Bavarian Nordic to produce vaccines with cell line from Valneva

Bavarian Nordic has licensed a cell line from Valneva to help it manufacture vaccines based on its modified vaccinia Ankara (MVA) vaccine platform currently used on a smallpox shot and a cancer vaccine.

An alternative to the widely used chicken eggs for large-scale production of vaccines, Valneva’s EB66 cell line, derived from duck embryonic stem cells, can be used for the manufacture of 20 different families of viruses, including inactivated viruses, live attenuated viruses and live vectors as vaccine components.

A 2016 research paper published by Elsevier showed that the EB66 cell line is a valuable cell substrate for production of MVA-based vaccine, several candidates of which Bavarian Nordic is developing. The study shows that the cells could propagate MVA viruses efficiently, while preserving viral attenuation and transgene expression for up to 20 serial passages. The cells' rapid growth rate also allows manufacture and purification of a recombinant MVA virus at the clinical production scale (100 L) in just three weeks.

Bavarian Nordic’s vaccine candidates currently use chicken embryonic fibroblast, and this new licensing deal gives the company the opportunity to switch to Valneva’s technology for production of its MVA-based vaccines. The companies did not disclose financial terms of the deal, but did say it includes upfront payments, milestones and future royalties on sales, and that Valneva will support BN with the manufacturing process.

A pandemic H5N1 influenza vaccine by a partnership between Chemo-Sero Therapeutic Research Institute and GlaxoSmithKline that was approved in Japan in March 2014 was the first human vaccine produced in the EB66 cell line.

Right now, the Lyon, France-based vaccine biotech holds more than 35 licensing agreements with biopharma companies involving application of EB66 in both human and veterinary vaccines.

In a statement, Valneva execs called the partnership with Bavarian Nordic strategically important for the biotech "as it could be the first time that a late stage clinical vaccine development program is transferred to our EB66 cell line and could therefore set a precedent."

MVA-BN is a further attenuated version of the MVA virus, which is itself an attenuated strain of a poxvirus. The Danish biotech has already used the technology on its smallpox vaccine marketed as Imvamune in Canada and as Imvanex in the EU, and it is currently in a phase 3 study, gunning for an FDA approval.

Other than infectious disease, Bavarian Nordic is also developing a cancer vaccine called CV301 based on the MVA-BN platform. That vaccine is being paired with Opdivo and Tecentriq as cancer combo therapies in early-phase clinical trials.