Bavarian Nordic A/S - Interim Report for the Period 1 January to 30... (following first or second-line chemother...)

Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008

Date:8/19/2008

following first or second-line chemotherapy (including Herceptin(R)). In the second study, performed in Serbia and Poland, MVA-BN(R)-HER2 is being evaluated following first or second-line chemotherapy or in combination with single-agent taxane chemotherapy. Both studies evaluate treatment of metastatic breast cancer patients, whose tumors overexpress HER2. Patients are vaccinated 3 times, at 3 week intervals, with the MVA-BN(R) viral vector which has been engineered to express the extracellular fragment of human HER2.

By July 2008 enrolment in the studies was completed. No drug-related severe adverse events have been reported thus far. The vaccine has been shown to be well tolerated and immunogenic.

Immune evaluation of samples from 18 patients treated with MVA-BN(R)-HER2 revealed that 12 patients developed an immune response (humoral and/or cellular response). These preliminary data show that MVA-BN(R)-based; HER2 directed vaccination is a biologically active treatment for patients with HER2 positive breast cancer. The final study data are expected around the turn of the year 2008/2009.

Prostate cancer

A Phase I/II, open-label safety and tolerability study in 18 male patients with non-metastatic hormone-insensitive prostate cancer has begun enrolment in the U.S. Secondary objectives of the trial include examining the ability of the vaccine to induce prostate antigen-specific immune responses, as well as clinical anti-tumor activity. Preliminary data is expected during second half year 2009.

The therapeutic vaccine, based on the Company's MVA-BN(R) technology, is designed to generate cellular and humoral immune responses to PSA and PAP (prostate specific antigen and prostatic acid phosphatase), which are both well-known prostate cancer tumor targets.

Infectious diseases

HIV

In first half of 2008, Bavarian Nordic initiated clinical trials its HIV vaccine candidate: MVA-BN(R) HIV multiantigen.

A Phase I/II
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Bavarian Nordic A/S - Interim Report for the Period 1 January to 30...(following first or second-line chemother...)