Immune Design, a clinical-stage biotechnology company focused on the development of novel immune-based therapies for cancer and other chronic conditions, has treated its first patient in a phase I clinical trial of ID-G100 in patients with Merkel cell carcinoma (MCC).

“This trial will provide insights into the ability of ID-G100 to stimulate an immune response in patients with Merkel cell carcinoma,” said Shailender Bhatia, MD, medical oncologist at Seattle Cancer Care Alliance, assistant professor, medical oncology division at the University of Washington School of Medicine and principal investigator. “New treatments are greatly needed for this aggressive disease, and we look forward to evaluating this novel immunotherapy approach.”

The phase I open label trial is designed to evaluate the safety, feasibility, clinical efficacy and immunogenicity of ID-G100 in patients with metastatic or logoregional MCC. The trial is being conducted at the University of Washington Medical Centre and Seattle Cancer Care Alliance, with support from the Life Sciences Discovery Fund.

“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,” said Richard Kenney, MD, chief medical officer of Immune Design. “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.”

ID-G100 is an investigational agent that includes GLA (Glucopyranosyl Lipid A, a synthetic, Tolllike Receptor-4 agonist) and is a product of the company’s GLAAS discovery platform. IDG100 is intended for intra-tumoral injection and is part of Immune Design’s “Endogenous Antigen” approach to treating cancer, which leverages an intratumoral activation of dendritic cells in the context of the tumour’s preexisting broad set of antigens to create a robust local and systemic anti-tumor immune response.  Preclinical and clinical data have demonstrated the ability of GLA to significantly activate dendritic cells in animal models and to increase antigen dependent humoral and cellular TH1 immune responses. Immune Design’s “Specific Antigen” approach, in contrast, delivers specific tumor antigens directly to cancer patients’ dendritic cells using a cutting edge delivery vector specific for a subset of skin dendritic cells. The company is pursuing this approach simultaneously in its IDG305 and ID-LV305 clinical programmes.

Merkel cell carcinoma is a rare aggressive form of skin cancer that most often occurs on the face, neck and back. The majority of cases are associated with the Merkel cell polyomavirus.

Seattle Cancer Care Alliance is a cancer treatment center that unites doctors from Fred Hutchinson Cancer Research Centre, UW Medicine and Seattle Children’s. Our goal is to turn cancer patients into cancer survivors. Our purpose is to lead the world in the prevention and treatment of cancer.