The Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have granted British pharmaceutical company Novartis access to commercially develop their therapeutic, biomaterial-based, cancer vaccine technology.

Under the licensing agreement, spearheaded by Harvard’s Office of Technology Development (OTD), Novartis will have worldwide rights, in target-limited applications, to bring the biomaterial-based cancer immunotherapies into clinical development and translate this approach to treat patients. The technology will aim to promote anti-cancer immunity.

While cell-based cancer immunotherapies rely on manipulating immune cells outside of the body and transferring them into patients, the implantable immuno-material approach activates endogenous immune cells inside the body to launch an attack on the patient’s own cancer.

The technique was developed, incubated, and advanced at the Wyss Institute and SEAS by Wyss core faculty member and lead of the Immuno-Materials initiative at the Wyss Institute David Mooney and SEAs family professor of bioengineering Robert P. Pinkas.

The first-generation therapy consists of a porous scaffold material made from a widely-used biodegradable medical polymer infused with inactivated antigens from the patient’s tumour cells, as well as immunostimulatory molecules that attract dendritic cells of the immune system to the immuno-material site and activate them to stimulate a host response. After activation, the dendritic cells home to nearby lymph nodes to orchestrate anti-tumour responses throughout the body.

Mooney said: “This work resulted from a remarkable cross-disciplinary effort using the combined expertise of bioengineers, cancer biologists and immunologists. We have demonstrated that these biomaterials can be easily delivered to patients, provide sustained and local release of immune-modulating factors, and bypass the need for modification of cells outside the body. This concept has led to a very promising platform for cancer immunotherapy.”

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By GlobalData

In 2013 the Wyss Institute and the Dana-Farber Cancer Institute (DFCI) initiated a Phase I clinical trial at DFCI to test the safety of the first of these implantable, immuno-material-based cancer vaccines in patients with melanoma. The trial, led by director of DFCI’s Melanoma Center and professor of medicine at Harvard Medical School F. Stephen Hodi is ongoing with many of its original patients.

The trial followed extensive preclinical studies performed by a collaborative team headed by Mooney and Glenn Dranoff, who at the time was a Wyss Institute associate faculty member and co-leader of Dana Farber’s Cancer Vaccine Center. The team demonstrated that the cancer vaccine could potentially shrink or eradicate multiple types of tumours, in addition to providing prophylactic protection, in various animal models. Dranoff is now global head of exploratory immuno-oncology at the Novartis Institutes for Biomedical Research.

Novartis has also established a collaboration agreement with the Wyss Institute to further develop biomaterial systems for its portfolio of second-generation immuno-oncology therapies.

Wyss Institute founding director Donald Ingber said: “This agreement is extremely exciting for us because it validates our innovation model, but even more importantly, it will bring an exciting new therapeutic modality into the clinic for patients with many different types of cancer.”