GV20-0251

BOSTON, Sept. 16, 2024 /PRNewswire/ -- GV20 Therapeutics, a clinical-stage AI-based next generation biotherapeutics company, today announced presentation of clinical results from its Phase 1/2 study of GV20-0251 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute gave an oral presentation on the clinical data from the monotherapy dose escalation portion of the ongoing study of GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in patients with advanced solid tumors (NCT05669430). Key highlights from the presentation include: Patient Population: The study enrolled 38 heavily pre-treated patients across six dose levels and two dosing schedules. The median age was 62 years, with a median of 4 prior lines of treatment. Safety: GV20-0251 was well-tolerated across all dose levels (0.5 to 20 mg/kg) with no dose-limiting toxicities observed. Most of treatment-related adverse events were grade 1/2, with only one case of grade 3 pneumonitis reported. Efficacy: Two confirmed partial responses were observed in 12 efficacy-evaluable metastatic cutaneous melanoma patients. Additionally, 14 of 29 efficacy-evaluable patients showed stable disease, including 4 with tumor shrinkage. Pharmacokinetics: Dose-proportional pharmacokinetics with half-life around 25.6 days and full target occupancy on circulating T cells were observed at doses ≥ 3 mg/kg. Click here to access the ESMO presentation. "We are excited by these encouraging results for GV20-0251, which represent a significant milestone as the first clinical data for an AI-designed antibody against an AI-predicted target," said Dr. Shirley Liu, Co-founder and Chief Executive Officer of GV20 Therapeutics. "The favorable safety profile and preliminary efficacy signals, particularly in melanoma patients, support the potential of IGSF8 as a novel immune checkpoint target." GV20-0251 is designed to enhance NK cell killing of malignant cells, upregulate dendritic cell antigen presentation, and increase T cell signaling. This mechanism of action may be particularly relevant for patients with antigen presentation-deficient tumors, which are often resistant to current immune checkpoint inhibitors. The company is currently recruiting anti-PD1-relapsed and refractory cancer patients to be treated by GV20-0251 in combination with pembrolizumab to further evaluate the drug safety, pharmacokinetics, pharmacodynamics, and efficacy. ABOUT GV20 THERAPEUTICS GV20 Therapeutics is developing a differentiated pipeline of next generation biotherapeutics integrating AI, genomics, & disease biology. Its lead program, GV20-0251, a first-in-class, fully human, Fc-attenuated IgG1 monoclonal antibody targeting a novel immune checkpoint IGSF8 to activate innate and adaptive immunity, is in a multi-center Phase 1/2 clinical trial in patients with advanced solid tumors (NCT05669430). Its discovery pipeline includes best-in-class and first-in-class ADCs and degraders. 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