Trial to Evaluate Antigen-Specific, Active Immunotherapy Approach

SEATTLE, WA and SAN FRANCISCO, CA, USA I February 27, 2014 I Immune Design, a clinical-stage immunotherapy company focused on the development of novel immune-based therapies for cancer and other chronic conditions, today announced treatment of the first patient in a Phase 1 clinical trial of ID-G305, a cancer immunotherapy investigational agent from the company’s GLAASTM platform.

The Phase 1 open label, dose-escalation trial is designed to evaluate the safety, tolerability and immunogenicity of ID-G305 in patients with unresectable, relapsed, or metastatic cancer expressing the NY-ESO-1 antigen, including melanoma, sarcoma, lung, ovarian or breast cancer. The trial is being conducted in up to 18 patients at several clinical centers in the United States.

“The development of agents that harness the patient’s cellular immune system to kill tumor cells is a promising approach for the treatment of human malignancies,” said Amit Mahipal, M.D., M.P.H., Medical Director, Clinical Research Unit, Moffitt Cancer Center, and a Principal Investigator in the study. “We look forward to evaluating this novel therapeutic candidate, ID-G305, and its ability to generate immune responses in cancer patients.”

“We are pleased to launch this first clinical trial of ID-G305, which has been designed to stimulate multiple arms of the immune system,” said Richard Kenney, M.D., Chief Medical Officer of Immune Design. “The adjuvant component, GLA-SE, is a unique, potent, clinical-stage toll-like receptor-4 (TLR4) agonist that has demonstrated favorable clinical safety in multiple clinical trials to date. Combining this with the targeted NY-ESO-1 protein offers the potential to generate effective immune activity in cancer patients.”

About ID-G305

ID-G305 triggers a potent and specific cellular and humoral anti-tumor response, as well as stimulating the innate immune response. This product candidate was generated from Immune Design’s GLAASTM discovery platform, which leverages a proprietary synthetic small molecule adjuvant glucopyranosyl lipid A (GLA), a novel TLR4 agonist. ID-G305 is part of Immune Design’s “Specific Antigen” approach, which drives the in vivo generation of a strong, antigen-specific CTL response against selected antigens present in the tumor. ID-G305 consists of recombinant NY-ESO-1 protein, which is expressed by a variety of cancers, formulated with GLA-SE. The NY-ESO-1 protein is provided by the Ludwig Cancer Research and Cancer Research Institute with which the company has a collaboration to advance cancer immunotherapy research.

GLA has been evaluated in multiple clinical studies involving nearly 1,000 patients to date, where it has been shown to be well tolerated.

About Immune Design

Immune Design is a clinical-stage immunotherapy company employing leading-edge technologies that target in vivo dendritic cells to generate and expand strong cytotoxic T cells (CTLs) for the treatment of cancer and other chronic diseases. The company’s clinical programs are the product of its two synergistic discovery platforms: DCVexTM, a novel lentiviral vector platform engineered to deliver antigen-encoding nucleic acids directly to dendritic cells in vivo, and GLAASTM, a TLR4-agonist platform that activates dendritic cells by up-regulating key molecules for efficient antigen presentation and produces Th1 cytokines to enhance the immune response. Immune Design has offices in Seattle, Washington and South San Francisco, California. For more information, visit

SOURCE: Immune Design