Bavarian Nordic Announces Drug Supply Agreement with Bristol-Myers Squibb for NSCLC Clinical Study

COPENHAGEN, Denmark, August 15, 2016 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the signature of a drug supply agreement with Bristol-Myers Squibb (BMS). Based on the agreement, BMS will supply OPDIVO® (nivolumab) to Bavarian Nordic for use in a clinical study. The trial, which will be sponsored by Bavarian Nordic, will enroll approximately 160 patients and will look to explore the benefit of combining CV301 with OPDIVO in patients with previously treated non-small cell lung cancer (NSCLC). OPDIVO is approved for treatment of patients with NSCLC in the second line setting, among other indications.

CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer. Similar to PROSTVAC®, CV301 uses an off-the-shelf, prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

Preclinical data shows the ability of CV301 to upregulate PD-L1 by mounting an immune response against a tumor target. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

“We are extremely excited to announce this agreement between Bavarian Nordic and BMS. While we have discussed the potential benefit of combining our cancer vaccines with checkpoint inhibitors for some time, this is now within reach as we have once again been able to strike an agreement with the leading immune-oncology company in the world, this time to explore the potential synergy between our programs to benefit patients with lung cancer. We look forward to the initiation of this study later this year,” stated Paul Chaplin, President and CEO of Bavarian Nordic.

Bavarian Nordic continues to retain all commercial rights for CV301. There is no obligation on behalf of BMS, beyond the contribution of drug material.

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company’s live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit or follow us on Twitter @bavariannordic.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271 

Company Announcement no. 23 / 2016