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Adagene to Present ADG126-KEYTRUDA Combination Data for MSS Colorectal Cancer at ASCO-GI 2025

Adagene will present new clinical data on ADG126 (muzastotug) in combination with KEYTRUDA for microsatellite stable colorectal cancer at ASCO-GI on January 25, 2025. The novel anti-CTLA-4 SAFEbody® has shown promising results with a 24% overall response rate and 88% disease control rate in recent studies, demonstrating potential in addressing unmet needs in MSS CRC treatment.

Adagene Inc. is set to unveil new clinical data for its innovative anti-CTLA-4 therapy ADG126 (muzastotug) in combination with Merck's KEYTRUDA® at the upcoming ASCO-GI symposium in San Francisco on January 25, 2025. The presentation will focus on results from their combination study in microsatellite stable colorectal cancer (MSS CRC).

Novel SAFEbody® Technology Platform

ADG126, developed using Adagene's proprietary SAFEbody® technology, represents a significant advancement in targeted cancer immunotherapy. The drug employs precision masking technology designed to minimize on-target off-tumor toxicity while enabling specific targeting within the tumor microenvironment. This approach particularly focuses on regulatory T cells in the tumor microenvironment, a crucial aspect of cancer immunotherapy.

Promising Clinical Outcomes

Recent studies have demonstrated encouraging results for the ADG126-pembrolizumab combination, achieving a confirmed overall response rate of 24% and a disease control rate of 88%. These findings, previously presented at the Society for Immunotherapy of Cancer (SITC) and European Society of Medical Oncology (ESMO) Congress, highlight the potential therapeutic value of this combination approach.

Expert Perspectives and Future Directions

Coinciding with the data presentation, Adagene will host a virtual key opinion leader (KOL) event featuring prominent medical experts. The discussion will focus on the current treatment landscape for advanced/metastatic MSS CRC and the strategic importance of CTLA-4 targeting in this patient population.

Market Analysis and Expert Opinions

While the clinical development shows promise, market analysts have expressed varying views on Adagene's prospects. Jefferies recently downgraded the stock to Hold with a $3.50 price target, noting that ADG126's efficacy appears more pronounced in specific patient subsets, excluding those with liver and peritoneal metastases. This assessment has pushed the projected commercial launch date from 2028 to 2029.
However, H.C. Wainwright maintains a Buy rating, considering the stock undervalued at its current market capitalization of approximately $100 million, given the promising clinical results.

Development Strategy

Adagene's approach combines computational biology and artificial intelligence through its Dynamic Precision Library platform to create differentiated immunotherapy programs. The company continues to pursue strategic collaborations with global partners to address unmet patient needs through its SAFEbody® technology platform.
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Reference News

[1]
Adagene to present new ADG126 clinical data at ASCO-GI
investing.com · Jan 21, 2025

Adagene's forward-looking statements highlight potential variances due to clinical development, regulatory milestones, a...

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