Bavarian Nordic and Pharmexa join forces to develop new breast cancer vaccine
Bavarian Nordic and Pharmexa 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.
Bavarian Nordic and Pharmexa 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.
Peter Wulff, President and CEO of Bavarian Nordic said, “The MVA-BN vector is the safest and most thoroughly tested virus vector in the market. In earlier clinical trials with the MVA-BN vector it has been confirmed that MVA-BN has an ability to generate a strong immune response in patients with malignant melanoma. Even though cancer vaccines are outside of our strategic focus, the reason for collaborating in this programme is primarily to establish a broader commercial platform for the MVA-BN vector in other company’s cancer projects and research and development programmes. Now we have the possibility to test and further validate MVA-BN together with Pharmexa’s technology, on the HER-2 receptor – the best validated cancer target on the market today. The HER-2 receptor targeting product Herceptin® (marketed by Genentech/Roche) has already documented that antibodies against HER-2 have an effect against breast cancer. There are many indications that the perceived combined killer-cell/antibody effect of HER-2 AutoVac™ MVA-BN will induce a positive effect in even more breast cancer patients.”
Søren Mouritsen, CEO of Pharmexa said, “We may still initiate the Phase ll trial with the HER-2 DNA AutoVac™ vaccine next year if we or a partner can finance it. In the meantime, the collaboration with Bavarian Nordic provides a unique opportunity to keep the momentum in the programme. In addition, the collaboration will add further support to our earlier results showing that the immune system’s killer cells can be particularly effective against breast cancer. HER-2 AutoVac™ MVA-BN could eventually be combined with Pharmexa’s other breast cancer product – the HER-2 Protein AutoVac™ vaccine – which is in a Phase l/ll trial soon to be completed in the USA. The collaboration with Bavarian Nordic will not significantly impact our resources, and will at the same time generate important new data in our HER-2 DNA AutoVac™ programme.”
The parties have agreed not to publish further financial details from the collaboration. However, the agreement does not impact Bavarian Nordic’s financial results for 2003.
