● Will initiate two global clinical trials evaluating the NEObody™ candidate ADG116 and the SAFEbody™ candidate ADG126 in combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with advanced/metastatic solid tumors.
On July 22, Adagene (hereinafter referred to as the "Company" or "Adagene") announced that it has entered into a clinical trial collaboration and supply agreement with MSD, a leading top-tier immuno-oncology (IO) therapeutics company, to evaluate Adagene’s anti-CTLA-4 monoclonal antibody (mAb) candidates ADG116 and ADG126 in combination with MSD’s anti-PD-1 drug KEYTRUDA®Two open-label, dose-escalation and expansion clinical trials will be initiated to evaluate the clinical efficacy of combination therapy with (Pembrolizumab) in patients with advanced/metastatic solid tumors.
“This collaboration with MSD and the active advancement of our global clinical studies mark a significant milestone in Adagene’s anti-CTLA-4 therapy development program,”Dr. Peizhi Luo, Co-founder, Chief Executive Officer and Chairman of Adagenestated, "ADG116 and ADG126 are two highly differentiated anti-CTLA-4 therapeutic candidates independently developed leveraging Adagene's AI-driven antibody discovery platform. The NEObody™ candidate ADG116 efficiently clears regulatory T cells (Tregs) through potent antibody-dependent cellular cytotoxicity (ADCC) and activates T cells by partially blocking CTLA-4 ligand binding, aiming to enhance efficacy while improving the safety profile. The SAFEbody™ candidate ADG126 effectively mitigates toxicities arising from target binding in non-tumor tissues (on-target, off-tumor toxicities). Through its design, it achieves superior systemic safety at therapeutically effective dose levels, significantly widening the therapeutic window and holding promise to overcome the safety limitations of existing anti-CTLA-4 therapies."
Dr. Luo continued, "While we see considerable promise for ADG116 and ADG126 as monotherapies, combining them with KEYTRUDA will further unlock the potential of PD-1/CTLA-4 combination therapy. This approach aims to overcome the safety concerns associated with existing combinations of these targets, while modulating distinct T-cell subsets to achieve novel immune functions and synergistic effects that cannot be driven by monotherapy alone. Adagene's extensive preclinical and early clinical data provide robust support for this strategic decision. We look forward to combining our anti-CTLA-4 therapies with anti-PD-1 checkpoint inhibitors, such as KEYTRUDA, to fully realize the potential of this combination regimen. Adagene is privileged to collaborate with MSD to explore combination therapies leveraging these two of the most effective immunotherapy targets."
“We are very pleased to partner with MSD to explore the therapeutic potential of ADG116 and ADG126 in combination with KEYTRUDA. This collaboration marks a significant milestone for Adagene and for patients with advanced/metastatic solid tumors.”Adagene Acting Chief Medical Officer Steven Fischkoff, M.D.said, “ADG116 has currently been dose-escalated to 3 mg/kg, which corresponds to the dosing level of commercialized anti-CTLA-4 therapies for monotherapy and combination therapy across approved indications. We look forward to demonstrating the differentiation between ADG116 and ADG126 as the trials progress.”
KEYTRUDA®is a registered trademark. The trademark owner is Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.
Regarding the Clinical Development Plan for Anti-CTLA-4 Therapy
ADG 116-P001: A Phase 1, open-label, dose-escalation and cohort expansion study of ADG116 in combination with KEYTRUDA in patients with advanced/metastatic solid tumors will be conducted at multiple clinical centers across Asia and the United States. The study aims to evaluate the safety, tolerability, and recommended Phase 2 dose of the ADG116 and KEYTRUDA combination, with dose escalation planned up to a maximum of 10 mg/kg. This study builds upon the favorable early clinical data from the ADG116-1003 trial (which demonstrated encouraging pharmacodynamic [PD] biomarkers and a favorable pharmacokinetic [PK] profile), as well as extensive preclinical safety and tolerability data and a successful Safety Review Committee meeting. In the ADG116-1003 trial, ADG116 was well-tolerated in 17 patients, with no dose-limiting toxicities (DLTs) or other unexpected safety signals observed. No drug-related Grade 2, 3, or 4 adverse events were observed. Dosing has been completed for three additional patients in the 3 mg/kg cohort, bringing the total number of patients treated to date to 17.
ADG 126-P001: A Phase 1, open-label, dose-escalation, and cohort-expansion study of ADG126 in combination with KEYTRUDA for the treatment of patients with advanced/metastatic solid tumors will be conducted at multiple clinical centers across Asia and the United States. It will evaluate the safety, tolerability, and recommended Phase 2 dose of the ADG126 and KEYTRUDA combination, with dose escalation planned up to a maximum of 10 mg/kg. This study builds upon a robust body of encouraging preclinical data demonstrating that ADG126 was well tolerated at doses up to 200 mg/kg and exhibited dose-dependent antitumor efficacy, both as a monotherapy and in combination with anti-PD-1 and other therapies, in various immunocompetent mouse tumor models. The ADG126-1001 trial has completed the dose-limiting toxicity (DLT) assessment for six patients in the 0.1 and 0.3 mg/kg cohorts.
About Adagene
Adagene Inc. (NASDAQ: ADAG) is a clinical-stage biopharmaceutical company driven by proprietary platforms and dedicated to developing platform-derived products. The Company is committed to discovering and developing novel cancer immunotherapies grounded in proprietary antibodies. Leveraging computational biology and artificial intelligence, and powered by its globally pioneering tri-body platform technologies—NEObody™ (neoepitope antibody), SAFEbody™ (safety antibody), and POWERbody™ (potency antibody)—Adagene has established a unique, proprietary antibody portfolio focused on novel tumor immunotherapies to address unmet clinical needs. Adagene has formed strategic collaborations with multiple globally renowned partners, empowering their novel drug discovery and development with its proprietary, cutting-edge technologies.