Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund (CVAF), a joint initiative with the Ludwig Institute for Cancer Research (LICR), has completed a new investment agreement with Oncovir, Inc., a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol® (Poly-ICLC).
"CVAF support is a critical factor enabling the manufacture of enough high-grade Hiltonol® for clinical testing not only in cancer vaccines, but also for many other diseases for which it holds promise," says Andres M. Salazar, M.D., founder, chief executive officer, and scientific director of Oncovir.
Through the collaboration, CVAF will provide $450,000 to Oncovir to help fund the manufacture of clinical grade Hiltonol®. As part of the agreement, 10,000 vials of Hiltonol® will be dedicated exclusively for use in 10 to 15 early- and mid-phase clinical trials designed and conducted within the CRI/LICR Cancer Vaccine Collaborative (CVC), a coordinated global network of 19 academic clinical trial sites and advanced immunological monitoring laboratories. Since it was established in 2001, the CVC has completed more than 22 early-phase clinical trials of different, multi-component cancer vaccine formulations, with an additional 21 trials currently ongoing and 4 more planned to begin patient accrual.
Members of the CVC's Coordinating and Review Committee have identified Hiltonol® as a powerful immunomodulator with the potential to enhance the efficacy of therapeutic cancer vaccines. In addition to holding a dedicated supply of Hiltonol®, CVAF will also receive a perpetual non-exclusive license for the agent's use in combination with therapeutic cancer vaccines, according to the terms of the agreement with Oncovir.
"The CVC was established on the fundamental premise that cancer vaccines must include multiple components, including an antigenic target or targets, a delivery system, an immunological stimulant, and a modulator of immunosuppression, or checkpoint blockade, to ensure that the anti-tumor immune response, once aroused, does not shut down prematurely," says Lloyd J. Old, M.D., director of the CRI Scientific Advisory Council and director of the CVC. "Providing funding that will enable a large quantity of clinical grade Poly-ICLC to be manufactured is essential to furthering both Oncovir's and our program's clinical research objectives. Specifically, having a supply of Hiltonol® under CVC control will make it possible for our investigators to identify its optimal use within the context of cancer vaccines, particularly in combination with other critical agents, such as antibodies that have the capacity to neutralize cancer-induced immunosuppression. The partnership with Oncovir brings us one step closer to an optimally effective therapeutic cancer vaccine for patients."
As part of its ongoing collaborative program to make Hiltonol® available for a variety of therapeutic applications, Oncovir plans to continue to distribute Hiltonol®, including the remaining portion of the CVAF-supported batch, to qualified scientists and companies testing next-generation cancer vaccines, as well as to scientists testing promising new immunologic therapies for HIV, malaria, influenza, SARS, hepatitis, and other infectious diseases.
"The CVAF strategy was designed to achieve two principal goals—to increase the number of promising vaccine components in global development, and to facilitate clinical research that will accelerate the refinement of powerful, multi-component cancer vaccines," says Adam Kolom, director of CVAF. "This new partnership with Oncovir will help us advance both, while also adding a valuable agent to our license and intellectual property portfolio, maximizing the potential for future financial returns and the impact of philanthropic support to CVAF."
The CVAF agreement with Oncovir is the second to be completed since the fund's public launch in late 2010. The first, a collaborative research agreement with the Cambridge, MA, biotechnology company Tolerx, Inc., provides for $1.5 million in research funding to support Tolerx's clinical development of TRX518, a monoclonal antibody designed to enhance the immune system by enabling T cells to attack cancer cells more effectively. TRX518 is the first anti-GITR (glucocorticoid-induced tumor necrosis factor receptor) drug candidate to enter human clinical trials. Upon completion of the phase I study, TRX518 may be evaluated in clinical trials in combination with therapeutic cancer vaccines that could complement TRX518's effect on T cells.
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