INGELHEIM & TUBINGEN, Germany & RIDGEFIELD, Conn.—Boehringer Ingelheim and CureVac have established an exclusive global license and development collaboration focused on CV9202, CureVac’s novel investigational therapeutic mRNA vaccine, which is in early clinical development for the treatment of lung cancer.
Under the agreement, Boehringer Ingelheim will initiate clinical investigation of the compound 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 3 NSCLC. CureVac will receive 35 million euros (approximately $45 million), and stands to receive payments of up to 430 million euros (approximately $556 million) if all milestones are met. CureVac will also be eligible for royalties on sales.
“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,” Prof. Klaus Dugi, chief medical officer at Boehringer Ingelheim, commented in a statement.
CV9202 consists of mRNA molecules that code for six antigens that are overexpressed in lung cancer, designed to induce an immune response against tumors. In initial clinical trials, CV9202 and its predecessor RNActive cancer vaccine CV9201 both showed activity in engendering immune responses against all anti-tumor antigens. At this point, CureVac has successfully completed Phase 1/2a clinical studies with its RNActive cancer vaccines in NSCLC and prostate cancer. So far, results have demonstrated that mRNA-based products can induce immune responses, including humoral and cellular, helped (Th1 and Th2) and effector and memory responses.
“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,” Ingmar Hoerr, co-founder and CEO of CureVac GmbH, commented in a press release. “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.”
This is the second agreement CureVac has signed in the past two months for its mRNA-based vaccines. On July 1, the company announced that it had executed an exclusive license agreement with Sanofi Pasteur S.A., Sanofi’s vaccine division, for the development and commercialization of an mRNA-based vaccine against an undisclosed pathogen. The two companies had previously signed a collaboration and license option agreement in 2011 for several predefined pathogens, and since CureVac met all agreed-upon milestones and acceptance criteria related to the agreements, Sanofi Pasteur exercised its first option and extended its exclusive and non-exclusive options on all five pathogens.