Boehringer will start clinical investigation of the vaccine, known as 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 with chemo-radiation therapy in patients with unresectable stage III NSCLC.
CV9202 is a mix of mRNA molecules coding for six antigens overexpressed in lung cancer, and is 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.
Manufacturing of the vaccine is expected to remain in-house with CureVac.
CureVac spokeswoman Verena Lauterbach explained the manufacturing process to BioPharma-Reporter.com: “The transcription of the target mRNA is conducted by RNA polymerases from a linearized plasmid DNA template, followed by enzymatic destruction by DNases of the DNA template and ultra-high purification of the resulting mRNA by precipitation and chromatographic methods according to the size; mRNA-based vaccines RNActive can encode almost any antigen, and they can be produced under GMP (Good manufacturing practices) conditions within six to seven weeks and the same production process can be used for any RNActive product.
Scale-up of the production “is feasible within a few years and for sure we will be prepared for it,” Lauterbach added.
CureVac receives €35 million ($45m) upfront and further potential milestone payments of up to €430 million ($556m) and royalties on sales.
Boehringer spokeswoman Susan Holz told us the company cannot speculate about any timelines for when the vaccine might hit the market. “It our goal to initiate trials in the near future and we will announce initiation at that point in time,” she said.
This new agreement is part of Boehringer Ingelheim’s long-term commitment to oncology. The company’s 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.
Boehringer’s oncology pipeline also 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.
“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.
Ingmar Hoerr, co-founder and CEO of CureVac added: “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.”