On September 22, 2026 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported that China’s National Medical Products Administration (NMPA) has approved the company’s investigational new drug (IND) application for ADG138, a double-masked HER2×CD3 bispecific T cell engager built on Adagene’s proprietary SAFEbody precision masking technology. Adagene expects to initiate a first-in-human Phase 1 study of ADG138 for the treatment of advanced solid tumors in the fourth quarter of 2026.
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"The NMPA’s rapid approval of our IND application for ADG138 speaks to the strength of the preclinical package and allows us to bring a differentiated, double-masked T-cell engager into the clinic for patients with HER2-expressing solid tumors," said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. "In preclinical studies, ADG138 achieved potent, T-cell mediated anti-tumor activity in Enhertu (DS-8201) resistant tumor models while retaining a substantial reduction in cytokine release and a wider therapeutic window relative to an unmasked T-cell engager. We look forward to advancing ADG138 into first-in-human studies and building on the safety and efficacy profile we believe our SAFEbody platform can bring to T-cell engagers in solid tumors."
A Phase 1, first-in-human, open-label clinical study is designed to evaluate the safety and preliminary efficacy of ADG138 in patients with advanced solid tumors as well as to determine the recommended dose for Phase 2.
About ADG138
ADG138 is a double-masked HER2×CD3 bispecific T cell engager designed using Adagene’s SAFEbody precision masking technology, which covalently links masking peptides to both the HER2- and CD3-binding arms of the molecule. In its inactivated state, ADG138 is designed to minimally bind HER2-expressing cancer cells and T cells; the molecule becomes activated within the tumor microenvironment and engages T cells to selectively kill HER2-expressing tumor cells while limiting off-target toxicity.
Preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in 2022 showed that double-masked ADG138 achieved approximately 220-fold and greater than 1,000-fold reductions in binding to HER2 and CD3, respectively, yet translating to high efficiency in T cell-mediated tumor cell killing and T cell activation. ADG138 drove regression in both HER2-high and HER2-low tumor models, including a model refractory and/or resistant to the Enhertu (DS-8201), and showed synergistic anti-tumor activity in combination with anti-CTLA-4, anti-PD-1, or anti-CD137 antibodies. In addition, ADG138 was tolerated at doses over 300-fold higher than an unmasked T-cell engager, with markedly reduced cytokine release and a favorable pharmacokinetic profile, including a longer apparent half-life and higher systemic exposure than the parental molecule.
(Press release, Adagene, SEP 22, 2026, View Source [SID1234670986])