company’s pipeline includes a growing number of clinical and preclinical programs for oncology, inflammation, neurology, and metabolic diseases. For more information, visit www.degrontx.com.（发布）