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Opal Therapeutics Inc (Opal) and Massachusetts General Hospital (MGH) have entered into a joint development collaboration agreement to develop a novel immunotherapy to treat HIV.

Human clinical trials for this new therapy will commence in London this week. Leading the collaboration for MGH are Drs. Philip Goulder and Bruce D. Walker. Dr. Walker is the director of the Ragon Institute of MGH, MIT and Harvard, professor of Medicine at Harvard University, and a Howard Hughes Medical Institute investigator. The Ragon Institute, established in 2009 and supported by the Phillip T and Susan M Ragon Foundation, seeks to establish a model of scientific collaboration that links the clinical, translational, and basic science expertise at MGH, MIT and Harvard to tackle the greatest global health challenges related to infectious disease research.

Opal Therapeutics Inc is an immunotherapy development company focusing on novel therapies for HIV and Hepatitis C (HCV) based on proprietary technology licensed from the University of Melbourne. The company is incorporated in Delaware with operations in Australia and the USA. Opal’s investors include Alloy Ventures, Alta Partners and GBS Ventures.

HIV and chronic HCV are viral infections inadequately treated by current therapies. Cellular immunity has an important role in the progression of both diseases, however, current treatments have generally failed to induce strong cellular immune responses. Opal has developed a unique approach to generate high levels of targeted cellular immune responses for the treatment of chronic infection.

“The studies under this collaboration will test and validate this novel approach as a therapeutic vaccine to treat HIV,” said Dr. Walker, who is the leader of the Ragon Institute’s Adaptive T Cell Immunity Research Program. “While we have made great strides in recent years in treating HIV and AIDS, we still have a long way to go. Our goal is to find ways to treat and ultimately cure and even prevent this disease, and then make sure that the therapies are available to patients around the globe.”

Under the joint development collaboration, Opal retains rights to commercialize the vaccine globally. Opal will not only develop a product for developed markets such as the US, Europe and Japan, but will also work together with other parties to ensure access to the vaccine to the least developed countries at minimum cost and without royalties. Opal will contribute funds, technology, intellectual property, and commercialization expertise to the collaboration. MGH Opal RELEASE GLOBAL will contribute funds, intellectual property, technical expertise, and clinical development capability to the collaboration.

“The joint development collaboration brings together the best of biotech with the best of academic research and the best of philanthropy for product development. Together we hope to develop a new therapeutic vaccine to treat HIV and make it available to all patients in need” said Dr. Joshua Funder, Chairman of Opal Therapeutics. “This unique model of development partnership is underpinned by our joint commitment to develop new therapies for HIV. Opal will be able to commercialize the product and the Ragon Institute will be able to fulfill its mandate to develop and make available new therapies to address the global health challenges related to infectious disease.”

Under the joint development agreement, Medicines Development Limited (MDL), a not-forprofit biotechnology company expert in the development of vaccines and treatments for  infectious diseases and oncology, has been engaged to undertake initial clinical studies of the Opal therapy. MDL employs pharmaceutical industry development methods to produce licensed medicines/vaccines for delivery to those most in need.

“We have demonstrated strong reduction of the AIDS virus in non-human primate studies with the Opal technology”, said Dr. Goulder, a paediatrician and research immunologist who runs the HIV Infection and Immune Control Group at Oxford University and is an associate member of the Ragon Institute at MGH. Dr. Goulder is the principal investigator for the studies under the joint development collaboration. “The clinical studies in London will assess the safety and immunogenicity of the therapy for the first time in humans,” he said. Opal immunotherapy uses short peptides from the target virus to generate a strong immune response so patients can improve control of the infection. The peptides are mixed ex vivo (outside the body) with blood where they bind to immune cells and are then distributed to all parts of the body to stimulate the immune response.