Phase I Trial for Implantable Melanoma Vaccine Begins

A cross-disciplinary team of scientists, engineers, and clinicians recently announced the start of a phase I clinical trial of an implantable vaccine to treat melanoma. The effort is the fruit of a new model of translational research being pursued at the Wyss Institute for Biologically Inspired Engineering at Harvard University that integrates the latest cancer research with bioinspired technology development. It was led by Wyss Core Faculty member David J. Mooney, PhD, who is also the Robert P. Pinkas Family Professor of Bioengineering at the Harvard School of Engineering and Applied Sciences, and Wyss Institute Associate Faculty member Glenn Dranoff, MD, who is co-leader of Dana-Farber Cancer Institute's Cancer Vaccine Center.

Unlike most therapeutic cancer vaccines available today that require doctors to first remove the patient's immune cells from the body, then reprogram them and reintroduce them back into the body, the new approach instead uses a small disk-like sponge about the size of a fingernail that is made from FDA-approved polymers, according to a press release from the Wyss Institue. The sponge is implanted under the skin, and is designed to recruit and reprogram a patient's own immune cells "on site," instructing them to travel through the body, home in on cancer cells, then kill them.

The researchers found that the technology, which was initially designed to target cancerous melanoma in skin, might have application to other cancers. In the preclinical study reported in Science Translational Medicine in 2009, 50 percent of mice treated with two doses of the vaccine — mice that would have otherwise died from melanoma within about 25 days — showed complete tumor regression.

Recruitment of participants for the clinical trial began recently under the leadership of F. Stephen Hodi, Jr, MD, Director of Dana-Farber's Melanoma Center and Associate Professor of Medicine at Harvard Medical School. The goal of the phase I study, which is expected to conclude in 2015, is to assess the safety of the vaccine in humans.