Pharmexa and Bavarian Nordic will collaborate on developing a new breast cancer vaccine that combines Bavarian Nordic’s MVA-BN vector technology and Pharmexa’s HER-2 DNA AutoVac™ vaccine. Clinical trials could start within 18 months in Germany and Italy.
Pharmexa and Bavarian Nordic have entered into a collaborative agreement that will test the use of Bavarian Nordic’s proprietary MVA-BN vector technology in combination with Pharmexa’s HER-2 DNA AutoVac™ vaccine. The parties expect that Phase l/ll clinical trials could begin in Germany and Italy within 18 months.
Last year, Pharmexa announced promising results with its HER-2 DNA AutoVac™ vaccine in a Phase l/ll clinical trial with 27 breast cancer patients. Trial results showed that the vaccine was safe and could induce a CTL (killer-cell)-based immune response in breast cancer patients. In the collaboration between the companies, this vaccine will be formulated in Bavarian Nordic’s proprietary MVA-BN vector.
By combining the HER-2 DNA AutoVac™ vaccine with the MVA-BN vector technology, the parties hope for a number of benefits. Specifically, it is hoped that using MVA-BN as a delivery mechanism, will provide an even stronger immune response than if the HER-2 DNA AutoVacä molecule is given alone. The MVA-BN vector will help transport the HER-2 DNA AutoVac™ molecule into the immune cells, which then start a killer-cell and antibody based immune response against breast cancer cells.
In addition to testing HER-2 AutoVac™ MVA-BN directly in patients, the parties also expect to test another possibility where HER-2 AutoVac™ MVA-BN will be combined in yet another way to stimulate the immune system. In this approach immune cells called dendritic cells will be removed from the breast cancer patient, stimulated with HER-2 AutoVac™ MVA-BN and then reinjected into the patient. Likewise, the purpose of this test is to create as strong an anti-cancer immune response as possible.
The parties expect that clinical trials could begin relatively quickly, not least as a result of the high safety level of the respective technologies demonstrated in earlier clinical trials.
In the spring of 2003, Pharmexa received approval to continue into a Phase ll trial with the HER-2 DNA AutoVac™ vaccine from the authorities in the United Kingdom and Denmark. However, the trial was postponed for priority reasons following a cost reduction process in the company in the first half of 2003. Subject to resource availability, Pharmexa may still initiate the Phase ll trial with HER-2 DNA AutoVac™ in 2004.
Read more at: www.pharmexa.com or www.bavarian-nordic.com