This section highlights FDA-related milestones and regulatory updates for drugs developed by Adagene (ADAG).
Over the past two years, Adagene has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADG126 and ADG126. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ADG126 - FDA Regulatory Timeline and Events
ADG126 is a drug developed by Adagene for the following indication: Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADG126
- Announced Date:
- May 22, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases at ASCO.
AI Summary
Adagene Inc. presented updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases at ASCO. The study focused on the 20 mg/kg dosing schedule every six weeks when used in combination with pembrolizumab. Researchers noted that this regimen resulted in fewer than 20% Grade 3 adverse events, with no patient discontinuations due to toxicity. Importantly, the confirmed overall response rate reached 29%, and all responders in the 20 mg/kg cohorts remain on treatment—with several patients continuing for over 40 weeks. These promising results were observed even in patients with peritoneal involvement. The data show both a favorable safety profile and durable responses compared to historical controls. Adagene plans to discuss dosing regimens with regulatory bodies as it continues to develop ADG126, aiming to maximize treatment efficacy while minimizing side effects.
Read Announcement- Drug:
- ADG126
- Announced Date:
- February 27, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced an investigator initiated (IIT) Phase 2 neoadjuvant trial of ADG126 for patients with stage II or stage III colorectal cancer.
AI Summary
Adagene Inc. announced a Phase 2 investigator-initiated neoadjuvant trial to evaluate ADG126 in patients with stage II or stage III colorectal cancer. The trial, scheduled to start enrollment in April 2025, will explore the use of ADG126 in combination with KEYTRUDA® prior to surgery. Led by Dr. Yong Wei Peng from the National University Cancer Institute in Singapore, the study aims to determine the rate of major pathologic response, which is defined as having 10% or less of viable tumor left after treatment. Up to 20 patients will be enrolled, and secondary goals include analyzing complete pathological response, disease-free survival, safety, and how the drugs affect the tumor’s immune environment.
Read Announcement- Drug:
- ADG126
- Announced Date:
- January 27, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA.
AI Summary
Adagene Inc recently shared promising clinical results for its cancer therapy ADG126 at the ASCO Gastrointestinal Cancers Symposium in San Francisco, CA. In a Phase 1b/2 trial for patients with microsatellite stable colorectal cancer, the study evaluated a 20 mg/kg loading dose of ADG126 followed by 10 mg/kg every three weeks, given together with the immunotherapy drug pembrolizumab. The updated data showed that 33% of the patients responded to treatment, with four out of twelve patients experiencing confirmed partial tumor shrinkage. Importantly, no severe treatment-related side effects were reported, and no patients had to stop treatment because of adverse events. These findings suggest that ADG126 has the potential to be a safe and effective option for patients battling this form of colorectal cancer, supporting further investigation in larger studies.
Read Announcement- Drug:
- ADG126
- Announced Date:
- October 9, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc announced poster presentations at the upcoming SITC 39th Annual Meeting, taking place in Houston, Nov. 6 – 10, 2024.
AI Summary
Adagene Inc has announced that it will present two posters at the upcoming SITC 39th Annual Meeting in Houston, scheduled from November 6 to 10, 2024. The company will share data on its clinical studies involving the masked anti-CTLA-4 SAFEbody, muzastotug (ADG126). One poster presentation will focus on how muzastotug shows an improved clinical therapeutic index compared to its unmasked form, ADG116, when used alone or alongside anti-PD-1 therapy. A separate presentation will detail findings from a Phase 1b/2 clinical study evaluating the combination of ADG126 with pembrolizumab in advanced or metastatic MSS colorectal cancers. Both sessions are set for November 9, featuring a lunchtime viewing followed by an evening poster reception, all held at the George R. Brown Convention Center. Additional details and the posters will be available on the company’s website.
Read Announcement- Drug:
- ADG126
- Announced Date:
- September 16, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced new ADG126 clinical data presented at the ESMO Congress, taking place in Barcelona, Spain, September 13-17.
AI Summary
Adagene Inc. has presented new clinical data for its ADG126 therapy at the ESMO Congress in Barcelona, Spain, held from September 13-17. The data comes from an ongoing phase 1b/2 trial where ADG126, a masked anti-CTLA-4 antibody, is being evaluated in combination with pembrolizumab for metastatic microsatellite-stable colorectal cancer (MSS CRC). In a specific patient subset without liver and peritoneal metastases, the overall response rate reached 24%, with partial responses doubling to four. These patients also experienced a median progression-free survival of 8.5 months at the 10 mg/kg dose level. The results further showed promising 12-month overall survival rates of 74% to 82% and a manageable safety profile, suggesting that the combination treatment could offer enhanced benefits in early disease control for MSS CRC patients.
Read Announcement- Drug:
- ADG126
- Announced Date:
- July 12, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Adagene Inc. announced a poster presentation at the upcoming ESMO Congress, taking place in Barcelona, Spain, 13-17 September 2024.
AI Summary
Adagene Inc., a biotechnology company focused on developing novel antibody-based cancer therapies, announced that it will present a poster at the upcoming ESMO Congress in Barcelona, Spain from September 13‑17, 2024. The poster presentation highlights promising results from an ongoing phase 1b/2 clinical trial using their masked anti‑CTLA‑4 SAFEbody, ADG126 (muzastotug), in combination with the anti‑PD‑1 drug pembrolizumab.
The study involves patients with metastatic microsatellite-stable colorectal cancer and is aimed at demonstrating an increased therapeutic index with a safer profile. Adagene hopes that the enhanced specificity of their SAFEbody technology in targeting the tumor microenvironment, while reducing exposure to healthy tissues, will allow significant clinical benefits. Details of the research will be shared following the ESMO embargo policy on the company’s website.
Read Announcement
ADG126 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events
ADG126 + KEYTRUDA (pembrolizumab) is a drug developed by Adagene for the following indication: Advanced/metastatic solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADG126 + KEYTRUDA (pembrolizumab)
- Announced Date:
- January 21, 2025
- Indication:
- Advanced/metastatic solid tumors
Announcement
Adagene Inc announced it will share updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA on Saturday, January 25, 2025.
AI Summary
Adagene Inc. announced it will share updated clinical data from its ongoing Phase 1b/2 study of ADG126, an anti-CTLA-4 SAFEbody, in patients with microsatellite stable colorectal cancer (MSS CRC). The study, conducted in combination with Merck’s KEYTRUDA® (pembrolizumab), previously showed efficacy with a 10 mg/kg dose every three weeks. The new data will include initial results using a 20 mg/kg loading dose followed by 10 mg/kg every three weeks, aiming to further evaluate the treatment’s potential in this hard-to-treat cancer type.
This presentation is scheduled for the ASCO Gastrointestinal Cancers Symposium in San Francisco, CA, on Saturday, January 25, 2025. Attendees will gain insights into the evolving treatment landscape for advanced/metastatic MSS CRC and the role of CTLA-4 targeting in overcoming challenges associated with these "cold" tumors.
Read Announcement- Drug:
- ADG126 + KEYTRUDA (pembrolizumab)
- Announced Date:
- January 14, 2025
- Estimated Event Date Range:
- January 25, 2025 - January 25, 2025
- Target Action Date:
- January 25, 2025
- Indication:
- Advanced/metastatic solid tumors
Announcement
Adagene Inc announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who will join company management to discuss the unmet need and current treatment landscape for patients with advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) and why CTLA-4 targeting is essential for achieving durable responses in this cold tumor type.
AI Summary
Adagene Inc. announced a virtual key opinion leader (KOL) event scheduled for Saturday, January 25, 2025 at 1:00 PM ET. The event will feature top experts including Dr. Aurélien Marabelle from Université Paris-Saclay, and Dr. Daneng Li and Dr. Marwan Fakih from City of Hope. They will join Adagene’s management team to focus on the current treatment challenges and unmet needs for patients with advanced or metastatic microsatellite-stable (MSS) colorectal cancer. The panel will discuss why targeting CTLA-4 is critical for achieving long-lasting responses in this challenging “cold” tumor type. By addressing the limitations of existing therapies, the discussion aims to shed light on innovative strategies that could improve patient outcomes in MSS colorectal cancer, a disease that has historically been resistant to many current treatment options.
Read Announcement
