"Our findings move the field forward by showing how personalized vaccines like PGV001 can work in bladder cancer," says Dr. Bhardwaj. "We’ve proven these custom vaccines can consistently activate the immune system in powerful, cancer-fighting ways." 

Building on the success of PGV001 in eliciting immune responses across multiple cancer types, the personalized vaccine is now demonstrating encouraging results in bladder cancer and shows potential for broader applications. Motivated by these promising early findings, the Mount Sinai team is working to accelerate the vaccine’s development, expand its accessibility, and test new combinations to help even more patients. This individualized approach offers renewed hope for patients, particularly those whose tumors are resistant to existing therapies. In the latest trial, 10 patients with bladder cancer received their own personalized version of PGV001, along with atezolizumab. Each vaccine was carefully crafted to match the patient’s specific tumor mutations and maximize the immune response. 

"This study adds to growing evidence that combining personalized vaccines with immunotherapy could help many more patients benefit," says Dr. Galsky. "It also lays the groundwork for larger trials that are now underway." Bladder cancer responds well to immune-based treatments, but not everyone benefits equally. According to the American Cancer Society, about 84,870 new cases and 17,420 deaths from bladder cancer are expected in the United States this year. 

A collaborative team at Mount Sinai, bringing together experts in immunology, oncology, genetics, and pathology, drove the study. Contributors included Mansi Saxena, PhD, Jonathan Anker MD, PhD, Julia Kodysh, Anna Kaminska, PhD, and more. The National Cancer Institute of the National Institutes of Health, the Cancer Research Institute, the Parker Institute of Cancer Immunotherapy, and industry partners supported the study.