ADG206 / Adagene - LARVOL DELTA

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Adagene Inc | Recruiting ➔ Active, not recruiting | N=21 ➔ 14 | Trial completion date: Oct 2025 ➔ Aug 2026

Enrollment change • Enrollment closed • First-in-human • Trial completion date • Solid Tumor

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Adagene Inc | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Apr 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Adagene Reports Six Month Financial Results for 2024 and Provides Corporate Update (GlobeNewswire) - "Phase 1 evaluation is ongoing for ADG206, a masked, IgG1 FC-enhanced anti-CD137 POWERbody in patients with advanced/metastatic tumors: Adagene has now enrolled 13 patients in an ongoing phase 1 trial of ADG206 to evaluate safety, efficacy and tolerability profiles for this next generation anti-CD137 candidate. Dose escalation continues with a cohort ongoing at 6 mg/kg Q3W. No maximum tolerated dose (MTD) has yet been reached."

Trial status • Solid Tumor

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - P1 | N=21 | NCT05614258 | Sponsor: Adagene Inc | "Adagene has enrolled 10 patients in an ongoing phase 1 trial of ADG206 to evaluate safety, efficacy and tolerability profiles for this next generation anti-CD137 candidate. Dose escalation continues with a cohort ongoing at 3 mg/kg Q3W. No maximum tolerated dose (MTD) has yet been reached."

P1 data • Trial status • Oncology • Solid Tumor

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Adagene Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Immune Modulation • Oncology • Solid Tumor

Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Adagene Inc

New P1 trial • Immune Modulation • Oncology • Solid Tumor

Adagene Reports Financial Results for the Six Months Ended June 30, 2022 and Provides Corporate Updates (GlobeNewswire) - "UPDATED MILESTONES & OUTLOOK: 2023: (i) Initiate patient dosing in ADG206 phase 1 trial; (ii) Submit IND or equivalent for ADG153, and initiate phase 1 trial; (iii) Results from IIT combination studies of ADG106; (iv) Additional collaborations and/or technology licensing agreements."

IND • Licensing / partnership • New P1 trial • Oncology

ADG206, an anti-CD137 agonistic POWERbodyTM with tailor-made efficacy and safety profiles by strong crosslinking and tumor selective activation for single and combinational cancer immunotherapy (AACR 2022) - "Utomilumab appears safe but has modest efficacy, while urelumab is more efficacious but causes severe dose-dependent liver toxicity...In normal tissues, the CD137 antigen binding interfaces of ADG206 are masked using a covalently linked designer peptide to limit on-target off-tumor toxicities, whereas in the tumor microenvironment (TME), the masked antibody can be activated to selectively bind CD137, promoting costimulatory signaling in situ...These results demonstrate that ADG206 POWERbody acquires a tailor-made product profile toward a best-in-class anti-CD137 immunotherapeutic agent that combines conditional activation in the TME with strong agonistic activity through heightened FcγR-mediated crosslinking. Further clinical development of ADG206 POWERbody may hold promises for achieving the long-awaited desirable tolerability and efficacy outcome of an anti-CD137 immunotherapy in either single agent or combination regimens."

Clinical • IO biomarker • Oncology

Adagene Presents Data Demonstrating First and Best-in-Class Potential for Differentiated Preclinical Antibody Candidates at American Association for Cancer Research (AACR) Annual Meeting 2022 (GlobeNewswire) - "Preclinical data demonstrated that ADG206 was well tolerated and had robust anti-tumor activity as a single agent in multiple tumor models, with 4-fold stronger anti-CD137 agonistic activity of its activated form than a benchmark antibody in development (analog of urelumab) for T cell co-activation....Adagene is preparing to submit an IND or equivalent filing for ADG206 during 2022."

IND • Preclinical • Oncology

Adagene Announces Four Poster Presentations on Robust Preclinical Pipeline of Antibody-Based Therapeutics at Upcoming American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Adagene Inc...announced publication of four abstracts featuring preclinical data from its expanding pipeline in advance of the AACR Annual Meeting 2022 in New Orleans, Louisiana from April 8-13, 2022. The full abstracts are available on the AACR meeting website. At AACR, presentations will include preclinical results showing the potential best-in-class profiles for three differentiated preclinical product candidates in IND-enabling studies: ADG138, ADG206 and ADG153. The fourth presentation introduces a new capability for the company’s proprietary bispecific T-cell engagers (TCEs) with CD28."

Preclinical • Oncology • Solid Tumor