Daiichi Sankyo's Novel TA-MUC1-Targeting ADC DS-3939a Granted IND Approval in China for Solid Tumors

Mar 06, 2025 13:29 CST Updated 13:29

Daiichi-Sankyo

Pharmaceutical R&D Developer

▎WuXi AppTec Content Team Report

Today (March 6), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Daiichi Sankyo's Class 1 new drug DS-3939a has been approved for clinical trials, intended for the development of solid tumor treatment.Public information shows,DS-3939a is a targetedTumor-associated MUC1Antibody-Drug Conjugates (ADC), currently in Phase 1/2 clinical trials globally. According to the CDE official website, this is the first time the product has been approved for clinical trials in China.

Screenshot Source: CDE Official Website

MUC1 is an emerging target for cancer immunotherapy.MUC1 is a highly glycosylated transmembrane protein that plays a crucial role in the lubrication and protection of normal epithelial cells. MUC1 undergoes hypoglycosylation due to alterations in the expression patterns of certain sialyltransferases, andExposure of a new epitope on MUC1 in tumors, referred to as tumor-associated MUC1 (TA-MUC1).。It is highly expressed in various human epithelial cancers, making it an attractive target for cancer therapy.

DS-3939a is an ADC targeting TA-MUC1, developed based on Daiichi Sankyo's DXd platform. The structure of this product consists of a humanized anti-TA-MUC1 antibody, an enzymatically cleavable tetrapeptide linker, and a DNA topoisomerase I inhibitor (DXd) with a high drug-to-antibody ratio (DAR).

▲Introduction to DS-3939a (Source of screenshot: Daiichi Sankyo 2024 R&D Day Materials)

According to the research results published by researchers at the 2024 American Association for Cancer Research (AACR) Annual Meeting, DS-3939a inhibited in in vitro experiments.TA-MUC1The growth of positive cancer cells, whileTA-MUC1Negative cancer cells have no inhibitory effect.In vitro studies have shown that DS-3939a exhibits TA-MUC1-dependent cell growth inhibition through DXD-mediated cytotoxic effects.In addition, DS-3939a demonstrated significant antitumor effects in several xenograft models derived from TA-MUC1-positive cancer cell lines and various PDX models. In several xenograft models, DS-3939a induced strong tumor regression even after treatment with other cytotoxic ADCs.

According toClinicalTrialsAccording to the official website, currently, Daiichi-Sankyo is conducting a Phase 1/2, first-in-human, open-label, multi-center, two-part, dose-escalation and dose-expansion study in the United States, Japan, South Korea, and other countries to evaluate...DS-3939aInAdvanced Solid TumorsSafety, Tolerability, and Effectiveness in Patients. The StudyPlan to recruit up to 470 adult patients, the first part (dose escalation) includes patients with locally advanced, metastatic or unresectable urothelial carcinoma, non-small cell lung cancer, breast cancer, ovarian cancer, biliary tract cancer or pancreatic cancer, the second part (dose escalation) includes various advanced solid tumors.TA-MUC1Expressing tumor patients.

The clinical approval of this innovative ADC in China means that it will enter the clinical research stage in China.

References:

[1] Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) website. Retrieved Mar 6, 2025, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Abstract 6579: DS-3939a, a novel TA-MUC1-targeting antibody-drug conjugate (ADC) with a DNA topoisomerase I inhibitor DXd, exhibits potent antitumor activity in preclinical models . Retrieved Mar 22, 2024 from https://aacrjournals.org/cancerres/article/84/6_Supplement/6579/738363/Abstract-6579-DS-3939a-a-novel-TA-MUC1-targeting

[3] Daiichi Sankyo Official Website. From https://www.daiichisankyo.com/investors/library/materials/

This articleFrom the WuXi AppTec content team. Individuals are welcome to share this article on their social media feeds, but unauthorized republication by media or organizations in any form on other platforms is strictly prohibited.For reprint authorization and other cooperation needs, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a regular hospital.