May 20, 2024
GigaGen Doses First Patient in Phase 1 Trial of Anti-CTLA-4 Oncology Drug Candidate GIGA-564 in Advanced Solid Tumors
- GIGA-564 is a differentiated anti-CTLA-4 antibody with potential to enhance anti-tumor activity and mitigate immune-related toxicities associated with CTLA-4 blockade
- Researchers from the National Cancer Institute will conduct the Phase 1 trial, as established in a recently signed Cooperative Research and Development Agreement (CRADA)
San Carlos, Calif., May 20, 2024 (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 first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of its anti-CTLA-4 oncology drug, GIGA-564, for the treatment of metastatic or locally advanced solid tumors.
“The initiation of this Phase 1 trial with GIGA-564 marks a significant milestone as it is GigaGen’s first oncology asset to enter the clinic,” said Carter Keller, senior vice president of Grifols and head of GigaGen. “We look forward to potentially translating the superior anti-tumor performance and reduced immune-related toxicity observed with GIGA-564 in pre-clinical studies into the clinical setting. There is a pressing need for innovative therapies for solid tumors and we believe GIGA-564 has the potential to improve outcomes for patients.”
The trial is being conducted by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, in close partnership with GigaGen. For more information about the trial, refer to clinicaltrials.gov identifier: NCT06258304. For patients interested in enrolling in this clinical trial, please call NCI’s toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615); visit the website: https://trials.cancer.gov; and/or email: NCIMO_referrals@mail.nih.gov.
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.