US-based clinical-stage biotechnology firm Immune Design has started treatment in a Phase I clinical trial of ID-G100 in patients with Merkel cell carcinoma (MCC).
ID-G100 is an investigational agent that includes GLA (Glucopyranosyl Lipid A, a synthetic, toll-like receptor-4 agonist). It is a product of the company's GLASS discovery platform.
The open label Phase I study is designed to assess the safety, feasibility, clinical efficacy and immunogenicity of ID-G100 in patients with metastatic or logoregional MCC.
The trial is being supported by the Life Sciences Discovery Fund, and carried out at the University of Washington Medical Center and Seattle Cancer Care Alliance.
Seattle Cancer Care Alliance medical oncologist and the University of Washington School of Medicine assistant professor of medical oncology division Shailender Bhatia said the trial will provide insights into the ability of ID-G100 to stimulate an immune response in patients with MCC.
"New treatments are greatly needed for this aggressive disease, and we look forward to evaluating this novel immunotherapy approach," Bhatia said.
ID-G100 is intended for intra-tumoural injection and is part of the company's 'Endogenous Antigen' approach to treating cancer, which leverages an intratumoural activation of dendritic cells in the context of the tumour's pre-existing broad set of antigens to create a robust local and systemic anti-tumour immune response.
Immune Design chief medical officer Richard Kenney said Merkel cell carcinoma is an aggressive cutaneous neuroendocrine carcinoma with few definitive treatment options.
"We hope this novel therapy will eventually provide these patients with a meaningful new treatment opportunity for this orphan disease," Kenney said.
"A core component of ID-G100, GLA, has been evaluated as a molecular vaccine adjuvant in more than 1,000 subjects and has demonstrated the ability to stimulate the innate and adaptive immune system while being well tolerated.
"The recent discovery of a polyoma virus that is associated with MCC supports the potential for an immunotherapeutic approach."
The company said that preclinical and clinical data have showed the ability of GLA to significantly activate dendritic cells in animal models and to increase antigen dependent humoral and cellular TH1 immune responses.
Image: Micrograph of a Merkel cell carcinoma. Photo: courtesy of Nephron.