ADG138 / Adagene - LARVOL DELTA

Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager (Yahoo Finance) - "Adagene expects to initiate a first-in-human Phase 1 study of ADG138 for the treatment of advanced solid tumors in the fourth quarter of 2026."

First-in-human • New P1 trial • Solid Tumor

ADG138, a novel HER2×CD3 POWERbody™ integrating bispecific TCE with precision masking to control cytokine release syndrome and on-target off-tumor toxicity for single agent and combination therapies in HER2-expressing solid tumors (AACR 2022) - "These nonclinical studies demonstrated that ADG138, a novel double masked HER2×CD3 POWERbody TCE, exhibited an impressively high therapeutic index relative to its parental non-masked TCE in HER2 high and low expressing solid tumors. This provides strong support for advancing the ADG138 prodrug into clinical development for treating HER2-expressing solid tumors as a single agent and in combination with other immune stimulatory agents."

Combination therapy • Cytokine release syndrome • Hematological Malignancies • Oncology • Solid Tumor • HER-2

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 ADG153 IgG1 was well tolerated, did not induce human hemagglutination and significantly reduced anemia-related and antigen sink liabilities. In particular, ADG153 IgG1 at a 10 mg/kg dose demonstrated only an 8 percent decrease in red blood cell counts, compared to a 49 percent decrease with a benchmark antibody which is in IgG4 format (analogue of magrolimab)....Adagene is preparing to submit an IND or equivalent filing for ADG153 during 2022....Preclinical data demonstrated the excellent safety profile of ADG138, including 100-fold greater reduction in cytokine release compared to its parental TCE."

IND • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

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