GigaGen Presents IND-Enabling Data and Phase 1 Trial Strategy for its Novel Anti-CTLA-4 Oncology Drug Candidate, GIGA-564, at SITC 2023

San Carlos, Calif., November 6, 2023 (GLOBE NEWSWIRE) --  GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, presented investigational new drug (IND)-enabling data and the clinical trial design for its first-in-human Phase 1 study evaluating the company’s oncology candidate, GIGA-564, at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting.

The comprehensive dataset from non-clinical models continues to demonstrate GIGA-564’s potential to improve outcomes for cancer patients through weak checkpoint inhibition of CTLA-4. GIGA-564 depletes intratumoral T regulatory cells (Tregs) within the tumor microenvironment, which enables the tumor-killing activity of cytotoxic T cells. Results also show that GIGA-564 offers increased anti-tumor efficacy and reduced toxicity compared to the commercially available drug ipilimumab, a monoclonal antibody designed to work through CTLA-4 checkpoint inhibition.

The Phase 1a/1b dose escalation and dose-expansion trial, expected to start in 2024, will evaluate GIGA-564 for the treatment of advanced solid tumors. The trial will be conducted by National Cancer Institute (NCI) researchers in close partnership with the GigaGen team, as established in the recently signed CRADA between GigaGen and NCI, a part of the National Institutes of Health.

“We are pleased to present the design of this first-in-human Phase 1 trial for GIGA-564,” said Erica Stone, vice president of Oncology at GigaGen. “GIGA-564’s weak CTLA-4 blockade differentiates the drug candidate from any other anti-CTLA-4 agent. We look forward to potentially translating the promising efficacy and safety profiles observed in preclinical models into the clinic and demonstrating its potential to improve the treatment landscape for patients with solid malignancies.”

About GIGA-564

GIGA-564, a fully human monoclonal antibody, distinguishes itself from currently available anti-CTLA-4 drugs. Previous anti-CTLA-4 drugs were designed to strongly block CTLA-4's interaction with its ligands, thereby enhancing T cell co-stimulation. However, this approach has been associated with heightened immune-related side effects. Moreover, recent insights reveal that previous anti-CTLA-4 drugs contribute to an increased proliferation of T regulatory cells (Tregs), which may dampen their intended effect of activating cytotoxic T cells that are vital for attacking tumors. In comparison, GIGA-564's uniqueness stems from its minimal CTLA-4 blockade and its ability to deplete intratumoral Tregs within the tumor microenvironment. Top of Form