GIGA 564 / Grifols - LARVOL DELTA

A phase 1 study of GIGA-564, a minimally blocking anti-CTLA-4 monoclonal antibody (SITC 2024) - P1 | "Exploratory endpoints: characterize preliminary anti-tumor activity (iRECIST) and immunogenicity, and investigate pharmacodynamics. Ethics Approval This study was approved by NIH Clinical Centers Institutional Review Board (IRBIRB001776/MOD007447)."

P1 data • Oncology • Solid Tumor

A phase I study of GIGA-564, a minimally blocking anti-CTLA-4 monoclonal antibody (ESMO 2024) - P1 | "Secondary endpoints: characterize preliminary anti-tumor activity (RECISTv1.1) and PK. Exploratory endpoints: characterize preliminary anti-tumor activity (iRECIST) and immunogenicity and investigate pharmacodynamics."

P1 data • Oncology • Solid Tumor

GigaGen Doses First Patient in Phase 1 Trial of Anti-CTLA-4 Oncology Drug Candidate GIGA-564 in Advanced Solid Tumors (GlobeNewswire) - "GigaGen Inc...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."

Trial status • Oncology • Solid Tumor

A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: GigaGen, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: GigaGen, Inc.

New P1 trial • Oncology • Solid Tumor

GigaGen Receives FDA Clearance of IND to Begin Phase 1 Trial of Oncology Drug Candidate, GIGA-564, in Solid Tumors (GlobeNewswire) - "GigaGen...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....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....GigaGen anticipates trial initiation in 2024."

IND • New P1 trial • Solid Tumor

GigaGen Presents IND-Enabling Data and Phase 1 Trial Strategy for its Novel Anti-CTLA-4 Oncology Drug Candidate, GIGA-564, at SITC 2023 (GlobeNewswire) - "The comprehensive dataset from non-clinical models continues to demonstrate GIGA-564’s potential to improve outcomes for cancer patients through weak checkpoint inhibition of CTLA-4. GIGA-564 depletes intratumoral T regulatory cells (Tregs) within the tumor microenvironment, which enables the tumor-killing activity of cytotoxic T cells. Results also show that GIGA-564 offers 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, expected to start in 2024, will evaluate GIGA-564 for the treatment of advanced solid tumors."

New P1 trial • Preclinical • Solid Tumor

Non-clinical results and design of first-in-human study for GIGA-564, a third-generation anti-CTLA-4 monoclonal antibody (SITC 2023) - "Background Anti-CTLA-4 antibodies, such as ipilimumab, were among the first immuno-oncology agents to provide significantly improved outcomes for patients. 2 days (consistent with a human IgG1 antibody). Conclusions The first-in-human Phase 1a/b clinical study has been designed based on the totality of the data and will be presented."

Clinical • P1 data • Oncology • CD80 • CD86

GigaGen Partners with the National Cancer Institute to Advance Oncology Drug Candidate GIGA-564 (GlobeNewswire) - "GigaGen Inc...and a subsidiary of Grifols, announced today that it has signed an agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, to advance development of the company’s differentiated anti-CTLA-4 antibody drug candidate for cancer treatment, GIGA-564. This Cooperative Research and Development Agreement enables further preclinical and clinical studies to assess GIGA-564's potential across various tumor types, including the first in-human Phase 1 clinical trial for the drug candidate in advanced solid tumors....GigaGen and NCI will present IND-enabling data and the clinical trial plan for GIGA-564 at the 2023 SITC Annual Meeting, to be held in San Diego, Calif., on November 1-5, 2023."

Clinical protocol • Licensing / partnership • Preclinical • Oncology

GIGA-564, a third generation anti-CTLA-4 with minimal ability to block CTLA-4 binding to B7 ligands, has enhanced efficacy but reduced toxicity compared to ipilimumab in pre-clinical models (SITC 2022) - "Importantly, we also showed that GIGA-564 was associated with lower toxicity in murine models. Conclusions Our work shows that in pre-clinical models GIGA-564 has enhanced efficacy but reduced toxicity compared to ipilimumab."

Preclinical • Oncology

GigaGen Publishes Research Describing Novel Mechanism of Action and Therapeutic Potential of its anti-CTLA-4 Drug Candidate, GIGA-564 (GlobeNewswire) - "GigaGen Inc...announced today publication of research in bioRxiv entitled, 'Lack of blocking activity in anti-CTLA-4 antibodies reduces toxicity, but not anti-tumor efficacy.' The publication describes the novel mechanism of action of its anti-CTLA-4 drug candidate, GIGA-564, selected due to its reduced checkpoint inhibition, which resulted in superior anti-tumor activity and lower toxicity in murine models compared to commercially available anti-CTLA-4 drugs....GIGA-564 has limited immune checkpoint inhibition activity and induced less proliferation of regulatory T cells compared to ipilimumab"

Preclinical • Oncology