On February 9, 2024 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported progress and expansion of the clinical collaboration development program for its masked, anti-CTLA-4 SAFEbody, ADG126 in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with metastatic microsatellite-stable (MSS) colorectal cancer (CRC) (Press release, Adagene, FEB 9, 2024, View Source [SID1234639955]).

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"Following completion of enrollment 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 (Free ASCO Whitepaper)-GI Symposium demonstrating the safety and efficacy profile of ADG126 in combination with pembrolizumab in MSS CRC," said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene.

He continued, "To address the requirements for Project Optimus by FDA, we have initiated evaluation of ADG126 20 mg/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. Additionally, we are now cleared to evaluate ADG126 in combination with pembrolizumab in China, strengthening our efficacy evaluation with additional patients enrolled at unprecedented dosing regimens for anti-CTLA-4 therapy."

The updates, which increase the ongoing phase 2 dose expansion in MSS CRC to over 50 patients, include the following:

· The company announced it completed enrollment of 12 additional patients in the fourth quarter of 2023 in the ongoing phase 2 dose expansion cohort evaluating ADG126 10 mg/kg Q3W in combination with pembrolizumab in MSS CRC. These Part 2 results are expected to support data from Part 1 of the dose expansion in MSS CRC that was recently presented at the 2024 ASCO (Free ASCO Whitepaper)-GI Symposium.

· Given the safety profile of ADG126, Adagene has also initiated evaluation of 20 mg/kg loading doses in combination with pembrolizumab in patients with advanced/metastatic cancer. Following the ongoing safety evaluation, the company plans to study efficacy of the loading doses followed by a maintenance regimen of ADG126 10 mg/kg Q3W in combination with pembrolizumab. The company plans dose expansion with this regimen in patients with MSS CRC in the US and Asia Pacific.

· Adagene has also received clearance from the CDE in China to initiate clinical evaluation of ADG126 in combination with pembrolizumab. This enables the company to broaden its dose expansion cohorts for MSS CRC at selected dosing regimens, and potentially in other tumor types.

2024 Milestones

Data from the ongoing phase 1b/2 clinical trial of ADG126 in combination with pembrolizumab, including dose expansion cohorts, are anticipated throughout 2024:

· Follow up of Part 1 evaluable patients at 10 mg/kg Q3W (n=12) and 10 mg/kg Q6W (n=10)
· Data from Part 2 patients at 10 mg/kg Q3W (n=12)
· Evaluation of 20 mg/kg loading doses for Project Optimus requirements:
o Safety data with repeat doses
o Dose expansion in MSS CRC (n~10)
· Additional patients in China (n≥10)