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SAN DIEGO/SUZHOU - Adagene Inc. (NASDAQ:ADAG), a clinical-stage biotech company with a market capitalization of $86.21 million, has received feedback from the U.S. Food and Drug Administration on its clinical development plan for muzastotug (ADG126) in combination with Merck’s pembrolizumab for patients with microsatellite stable colorectal cancer (MSS CRC), the company announced Tuesday. According to InvestingPro data, while the company maintains a healthy balance sheet with more cash than debt, it faces challenges with rapid cash burn.
The FDA endorsed Adagene’s plan to begin a Phase 2 trial in the second half of 2025, which will evaluate two dosing regimens of the masked anti-CTLA-4 SAFEbody therapy in combination with pembrolizumab. The trial will enroll approximately 60 patients, with 30 patients randomized to either 10 mg/kg or 20 mg/kg of muzastotug. With analyst price targets ranging from $3.50 to $8.00, significantly above the current trading price of $1.83, market watchers appear optimistic about the company’s clinical progress.
According to the company, the Phase 2 study will primarily determine which dosage will advance to Phase 3 trials. The FDA agreed with Adagene’s proposed trial design, including the primary endpoint of overall response rate, with secondary endpoints of duration of response, progression-free survival, and overall survival.
The regulator also confirmed that a standard-of-care control arm would be appropriate for the future Phase 3 trial, with overall survival as the primary endpoint.
Muzastotug targets regulatory T cells in the tumor microenvironment and has been administered to over 150 patients to date, either as monotherapy or in combination with anti-PD-1 therapy. The company has completed patient enrollment for MSS CRC dose expansion cohorts in its ongoing Phase 1b/2 trial.
Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope, noted in the press release that the company has observed dose-dependent efficacy with the treatment, with response rates increasing from 17% at the 10 mg/kg dose to 29% at 20 mg/kg.
The information in this article is based on a company press release statement. Investors should note that InvestingPro analysis indicates the company’s overall financial health score is currently WEAK, with its next earnings report expected on August 27, 2025. For deeper insights into Adagene’s financial metrics and 12 additional ProTips, consider subscribing to InvestingPro.
In other recent news, Adagene Inc. announced a strategic partnership with ConjugateBio Inc. to supply a proprietary antibody for bispecific antibody-drug conjugate (ADC) development programs. This collaboration includes an undisclosed upfront payment to Adagene, along with potential milestone and royalty payments. Additionally, Adagene received a strategic investment of up to $25 million from Sanofi, which will support the development of its anti-CTLA-4 SAFEbody, muzastotug (ADG126), through a randomized phase 2 trial in microsatellite stable colorectal cancer. As part of this expanded collaboration, Adagene will provide muzastotug to Sanofi for evaluation in combination with other anticancer therapies. Sanofi also exercised its option to select a third SAFEbody discovery program, triggering an option exercise fee and potential milestone payments. Recent clinical trial results for ADG126 in advanced microsatellite stable colorectal cancer showed a confirmed overall response rate of 29% when combined with pembrolizumab. The study reported less than 20% Grade 3 adverse events with the 20 mg/kg dosing regimen, with no treatment discontinuations. These developments highlight the ongoing progress and strategic partnerships that Adagene is pursuing in the biotechnology sector.
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