CureVac has licensed exclusive global rights to its ready-for-Phase I CV9202 to Boehringer Ingelheim—which plans to launch clinical trials that include the lung cancer mRNA vaccine candidate in two combination immunotherapies. The deal could net CureVac up to €465 million (about $600 million).

Boehringer Ingelheim said it will begin two clinical studies of CV9202 in at least two different lung cancer settings, in combination with its already-marketed afatinib in patients with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC), as well as in combination with chemo-radiation therapy in patients with unresectable stage III NSCLC.

CV9202 is a combination of mRNA molecules coding for six antigens overexpressed in lung cancer, designed to induce an immune response against the tumor. CureVac says CV9202 and an earlier RNActive® cancer vaccine (CV9201) tested in initial clinical trials have demonstrated activity in generating immune responses against all anti-tumor antigens.

CV9202 is based on CureVac’s RNActive® technology, which uses optimized, antigen-encoding and complexed mRNA molecules to produce mRNA-based vaccines against infectious diseases and cancer. RNActive vaccines are designed to be protected against elevated temperature, as well as inadvertent freezing. CureVac operates its own multi-product GMP facility that allows the production of all mRNA vaccines from a common platform.

Boehringer Ingelheim is the second pharma giant in recent months to disclose a collaboration with CureVac based on RNActive. In July, CureVac licensed to Sanofi Pasteur rights to develop and commercialize an mRNA-based vaccine against an undisclosed pathogen, in a deal expected to net CureVac more than €150.5 million (almost $194 million).

“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,” Professor Klaus Dugi, Boehringer Ingelheim’s CMO, said in a statement.

Boehringer Ingelheim agreed to pay CureVac €35 million ($45.1 million) upfront, as well as milestone payments of up to €430 million ($554.4 million), and royalties on sales.

“This new agreement [with CureVac] 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 stated.

Lung cancer is one of eight indications for which Boehringer Ingelheim vowed in April to launch 10 new drugs by 2016. The company entered the oncology drug market just last year with the launch of afatinib, which is marketed in the U.S. as Gilotrif® for first-line treatment of NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a companion diagnostic, a Therascreen EGFR test developed by Qiagen with Boehringer Ingelheim.

Afatinib is also marketed as Giotrif® in the European Union, where it is indicated for treatment of EGFR TKInaïve adult patients with locally advanced or metastatic NSCLC with activating EGFR mutation(s).

Boehringer Ingelheim is intent on expanding its cancer drug portfolio. The company’s clinical-phase offerings include two Phase III candidates — nintedanib in NSCLC and colorectal cancer, and the PLK-1 antagonist volasertib in acute myeloid leukemia – as well as what Boehringer said was “a growing pipeline of early-stage oncology compounds in areas such as growth/survival signaling, immunotherapy and epigenetics.”

In Europe, Nintedanib has already been submitted for registration under the NSCLC indication. Nintedanib is designed as a triple angiokinase inhibitor, simultaneously blocking VEGFR, FGFR, and PDGFR.

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