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Adagene Announces First Patient Dosed with Novel, Proprietary Combination of Anti-CD137 Agonist, ADG106, and Anti-CTLA-4 Monoclonal Antibody, ADG116

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SAN DIEGO and SUZHOU, China, Jan. 27, 2022 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced the first patient has been dosed in a combination cohort of its anti-CD137 agonist, ADG106, with its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in patients with advanced/metastatic solid tumors. The dose escalation cohort will evaluate the safety and tolerability of this novel, proprietary combination in patients with advanced/metastatic solid tumors.

“Existing cancer therapies that target CD137 and CTLA-4 are associated with safety concerns, creating a significant unmet need and high threshold for agents that are both safe and potent. With ADG106 and ADG116, we now have two promising agents to test the therapeutic potential of these two potent pathways together to safely inhibit tumor growth,” said Anthony W. Tolcher, M.D., FRCPC, FACP, co-founder of NEXT Oncology™ and study investigator. “While the oncology community has long known of the compelling preclinical rationale for this intriguing combination, safety has been a barrier to further exploration. Given the encouraging individual safety profiles of both ADG 106 and ADG116 in patients so far, we finally have the rare and exciting opportunity to be the first to move this combination into clinic and improve patient care.”

The combination is part of an open-label, global phase 1b/2 clinical trial (ADG116-1003) at multiple sites in the U.S. and Asia Pacific (APAC). The combination part begins with dose-escalation, followed by dose expansion once a recommended dose is established.

Published research in preclinical models underscores the potential synergistic effect of combining these two potent pathways. We are proud to pioneer exploration of this novel combination, which also demonstrates the translational power of our NEObody™ platform — targeting unique epitopes with novel mechanisms of action by species cross reactive antibodies that can move directly from preclinical syngeneic mouse models to clinical studies,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. “This innovative clinical research will establish the safety and potential complementary effects of ADG106 and ADG116 against two challenging but orthogonal pathways for T-cell priming by anti-CTLA-4 and proliferation by anti-CD137, respectively, building on the promising preclinical and clinical data on safety and preliminary efficacy from our global trials. This pursuit aligns with our goal to transform the development paradigm of antibody-based immunotherapies for global cancer care.”