Adagene(ADAG)
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Adagene to Present at Leerink's Global Healthcare Conference 2025
GlobeNewswire News Room· 2025-03-06 13:00
Core Insights - Adagene Inc. is participating in Leerink's Global Healthcare Conference 2025, where the CEO will provide a corporate update and engage in one-on-one investor meetings [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3] - The company has established strategic collaborations with global partners to leverage its SAFEbody® precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to enhance the safety and efficacy of antibody therapeutics [4] - The SAFEbody technology specifically addresses safety challenges by masking the binding domain of biologic therapies, allowing for targeted action in the tumor microenvironment while reducing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies in combination with anti-PD-1 therapy for Metastatic Microsatellite-stable Colorectal Cancer [5] - The SAFEbody platform is validated for various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5]
Adagene Announces Investigator Initiated Phase 2 Trial for Neoadjuvant Muzastotug (ADG126) in Colorectal Cancer
Globenewswire· 2025-02-27 13:00
Core Insights - Adagene Inc. announced a Phase 2 neoadjuvant trial of ADG126 for stage II or III colorectal cancer, with patient enrollment expected to begin in April 2025 and primary completion anticipated by mid-2027 [1][2] Group 1: Trial Details - The trial, led by Dr. Yong Wei Peng, will evaluate the efficacy of ADG126 in combination with KEYTRUDA, focusing on the rate of Major Pathologic Response (MPR) as the primary endpoint [2][3] - Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability, with the study also exploring pharmacodynamic effects on the tumor microenvironment [2][3] Group 2: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4][5] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology to address unmet patient needs in cancer treatment [4][5] Group 3: Technology and Pipeline - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies for Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform aims to enhance safety and tolerability of antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [5][6]
Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at ASCO Gastrointestinal Cancers Symposium
Newsfilter· 2025-01-27 12:00
Core Insights - Adagene Inc. announced updated clinical data for ADG126, an anti-CTLA-4 SAFEbody, showing a 33% overall response rate in microsatellite stable colorectal cancer when combined with pembrolizumab [1][2][4] Group 1: Clinical Data and Efficacy - The Phase 1b/2 trial demonstrated four confirmed partial responses out of twelve patients with a 20 mg/kg loading dose followed by 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab [1][3] - The previous data at a 10 mg/kg Q3W dose showed an overall response rate of 23%, indicating an improvement in efficacy with the new dosing regimen [3] - All responders remain on treatment at a maintenance dose of either 10 mg/kg Q3W or 10 mg/kg every six weeks (Q6W) in combination with pembrolizumab [3] Group 2: Safety Profile - No Grade 4 or 5 treatment-related adverse events were observed, with pruritus being the most common treatment-related adverse event at 25% [4] - Higher Grade 2/3 treatment-related adverse events were managed through dose modifications, resulting in no treatment discontinuations to date [4] Group 3: Technology and Innovation - ADG126 utilizes a masking technology that enhances intra-tumoral accumulation and maintains optimal plasma concentration, positioning it as a potential best-in-class CTLA-4 inhibitor [3][6] - The SAFEbody technology aims to address safety and tolerability challenges associated with antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [6][7] Group 4: Future Plans - Due to the enhanced therapeutic index of ADG126, the company plans to evaluate a broader patient population, including those with liver metastases, in the dose expansion cohort [3]
Adagene to Announce Updated Data from Phase 1b/2 Study of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at ASCO Gastrointestinal Cancers Symposium
Globenewswire· 2025-01-21 22:00
Core Insights - Adagene Inc. is set to present updated clinical data for its drug ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal Cancers Symposium on January 25, 2025 [1][2] Group 1: Clinical Study Details - The Phase 1b/2 study of ADG126 in combination with Merck's KEYTRUDA has shown efficacy at a 10 mg/kg dose, with new data to include results from a 20 mg/kg loading dose followed by 10 mg/kg [2] - The presentation will take place on January 25, 2025, from 7:00 a.m. to 7:55 a.m. Pacific Time at Moscone West, San Francisco, with the abstract number 193 [3] Group 2: Virtual Event Information - A virtual key opinion leader (KOL) event will be hosted on January 25, 2025, featuring experts discussing the treatment landscape for advanced/metastatic MSS CRC and the importance of CTLA-4 targeting [4] Group 3: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [5] - The company’s SAFEbody technology aims to improve safety and tolerability of antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [6] - ADG126, the lead clinical program, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in clinical studies for MSS CRC [7]
Adagene to Host Virtual KOL Event to Discuss Anti-CTLA-4 SAFEbody® ADG126 in Advanced/Metastatic Microsatellite-Stable (MSS) Colorectal Cancer (CRC) on January 25, 2025
Globenewswire· 2025-01-14 13:00
Core Insights - Adagene Inc. is hosting a virtual key opinion leader (KOL) event on January 25, 2025, to discuss the treatment landscape for advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) and the importance of CTLA-4 targeting for durable responses [1] - The event will provide updates on the Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA (pembrolizumab) for advanced/metastatic MSS CRC, which will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium [2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [8] - The company’s SAFEbody technology aims to improve safety and tolerability of antibody therapeutics by utilizing precision masking to target tumors while minimizing toxicity to healthy tissues [9] - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody currently in Phase 1b/2 studies, specifically targeting MSS colorectal cancer [10] Key Opinion Leaders - Aurélien Marabelle, MD, PhD, is an expert in oncology and immunology, leading early-phase clinical trials of cancer immunotherapies and has published over 280 peer-reviewed articles [4] - Daneng Li, MD, focuses on gastrointestinal malignancies and the development of novel therapeutics, with a strong background in medical oncology [5] - Marwan Fakih, MD, has extensive experience in gastrointestinal cancers and has led numerous clinical trials, particularly in colorectal cancer [6][7]
Adagene(ADAG) - 2024 Q2 - Quarterly Report
2024-11-07 15:10
Safety and Efficacy of ADG126 - ADG126 (Muzastotug) demonstrated improved safety and efficacy profiles compared to ipilimumab, driven by precision masking and enhanced antibody-dependent cellular cytotoxicity (ADCC) [1] - The rate of Grade 3 and higher treatment-related adverse events (TRAEs) for ADG126 in combination with pembrolizumab was significantly lower than historically reported rates for other anti-CTLA-4 therapies [6] - Repeat dosing of ADG126 at 10 mg/kg in combination with pembrolizumab showed encouraging clinical efficacy and well-tolerated safety, supporting its potential as a best-in-class anti-CTLA-4 therapy [7] Clinical Trial Results - The clinical trial for ADG126 in combination with pembrolizumab showed durable disease control and early survival benefits in patients with advanced MSS CRC, with a dose-dependent efficacy observed [5] - One patient in the trial experienced an 80% decrease in target lesions after treatment with ADG126 and pembrolizumab, correlating with a 100% decrease in carcinoembryonic antigen (CEA) levels [6] Dosing Regimen and Future Studies - A single dose of ADG126 at 10 mg/kg resulted in a three-fold increase in active drug exposure in tumor tissue compared to ipilimumab at 1 mg/kg, while maintaining similar plasma active drug levels [6] - Adagene is evaluating a new dosing regimen of ADG126 at 20 mg/kg followed by a 10 mg/kg maintenance dose in combination with pembrolizumab, with data expected in 2025 [7] Technology and Platform - The unique epitope of ADG126 allows for cross-reactivity across species, enhancing pharmacokinetic modeling and tumor-specific engagement of CTLA-4 [3] - The ongoing clinical studies validate the SAFEbody platform's applicability to various antibody-based therapeutic modalities, including antibody-drug conjugates [11] - Adagene's SAFEbody technology aims to minimize on-target off-tumor toxicity while enabling tumor-specific targeting in the tumor microenvironment [10]
Are Medical Stocks Lagging Adagene (ADAG) This Year?
ZACKS· 2024-09-11 14:45
Company Performance - Adagene Inc. Sponsored ADR (ADAG) has shown a year-to-date performance increase of approximately 60.5%, significantly outperforming the Medical sector's average return of 10.5% [2] - The Zacks Consensus Estimate for ADAG's full-year earnings has risen by 8.9% over the past quarter, indicating improving analyst sentiment and a positive earnings outlook [2] - Adagene Inc. is currently ranked 2 (Buy) in the Zacks Rank system, which is a stock-picking model based on earnings estimates and revisions [1] Industry Comparison - Adagene Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 497 companies and is currently ranked 82 in the Zacks Industry Rank. This industry has seen a year-to-date gain of about 0.6% [3] - In contrast, DaVita HealthCare (DVA), another stock in the Medical sector, belongs to the Medical - Outpatient and Home Healthcare industry, which has a ranking of 45 and has increased by 15.7% year-to-date [3] - Both Adagene Inc. and DaVita HealthCare are noted for their solid performance, suggesting that they are worth monitoring for investors interested in Medical stocks [3]
Is Adagene (ADAG) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2024-08-26 14:41
Group 1 - Adagene Inc. Sponsored ADR (ADAG) is currently outperforming its peers in the Medical sector with a year-to-date return of 52.7%, compared to the sector average of 11.9% [2][3] - The Zacks Rank for Adagene Inc. is 2 (Buy), indicating a positive earnings outlook and improving analyst sentiment, with a 24.4% increase in the consensus estimate for full-year earnings over the past quarter [2][3] - Adagene Inc. is part of the Medical - Biomedical and Genetics industry, which includes 497 companies and is currently ranked 81 in the Zacks Industry Rank, showing better performance than the industry average gain of 3% this year [3] Group 2 - DaVita HealthCare (DVA) has also shown strong performance, with a year-to-date return of 47% and a Zacks Rank of 2 (Buy) [2][3] - The consensus EPS estimate for DaVita HealthCare has increased by 3.8% over the past three months, reflecting a positive trend in earnings expectations [3] - DaVita HealthCare belongs to the Medical - Outpatient and Home Healthcare industry, which is ranked 60 and has gained 16.4% so far this year [3]
Adagene Announces Poster Presentation on Masked Anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in Combination with Pembrolizumab in MSS CRC at Upcoming European Society for Medical Oncology (ESMO) Congress in September
GlobeNewswire News Room· 2024-07-12 11:00
SAN DIEGO and SUZHOU, China, July 12, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced a poster presentation at the upcoming ESMO Congress, taking place in Barcelona, Spain, 13-17 September 2024. The poster will report results of an ongoing phase 1b/2 trial of Adagene’s masked anti-CTLA-4 SAFEbody in combination with the anti-PD-1 treatment pembrolizumab. The title is: Increased Therapeut ...
Adagene Announces Poster Presentation on Masked Anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in Combination with Pembrolizumab in MSS CRC at Upcoming European Society for Medical Oncology (ESMO) Congress in September
Newsfilter· 2024-07-12 11:00
SAN DIEGO and SUZHOU, China, July 12, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. ("Adagene") (NASDAQ:ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced a poster presentation at the upcoming ESMO Congress, taking place in Barcelona, Spain, 13-17 September 2024. The poster will report results of an ongoing phase 1b/2 trial of Adagene's masked anti-CTLA-4 SAFEbody in combination with the anti-PD-1 treatment pembrolizumab. The title is: Increased Therapeuti ...