Adagene presents data on ADG126 at SITC Annual Meeting

Adagene presented new data on its masked, anti-CTLA-4 SAFEbody ADG126 at the Society for Immunotherapy of Cancer 38th Annual Meeting taking place in San Diego. The poster presentation, Optimal Dose Selection of ADG126 with Significantly Widened Therapeutic Index Compared to Ipilimumab in Combination with anti-PD-1 Antibodies Informed by QSP Modeling, is available on the company’s website. The data, which integrate clinical results with physiologically based pharmacokinetic and quantitative systems pharmacology modeling, demonstrated that Adagene’s lead SAFEbody candidate, ADG126, is effective at targeting CTLA-4 within the tumor microenvironment. This resulted in an approximately 30-fold projected pharmacokinetic difference at 10 mg/kg every three weeks in the TME indicating a wider therapeutic index compared to ipilimumab at 1 mg/kg Q6W, when either is combined with anti-PD-1 therapies. Importantly, a clinical case example presented for the first time from an ongoing dose expansion cohort in advanced/metastatic MSS CRC patients free of liver metastases showed that ADG126 10 mg/kg Q3W plus pembrolizumab resulted in a confirmed PR after four cycles. The patient was previously treated with two lines of therapy and experienced manageable Grade 3 TRAEs consistent with known adverse events from immunotherapy. The poster concluded that initial clinical data from the SAFEbody ADG126 program support that ADG126 may provide greater clinical benefit than ipilimumab in combination with anti-PD-1 in both ‘hot’ and ‘cold’ tumors, including MSS CRC, driven by better target engagement in the TME and a favorable safety profile that enables higher, more frequent and repeat dosing.