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. GigaGen anticipates trial initiation in 2024.
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.
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