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Adagene Showcases Findings Exhibiting Top-of-the-Line Therapeutic Index for Concealed Anti-CTLA-4 SAFEbody® ADG126 at 2023 SITC Event

13 November 2023
3 min read

At the 38th Annual Society for Immunotherapy of Cancer Meeting in San Diego, Adagene Inc., a firm that is revolutionizing the creation and advancement of new antibody-related therapies, showcased fresh information about its covered anti-CTLA-4 SAFEbody ADG126.

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The analyzed information, which unifies clinical outcomes with physiologically based pharmacokinetic and quantitative systems pharmacology modeling, revealed that Adagene's primary SAFEbody contender, ADG126, is proficient at targeting CTLA-4 within the tumor microenvironment. 

This culminated in a roughly 30-fold anticipated pharmacokinetic disparity at a dosage of 10 mg/kg every three weeks in the TME, implying a broader therapeutic index in comparison to ipilimumab at 1 mg/kg every six weeks, when teamed up with anti-PD-1 treatments.

The enhanced therapeutic index of ADG126 fosters larger, more regular, and recurring doses of ADG126 in synergy with anti-PD-1, leading to a substantial boost in CTLA-4 interaction by the activated ADG126 at steady-state in tumors versus circulating blood. 

Scrutinies further revealed that the ideal dose of ADG126 at 10 mg/kg every three weeks combined with pembrolizumab culminates in a dose-dependent effectiveness profile, without significantly heightening treatment-related adverse occurrences.

Significantly, a clinical instance provided for the first time from a present dose expansion group in advanced/metastatic MSS CRC* patients excluding liver metastases showed that ADG126 at 10 mg/kg every three weeks along with pembrolizumab led to a confirmed partial response after four cycles. The patient had previously undergone two lines of treatment and had manageable Grade 3 treatment-related adverse events that were consistent with known side effects from immunotherapy.

ADG126 SAFEbody is the most progressed clinical phase anti-CTLA-4 candidate incorporating masking technology and Treg reduction for superior safety and efficacy profiles. A phase 2 dose expansion cohort is continuing to assess ADG126 combined with pembrolizumab in patients with MSS CRC devoid of liver metastases.

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According to the data provided by the Synapse Database, As of November 11, 2023, there are 115 investigational drugs for the CTLA4 target, including 160 indications, 150 R&D institutions involved, with related clinical trials reaching 1588, and as many as 35097 patents.

ADG-126 is indicated for the treatment of solid tumors, including advanced malignant solid neoplasms and metastatic solid tumors. The drug has reached Phase 2 globally, indicating promising results in earlier stages of clinical trials, while in China, it is in Phase 1. ADG-126's development highlights the potential of monoclonal antibodies in the field of biomedicine for targeted cancer therapies.

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