takes a lot longer until industry believes in it and is willing to invest in it.” In November, the National Cancer Institute awarded $2 million in funding for a Phase 2a multi-center trial for Porter’s treatment for acute leukemia patients – according to June, just enough money to get started but not enough for the number of patients treated in a typical Phase 2 trial. The Special Translational Research Acceleration Project grant, designed for projects “ripe” for translation, was awarded to project director Renier J. Brentjens, M.D., Ph.D., of Memorial Sloan-Kettering Cancer Center, with subcontracts to Stephan A. Grupp, M.D., Ph.D. associate professor of pediatrics at Penn and a physician-scientist at the Children’s Hospital of Philadelphia, and June. Porter is the clinical principal investigator. The team is pursuing additional funding for the Phase 2 trial. Lack of sufficient funding threatens to stall other promising leads on personalized vaccines in the pipeline. As Czerniecki puts it, “The science for this field has outpaced the funding model. Because grants from N.I.H. are small, most people have to stick with animal models. Then, when people conduct clinical trials, they have to limit it to five or six patients because they can’t get more funding.” “National Cancer Institute funding for research has been cut more than five years in a row,” June notes. “That’s a real strain on the system, compounded by the fact that the pharmaceutical industry has run out of gas. They’ve invested a lot of money but aren’t coming up with new drugs. Once things start to work with personalized vaccines, then industry will jump in.” Precedents are emerging for commercializing cellular therapies that are specific to patients. Last April, the first autologous cellular immunotherapy was approved by the F.D.A.: Provenge, for treating prostate cancer, by Dendreon, a publicly held bio-
The Clinical Cell and Vaccine Production Facility plays a crucial role in developing new therapeutic vaccines.
tech company. Provenge has already been approved for reimbursement by such health insurers as Aetna, Humana, and Kaiser. If the funding and science of personalized vaccines both fall into place, physician training and practices will also need to
change. June anticipates relatively swift acceptance among doctors trained in bone-marrow transplantation. Familiar with blood transfusion protocols, they are well aware of the limitations of bone-marrow transplants, which have high toxicity and are typically limited to relatively young patients who have sib-
ling donors. June expects a slower rate of acceptance among oncologists and cancer doctors who don’t typically give transfusions – and who will need to learn about the immune system. According to June, Dendreon’s prostatecancer treatment involves a very similar change of practice for physicians who perform it. “If that goes smoothly, it bodes well for the kind of technology we’re developing at Penn.” Tebas likens the quest to move promising new personalized vaccines through the research pipeline toward clinical use to “running two or three marathons one after another!” In his view, “There are so many steps along the way that can go wrong. Only a fraction, probably less than one percent of products in development, reach the end of the line in that marathon. We’re working against the odds, but that’s the nature of it.” Information about eligibility and enrollment in all clinical trials at the Abramson Cancer Center is available at http://www.penncancer.org/patients/centersprograms-services/phase-i-and-ii-clinical-trialsdevelopmental-therapeutics/
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