As Ingmar Hoerr toured the playing field at BIO last week, there was no mistaking the undercurrent of excitement revolving around therapeutic vaccines in the wake of the big Provenge approval.
"There is now high interest in therapeutic vaccines," says Hoerr, the CEO of CureVac, which is based in Tübingen, Germany. And he couldn't be happier to see it.
The spike in interest is occurring as CureVac is taking its own lead therapeutic vaccine through a Phase IIa trial for prostate cancer. With a new injection of $35 million from its one and only investor--dievini Hopp Biotech Holding--CureVac's 65 staffers have the budget to not only garner that mid-stage data later this year, but also collect data from a separate IIa study for lung cancer next year.
Investigators are assembling what will be a cocktail of four antigens that can be used to fight cancer. This involves putting the platform strategy to the test by injecting messenger RNA directly into the skin--an approach that would circumvent Dendreon's use of patient cells to manufacture its personalized Provenge therapy. In CureVac's IIa trials, different antigens will be used in each injection site to validate the technology by looking for signs of an immune response. The cocktail comes later.
With enough money on hand to cover the burn rate into 2012, CureVac's strategy is to start partnering on its therapeutic vaccine work in 2011. And the developer, large by U.S. standards at this stage of the development game, will pursue synergistic development work on new prophylactic vaccines for infectious diseases as well as new adjuvant technology.
"We are in talks with Big Pharma now," says Hoerr. "We wanted to get the money for our own research and gain as much value as we could, as much data as we can, to have a very valuable pharma package.
"We will gather data from clinical trials, set up the pharma package and then it's very likely we could do a pharma deal," adds Hoerr, whose company is at the point where it could expect to raise more money at a later stage, go public perhaps or look for closer business ties to the pharma world. But Hoerr doesn't see CureVac going it alone all the way through to an approval.
"Collaboration is a must," he says. "We want to take advantage of expertise in pharma companies for clinical development and approval."
With only one big investor backing its R&D work, says Hoerr, coming to terms with a prospective partner should be relatively easy. - John Carroll (twitter | email)