GV20-0251

NEWTON, Mass., June 2, 2025 /PRNewswire/ -- GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, today announced that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute presented updated clinical and translational data of GV20-0251 monotherapy from the ongoing Phase 1/2 clinical trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430) at the American Society of Clinical Oncology 2025 Annual Meeting. GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic. The presentation highlights favorable safety profile, promising monotherapy efficacy, substantial immune activation, and desirable pharmacokinetic properties in patients with advanced solid tumors. Key highlights from the presentation: Favorable safety profile No dose-limiting toxicity up to 20mg/kg, highest dose tested All treatment-related adverse events (TRAEs) are grade 1 or 2, except 1 grade 3 TRAE Monotherapy efficacy 3 confirmed partial responses and 3 more with tumor shrinkage (ORR 33.3%, DCR 66.7%) observed in 9 patients with cutaneous melanoma with primary resistance to anti-PD1 2 of the 3 partial responders have liver metastasis with 1 on treatment > 14 months Additional tumor shrinkage in non-small cell lung cancer and cervical cancer Translational insights Linear PK with T1/2 of 26 days and full target occupancy observed with top two dose levels Substantial immune activation with increased T and NK cell infiltration observed with treatment, consistent with the mechanism of action and preclinical findings Detail of the presentation can be found on gv20tx.com. ABOUT GV20 THERAPEUTICS GV20 Therapeutics is a clinical-stage biotech company dedicated to developing next-generation cancer biotherapeutics. GV20's AI-driven STEAD platform integrates massive B cell repertoire data, -omics data, and advanced AI models to provide deep insights into the tumor microenvironment and uncover targets and therapeutic antibodies that elude other approaches. GV20's pipeline includes best-in-class and first-in-class monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The lead program, GV20-0251, is an AI-designed, first-in-class, fully human monoclonal antibody targeting the novel immune checkpoint IGSF8 (Li et al, Cell 2024). GV20-0251 advanced from target discovery to IND in three years, marking a paradigm shift in AI-driven antibody drug discovery. Preclinical studies show that anti-IGSF8 antibodies enhance NK cell cytotoxicity, dendritic cell antigen presentation, and T cell activation, both alone and with anti-PD1. In an ongoing Phase 1/2a trial (NCT05669430) for advanced solid tumors, GV20-0251 demonstrated favorable safety and promising monotherapy efficacy (Wentzel et al, ASCO 2025). To learn more about GV20, please visit and follow the company on LinkedIn. Business Contact Ying Gong, Ph.D., CBO [email protected] SOURCE GV20 Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEWTON, Mass., May 23, 2025 /PRNewswire/ -- GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, today announced that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute will present updated clinical and translational data of GV20-0251 monotherapy at the American Society of Clinical Oncology 2025 Annual Meeting, taking place in Chicago, IL on May 30- June 3, 2025. This presentation at ASCO builds on previously presented clinical data of the novel immune checkpoint IGSF8 inhibitor GV20-0251 (Wentzel et al, ESMO 2024) and will report updated clinical and translational findings from the monotherapy dose escalation portion of the ongoing Phase 1/2 trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430). GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic. Presentation details (Abstract 2531): Title: Preliminary monotherapy efficacy of novel immune checkpoint blockade GV20-0251 (anti-IGSF8) in advanced melanoma patients with primary resistance to anti-PD1 Session Title: Developmental Therapeutics—Immunotherapy Session Type: Poster session Session Date/Time: Monday, June 2, 2025, 1:30 PM – 4:30 PM CDT Location: Hall A - Posters and Exhibits Board Number: 178 ABOUT GV20 THERAPEUTICS GV20 Therapeutics is a clinical-stage biotech company dedicated to developing next-generation cancer biotherapeutics. GV20's AI-driven STEAD platform integrates massive B cell repertoire data, -omics data, and advanced AI models to provide deep insights into the tumor microenvironment and uncover targets and therapeutic antibodies that elude other approaches. GV20's pipeline includes best-in-class and first-in-class monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The lead program, GV20-0251, is an AI-designed, first-in-class, fully human monoclonal antibody targeting the novel immune checkpoint IGSF8 (Li et al, Cell 2024). GV20-0251 advanced from target discovery to IND in three years, marking a paradigm shift in AI-driven antibody drug discovery. Preclinical studies show that anti-IGSF8 antibodies enhance NK cell cytotoxicity, dendritic cell antigen presentation, and T cell activation, both alone and with anti-PD1. In an ongoing Phase 1/2 trial (NCT05669430) for advanced solid tumors, GV20-0251 demonstrated favorable safety and promising monotherapy efficacy (Wentzel et al, ESMO 2024). To learn more about GV20, please visit and follow the company on LinkedIn. Business Contact Ying Gong, Ph.D., CBO [email protected] SOURCE GV20 Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED