|Dr. Pramod Srivastava--Courtesy of UConn Health|
Cancer vaccine developers have seen their fair share of disappointments, and failures have spurred some companies to test their treatments in smaller patient subpopulations. Now, researchers at the University of Connecticut are narrowing their focus even further as they gear up to trial personalized cancer vaccines.
Using genome sequencing to identify the differences between protein sequences--called epitopes--in healthy versus cancerous tissue, they'll start up an initial clinical study for ovarian cancer patients once they nab FDA approval. The team will sequence DNA from the tumors of 15 to 20 women with ovarian cancer, using that information to make a personalized vaccine for each woman.
"This has the potential to dramatically change how we treat cancer," Dr. Pramod Srivastava, director of the Carole and Ray Neag Comprehensive Cancer Center at UConn Health and one of the principal investigators on the study, told UConn Today.
Cancer vaccine makers could use some new approaches now that a series of high-profile misfires has cast doubt on the field. GlaxoSmithKline ($GSK) and Merck KGaA both aimed their cancer fighters at subpopulations after flunking Phase III trials, only to later give up on the quest to find a group that would benefit.
Some, like Amgen ($AMGN), have caught on. The California company is testing its melanoma candidate, T-Vec, in conjunction with Merck ($MRK) checkpoint inhibitor Keytruda in what David Reese, the company's VP of translational sciences, told FierceVaccines was a "complementary biologic approach."
But even if such new approaches yield a path to regulatory approval, the market holds plenty of its own challenges for cancer vaccine makers post-FDA green light. Provenge maker Dendreon ($DNDN) has seen that firsthand, with oral competition and manufacturing challenges taking a hefty toll on sales.
Makers of personalized vaccines could experience some of the same problems, Decision Resources Group said in a report this summer. Experts interviewed by DRG said they were "uncertain about the logistics and processes involved in the manufacture of personalized therapeutic vaccines … and are concerned about potential impact on patient management in routine practice."
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