GigaGen Begins Phase 1 Trial of GIGA-564 for Advanced Tumors

GigaGen Inc., a biotechnology firm focused on developing innovative antibody treatments for immune deficiencies, infectious diseases, and cancers resistant to checkpoint inhibitors, has commenced a Phase 1 clinical trial for its oncology drug, GIGA-564. This trial, designed to evaluate the safety and tolerability of GIGA-564, marks a significant milestone for GigaGen as it represents the company's first oncology asset to progress to the clinical stage.

Carter Keller, Senior Vice President of Grifols and head of GigaGen, expressed enthusiasm about the trial's initiation, emphasizing GIGA-564's potential to translate its promising pre-clinical outcomes into clinical success. Keller highlighted the urgent need for new therapies in the treatment of solid tumors, noting that GIGA-564 could potentially offer improved patient outcomes due to its unique properties.

The National Cancer Institute (NCI), part of the National Institutes of Health, is conducting this trial under a Cooperative Research and Development Agreement (CRADA) with GigaGen. This collaboration aims to leverage NCI's expertise in clinical research to thoroughly investigate GIGA-564’s therapeutic potential.

GIGA-564 is a fully human monoclonal antibody that differentiates itself from existing anti-CTLA-4 drugs. Traditional therapies in this category have been associated with significant immune-related side effects due to their approach of robustly blocking CTLA-4 interactions, which can inadvertently stimulate regulatory T cells (Tregs) that suppress the immune response against tumors. In contrast, GIGA-564 minimizes CTLA-4 blockade and uniquely targets and depletes Tregs within tumors, thereby enhancing the activation of cytotoxic T cells that play a crucial role in combating tumors.

Grifols, the parent company of GigaGen, is a global healthcare leader recognized for its advancements in plasma-derived medicines and transfusion medicine. Founded in 1909 in Barcelona, Grifols develops, produces, and provides healthcare solutions across more than 110 countries. The company’s innovation is driven by an in-depth understanding of chronic, rare, and often life-threatening conditions. Grifols focuses on a wide range of therapeutic areas, including immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases.

Grifols has built an extensive network of plasma donation centers—the largest globally, with over 390 locations across North America, Europe, Africa, the Middle East, and China. The company is also a leader in transfusion medicine, offering a comprehensive suite of solutions to ensure safety from donation to transfusion. Additionally, Grifols provides high-quality biological supplies for life-science research, clinical trials, and the manufacture of pharmaceutical and diagnostic products. Their portfolio includes tools, information, and services designed to help healthcare professionals deliver expert medical care efficiently.

With more than 23,000 employees spread across over 30 countries, Grifols is committed to sustainable business practices that prioritize continuous innovation, quality, safety, and ethical leadership. The company’s shares are publicly traded on the Spanish Stock Exchange and the U.S. NASDAQ.

GigaGen leverages cutting-edge single-cell technologies to advance transformative antibody drugs that capture and recreate complete immune repertoires as functional antibody libraries. This approach has led to the development of groundbreaking recombinant polyclonal antibody therapies for infectious diseases. GigaGen’s lead oncology asset, GIGA-564, has demonstrated superior anti-tumor efficacy and reduced toxicities in preclinical models due to its novel mechanism of action.

The initiation of the GIGA-564 Phase 1 trial represents a promising step forward in the quest to develop more effective and safer treatments for solid tumors. GigaGen, in partnership with the National Cancer Institute, hopes that the clinical outcomes will reflect the encouraging pre-clinical results, ultimately providing new hope for patients battling challenging cancers.