“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
The combination is part of an open-label, global phase 1b/2 clinical trial (ADG116-1003) at multiple sites in the
“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
As single agents, both ADG106 and ADG116 have demonstrated robust safety profiles and early signals of efficacy. In monotherapy trials in 98 patients, ADG106 was well tolerated at doses of 3 mg/kg and 5 mg/kg and at 300mg and 400mg flat doses, with limited liver toxicity or hematologic abnormalities observed. Results showed evidence of efficacy and a potential biomarker associated with tumor shrinkage was identified.
In monotherapy evaluation, ADG116 demonstrated a strong safety profile at doses up to 10 mg/kg, and showed early signals of efficacy, including in treatment-resistant “cold” and “warm” tumors such as ovarian and pancreatic cancers. ADG116 has achieved the recommended dosing range as a single agent and for evaluation in combination therapy.
ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft ligand blocking thereby addressing safety concerns associated with existing CTLA-4 therapeutics.
ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. Clinical trials of ADG106 as monotherapy have been conducted in the
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This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the
Source: Adagene, Inc.