Bavarian Nordic Announces Updated Overall Survival Data from Combination Immunotherapy Data of PROSTVAC plus Ipilimumab at the 2015 Genitourinary Cancers Symposium

  • Approximately 20% of men with advanced prostate cancer treated with PROSTVAC and Ipilimumab remain alive at 80 months after initiating treatment

KVISTGAARD, Denmark, February 24, 2015 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that updated overall survival data from an NCI sponsored combination study of Bavarian Nordic's active prostate cancer immunotherapy candidate PROSTVAC and ipilimumab, an immune checkpoint inhibitor will be presented at the Genitourinary Cancers Symposium in Orlando, FL on Thursday, February 26, 2015.

30 patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled in the Phase 1 combination study. At the time of enrollment docetaxel was the only FDA-approved treatment that improved overall survival. The median predicted overall survival (OS) was 18.5 months. Patients were treated with PROSTVAC plus escalating doses of ipilimumab. The observed median OS was 31.3 months for all dose cohorts and 37.2 months for patients treated at 10 mg/kg based on updated overall survival data. Furthermore, approximately 20% of patients at 10 mg/kg remain alive at 80 months.

The senior author for the presentation as a poster is Dr. James L. Gulley, Laboratory of Tumor Immunology and Biology, National Cancer Institute at the National Institutes of Health. The presentation will take place during General Poster Session A on Thursday, February 26, 2015 from 11:30 AM - 1:00 PM EST at board H8. An abstract entitled: "Combining active immunotherapy and immune checkpoint inhibitors in prostate cancer" (Abstract #172) is also available online at http://abstracts.asco.org/159/AbstView_159_141599.html.

Paul Chaplin, President & CEO of Bavarian Nordic, said: "The updated long-term survival data presented by our partners at NCI is further evidence of improved OS following treatment with PROSTVAC. These data represent perhaps the most compelling survival benefit seen to date in this late-stage setting, and provide a strong rationale to continue to evaluate the combination of PROSTVAC and checkpoint inhibitors in follow-on clinical studies. Given the unique product profile of PROSTVAC, with a favorable risk-benefit profile and ease of use, we see PROSTVAC as an ideal immunotherapy to combine with both approved and emerging therapies for prostate cancer and we look forward to exploring these further in the clinic."

Contacts
Rolf Sass Sørensen, Vice President Investor Relations (EU). Phone +45 61 77 47 43
Seth Lewis, Vice President Investor Relations (US). Phone + 1 978 341 5271

About PROSTVAC
PROSTVAC is a PSA-targeted, ready-to-use active immunotherapy for the treatment of prostate cancer. Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells. A robust data package has been established through 12 ongoing and completed clinical Phase 1 and Phase 2 trials, where more than 300 patients have been treated, and the immunotherapy candidate has been generally well-tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the potential of PROSTVAC to extend the median overall survival by 8.5 months in patients with advanced prostate cancer. These results led to the initiation of the PROSPECT pivotal Phase 3 clinical trial study, which completed enrollment in December 2014.

PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement. In April 2010, PROSTVAC was granted Fast Track designation by the FDA for the treatment of men with asymptomatic or minimally symptomatic mCRPC.

More information available at http://ci.bavarian-nordic.com/pipeline/prostvac.aspx.

About ipilimumab
Ipilimumab (Yervoy®), is an immune checkpoint inhibitor developed and marketed by Bristol-Myers Squibb. It is approved by the FDA for the treatment of melanoma, and is also evaluated in a Phase 3 trial in chemo-naïve mCRPC. 

About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC, an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial, and IMVAMUNE®, a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX. Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY. For more information, visitwww.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.

 

 

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