Core Insights - Adagene Inc. reported a 33% overall response rate in its Phase 2 dose expansion study for muzastotug (ADG126) in microsatellite stable colorectal cancer (MSS CRC) with a 20 mg/kg loading dose regimen, including four confirmed partial responses [1][4] - The company has a cash balance of $85.2 million, which is expected to fund operations into late 2026 [1][9] - Adagene's SAFEbody technology is designed to enhance the safety profile and therapeutic index of antibody-based therapies, particularly in combination with existing treatments like pembrolizumab [2][25] Clinical Development - The clinical data generated in 2024 with ADG126 supports the expansion of studies to include earlier lines of therapy and patients with liver metastases, who have historically benefited little from checkpoint inhibitors [2] - ADG126 is currently in Phase 1b/2 clinical studies in combination with pembrolizumab, showing good tolerability and a low discontinuation rate of 6% in the MSS CRC expansion cohort [4][26] - The company plans to initiate an investigator-initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer in April 2025 [4] Financial Performance - For the year ended December 31, 2024, Adagene reported a net revenue of $0.1 million, a significant decrease from $18.1 million in 2023 [14] - Research and development expenses decreased by approximately 21% to $28.8 million in 2024, reflecting a focus on the ADG126 program [15] - The net loss attributable to shareholders was $33.4 million for 2024, compared to $18.9 million in 2023 [18] Collaborations and Partnerships - Adagene has ongoing collaborations with Exelixis, Sanofi, and Roche, which include milestone payments and the development of novel antibody-drug conjugates and SAFEbody candidates [6][7][8] - The collaboration with Exelixis has resulted in over $18 million in total payments to date [6] Pipeline Highlights - ADG138, another SAFEbody engineered T cell engager targeting HER2, is IND-ready and has shown a wide therapeutic window in preclinical models [3] - ADG152, targeting CD20, is in the IND-enabling phase and is designed to minimize cytokine release syndrome [5]

Core Insights - Adagene Inc. is set to present at the 11th Annual Immuno-Oncology 360⁰ Summit in Boston on March 26, 2025, focusing on advancements in antibody-based cancer therapies [1][2]. Company Overview - Adagene Inc. is a clinical-stage biotechnology company specializing in the discovery and development of novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4]. - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology, which is at the forefront of immuno-oncology [4]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, aimed at addressing safety and tolerability challenges in antibody therapeutics [5]. - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing toxicity to healthy tissues by activating in the tumor microenvironment [5]. - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6]. Event Details - The presentation titled "ADG126 SAFEbody: Targeting CTLA-4+ Tregs to Overcome MSS CRC Resistance" is scheduled for March 26, 2025, from 11:30 AM to 11:50 AM Eastern Time at the Sheraton Boston Hotel [9].

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]

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]

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]

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]

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]

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]

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Adagene Inc. Sponsored ADR (ADAG) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Adagene Inc. Sponsored ADR is one of 1019 individual stocks in the Medical sector. Collectively, these companies sit at #4 in the Zacks Sector Rank. The Zacks Sector Rank gau ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Is Adagene Inc. Sponsored ADR (ADAG) one of those stocks right now? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Adagene Inc. Sponsored ADR is one of 1017 individual stocks in the Medical sector. Collectively, these companies sit at #5 in the Zacks Sector Rank. The Zacks Sector Ra ...