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SAN DIEGO and SUZHOU, China - Adagene Inc. (NASDAQ: ADAG), a biotechnology firm specializing in antibody-based cancer immunotherapies with a current market capitalization of $78.2 million, has announced encouraging results from a clinical trial involving its drug ADG126 for the treatment of advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases. The findings were shared at the American Society of Clinical Oncology (ASCO) on May 31, 2025. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it faces challenges with rapid cash burn.
The Phase 1b/2 study reported a confirmed overall response rate (ORR) of 29% in patients treated with a combination of ADG126 and pembrolizumab, an anti-PD-1 therapy marketed by Merck & Co., Inc. under the name KEYTRUDA®. Notably, the 20 mg/kg dosing regimen of ADG126 administered every six weeks (Q6W) resulted in less than 20% Grade 3 adverse events, with no treatment discontinuations reported.
The 20 mg/kg cohorts have not reached a median overall survival (OS) yet, while the 10 mg/kg cohorts showed a median OS of 19.4 months, surpassing current standards and historical benchmarks. All six responders in the 20 mg/kg cohorts remain on treatment, with some patients participating for over forty weeks.
Dr. Marwan Fakih from City of Hope highlighted the significance of the reduced treatment-related toxicities and the durable responses observed. Peter Luo, CEO and President of R&D at Adagene, credited their predictive PK/PD framework and masking technology for optimizing the therapeutic index of ADG126.
A total of 67 MSS CRC patients without liver metastases were treated with ADG126 in the study. The positive outcomes suggest potential benefits for patients, particularly those with peritoneal involvement. The company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development.
Adagene’s approach involves computational biology and artificial intelligence to create novel antibodies. Its SAFEbody® precision masking technology is designed to minimize on-target off-tumor toxicity by activating in the tumor microenvironment, allowing for tumor-specific targeting of antibodies.
The information in this article is based on a press release statement. Despite recent positive clinical developments, Adagene’s stock has experienced significant volatility, trading at $1.62 with a -24.3% return over the past six months. The company’s overall financial health score from InvestingPro currently indicates challenges ahead, particularly regarding profitability and cash flow metrics.
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