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• W2046270370 abstract "In an effort to speed the clinical development of promising therapeutic cancer vaccines and other immune system-based therapies, 2 nonprofit organizations have joined forces to create a unique venture philanthropy mechanism, the Cancer Vaccine Acceleration Fund (CVAF). The CR1 and the Ludwig Institute for Cancer Research (LICR), both in NewYork City, announced the formation of the fund in December 2010 and since then have announced collaborative research agreements with 2 biopharmaceutical companies, Tolerx, Inc and Oncovir, Inc. “Other organizations have pioneered venture philanthropy, but I think we're one of the only ones that have taken the model further, offering a full turnkey value proposition of how we can be the center of designing clinical trials;' says Adam Kolom, director of the CVAF. Encouraging early-stage drug development by providing young start-up technology companies with the financing and infrastructure to develop trials for promising new agents; Providing a mechanism for large pharmaceutical companies to bring “on-the-shelf” agents to trial for immunotherapy applications; and Acting as a neutral third party in coordinating companies that own different agents in an effort to test them in combination. Tolerx, headquartered in Cambridge, Massachusetts, is an example of the second approach. The company was immediately focused on therapies for autoimmune diseases, but it also had several agents for cancer that it was not planning on developing for several years. Kolom and colleagues encouraged the company to begin developing the products sooner with the organizations' infrastructure and support. As a result, in December 2010 they announced a collaboration in which the CVAF provided $1.5 million in funding to support Tolerx's clinical development ofTRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to attack cancer cells more effectively. TRX5 18 is the first antiglucocorticoid-induced tumor necrosis factor receptor drug candidate to enter human clinical trials. At the time of completion of the phase 1 study, led by the Memorial Sloan-Kettering Cancer Center in New York City, the drug may be evaluated with other vaccines that could complement its effect on T cells. In addition, the CVAF awarded $450,000 to Oncovir, based in Washington, DC, to enable production of the immunological stimulant poly-ICLC (Hiltonol). “We now have very clear set of agents and combinations, and I suspect in next 3 to 4 months, we'll have an announcement of 2 to clinical trials that we'll be supporting:' Kolom says. “Hopefully, we'll partner with other cancer charities too.” The CR1 was formed in 1953 to advance the science of immunology and foster the discovery of new cancer immunotherapies, whereas LICR's mission is to improve cancer control by coupling basic laboratory discoveries from its research locations around the world with strong intellectual property positions, clinical development expertise, and the performance of institute-sponsored clinical trials. LICR provides its clinical trials management and immunology expertise as well as some of their intellectual property for CVAF-supported research. New optimism in the field of cancer immunotherapy prompted both organizations to pool their capabilities and expertise in an effort to advance therapies that might not otherwise be tested as quickly, if at all. “The whole cancer immunology field has had a checkered past,” says Jill O'Donnell-Tormey, PhD, executive director of the CVAE “There's been a lot of optimism and disappointment. People have rushed to go forward in the clinic without understanding the basic biology in many cases.” Scientists in the field are beginning to realize that immunotherapy cannot be considered in the same category as chemotherapy, which treats the cancer, she adds. Instead, it must be viewed as a way of treating the patient's immune system, which needs to be activated. A combination of therapies is essential, including the antigen that directs the immune system toward the cancer target, a delivery system, an adjuvant that is stimulating the immune response, a modulator of immunosuppression, and other treatment modalities. “We always thought that chemotherapy was bad for immunotherapy, but we're learning that at least low-dose chemotherapy can act in synergy with it,” Dr. O'Donnell Tormey says. “We've also learned in the last decade that there's a lot of immunosuppression naturally from the tumor itself, and the immune system wants to turn itself off once it gets activated, so we need a modulator:' Bringing all these components together means that there are many possible combinations that need to be tested earlier in the development process. Consequently, scientists need to examine whether specific formulations are producing an integrated immune response in patients; otherwise they will not have a clinical response. “It comes down to a formulation of an immunotherapy that is not just 1 drug but multiple agents coming together in the right way to generate the response you want in patients;' Dr. O'Donnell Tormey says. Although the CR1 has been in existence since 1953, most of the work they supported was basic research, which was necessary to learn more about the immune system. About decade ago, however, the organization began to support ways to bring that knowledge into the clinical setting. Furthermore, the CR1 wanted to move beyond funding phase studies that did not necessarily get continued. To do so, they partnered with LICR to form the Cancer Vaccine Collaborative (CVC), a global network of 19 academic clinical trial sites. These investigators have expertise in immunology and are conducting parallel early stage clinical trials to identify the optimal composition of successful therapeutic cancer vaccines. Since it was formed in 2001, the CVC has completed more than 22 early phase clinical trials of multicomponent vaccine formulations with an additional 21 trials currently ongoing and 4 more planned for patient accrual. We always thought that chemotherapy was bad for immunotherapy, but we're learning that at least low-dose chemotherapy can act in synergy with it.—Jill O'Donnell-Tormey, PhD One of CVC's major focuses is on the NY-ESO-1 antigen, a promising target because it is only found on cancer cells and is extremely immunogenic. Because it is found in a variety of cancers, it has multiple potential applications. Investigators hope the lessons they learn in how best to deliver and combine it will be applicable to other antigens. Despite their discoveries, the CR1 still found that one of the major roadblocks was getting access to agents and combinations for formulations. That is how CVAF's venture philanthropy model came about. The concept is that expert investigators identify and prioritize promising agents that are not being tested for immunotherapy. Then, instead of simply providing funds to companies to develop the drugs, CVAF would offer its own clinical network and expertise as well as money to move these agents into trials. CVAF also negotiates a return on investment so that if the drug is ultimately commercialized, some of the profits will be returned to the organization to fund future research. “Our board is made up of businesspeople, and they like the idea of a fund that's self-sustaining,” Kolom notes. Another advantage CVAF offers is that, as a nonprofit, its decision-making is not driven by how fast they can bring a drug to market but, rather, “by the science first,” Dr. O'Donnell-Tormey says. “Hopefully, by providing information early on in these small trials, there will be more likelihood of success than trials in the past when they rushed to phase 3 without really understanding the biology of what was happening in the patient,” she adds." @default.
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• W2046270370 title "Organizations hope new fund accelerates cancer vaccine research" @default.
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