First Patient Enrolled in Phase 1/2 Trial for Recurrent Ovarian Cancer

First Patient Enrolled in Phase 1/2 Trial for Recurrent Ovarian Cancer

The first patient has been dosed in a Phase 1/2 trial assessing OncoQuest‘s anti-CA125 antibody oregovomab in combination with Opdivo (nivolumab) in women with recurrent ovarian cancer.

The ORION-01 trial (NCT03100006), which is currently enrolling participants, is being conducted at the National Cancer Centre in Singapore (NCCS). Dr. Tira Tan is leading the study, and Prof. John Chia, from Oncocare Cancer Centre, is the study’s chair.

“We are extremely excited about launching this study,” Chia said in a press release. “Ovarian cancer is a lethal disease, and this trial may offer new hope for our patients.”

“Early clinical data suggests that oregovomab may improve the immune system’s processing of cancer antigens, and enhance the immune ability to recognize these cancer targets,” he added. “We believe that the combination of oregovomab and [Opdivo], which amplifies such immune activity, will have a synergistic effect to elicit a higher quality tumor immune response, and hence improve control of the cancer.”

CA125 is a glycoprotein (a protein attached to sugar molecules) expressed at the surface of ovarian cancer cells and that is also shed into circulation. OncoQuest’s oregovomab targets this circulating tumor-associated antigen, inducing strong immune responses. Indeed, the CA-125 oregovomab complex is designed to prime dendritic cells, which then activate T-cells to recognize and attack CD125-positive cells.

To date, more than 950 ovarian cancer patients have been treated in oregovomab clinical trials. Results have shown the drug to be safe and well tolerated, with patients maintaining a good quality of life. Combining oregovomab with front-line chemotherapy also induces better immune responses than chemotherapy alone.

ORION-01 will assess the safety and effectiveness of vaccination with oregovomab in combination with Opdivo in up to 32 ovarian cancer patients who progressed after two or more prior lines of chemotherapy.

The study’s primary goals are to establish the recommended Phase 2 dose and to determine the overall response rate and progression-free survival. Secondary endpoints include overall response rate per immune-related response criteria, disease control rate, and overall survival.

This will be the first clinical trial evaluating oregovomab in combination with an immune checkpoint inhibitor in recurrent ovarian cancer patients.

“We continue to explore the potential of oregovomab in various stages of the progression of ovarian cancer,” said Dr. Ragupathy Madiyalakan, PhD, the CEO of OncoQuest.

“In the recurrent setting, we are exploring the use of oregovomab with immune adjuvants in two clinical trials,” he said. “The trial NCCS is conducting is in combination with a checkpoint inhibitor. We are also in the process of initiating a trial in U.S. in combination with a TLR3 agonist, Hiltonol.”