South Korean biopharmaceutical company CanariaBio has concluded the subject enrolment in a Phase II clinical trial of oregovomab in combination with chemotherapy for advanced epithelial ovarian cancer.
Dubbed FLORA-6, the double-blinded, placebo-controlled, multicentre trial is designed to assess oregovomab with chemotherapy agents — paclitaxel and carboplatin as a neo-adjuvant treatment for newly diagnosed patients.
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This study enrolled a total of 88 patients.
It aims to measure the 12-month progression-free survival (PFS) rate, PFS, overall survival (OS), disease control rate, and the immunological and early humoral response of concomitant oregovomab and chemotherapy.
Oregovomab is an antibody targeting CA 125, a biomarker prevalent in ovarian cancer cases.
The indirect immunisation strategy employed by oregovomab leverages the immune-modulating effects of the infused chemotherapy drugs, paclitaxel and carboplatin, which have shown synergistic clinical benefits in a previous Phase II trial.
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By GlobalDataCurrently, it is under investigation in multiple trials for ovarian cancer treatment, including a Phase III study.
The company’s technology platform comprises a portfolio of tumour antigen specific monoclonal immunoglobulins that act on CA-125, MUC1, PSA and Her2/neu.
CanariaBio is also exploring the therapeutic potential of these antibodies as indirect immunisers, in combination with other immune-modulating drugs or drug combinations, to meet the unmet medical needs in oncology.
In October last year, CanariaBio and Hikma signed a distribution and license agreement for oregovomab in the Middle East and North Africa (MENA) region.
Since commencing subject recruitment in October 2020, the global Phase III trial for the Oregovomab for ovarian cancer treatment is being carried out at 163 sites across 16 countries.
