GV20 Presents Promising Phase 1 Monotherapy Data on GV20-0251 at ESMO 2024

BOSTON, Sept. 16, 2024 /PRNewswire/ -- GV20 Therapeutics, an AI-driven, clinical-stage biotherapeutics company, presented 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 delivered an oral presentation shedding light on the clinical findings from the monotherapy dose escalation segment of the ongoing study. GV20-0251 is a pioneering antibody aimed at the novel immune checkpoint IGSF8, intended for patients with advanced solid tumors (NCT05669430).

Key findings from the presentation are as follows:

**Patient Demographics**: The study included 38 heavily pre-treated patients across six dose levels and two dosing schedules. The median age was 62 years, with a median of four previous treatment lines.

**Safety Profile**: GV20-0251 was well-tolerated across all dose levels ranging from 0.5 to 20 mg/kg, with no dose-limiting toxicities detected. Most treatment-related adverse events were of grade 1 or 2, with only one instance of grade 3 pneumonitis.

**Efficacy**: Among the 12 efficacy-evaluable metastatic cutaneous melanoma patients, two exhibited confirmed partial responses. Additionally, 14 out of 29 efficacy-evaluable patients demonstrated stable disease, with four showing tumor shrinkage.

**Pharmacokinetics**: The study observed dose-proportional pharmacokinetics with a half-life of approximately 25.6 days. Full target occupancy on circulating T cells was achieved at doses of 3 mg/kg and above.

Dr. Shirley Liu, Co-founder and CEO of GV20 Therapeutics, expressed enthusiasm about the promising results of GV20-0251, highlighting it as a significant milestone. She emphasized that these findings represent the first clinical data for an antibody designed by AI against an AI-predicted target. The favorable safety profile and early signals of efficacy, especially in melanoma patients, point towards the potential of IGSF8 as a groundbreaking immune checkpoint target.

GV20-0251 aims to enhance NK cell-mediated killing of malignant cells, boost dendritic cell antigen presentation, and amplify T cell signaling. This mechanism could be particularly beneficial for patients with antigen presentation-deficient tumors, which are often resistant to existing immune checkpoint inhibitors.

Currently, the company is enrolling patients with anti-PD1-relapsed and refractory cancers to be treated with GV20-0251 combined with pembrolizumab. This phase aims to further assess the drug's safety, pharmacokinetics, pharmacodynamics, and efficacy.

GV20 Therapeutics is at the forefront of developing next-generation biotherapeutics by integrating AI, genomics, and disease biology. Their lead program, GV20-0251, is in a multi-center Phase 1/2 clinical trial for patients with advanced solid tumors. The company’s pipeline includes cutting-edge antibody-drug conjugates (ADCs) and molecular degraders, aiming to offer innovative treatment solutions.

In summary, the presentation at the ESMO Congress highlighted the potential of GV20-0251, offering hope for patients with advanced solid tumors through a novel approach in targeting immune checkpoints.