Boehringer Ingelheim and CureVac announce collaboration to develop next generation lung cancer immunotherapy

Boehringer IngelheimBoehringer Ingelheim and CureVac, leader in mRNA (messenger ribonucleic acid)-based drug development, have announced an exclusive global license and development collaboration. The new collaboration focuses on CureVac's CV9202, a novel investigational therapeutic mRNA vaccine, in early clinical development for the treatment of lung cancer. Boehringer Ingelheim will start clinical investigation of CV9202 in at least two different lung cancer settings, in combination with afatinib in patients with advanced or metastatic epidermal growth factor (EGFR) mutated non-small cell lung cancer (NSCLC) and in combination with chemo-radiation therapy in patients with unresectable stage III NSCLC. Upon signature, CureVac receives EUR 35 million. Further, CureVac can achieve milestone payments of up to EUR 430 million and royalties on sales.

This new agreement is part of Boehringer Ingelheim's long-term commitment to delivering tomorrow's cancer therapies through the discovery of novel treatment options with high therapeutic value for patients. The company's oncology portfolio includes Giotrif® (afatinib)*, an irreversible ErbB family blocker, approved in a number of markets, including the EU, the US and Japan for the treatment of distinct types of EGFR mutation-positive NSCLC. Boehringer Ingelheim's oncology pipeline covers a broad range of solid tumors and haematologic malignancies (blood cancer), including two investigational compounds in Phase III clinical development: nintedanib in distinct types of NSCLC and colorectal cancer, and volasertib in acute myeloid leukemia.

"At Boehringer Ingelheim we are proud of our commitment to help improve the treatment of cancers with a high medical need. In our collaboration with CureVac, we will investigate combining existing treatments with the approach of sustained activation of the immune system. With this we hope to be able to develop new treatments and further expand our broad pipeline in lung cancer." said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

CureVac's mRNA-based technology represents a novel approach in cancer treatment. For the first time, mRNA could be optimised to mobilise the patient's own immune system to fight the tumour with a specific immune response elicited through the RNActive® vaccine. Cancer immunotherapy has been chosen as the "Breakthrough of the year 2013" by SCIENCE magazine. CV9202 is a combination of mRNA molecules coding for six antigens overexpressed in lung cancer, designed to induce an immune response against the tumour. CV9202 and the preceding RNActive® cancer vaccine CV9201 tested in initial clinical trials by CureVac demonstrated clinical safety and activity in generating immune responses against all anti-tumour antigens.

Ingmar Hoerr, co-founder and CEO of CureVac GmbH commented: "This collaboration is extremely relevant for CureVac because, as a biotech enterprise, we rely on collaboration with strong partners for the clinical development and commercialisation of our compounds. Cancer immunotherapy represents one of the biggest innovations in cancer treatment of recent times and we are delighted to now be working with Boehringer Ingelheim. The out-licensing and clinical development of our promising therapeutic vaccine CV9202 represents the logical next step in developing this novel treatment for cancer patients and the significant commitment from Boehringer Ingelheim underscores the relevance of the mRNA technology."

About CureVac
CureVac, a clinical stage biopharmaceutical company from Tübingen, Germany, is pioneering the field of mRNA-based technology platforms for medical purposes with which mRNA is specifically optimised and formulated. Since 2000 the company develops novel mRNA-based cancer immunotherapies and prophylactic vaccines against infectious diseases - both under the brand RNActive®. CureVac has successfully established the first GMP (good manufacturing practice) facility worldwide for the manufacture of RNA and mRNA and has pioneered mRNA-based drugs in clinical studies.

The company has successfully completed Phase I/IIa clinical 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 showed a favorable safety profile and induced immune responses including humoral and cellular, helper (both Th1 and Th2) and effector and memory responses. CureVac is currently conducting a number of clinical trials with its RNActive® vaccines. A large randomised Phase IIb clinical trial in castrate resistant prostate cancer with CV9104 has been fully enrolled in December 2013. In the field of cancer immunotherapy CureVac is already collaborating with the Ludwig Cancer Research Institute to enable clinical testing of novel cancer immunotherapy treatment options.

CureVac's RNActive® technology is also used to develop prophylactic vaccines for infectious diseases. In March 2014, CureVac received the EUR 2 million Vaccine Prize from the European Commission for its RNActive® vaccine technology. In particular, the jury acknowledged the fact that the RNActive® vaccines represent a novel technology enabling the production of safe, efficacious and cost-effective vaccines that are protected against elevated temperature as well as inadvertent freezing. In the field of prophylactic vaccines CureVac is amongst others collaborating with Sanofi Pasteur, In-Cell-Art, DARPA and Janssen Pharmaceuticals.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim has a long-term commitment to deliver tomorrow's cancer therapies by discovering and developing novel treatment options that combine ground-breaking science with the intent of high therapeutic value for patients. It runs an extensive and diverse study programme involving investigators and patients from around the world. This is supported by a significant financial investment, with the aim of developing treatments, which will make a difference to the lives of patients and their families.

The current focus of research includes compounds in signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. Boehringer Ingelheim's first oncology compound afatinib, approved as Giotrif®/Gilotrif®, is available to patients with distinct types of Epidermal Growth Factor Receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Two investigational compounds are in Phase III clinical development: nintedanib in distinct types of NSCLC and colorectal cancer, and volasertib in acute myeloid leukemia. A growing pipeline of early-stage oncology compounds in areas such as growth/survival signaling, immunotherapy and epigenetics adds to the later stage compounds and the CV9202 RNActive® vaccine will now be investigated in combination with afatinib and chemo-radiation therapy for the treatment of patients with NSCLC.

More than 400 employees around the world (including 250 highly skilled scientists in Vienna, Austria at the Boehringer Ingelheim cancer research centre) are dedicated to the discovery and development of new cancer treatments. They work with the Research Institute of Molecular Pathology (IMP) in Austria and experts in universities, hospitals and companies around the world.

* Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF®® and in the U.S. under the brand name GILOTRIF®. It is under regulatory review in other countries.

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