GigaGen Receives FDA clearance of IND to begin Phase 1 Trial of Oncology Drug Candidate, GIGA-564, in solid tumors

San Carlos, Calif., December 12, 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, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company’s oncology candidate, GIGA-564, for the treatment of solid tumors.

“We are pleased to have reached this significant milestone, paving the way for our first oncology asset to enter clinical development,” said Carter Keller, senior vice president of Grifols and head of GigaGen. “GIGA-564 introduces a novel approach to CTLA-4 targeting, with the promise of enhanced anti-tumor activity and lower side effects compared with existing anti-CTLA-4 agents. We look forward to initiating the trial in 2024 and translating this potential into tangible clinical outcomes for patients.”

In non-clinical models to date, GIGA-564 depleted intratumoral T regulatory cells (Tregs) within the tumor microenvironment, which enables the tumor-killing activity of cytotoxic T cells. It also led to 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 will evaluate GIGA-564 for the treatment of advanced solid tumors. The trial will be conducted by National Institutes of Health’s National Cancer Institute (NCI) researchers in close partnership with the GigaGen team.

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.