Muzastotug

Muzastotug (ADG126), an Anti-CTLA-4 SAFEbody ® in Combination with pembrolizumab showed 33% overall response rate in microsatellite stable colorectal cancer Four confirmed partial responses out of twelve patients with 20 mg/kg loading dose followed by 10 mg/kg Q3W + pembrolizumab No Grade 4/5 treatment related adverse events were observed and no discontinuations occurred to date SAN DIEGO, CA, USA and SUZHOU, China I January 27, 2025 I Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, announced updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA. “These data, from the loading dose expansion cohort of our Phase 1b/2 trial, continue to demonstrate ADG126’s potential for patients with colorectal cancer.  Seeing four confirmed partial responses out of twelve patients, with no treatment related discontinuations, also highlights the differentiated therapeutic index of ADG126. CTLA-4 is clinically validated with a known correlation between dose, efficacy and toxicity to improve outcomes with PD-1 inhibitors, and now we know that our SAFEbody can deliver benefit to patients in a safe and efficacious way,” said Peter Luo, Chairman, CEO & President of R&D at Adagene. Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope added, “Masking technology, which leads to increased intra-tumoral accumulation of cleaved ADG126 and maintains an optimal plasma concentration following higher and repeat dosing of ADG126, as well as enhanced Treg depletion through binding to a novel epitope without Fc engineering, position ADG126 to be a best-in-class CTLA-4 inhibitor.” This Phase 1b/2, open-label, multicenter dose escalation and expansion combination study of ADG126 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab; 200 mg, Q3W) in MSS CRC with no liver and peritoneum metastases previously demonstrated efficacy at the 10 mg/kg Q3W dose, with overall response rate (ORR) of 23%, including four confirmed partial responses and one unconfirmed partial response. Newly shared data with the 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab achieved an improved ORR of 33%, and all responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab. Per protocol, dose modifications were permitted to manage toxicity, enabling investigators to optimize each patient’s course of treatment to further improve the duration of responses. Time to event endpoints will be reported when the data mature in 2025. Due to the enhanced therapeutic index of ADG126 in combination with anti-PD-1, the Company plans to evaluate a broader patient population in the dose expansion cohort, including patients with liver metastases, with standard of care combinations. No Grade 4/5 safety events were seen with ADG126 to date and pruritus (25%) was the most commonly observed treatment-related adverse event (TRAE). Higher G2/G3 TRAEs were observed in the loading dose cohort but were managed through dose modification and infrequent use of infliximab/medical intervention, resulting in no discontinuations to date. The totality of data to date supports that Adagene’s anti-CTLA-4, ADG126, plus pembrolizumab has potential to be a best-in-class treatment for patients with MSS CRC. About Adagene Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody ® precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers. For more information, please visit: https://investor.adagene.com . Follow Adagene on WeChat , LinkedIn and Twitter . SOURCE: Adagene

Studies Selected for Presentation at Global Gathering FORT MYERS, Fla., Nov. 7, 2024 /PRNewswire/ -- Clinical research conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) continues to advance science and breakthroughs in cancer immunotherapy, which uses the body's immune system to find, target and fight many forms of the disease. FCS physician investigators are co-authors of research results being presented this week at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the largest cancer immunotherapy conference of international leaders in the field. Continue Reading FCS physician investigators are co-authoring research being presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the world’s largest gathering of leaders in immunotherapy research. FCS President & Managing Physician Lucio N. Gordan, MD said, "Our shared aim is to make immunotherapy a standard of care to improve outcomes for cancer patients. Each discovery achieved through our robust clinical trials research program is bringing us closer to that reality." The following FCS physician investigators are co-authors of research results being presented during oral and/or poster abstract presentations: FCS Director of Drug Development Manish Patel, MD: Phase 1B/2, multicenter dose escalation and expansion of muzstotug (ADG126, a masked anti-CTLA-4 SAFEbody®) in combination with Pembrolizumab in advanced/metastatic MSS CRC (abstract #744); Noted as a "Top 100" Evaluation of immunomodulatory effects of ifinatamab deruxtecan (I-DXd) in the IDeate-Pantumor01 phase 1/2 study in patients with advanced solid tumors (abstract #629) A phase 1/2 clinical trial of anti-VISTA KVA12123 alone and in combination with Pembrolizumab in patients with advanced solid tumors (abstract #625) Triple blockade of DNAM-1 axis with COM701 (anti-PVRIG) + COM902 (anti-TIGIT) + pembrolizumab shows preliminary antitumor activity in patients with platinum resistant ovarian cancer, interim results of a phase I trial (abstract #985) Peripheral Blood and Tumor Gene Expression as Biomarkers and Potential Predictors of Clinical Outcome with HST-1011, an Oral CBL-B inhibitor (abstract #1310) Director of Drug Development, Lake Nona DDU Cesar Perez, MD – the late-breaking abstract: Phase 1 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with advanced solid tumors (abstract #1455) Alexander Philipovskiy, MD, PhD – Abequolixron (RGX-104), a first-in-class oral immunotherapy targeting the liver-X receptor (LXR), in combination with docetaxel in recurrent advanced/metastatic non-small cell lung cancer (NSCLC) (abstract #657). FCS Associate Director of Drug Development Judy Wang, MD: CONSORTIUM-IO: A phase 1 study evaluating a combination of an 11-strain bacterial consortium (VE800) and Nivolumab in treatment of select refractory or metastatic cancers (abstract #607); Noted as a "Top 100" Pharmacodynamic activities of the anti-MICA/B monoclonal antibody CLN-619, evaluated as a monotherapy, support the proposed mechanisms of action and correlate with response (abstract #195) "Immunotherapy clinical trials continue to play a large role in oncology drug development," notes Dr. Manish Patel. "In ongoing studies conducted at our three drug development units, we continue to uncover critical new information about the body's response to immunotherapy, which is improving effectiveness and offering new hope for cancer patients worldwide." As one of the largest clinical research programs in the country, FCS provides access to more than 300 clinical trials at any given time within its 32 late-phase designated FCS clinics and three Drug Development Units, where research is conducted on new treatments when they are first developed, prior to FDA approval. In fact, the majority of new cancer drugs approved for use in the U.S. have been studied in clinical trials with FCS participation. Learn more about clinical trials and advance research conducted a FCS here: . About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED