OncoQuest Pharmaceuticals Plans to Start Phase 3 Clinical Trial of Oregobomab for Ovarian Cancer Treatment in the Second Half of the Year

[Asia Economy Reporter Jang Hyowon] OncoQuest Pharmaceuticals (CEO Changhyun Lee) announced on the 3rd that it plans to officially begin the global Phase 3 clinical trial of the ovarian cancer treatment drug ‘Oregovomab’ in the second half of this year.

The Phase 2 clinical trial of Oregovomab, conducted from 2012 to 2018, involved 97 patients who received the standard ovarian cancer chemotherapy regimen of carboplatin and paclitaxel combination therapy with the addition of Oregovomab. An average follow-up study of 42 months was conducted, showing statistically superior results in both progression-free survival and overall survival rates.

In particular, the progression-free survival period showed excellent results of 41.8 months compared to 12.2 months with the existing chemotherapy regimen, with a reduction in mortality risk by more than 50%. It was also proven that Oregovomab does not add additional toxicity to the existing standard chemotherapy regimen.

Based on the Phase 2 clinical trial results, the company is designing and conducting the Phase 3 clinical trial ‘FLORA-5’ in collaboration with the Gynecologic Oncology Group Foundation (GOG-F) in the U.S. and the global leading clinical trial contract research organization IQVIA. The final protocol was submitted to the U.S. FDA in November last year.

The Phase 3 clinical trial will analyze the effects of combining Oregovomab with the standard chemotherapy regimen of carboplatin and paclitaxel in two study groups: ‘adjuvant therapy after surgery’ and ‘neo-adjuvant therapy before surgery.’

Patient enrollment for Phase 3 will be conducted through IQVIA at over 140 hospitals in 17 countries worldwide. In South Korea, six hospitals including Catholic University Seoul St. Mary’s Hospital, Yonsei Severance Hospital, Bundang Seoul National University Hospital, National Cancer Center, Korea University Anam Hospital, and Seoul Asan Hospital are considering participation in the Phase 3 trial. The company expects to complete enrollment of more than 600 patients within two years after the start of Phase 3.

Dr. Eliel Bayever, Chief Medical Officer (CMO) of OncoQuest, said, “Following the completion of Phase 2, we have maintained continuous and close consultations with the U.S. FDA and are preparing for the full-scale start of the Phase 3 ‘FLORA-5’ trial in the second half of this year. We expect the Phase 3 trial to yield excellent results similar to those of Phase 2.”

Meanwhile, OncoQuest Pharmaceuticals, a new drug development specialized bio company that changed its name from Duol Industry last month, is developing treatments for ovarian cancer, pancreatic cancer, and breast cancer as its main pipelines. The company plans to start Phase 1/2 clinical trials for the pancreatic cancer treatment simultaneously with the Phase 3 trial for the ovarian cancer treatment this year.