Bavarian Nordic

Regulatory Filings • Feb 23, 2012

PROSTVAC® and Ipilimumab Phase 1 Study Supports Rationale for Combining Two Immunotherapies for Prostate Cancer

PROSTVAC® and Ipilimumab Phase 1 Study Supports Rationale for Combining Two Immunotherapies for Prostate Cancer

KVISTGAARD, Denmark, February 23, 2012 - Bavarian Nordic A/S (OMX: BAVA) announced today that a newly published study suggests potential synergy of the Company's PROSTVAC® investigational therapeutic cancer vaccine when used in combination with ipilimumab, another immune therapy.  Results of the Phase 1 dose escalation study were published in the journal The Lancet Oncology. The scientific findings of this Phase 1 potentially provide proof of concept that the combination of an immune checkpoint inhibitor with a therapeutic cancer vaccine is feasible and might enhance the clinical efficacy of the combination treatment. Several other NCI-funded combination studies with PROSTVAC® are currently ongoing.

According to James L. Gulley, M.D., Ph.D., Director of the Clinical Trials Group at the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI), stated in the paper that although the Phase 1 trial was small and non-randomized, the median overall survival of 34.4 months for the 30 patients treated raises the possibility that the combination ipilimumab and PROSTVAC® might result in prolonged overall survival.

"In a randomized placebo-controlled Phase 2 study, PROSTVAC® demonstrated an 8.5-month improvement in median overall survival, in men with mCRPC. Based upon these encouraging results, we recently initiated our pivotal global Phase 3 clinical study PROSPECT," stated Anders Hedegaard, President & CEO of Bavarian Nordic. "To further enhance the potential efficacy of PROSTVAC®, we studied PROSTVAC® in combination with ipilimumab and are encouraged by the observed safety and efficacy profile of the immunotherapeutic combination."

Asger Aamund

Chairman of the Board

Contact

Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

About PROSTVAC®

PROSTVAC® is an investigational therapeutic cancer vaccine, subcutaneously administrated in a prime-boost schedule to sequentially combine two different poxviruses (vaccinia and fowlpox). PROSTVAC® induces a PSA-specific, targeted immune response that attacks prostate cancer cells. Conventional chemotherapy currently used to treat prostate cancer has shown limited improvement in OS and is often associated with serious side effects. In contrast, PROSTVAC® has the potential to extend survival with minimal toxicity.

About the PROSPECT Clinical Study Program

The global, randomized, double-blind, placebo-controlled Phase 3 study, PROSPECT, is expected to enrol about 1,200 patients. For additional information about PROSPECT, please visit www.continueyourfight.com.

About Bavarian Nordic

Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases, and includes ten development programs. In oncology, the company's lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In clinical Phase 1 and Phase 2 trials, PROSTVAC® has been tested in nearly 600 patients. In infectious diseases, the company's lead program is IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. For more information, visit www.bavarian-nordic.com

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. 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.

HUG#1588442

Attachments:

• 201201uk

  ---

  This content was distributed through

  

  Create value through communication

  Visit us here.