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Clinical Trial Tests Implantable Melanoma Vaccine

Disk-shaped, bio-compatible sponge contains deactivated cells

Disk-shaped bio-compatible sponge contains deactivated cells from a patient’s melanoma tumors. (Amos Chan, Harvard University)

Engineering and medical researchers at Harvard University, with colleagues from the Dana-Farber Cancer Institute, started an early-stage clinical trial testing an implanted vaccine to treat melanoma, an aggressive form of skin cancer.The trial is designed primarily to test the safety of the proposed treatments with patients having advanced melanoma that has spread in the body, but also gather evidence of therapeutic activity, including immune response and effects on the patients’ tumors.

David Mooney of Harvard’s Wyss Institute for Biologically Inspired Engineering and Dana-Farber’s Glenn Dranoff are leading the project; Dranoff is also on the faculty at the Wyss Institute and Harvard Medical School. Stephen Hodi Jr., director of Dana-Farber’s Melanoma Center, is leading the clinical trial.

Most cancer therapies designed to harness the body’s immune system first require extracting immune cells from the patient, then reprogramming the cells to act as a treatment and returning the cells to the patient’s body. The approach tested in the trial uses a small disk, about the size of an aspirin tablet, made from bio-compatible polymers. The disk, implanted under the skin, attracts and reprograms the immune cells, then directs the reprogrammed cells to find and kill the cancer cells.

Mooney, Dranoff, and colleagues tested this new approach in mice (paid subscription required), and found half of the mice treated with the two doses of the implanted vaccine showed complete remission of their melanoma. The researchers say without the treatments, the mice would have died in 25 days.

The clinical trial aims to enroll 25 patients to test the vaccine, code-named WDVAX. The vaccine will contain the patient’s tumor cells, deactivated through a freezing and thawing process, but still containing the some of the tumor’s proteins for generating an immune response. These deactivated cells are combined with other proteins in the sponge-like scaffolding made of polylactide-co-glycolide or PLGA, the same bio-compatible material used today in sutures that are absorbed into the body.

The trial’s main goal is to determine if this immunotherapy is feasible and safe for patients. The researchers, however, are also tracking biologic activity of the vaccine, specifically the immune response and effects on tumors, as well survival of the patients and their response to subsequent immune therapies. The study is expected to be completed in June 2017.

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