Adagene announces the first patient to receive a novel,

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 therapies, announced today the first patient received in a combined cohort 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 assess the safety and tolerability of this new 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 a high threshold for agents that are both safe and potent. With ADG106 and ADG116, we now have two promising agents to jointly test the therapeutic potential of these two powerful pathways to safely inhibit tumor growth,” said Anthony W. Tolcher, MD, FRCPC, FACP, co- Founder of NEXT Oncology™ and Study Investigator. “While the oncology community has long known the compelling preclinical rationale for this intriguing combination, safety has been a barrier to further exploration. Given the encouraging individual safety profiles of ADG 106 and ADG116 in patients so far, we finally have the rare and exciting opportunity to be the first to bring this combination into the clinic and improve patient care.

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

“Research published in preclinical models highlights the potential synergistic effect of combining these two powerful pathways. We are proud to pioneer the exploration of this novel combination, which also demonstrates the translational power of our NEObody™ platform – targeting unique epitopes with novel mechanisms of action by cross-reacting antibodies of species that can move directly from preclinical syngeneic mouse models to clinical studies,” said Peter Luo, Ph.D., co-founder, CEO and president 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, based on promising preclinical and clinical studies. preliminary safety and efficacy data from our global trials. This pursuit aligns with our goal to transform the development paradigm of antibody-based immunotherapies for global cancer care.

As single agents, ADG106 and ADG116 demonstrated robust safety profiles and early signs of efficacy. In monotherapy trials in 98 patients, ADG106 was well tolerated at doses of 3 mg/kg and 5 mg/kg and at flat doses of 300 mg and 400 mg, with limited hepatic toxicity or hematological abnormalities observed. The 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 signs of efficacy, including in “cold” and “hot” tumors » resistant to treatment such as ovarian and pancreatic cancers. ADG116 has reached the recommended dosage range as a single agent and for evaluation in combination therapy.

About ADG116
ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using Adagene’s proprietary NEObody technology and developed for the treatment of advanced/metastatic solid tumors. ADG116 is designed to improve efficacy through potent depletion of Tregs in the tumor microenvironment (TME) and to maintain its physiological function through soft ligand blockade, thereby addressing safety issues associated with existing CTLA-4 therapies.

About the ADG106
ADG106 is a fully human ligand-blocking anti-CD137 agonist IgG4 mAb generated using Adagene’s proprietary NEObody technology and 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 United States and China, and combined trials are in progress with several anti-PD-1 therapies.

About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary Dynamic Precision Library (DPL) platform, comprised of NEObody™, SAFEbody® and POWERbody™ technologies, Adagene’s highly differentiated pipeline delivers novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the forefront of science.

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SAFE body® is a registered trademark in the United States, China, Australia, Japan, Singapore and the European Union.

Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, as well as Adagene’s anticipated preclinical progress and activities, clinical development, regulatory milestones and commercialization of its candidate products. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including, but not limited to, Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results of its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by relevant regulatory authorities regarding the 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 intellectual property protection for its technology and medicines; Adagene’s reliance on third parties to carry out drug development, manufacturing and other services; Adagene’s limited operating history and its ability to obtain additional financing for its 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 the risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the United States Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. except as required by law. .

Internal contact person:
Ami Knoefler

External contact:
Bruce Mackle
LifeSci Advisors

Irene B. Bowles