達歌生物全球首個針對HuR靶點的分子膠降解劑新藥DEG6498的IND申請獲美國FDA批准在實體瘤中開展臨牀試驗

達歌生物（簡稱“達歌”），一家致力於針對不可成藥靶點開發新型分子膠降解劑藥物的生物技術公司，宣佈公司全球首個針對First-in-Class靶點HuR（Human antigen R）的分子膠降解劑DEG6498的美國新藥臨牀試驗申請（IND），已於2025年1月29日成功獲得美國食品藥品監督管理局（FDA）的批准。達歌即將啓動該藥物在結直腸癌、肺癌、肝癌和其他類型實體腫瘤患者中的全球臨牀開發。

DEG6498是針對HuR靶點開發的全球首創分子膠藥物，它也是達歌在研管線中第一款進入臨牀開發藥物。HuR是一種RNA結合蛋白，此前被業界認為是無法成藥的靶點，它在癌症、炎症和代謝等疾病的進程中發揮着關鍵性的作用。達歌生物首席執行官鄒麗暉博士表示：“FDA批准達歌第一個IND申請是公司的一個重要里程碑。它驗證了達歌的GlueXplorer平台在發現和驗證針對過往無法成藥靶點的創新型分子膠降解劑的能力，也展示了達歌從一個“藥物發現引擎”，快速成長為臨牀階段公司。達歌是全球首個發現HuR分子膠降解劑並將其推進至臨牀開發的公司。我們對該項目的潛力充滿期待，希望為患者帶來全新的治療方案，併成功驗證分子膠降解劑是針對不可成藥靶點的一種全新治療方法。”

達歌自主研發的GlueXplorer®平台，目前已囊括了超過10,000個具有獨特結構的分子膠化合物，以及這些化合物誘導鄰近和降解靶點蛋白的數據。憑藉這一基於生物學研究的化合物庫，結合公司完善的分子膠藥物篩選和驗證體系，達歌能夠發現全新的分子膠靶點並優化新型分子膠降解劑。除了HuR項目，公司還在推進多個分子膠藥物項目，旨在攻克多個傳統方法無法成藥但被廣泛研究的疾病靶點。公司的戰略目標是為了改善人類健康不斷提供突破性治療方法，為全球患者帶來福音。

關於**DEG6498

DEG6498是一種強效、口服生物利用度高的分子膠降解劑小分子藥物，能誘導E3泛素化連接酶Cereblon（CRBN）與RNA結合蛋白HuR的相互作用，從而促進HuR蛋白的靶向降解。我們的早期臨牀開發計劃旨在評估DEG6498在多種實體腫瘤中的安全性、耐受性、藥代動力學、藥效動力學和抗腫瘤活性。

關於達歌生物（Degron Therapeutics）

達歌生物是一家用全球領先的分子膠藥物發現平台來開發全新的蛋白降解藥物-分子膠類小分子新藥的研發公司。公司獨特的GlueXplorer®平台包括自研的具有特殊骨架結構和專利保護的化合物庫和篩選驗證系統，以發現針對重要疾病靶點的新型小分子藥物，包括以前無法成藥的靶點。公司的產品管線包括在癌症、炎症，神經生物學，和代謝等多個領域不斷增加的管線項目，以造福人類健康為使命。欲瞭解更多信息，請訪問 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.（發佈）