Adagene Presents Interim Monotherapy Data at ESMO 2022

– Best-in-class profile demonstrated with repeat doses at all dose levels –

– Antitumor activity observed in cold tumors with constant accumulation of activated ADG126 –

– On track in 2022 to report results of ADG126 dose escalation in combination with anti-PD-1 therapy, establishing a dosing regimen for Phase 2a dose expansion cohorts –

SAN DIEGO and SUZHOU, China, Sept. 10, 2022 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody therapies, announced today the publication of data showing the best potential of ADG126, an anti-CTLA-4 masked SAFEbody®. Interim Phase 1 results from an ongoing Phase 1b/2 trial of ADG126 are being presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris, September 9-13, 2022.

The poster, titled “Phase 1 results demonstrate a highly differentiated safety and pharmacokinetic profile of ADG126, a masked anti-CTLA-4 SAFEbody® in patients with advanced solid tumors,” reviewed data from the first open-label phase 1 study in humans dose escalation and dose expansion. The poster reports data on 26 patients with advanced metastatic solid tumors, the majority (58%) of whom received three or more lines of prior therapy and nearly half (42%) of whom progressed from prior immuno-oncology (IO) treatment.

Key findings include:

  • Security: ADG126 monotherapy has shown an unprecedented clinical safety profile at dosage levels up to 20 mg/kg when administered to this heavily pretreated patient population once every three weeks. ADG126 was well tolerated with no dose-limiting toxicity or treatment-related Grade 3 or higher adverse events. The most common treatment-related adverse events (≥10%) were fatigue (12%), pruritus (12%), rash (12%) and diarrhea (12%). Dose escalation is complete at 20 mg/kg and dose escalation is in progress at 10 mg/kg.
  • Antitumor activity in cold tumors: With 18 cycles of treatment at 1 mg/kg, a patient with ovarian cancer showed a significant and continuous reduction in an established biomarker of ovarian cancer, CA125, falling by 90% in the normal range for full clinical benefit. From Cycle 16, the patient showed a 22% decrease in target lesions. Previously, this patient had undergone surgery and five previous lines of systemic therapies. As of the data cut-off date of August 17, 2022, the disease control rate was 39% (9/23 evaluable patients).
  • Pharmacokinetics: Plasma pharmacokinetics (PK) of ADG126 were approximately linear, and activated ADG126 steadily accumulated upon repeated administration at different dose levels. This suggests prolonged exposures to activated ADG126 in the tumor microenvironment (TME), with cleaved ADG126 accumulating on average ≥3-fold upon repeated administration, resulting in an approximately 1.5-fold longer half-life of total ADG126 relative to its parent antibody.

“ADG126 continues to demonstrate a remarkable safety profile, highly differentiated from both currently approved anti-CTLA-4 therapy and others in development, as well as antitumor activity in heavily pretreated patients with cold tumors. said Dr Gary Richardson, OAM, MBBS, FRACP, Group Director at Cabrini Health Research, Neil Beauglehall Endowed Chair, Medical Oncology Research and Professor of Medicine at Monash University, Australia, said: “A study of intriguing case of our poster is the experience of a patient with ovarian cancer, whose tumor shrank by 22% accompanied by the normalization of an established clinical biomarker, CA125, which increased tenfold after more than a year of treatment with ADG126 administered every three weeks at only 1 mg/kg. These data clearly demonstrate the monotherapy activity of this novel antibody, ADG126, supporting its ongoing evaluation both as monotherapy and in combination with anti-PD-1 agents.

Trials evaluating the combination of ADG126 and anti-PD-1 therapies are underway in patients with advanced metastatic tumors in the United States, China and Asia-Pacific (APAC), evaluating optimized doses of ADG126 in targeted tumors.

ADG126 SAFEbody applies precision masking technology to the parental anti-CTLA-4 antibody, ADG116, for conditional activation in the TME to expand the therapeutic index and further address safety concerns with CTLA-4 therapies. 4 existing. Binding to the same unique epitope as ADG116, masked ADG126 is designed to provide improved safety and efficacy profiles due to the combination of potent Treg depletion in TME and partial ligand blockade by activated ADG126, which steadily accumulates for prolonged tumor killing effect in TME.

About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology 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, consisting 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 certain clinical results of ADG126, potential clinical outcome implications of the product candidate, and Adagene’s progress and anticipated clinical development, regulatory milestones and commercialization. candidates from the Adagene pipeline. 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. .


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