The technology, developed by the Wyss Institute for Biologically Inspired Engineering at Harvard University, uses 8.5 millimetre disk-like sponges made from US FDA-approved polymers.
The disks, which release cytokines, recruit dendritic cells that enter the implants’ pores where they are exposed to antigens specific to the type of tumor being targeted. The dendritic cells then report to nearby lymph nodes, where they direct the immune system's T-cells to kill tumor cells, according to the preclinical study results from 2009 published in Science Translational Medicine.
In simpler terms, the sponge implanted under the skin is designed to recruit and reprogram a patient's immune cells, and then instructs them to travel through the body and kill the cancer cells.
Dr. David Mooney, PhD, professor of bioengineering at Harvard, told BioPharma-Reporter.com, “The polymer [that makes up the disks] is poly(lactide-co-glycolide) - the same polymer used to fabricate biodegradable sutures.” He added that “the process we use [to manufacture the sponges] is a high pressure, carbon dioxide foaming technique.”
The vaccine technology is unlike what’s used in most therapeutic cancer vaccines available today, such as Denderon’s prostate cancer vaccine Provenge, where doctors must initially remove the patient's immune cells, then reprogram them and reintroduce them back into the patient. More than 90 percent of reinjected cells from vaccines currently available die before having any impact, according to Harvard.
Early Progress
The success of the preclinical study, which found 50 percent of mice treated with two doses of the vaccine showed complete tumor regression, means the vaccine was able to enter human trials earlier.
"It is rare to get a new technology tested in the laboratory and moved into human clinical trials so quickly," said Dr. Glenn Dranoff, professor of medicine at Harvard Medical School.
Dr. Mooney added that the Phase I trial began three to four years “after we first published on the technology, which is considered quite fast.”
The use of the vaccine technology also may not be just limited to fighting melanoma.
“This is potentially useful for a range of solid tumors,” Dr. Mooney said. “But this trial will only examine its utility in melanoma.”