UConn to Initiate a Personalized Vaccine Trial to Prevent Relapse in Advanced Ovarian Cancer

The University of Connecticut has initiated recruitment for a phase I trial to test the safety and efficacy of OncoImmunome, a personalized vaccine designed to prevent relapse in patients diagnosed with Stage III or IV ovarian cancer.

The study plans to recruit 15 women who would have completed standard of care surgical debulking followed by chemotherapy treatment (6 to 8 cycles, every 3 weeks), and would be in clinical remission prior to receiving the vaccine. Participants will receive 6 doses of the vaccine, 1 every month, and immune response to the vaccine will be monitored through a blood draw. Follow-up will continue for a period of 5 years post vaccination.

Tumor samples collected during the women’s surgery will be used for vaccine production—the personalized nature of this trial.

“We are pleased that this moment has come,” said Pramod K. Srivastava, PhD, MD, director of the Neag Comprehensive Cancer Center at UConn Health. “This clinical trial will test the power of a patient’s own immune system to prevent recurrence of this often-fatal disease. We hope this vaccine can fill the huge gap in therapy options for ovarian cancer patients and potentially bring a long-term solution and cure for women battling the disease.”

Srivastava’s team, responsible for inventing the vaccine, could show the effectiveness of this vaccine in an animal model—these results led to the FDA’s go-ahead for a first-in-human trial of OncoImmunome.

Each vaccine will be derived using information on mutant peptide sequences from a patient’s tumor transcriptome, and is designed to be a composite mixture of 7-10 peptides, each 17-18 amino acids in length. Tumor mutations will be identified by comparing the genetic differences between the patient’s healthy blood cells and the tumor tissue. Based on the cancer’s signature, bioinformatic scientists led by Ion Mandoiu, PhD, of the School of Computer Sciences and Engineering at UConn in Storrs, will design the personalized vaccine.

“Since this trial is a first of its kind, there are a lot of unknowns. We are hopeful the study will answer some of them,” added Srivastava.

Trial inclusion criteria, in addition to Stage III/IV disease, include, age 18 years and over, completion of standard platinum-based adjuvant chemotherapy, life expectancy of at last 6 months, among others.