Adagene Provides Business Update and 2026 Objectives

Core Insights - Adagene Inc. announced an update on its ongoing Phase 1b/2 study of muzastotug in combination with pembrolizumab for patients with microsatellite stable metastatic colorectal cancer (MSS CRC), with data expected in Q1 2026 [1][6] - The company reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025, which is anticipated to provide sufficient runway until late 2027 [1][3] 2025 Key Accomplishments - The company demonstrated a favorable safety profile for muzastotug at doses 10-20 times higher than first-generation CTLA-4 inhibitors, with encouraging overall response rates and durable responses [5] - Muzastotug received FDA Fast Track designation for use in combination with KEYTRUDA for adult patients with MSS CRC without current or active liver metastases [5] - Adagene secured a strategic investment of up to $25 million from Sanofi to support the randomized Phase 2 study of muzastotug [5] - Collaborations were established with Third Arc Bio for developing next-generation T cell therapies and with Exelixis for advancing a third masked ADC against a solid tumor target [5] 2026 Objectives - The company aims to provide a data update from the ongoing Phase 1b/2 study, including results from 41 patients in the 10 mg/kg cohort and 26 patients in the 20 mg/kg cohort [6] - Complete enrollment of the randomized Phase 2 dose-optimization study with muzastotug, aligned with FDA Project Optimus [6] - Share results from a clinical trial collaboration with Roche evaluating muzastotug in combination with atezolizumab and bevacizumab for liver cancer [6] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [8] - The company's lead clinical program, muzastotug, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in Phase 1b/2 and Phase 2 studies [10]