CanariaBio Inc Announces Enrollment Completion of randomized Phase 2 study of Oregovomab in combination with chemotherapy as neo-adjuvant treatment of patients with Advanced Ovarian Cancer

SEOUL, South Korea, Aug. 23, 2024 /PRNewswire/ -- CanariaBio Inc, a leading late-stage biotechnology company, announces the successful completion of enrollment of 88 patients in a randomized Phase 2 study of oregovomab in combination with chemotherapy (paclitaxel and carboplatin) as neo-adjuvant treatment of patients with newly diagnosed advanced epithelial ovarian cancer.

This trial, known as FLORA-6 (NCT05605535) is a Phase 2, double-blinded, placebo-controlled, multi centered clinical trial in neo-adjuvant setting in patients with newly diagnosed advanced epithelial ovarian cancer.  The study will assess 12 months progression free survival (PFS) rate, PFS, overall survival (OS), disease control rate, the immunological and early humoral response of concomitant oregovomab and chemotherapy.

Ovarian cancer is known for its high recurrence rate. Despite numerous clinical trials conducted, the development of an effective and specific treatment has proven challenging due to treatment resistance, toxicity, and limited efficacy. In this difficult landscape, oregovomab has the potential of emerging as a promising immunotherapeutic agent.

About Oregovomab

Oregovomab is a murine monoclonal antibody against CA 125, a biomarker commonly found in ovarian cancer. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefits as observed in a Phase II trial (Gynecology Oncology (2020) 156:523-529). Oregovomab is currently undergoing multiple clinical trials for the treatment of ovarian cancer in various setting including a Phase 3 study (NCT04498117, NCT05605535, NCT05335993, NCT05407584, NCT04938583)

About CanariaBio Inc.

CanariaBio Inc. is a Korean biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer. CanariaBio's technology platform includes a portfolio of tumor antigen specific monoclonal immunoglobulins targeting CA-125, MUC1, PSA and Her2/neu. The company is exploring the therapeutic potential of these antibodies as indirect immunizers in combination with other immune modulating drugs or drug combinations to address unmet medical needs in oncology.

Forward Looking Statements

This press release includes forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

SOURCE CanariaBio Inc.