Phase 1 Trial Testing IMV’s Tailored Immunotherapy Doses First Ovarian Cancer Patient

Phase 1 Trial Testing IMV’s Tailored Immunotherapy Doses First Ovarian Cancer Patient

IMV’s Phase 1 clinical trial evaluating a personalized immunotherapy that targets mutated proteins called neoepitopes in ovarian cancer patients has started dosing participants, the company announced.

“The first immunization of the first ovarian cancer patient with our personalized, patient-specific neoepitopes developed at the University of Connecticut using our proprietary technology … is a major milestone for us,” Pramod K. Srivastava, PhD, MD, director of the Neag Comprehensive Cancer Center at the University of Connecticut School of Medicine and the trial’s lead investigator, said in a press release.

Cancers typically develop when cells undergo changes in their genetic makeup. While these mutations usually give them an advantage over other cells, allowing them to proliferate and survive unchecked, they also compromise the cells’ disguise from the immune system.

The logic is simple. A genetic mutation will produce a new, abnormal protein — called a neoantigen — that is seen by the immune system as foreign, cuing immune cells to attack the cancer cells. In particular, immune cells target a small portion of neoantigens, called the neopitope.

Based on this process, researchers have been developing strategies that prime immune cells toward these abnormal proteins. IMV’s approach is to develop a personalized cancer vaccine that contains multiple neoepitopes from a cancer patient. When delivered into the blood, immune cells attack the small proteins in the vaccine and become primed to kill all cells producing these proteins.

In mice, IMV’s vaccine triggered a strong anti-cancer immune response against multiple cancer types.

The ongoing Phase 1 trial will now test the neoepitope-based vaccine in 15 women with ovarian cancer. These women will be genetically tested for neoantigens at the UConn Health, which is also funding the trial.

The trial is part of IMV’s DPX-NEO program aimed at developing immunotherapies for cancer, established as a collaboration between UConn Health and IMV.

“We believe that the potential of neoepitope-based therapies could be a significant advance in the way physicians treat patients with ovarian cancer who today face a high unmet medical need. We look forward to working with UConn Health to advance this program as IMV is committed to developing an immunotherapy option for women affected by this disease,” said Frederic Ors, CEO of IMV.

IMV is also developing what it calls a “leading” therapy candidate for ovarian cancer patients. The approach, called DPX-Survivac, is a T-cell-activating immunotherapy that aims to trigger a strong immune responses against the survivin protein, which plays a key role in tumor growth and resistance to anti-cancer treatments.

DPX-Survivac in being tested in two clinical studies, a Phase 2 trial (NCT03029403) in combination with the immune checkpoint inhibitor Keytruda (pembrolizumab), and a Phase 1/2 trial (NCT02785250), along with the investigational immunotherapy epacadostat. Both are still recruiting participants at sites in the U.S. and/or Canada.

“Expanding our DPX-based clinical immunotherapy program beyond DPX-Survivac is an important milestone for IMV, and we are pleased to be able to do so with this type of cutting-edge program in which the novel mechanism of action underscoring all DPX-based candidates plays a critical role,” Ors said.