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 LV305, an immuno-oncology investigational agent from the company's DCVexTM lentiviral vector platform.
The Phase 1 open label, multi-center trial (NCT02122861) is designed to evaluate the safety, tolerability and immunogenicity of LV305 in patients with locally advanced, relapsed, or metastatic breast cancer, melanoma, non-small cell lung cancer, ovarian cancer or sarcoma. The trial will enroll up to 36 patients at several clinical centers in the United States.
"The advancement of novel immuno-oncology agents such as LV305 that induce a tumor-specific in vivo T-cell response holds promise for the development of new and targeted approaches to cancer treatment," said Seth M. Pollack, M.D., Principal Investigator at the Fred Hutchinson Cancer Research Center.
"LV305, which targets the NY-ESO-1 antigen expressed in a number of tumors, offers a targeted, tumor-specific in vivo approach to activating a T-cell immune response that we believe may provide benefit to a wide range of cancer patients," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer at Immune Design. "LV305 is an integral part of our prime-boost strategy that is designed to provide a superior approach to fighting cancer. Data from the trial will include immunogenicity and initial indications of efficacy, and is intended to support the combination of LV305 with a second proprietary agent, G305, into our prime-boost strategy known as CMB305. We intend to commence a Phase 1 trial for CMB by the end of 2014."
"I am excited to see that a novel and perhaps bold idea has matured into a product candidate now being clinically evaluated, and believe that using a novel vector of this type to deliver genetic information specifically to dendritic cells opens a new avenue that holds much promise for treating cancer," said David Baltimore, Ph.D., President Emeritus, Robert Andrews Millikan Professor of Biology, California Institute of Technology.