GigaGen Inc., a biotechnology company specializing in the development of innovative antibody drugs for immune deficiencies, infectious diseases, and checkpoint-resistant cancers, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This regulatory approval allows the commencement of a Phase 1 trial for GigaGen's oncology candidate, GIGA-564, designed for the treatment of solid tumors.

Carter Keller, Senior Vice President of Grifols and Head of GigaGen, expressed satisfaction with this noteworthy achievement, marking the initiation of their first oncology asset into clinical development. GIGA-564 introduces a fresh approach to CTLA-4 targeting, offering the potential for improved anti-tumor activity and decreased side effects compared to existing anti-CTLA-4 agents. The company aims to begin the trial in 2024 and is enthusiastic about translating this potential into tangible clinical benefits for patients.

In preclinical models, GIGA-564 demonstrated the ability to deplete intratumoral T regulatory cells (Tregs) within the tumor microenvironment. This depletion facilitates the tumor-killing activity of cytotoxic T cells and results in increased anti-tumor efficacy and reduced toxicity compared to the currently available drug, ipilimumab.

The Phase 1a/1b dose escalation and dose-expansion trial will evaluate GIGA-564's effectiveness in treating advanced solid tumors. The trial will be conducted by researchers from the National Institutes of Health's National Cancer Institute (NCI) in collaboration with the GigaGen team.

GIGA-564, characterized as a fully human monoclonal antibody, distinguishes itself from existing anti-CTLA-4 drugs. Unlike previous drugs that strongly block CTLA-4's interaction with its ligands, causing heightened immune-related side effects, GIGA-564 minimally blocks CTLA-4 and demonstrates the ability to deplete intratumoral Tregs within the tumor microenvironment. This distinctive approach aims to address the challenges associated with existing anti-CTLA-4 drugs and optimize the activation of cytotoxic T cells crucial for attacking tumors.

 

Source: globenewswire.com

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