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Cancer Research Institute Announces Second Investment from Its Cancer Vaccine Acceleration Fund to Enable Manufacture of Powerful Immune Stimulant

$450,000 awarded to Oncovir, Inc., to produce and supply Hiltonol® (Poly-ICLC) for use in clinical trials of cancer vaccines and other immunotherapies

NEW YORK, NY – January 21, 2011 – 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.


Media Contact
Brian M. Brewer, Cancer Research Institute
+212.688.7515, ext. 242, or bbrewer@cancerresearch.org

About Hiltonol® (Poly-ICLC)
As a natural pathogen-associated molecular pattern (PAMP), Hiltonol® provides the critical ‘danger signal’ needed by the body for generation, targeting, and maintenance of an effective high-quality, long-term immune response against multiple pathogens and tumors. This ‘danger signal,’ which is usually generated by a replicating virus, has been missing from most modern cancer and HIV vaccines. It includes induction by Hiltonol® of a ‘natural mix’ of interferons, cytokines, chemokines, natural killer cells, myeloid dendritic cells via toll-like receptor 3 and MDA5, T-cells, and various other dsRNA-dependent host defenses such as the OAS, PKR, and RIG-I enzyme systems. In other words, when properly presented together with vaccine antigen, Hiltonol® serves as a core immunogenic vaccine platform by inducing a comprehensive immune response that includes activation of antigen-presenting dendritic cells, generation of a high-quality polyfunctional cellular and humoral immune response best suited for antiviral and anti-tumor action, targeting of that response via induction of chemokines at the tumor site, and stimulation of memory cells via interleukin 15 and MDA5.

About Oncovir, Inc.
Oncovir, Inc., is a pharmaceutical company dedicated to the development of nucleic acid-based clinical therapies for cancer, infectious, immune, and degenerative disorders. Founded in order to develop the potent stabilized dsRNA therapeutic viral mimic Poly-ICLC (Hiltonol®) for treatment of malignant gliomas (brain cancer), Oncovir has now continued this work in other cancer vaccine, infectious disease, and biodefense indications. Oncovir is currently collaborating in two dozen separate ongoing or completed phase I-II clinical trials using Hiltonol® alone or combined with a variety of therapeutic or preventive cancer vaccines in patients with gliomas, hepatomas, lymphomas, melanomas, and prostate, breast, ovarian, cervical, bladder, colorectal, liver, and pancreatic cancers. An HIV vaccine trial is also under way and others are in planning.

About the Cancer Vaccine Acceleration Fund (CVAF)
CVAF is a nonprofit venture philanthropy fund established in 2010 by the Cancer Research Institute in partnership with the Ludwig Institute for Cancer Research Ltd (LICR). CVAF is designed to speed the clinical development of therapeutic cancer vaccines and other immune system-based cancer therapies by providing funding, scientific expertise, and clinical trials management resources for phase I and II clinical trials. The fund works with leading scientists and clinicians around the world to identify the most promising new cancer immunotherapies, and then partners with biopharmaceutical companies to help lower the initial hurdle to investment, kick-start their clinical development, and generate important new insights into the immunological and therapeutic efficacy of novel cancer immunotherapies. Availability of CVAF resources helps to mitigate the significant funding gap that exists in the early stages of clinical trials where the economic risk is highest, where critical new scientific insights can be garnered most cost-effectively, and where the backlog of promising new immunological cancer drugs is the greatest. 

About the Ludwig Institute for Cancer Research
The Ludwig Institute for Cancer Research Ltd is a nonprofit research organization committed to improving the control of cancer through integrated laboratory and clinical research and novel therapeutic strategies based on the emerging understanding of cancer. The Institute translates these strategies into applications for human benefit by coupling discoveries from its basic laboratory research and renowned scientists with strong intellectual property positions, clinical development expertise, and the conduct of Institute-sponsored, GCP-compliant clinical trials.

The core of the Institute is concentrated at ten research locations two each in Australia, Sweden, and the U.S., and one each in Belgium, Brazil, Switzerland, and the UK. Each research site is led by a Director who is a Member scientist of the Institute and part of the management team. For more information, visit www.licr.org.

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