Adagene Inc. Stock Price, News & Analysis

Adagene (Nasdaq: ADAG), a pioneer in antibody-based therapy development, has announced its participation in Leerink's Global Healthcare Conference 2025. The event will take place from March 10-12 in Miami, Florida.

Dr. Peter Luo, who serves as the company's Chairman, CEO, and President of R&D, will engage in one-on-one investor meetings and deliver a corporate presentation. The presentation is scheduled for Wednesday, March 12, from 10:40-11:20 AM Eastern Time at W South Beach.

Investors and interested parties can access the presentation webcast through the Investors section of Adagene's website (www.adagene.com), where it will remain available for a minimum of 30 days.

Adagene (NASDAQ: ADAG) has announced an investigator initiated Phase 2 neoadjuvant trial of ADG126 for stage II or III colorectal cancer patients. The trial, identified as NCT06846268, will begin enrollment in April 2025 with expected primary completion in mid-2027.

The study will evaluate ADG126 in combination with KEYTRUDA® before surgery, with a primary endpoint measuring Major Pathologic Response (MPR) in up to 20 patients. MPR is defined as ≤10% residual viable tumor in surgical specimens. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability.

Led by Dr. Yong Wei Peng from the National University Cancer Institute, Singapore, the trial will also explore pharmacodynamic effects on the tumor microenvironment's immune profile and ADG126's pharmacokinetic profile in tumor tissues.

Adagene (NASDAQ: ADAG) announced updated clinical data for their Phase 1b/2 study of Muzastotug (ADG126) in combination with KEYTRUDA® for colorectal cancer treatment. The study showed promising results with a 33% overall response rate in microsatellite stable colorectal cancer patients, achieving four confirmed partial responses out of twelve patients using a 20 mg/kg loading dose followed by 10 mg/kg Q3W + pembrolizumab.

The treatment demonstrated a favorable safety profile with no Grade 4/5 treatment-related adverse events and no discontinuations to date. Pruritus was the most common side effect, occurring in 25% of patients. The company plans to expand the study to include patients with liver metastases. All responding patients remain on treatment at maintenance doses of either 10 mg/kg Q3W or Q6W in combination with pembrolizumab.

Adagene (NASDAQ: ADAG) will present updated clinical data from its Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA® for microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal Cancers Symposium. The presentation will take place on January 25, 2025, in San Francisco.

The study previously showed efficacy at 10 mg/kg Q3W dose, and new data will include results from a 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab. The company will also host a virtual KOL event featuring experts from Université Paris-Saclay and City of Hope to discuss the unmet need in MSS CRC treatment and the importance of CTLA-4 targeting for achieving durable responses in this cold tumor type.

Adagene (Nasdaq: ADAG) has announced a virtual KOL event scheduled for January 25, 2025, at 1:00 PM ET, focusing on their anti-CTLA-4 SAFEbody® ADG126 treatment for advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC).

The event will feature distinguished experts including Dr. Aurélien Marabelle from Université Paris-Saclay and Drs. Daneng Li and Marwan Fakih from City of Hope. They will discuss the unmet needs in MSS CRC treatment and the importance of CTLA-4 targeting for achieving durable responses in this cold tumor type.

The presentation will include updates on the Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA® (pembrolizumab), which will be featured at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. ADG126 is designed to target CTLA-4 on regulatory T cells within the tumor microenvironment, offering potent anti-tumor activity with reduced toxicity.

Adagene presented two posters at SITC's 39th Annual Meeting showcasing new insights on ADG126 (Muzastotug), their masked anti-CTLA-4 SAFEbody®. The data demonstrates improved safety and efficacy profiles compared to ipilimumab, driven by precision masking and novel epitope-dependent antibody-dependent cellular cytotoxicity. Clinical results show promising outcomes when combining ADG126 with pembrolizumab in MSS CRC patients, with four partial responses reported in the 10 mg/kg Q3W combination cohort. The treatment showed lower rates of adverse events compared to standard therapies, with no Grade 3 or higher colitis reported in combination therapy.

Adagene Inc. (Nasdaq: ADAG) has announced upcoming poster presentations at the SITC 39th Annual Meeting in Houston, scheduled for November 6-10, 2024. The presentations will focus on Muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody®.

Two posters will be presented on November 9:

• Abstract 506: Comparing the clinical therapeutic index of Muzastotug to its unmasked form (ADG116) as monotherapy or combined with anti-PD-1 therapy.
• Abstract 744: Phase 1b/2 study of Muzastotug combined with Pembrolizumab in advanced/metastatic MSS CRCs.

Both posters will be viewable during lunch (12:15-1:45 PM CST) and at the poster reception (7:10-8:30 PM CST) at the George R. Brown Convention Center. The posters will also be available on Adagene's website.

Adagene Inc. (Nasdaq: ADAG) presented promising results for its anti-CTLA-4 SAFEbody® ADG126 (Muzastotug) in combination with KEYTRUDA® (Pembrolizumab) at the ESMO Congress. The phase 1b/2 trial focused on advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) patients. Key findings include:

1. Doubled confirmed partial responses to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases, with a 24% overall response rate.

2. Median progression-free survival of 8.5 months in patients without liver and peritoneal metastases at ADG126 10 mg/kg Q3W dose.

3. 12-month overall survival rates of 74% for patients without liver metastases and 82% for those without liver and peritoneal metastases at 10 mg/kg dose.

4. Maintained safety profile with only 16% Grade 3 TRAEs in patients treated with ADG126 10 mg/kg Q3W combined with pembrolizumab.

Adagene Inc. (Nasdaq: ADAG), a clinical-stage biotechnology company, has announced its participation in several upcoming investor conferences in New York City this September. The company's management will host investor meetings, and Peter Luo, Ph.D., Adagene's Chairman, CEO, and President of R&D, will present at three major events:

1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 6
2. H.C. Wainwright 26th Annual Global Investment Conference on September 9
3. 2024 Cantor Fitzgerald Global Healthcare Conference on September 18

Live webcasts of the presentations will be available on Adagene's website, with replays accessible for at least 30 days. These conferences provide an opportunity for Adagene to showcase its platform-driven approach to discovering and developing novel antibody-based therapies.