GigaGen Initiates Phase I Trial for GIGA-564 Oncology Drug

GigaGen Commences Phase I Clinical Trial for GIGA-564 Oncology Drug

Grifols' subsidiary, GigaGen, has initiated a Phase I clinical trial for its novel oncology drug candidate, GIGA-564. The drug targets metastatic or locally advanced solid tumors and is being evaluated in collaboration with researchers at the National Cancer Institute, a part of the National Institutes of Health. The primary objective of the trial is to assess the drug's safety, tolerability, and establish the maximum tolerated dose, as well as the recommended Phase II dose level(s). GIGA-564, a fully human monoclonal antibody, is specifically designed to minimize CTLA-4 blockage and selectively deplete intratumoral T regulatory cells, potentially reducing immune-related side effects and enhancing cytotoxic T cell activation. This marks a significant milestone for GigaGen as it marks the introduction of its first oncology asset into clinical studies.

Key Takeaways

• GigaGen, a subsidiary of Grifols, has administered the first patient in a Phase I clinical trial for GIGA-564, an oncology drug tailored to address metastatic or locally advanced solid tumors.
• The trial, conducted in collaboration with the National Cancer Institute, is intended to evaluate the safety and tolerability of GIGA-564.
• GIGA-564, a fully human monoclonal antibody, aims to minimize CTLA-4 blockage and selectively deplete intratumoral T regulatory cells, potentially diminishing immune-related side effects.
• Conventional anti-CTLA-4 medications have exhibited enhanced T-cell co-stimulation but have also resulted in increased Tregs proliferation, leading to reduced cytotoxic T cell activation.
• Grifols acquired the remaining 56% stake in GigaGen in March 2021, and GigaGen secured a contract with the US Department of Defense in September 2022 to demonstrate its recombinant human polyclonal antibody platform against biological threats.

Analysis

The launch of the Phase I trial for GIGA-564, an oncology drug targeting solid tumors, holds the potential to mitigate immune-related side effects by minimizing CTLA-4 blockage and selectively depleting intratumoral T regulatory cells. This development can potentially benefit cancer patients, the National Cancer Institute, and Grifols, opening up the prospect of a more effective and safer anti-CTLA-4 treatment. Furthermore, the success of GIGA-564 may influence other pharmaceutical companies involved in similar therapies, thereby stimulating competition and innovation within the oncology drug sector.

Did You Know?

• Phase I clinical trial: This initial phase of testing a new drug on human subjects seeks to evaluate the drug's safety and tolerability, determine the maximum tolerated dose, and establish the recommended dose level(s) for future studies. For GigaGen's GIGA-5