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CureVac Collaborates with CRI and Ludwig to Enable Immunotherapy Clinical Testing

TÜBINGEN, Germany, and NEW YORK, November 4, 2013—The non-profit Cancer Research Institute (CRI) and Ludwig Cancer Research (Ludwig), and CureVac, a clinical stage biopharmaceutical company that has pioneered the development of a new class of therapies and vaccines based on messenger RNA (mRNA), today announced that they will collaborate to enable clinical testing of novel cancer immunotherapy treatment options.

Amplifying the immune system’s ability to recognize, attack, and destroy cancer, is a therapeutic strategy that recent studies have demonstrated to be a potent and effective approach to treatment of some cancers. Product approvals and promising clinical data for various checkpoint inhibitors, which block proteins responsible for immune system inhibition, support the potential of combining CureVac's RNActive® vaccines with this new class of treatment to significantly improve cancer patient survival.

"The collaboration with CureVac is the fourth in a series of partnerships CRI and Ludwig have struck with biotech and pharmaceutical companies in order to bring next-generation combination immunotherapies into clinical studies sooner than would otherwise happen," said Adam Kolom, managing director of CRI’s non-profit venture fund, which makes investments to support the costs of innovative immunotherapy clinical trials. "Each of our partnerships increases investigator access to one or more high-promise immune reagents, and brings new and potentially more effective combination treatments to patients."

Ludwig and CRI will conduct up to five clinical studies of cancer immunotherapy combinations through their jointly coordinated CVC Trials Network using CureVac’s investigational clinical stage drug, CV9202, combined with other priority agents available to CRI and Ludwig from their internal portfolios or accessed through additional industry partnerships. CV9202 contains NSCLC-associated antigens and is the optimized successor of CV9201, which has successfully completed a phase I/IIa clinical trial demonstrating its safety and immunogenicity. Additional investigational clinical stage drugs from CureVac’s product pipeline can be added.

"Combining immunotherapy approaches holds great potential for the treatment of cancer," said Jonathan Skipper Ph.D., executive director of technology development at the Ludwig Institute for Cancer Research. "CureVac’s immunotherapy platform, which contains several Ludwig antigens, has shown promising results in early stage clinical trials. Our collaboration will enable us to combine this novel technology with different immunotherapeutic approaches to attack a patient’s cancer on multiple fronts and therefore decrease the chances of immune escape," added Skipper.

"There has been a great amount of progress made in the cancer immunotherapy field recently, and we believe that checkpoint inhibitors could work even more efficiently with fewer side effects when combined with targeted anti-tumor guidance through an efficient vaccination approach such as RNActive®," said Ingmar Hoerr, Ph.D., chief executive officer at CureVac. "The collaboration with the Cancer Research Institute and Ludwig Cancer Research will provide us with important insights about combination immunotherapies such as combinations with checkpoint inhibitors. RNActive® vaccines have been shown to elicit a safe, effective and robust immune response against encoded cancer antigens in cancer patients, and we continue to work with partners worldwide to develop immune-based therapies to combat debilitating diseases such as cancer."

Financial terms were not disclosed.


About RNActive®
CureVac is combining both the antigenic and adjuvant properties of mRNAs to develop novel and effective mRNA vaccines. RNActive® vaccines are comprised of modified and formulated mRNA with three distinct features: The mRNA vaccines are translated into the target antigens, and the formulation and modifications lead to translatability ensuring (1) strong antigen expression, (2) increased stability and (3) enhanced immune-stimulatory activity.

About CV9202
CureVac’s CV9202 RNActive® vaccine is being developed for the treatment of patients with non-small cell lung cancer (NSCLC). CV9202 consists of six RNActive®-derived molecules coding for six different NSCLC-associated antigens.

About Ludwig Cancer Research
Ludwig Cancer Research is an international collaborative network of acclaimed scientists with a 40-year legacy of pioneering cancer discoveries. Ludwig combines basic research with the ability to translate its discoveries and conduct clinical trials to accelerate the development of new cancer diagnostics and therapies. Since 1971, Ludwig has invested more than $1.6 billion in life-changing cancer research through the not-for-profit Ludwig Institute for Cancer Research and the six U.S.-based Ludwig Centers.
www.ludwigcancerresearch.org

About CureVac
CureVac, a clinical stage biopharmaceutical company from Tübingen, Germany, is advancing the field of mRNA-based vaccination. The company uses its technology platforms for the development of novel therapeutic mRNA vaccines (RNActive®) for cancer and prophylactic vaccines for infectious diseases. Furthermore CureVac develops adjuvants based on non-coding RNAs (RNAdjuvant®) for enhancing the immune response of other vaccines. The company has successfully completed Phase I/IIa studies with its RNActive® cancer vaccines in prostate cancer and non-small cell lung cancer (NSCLC). Results so far have shown that mRNA-based products are safe and capable of inducing balanced immune responses including humoral and cellular, Th1 and Th2 and effector and memory responses. CureVac is currently running a number of clinical trials with its RNActive® vaccines, including a large randomized Phase IIb clinical trial in prostate cancer. In addition to developing its own pipeline, CureVac is collaborating with Sanofi Pasteur, In-Cell-Art and Janssen Pharmaceuticals for the development of prophylactic vaccines in infectious diseases utilizing its RNActive® technology platform.
www.curevac.com

*Immunotherapy results may vary from patient to patient.

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