Adagene has announced the expansion of its Phase II clinical trial for ADG126, a new anti-CTLA-4 SAFEbody, plus Merck (MSD)’s Keytruda (pembrolizumab), for metastatic microsatellite-stable (MSS) colorectal cancer (CRC).

The trial will now include more than 50 patients, with the expansion driven by promising safety profiles and preliminary efficacy findings.

The company recently concluded subject enrolment by including an additional 12 patients in the fourth quarter of 2023 for the ongoing dose expansion cohort.

This segment is assessing a combination of ADG126 at a dosage of 10mg/kg every three weeks (Q3W) with pembrolizumab in MSS CRC.

These part two results are anticipated to bolster already reported data from part one.

Adagene has also begun evaluating higher loading doses of ADG126 at 20mg/kg in combination with pembrolizumab for patients with advanced or metastatic cancer.

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The investigation follows a safety evaluation, after which the company intends to assess the efficacy of the loading doses and then proceed with a maintenance regimen of ADG126 at 10mg/kg Q3W plus pembrolizumab.

Plans are in place to extend the dose expansion to include MSS CRC patients in both the US and Asia Pacific regions.

Additionally, the Center for Drug Evaluation (CDE) in China has granted Adagene clearance to initiate clinical evaluation of ADG126 in combination with pembrolizumab, allowing for a broader dose expansion in MSS CRC at selected dosing regimens and potentially in other tumour types.

In 2024, the company expects to report data from the ongoing Phase Ib/II clinical trial of ADG126 with pembrolizumab, including the dose expansion cohorts.

This will include follow-up data on part one evaluable patients at 10mg/kg Q3W and 10mg/kg Q6W, data from part two patients at 10mg/kg Q3W, and evaluation of the 20mg/kg loading doses to meet Project Optimus requirements.

Adagene R&D chairman, CEO and president Peter Luo said: “Following the completion of enrolment of 12 additional patients at the end of last year, together with our ongoing expansion plans, we are on track to deliver data in 2024 that support the findings released at the recent ASCO-GI Symposium demonstrating the safety and efficacy profile of ADG126 in combination with pembrolizumab in MSS CRC.

“To address the requirements for Project Optimus by FDA, we have initiated the evaluation of ADG126 20mg/kg loading doses in combination with pembrolizumab, which we believe can unlock even greater efficacy for MSS CRC in planned cohort expansion, while still maintaining a robust safety profile.”