Boehringer Ingelheim & CureVac Announce Major Development Collaboration

Boehringer Ingelheim and CureVac recently 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 receptor (EGFR) mutated non-small cell lung cancer (NSCLC) and in combination with chemo-radiation therapy in patients with unresectable stage III NSCLC. CureVac receives EUR 35 million (approximately $45 million). Further, CureVac can achieve milestone payments of up to EUR 430 million (approximately $556 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 afatinib, a once-daily kinase inhibitor that irreversibly binds and inhibits ErbB1, ErbB2, and ErbB4 receptors and is approved in a number of markets, including the EU and US. In the US, afatinib is marketed as Gilotrif for the first-line treatment of common types of EGFR-mutation positive metastatic NSCLC (Del 19 or L858R). Boehringer Ingelheim’s oncology pipeline covers a broad range of solid tumors and hematologic malignancies (blood cancer), including two investigational compounds in Phase III clinical development: nintedanib in NSCLC and colorectal cancer, and volasertib in acute myeloid leukemia. These compounds are not approved and their safety and efficacy have not been established.

“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 potential novel approach in cancer treatment. For the first time, mRNA could be optimized to mobilize the patient’s own immune system to fight the tumor 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 tumor. CV9202 and the preceding RNActive cancer vaccine CV9201 tested in initial clinical trials by CureVac demonstrated activity in generating immune responses against all anti-tumor 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 commercialization 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.”

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 optimized 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 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 randomized 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 that mRNA-based (RNActive) vaccines represent a novel technology enabling the development 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. For more information, visit www.curevac.com.