CureVac ready to take CV9103 into Phase IIb clinical trials


According to a story yesterday on the FierceBiotech web site, a German multibillionaire is investing > $100 million into a company called CureVac that has a new prostate cancer “vaccine” ready for Phase IIb clinical trials.

More information is available in a media release from CureVac and additional information about CV9103 can be found on the company’s web site. Specifically, data from very early stage (Phase I/IIa) clinical trials is also available on the web.

There seem to be similarities to the approach being used by CureVac to immunotherapy for the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) and that originally pioneered by Dendreon. However, there are also considerable differences. CV9103 can be administered by subcutaneous injection, whereas Dendreon’s sipuleucel-T requires infusions. Furthermore, CP9103 apparently carried four different prostate cancer antigens which may therefore increase the level of activity of the product. In the Phase I/IIa study mentioned above, nearly 80 percent of patients demonstrated an antigen-specific immune response to at least one of these four antigens.

The proposed Phase IIb trial will run through about 2017. If this trial is again successful, we might expect to be able to see a Phase III clinical trial that could be completed in about 2020 or 2021 … but the early results of the Phase IIb trial will be critical to that possibility.

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