CanariaBio Closes Patient Recruitment for Global Phase 3 Clinical Trial Preceding Anticancer Cohort

Canaria Bio (CEO Nahanik) announced on the 10th that it will close patient recruitment for the neoadjuvant chemotherapy cohort in the ongoing global Phase 3 trial of Oregovomab for new ovarian cancer patients.

The global Phase 3 trial of Oregovomab is being conducted at 161 sites across 16 countries, led by Dr. Angeles Secord of the Duke University Cancer Institute in the United States. This global Phase 3 trial is divided into two cohorts: adjuvant chemotherapy and neoadjuvant chemotherapy. The US FDA has indicated that approval of the new drug is possible if either one of the cohorts is successful.

The neoadjuvant chemotherapy cohort aims to recruit a total of 230 patients. An interim analysis will be conducted after 83 patients reach progression-free survival (PFS), and a final analysis after 165 patients reach PFS. Currently, 225 patients have passed eligibility screening and been randomized, with 18 patients undergoing eligibility screening. Considering the approximately 30% screening failure rate so far, the final number of recruited patients is expected to be 238.

The adjuvant chemotherapy cohort plans to recruit a total of 372 patients. An interim analysis will be conducted after 117 patients reach PFS, and a final analysis after 232 patients reach PFS. Currently, 314 patients have been recruited.

Oregovomab is a new drug that showed a progression-free survival (PFS) of 42 months, which is 30 months longer than the existing standard treatment, in a Phase 2 clinical trial conducted on 97 patients in the United States and Italy. CEO Nahanik stated, “Considering that global blockbuster-level immuno-oncology drugs generating sales in the trillion-won range in the market extend PFS by about 3 to 5 months, this is an encouraging result,” and added, “Oregovomab will become a global blockbuster new drug.”