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 cancer treatment. 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 a novel innate immune checkpoint 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 https://gv20tx.com/ and follow the company on LinkedIn.

Business Contact
Ying Gong, Ph.D., CBO
BD@gv20tx.com