IGSF8

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

CAMBRIDGE, Mass., Aug. 21, 2024 /PRNewswire/ -- GV20 Therapeutics, a clinical-stage AI and genomics-based next generation biotherapeutics company announced today that Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute will present the clinical data on GV20-0251 monotherapy dose escalation at the ESMO Congress 2024, taking place in Barcelona on Sept 13-17, 2024. GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic. The monotherapy dose escalation study started on Mar 27, 2023, and has enrolled across six dose cohorts and two schedules. GV20-0251 has shown favorable safety profile and promising monotherapy clinical efficacy. Details of the oral presentation are below: Title: "A phase 1/2, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors" Session Type: Mini oral session Session Title: Investigational Immunotherapy Session Date/Time: Monday Sep 16, 2024, 10:15-11:45AM Session Room: Granada Auditorium - Hall 6 Presentation Number: 1000MO ABOUT GV20 THERAPEUTICS GV20 Therapeutics is developing a differentiated pipeline of next generation biotherapeutics integrating AI, genomics, & disease biology. Our 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). Our discovery pipeline includes best-in-class and first-in-class ADCs and degraders. GV20 is headquartered in Cambridge, MA. 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

CAMBRIDGE, Mass., April 18, 2024 /PRNewswire/ -- GV20 Therapeutics, a clinical stage biotechnology company integrating AI, genomics, and disease biology to create next-generation antibody therapeutics, today announced that it has entered into a clinical collaboration and supply agreement with Merck (known as MSD outside the US and Canada). Under the terms of the agreement, GV20 will evaluate its lead investigational program GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in combination with Merck's anti-PD-1 therapy, KEYTRUDA®(pembrolizumab), in patients with advanced solid tumors in an ongoing Phase I study (NCT05669430). "We are excited to advance the development of GV20-0251 and explore its potential in combination with KEYTRUDA," said Dr. Shirley Liu, Co-Founder and CEO of GV20 Therapeutics. "IGSF8 is a novel immune checkpoint target that inhibits the function of natural killer cells and dendritic cells. By releasing this inhibition, the antagonistic antibody GV20-0251 has the potential to become another pillar in cancer immunotherapy and bring significant benefits to cancer patients." GV20 is currently enrolling an open-label, multi-center, dose-escalation and dose-expansion Phase I clinical trial testing GV20-0251 in patients with advanced solid tumors who are not eligible for standard of care therapies (NCT05669430). The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of GV20-0251 as a single agent and in combination with KEYTRUDA®(pembrolizumab). GV20 has generated preclinical data demonstrating that antibody blockade of IGSF8 results in compelling anti-tumor activity as monotherapy as well as in combination with anti-PD-1 across multiple tumor models. Recently, at the American Association for Cancer Research (AACR) Annual Meeting 2024, GV20 delivered an oral presentation titled "IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target" during the immunology mini-symposium session. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ABOUT GV20 THERAPEUTICS At GV20 Therapeutics, our mission is to develop a differentiated pipeline of innovative antibody therapeutics to transform the treatment of cancer. We leverage our in-house STEAD platform (Simultaneous Target Evaluation and Antibody Discovery), which integrates AI, genomics, and disease biology to identify novel drug targets and create next-generation therapies against these targets. Our lead program, GV20-0251, a first-in-class, fully human, Fc-attenuated IgG1 monoclonal antibody targeting IGSF8, is in a multi-center Phase I clinical trial in patients with advanced solid tumors (NCT05669430). GV20 is headquartered in Cambridge, MA. 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