Immune Design Announces Treatment of First Patient in Phase 1 Clinical Trial of ID-G100, an Investigational Immuno-Oncology Agent

January 27 , 201 4 , Seattle, WA and South San Francisco, CA – Immune Design, a clinical - stage biotech nology 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 - G100 in patients with Merkel cell c arcinoma (MCC) .

“ This trial will provide insights into the ability of ID - G 100 to stimulate an immune response in patients with Merkel cell carcinoma ,” said Shailender Bhatia, M.D., 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 fo rward to evaluating this novel immunotherapy approach.”

The Phase 1 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 Center and Seattle Cancer Care Alliance , with support from the Life Sciences Discover y 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 opportunit y for this orphan disease ,” said Richard Kenney, M.D., Chief Medical O fficer 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. ”

About ID-G100

ID-G100 is an investigational agent that includes GLA ( Glucopyranos yl Lipid A , a synthetic, Toll - like Receptor - 4 agonist ) and is a product of the company’s GLA A S TM discovery platform . ID - G100 is intended for intra - tumoral injection and is part of Immune Design’s “ Endogenous Antigen ” approach to treating cancer, which leverages a n intratumoral activation of dendritic cells in the context of the tumor’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 ID - G305 and ID - LV305 clinical programs.

For Patients

More information about this study, including additional eligibility criteria and contact information, can be found on clinicaltrials.gov.

About Merkel cell carcinoma

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 . Approximately 1,500 new cases of Merkel cell carcinoma are reported in the United States each year and the incidence of the disease has almost tripled in the past two decades . Common treatment options include surgery, chemotherapy and radiation therapy. For more information about Merkel cell carcinoma and available treatme nt options visit www.merkel cell .org .

About the Life Sciences Discovery Fund

The Life Sciences Discovery Fund (LSDF) was established in 2005 by the Governor and Legislature of Washington to foster growth of the state’s life sciences sector and improve the health and economic wellbeing of its residents. LSDF invests monies from the Master Tobacco Settlement Agreement in research and development across Washington that demonstrate the strongest potential for delivering health and economic returns to the state. To date, LSDF has produced a 7:1 return on Washington’s investment, includin g over $445 million in additional funding and more than $67 million in health - care cost savings. For more information about LSDF and its grant making, visit: www.lsdfa.org .

About Seattle Cancer Care Alliance

Seattle Cancer Care Alliance is a cancer treatment center that unites doctors from Fred Hutchinson Cancer Research Center, UW Medicine and Seattle Children’s. Our goal, every day, is to turn cancer patients into cancer survivors. Our purpose is to lead the world in the prevention and treatment of cancer. SCCA has five clinical care sites: an outpatient clinic on the Hutchinson Center campus, a pediatric inpatient unit at Seattle Children’s, an adult inpatient unit at UW Medical Center, a medical oncology cl inic at EvergreenHealth, and medical and radiation oncology clinics at UW Medicine / Northwest Hospital & Medical Center. Additionally, proton therapy services are provided at SCCA Proton Therapy, A Procure Center . For more information about SCCA, visit www.seattlecca.org .

About Immune Design

Immune Design is a clinical - stage biotechnology company employing leading - edge technologies that target dendritic cells for a more precise immune response for the treatment of cancer and other chronic conditions. The company’s clinical programs are the product of its two synergistic discovery platforms: DCVex T M , a novel lentiviral vector platform engineered to deliver antigen - encoding nucleic acids directly to dendritic cells in vivo , and GLAAS TM , 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 inf ormation, visit www.immunedesign.com .

Source: Immune Design

Posted: January 2014

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