CanariaBio, a KOSDAQ-listed and a leading late-stage biotechnology company, announces the successful enrollment completion of a Phase 2 study of Oregovomab in combination with niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, for treatment of patients with platinum-sensitive recurrent ovarian cancer.
This trial, known as FLORA-4 (NCT05335993), is being conducted by CanariaBio, with GSK providing clinical trial supply of niraparib. The study will assess the immunological and clinical activity, early humoral response, and disease control rate of concomitant Oregovomab and daily oral niraparib. This will be a preliminary investigation of the interaction of indirect immunization with Oregovomab and concomitant niraparib therapy and the immune modulatory effects associated with PARP inhibition. The key aim of the study is to explore whether a non-chemotherapy combination of Oregovomab and niraparib would potentially extend the platinum-free interval, which is known to have a favorable impact on subsequent treatment with platinum-based combination chemotherapy.
Ovarian cancer is known for its high recurrence rate. In this difficult landscape, Oregovomab has the potential of emerging as a promising immunotherapeutic agent. Through rigorous Phase II clinical trials, Oregovomab has not only demonstrated its safety profile but also showcased remarkable results by extending PFS by approximately 30 months when combined with chemotherapy, compared to conventional chemotherapy alone.
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. In a randomized Phase II clinical trial of 97 patients, treatment with Oregovomab in combination with chemotherapy had demonstrated a highly statistically significant and clinically meaningful outcome for both progression-free and overall survival compared to standard-of-care chemotherapy (carboplatin and paclitaxel). The risk of progression and of death was reduced by more than 50% when compared to control arm, and safety data showed that Oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecology Oncology (2020) 156:523-529 and Cancer Immunology and Immunotherapy (2020) 69: 383-397, respectively.
About ZEJULA (niraparib)
Niraparib is an oral, once-daily poly (ADP-ribose) polymerase inhibitor approved by FDA and EMA for the use in ovarian cancer, marketed as ZEJULA by GSK. Niraparib is currently being evaluated in multiple pivotal trials. GSK is building a robust clinical development programme by assessing activity across multiple tumour types and evaluating several potential combinations of niraparib with other therapeutics. For questions or more information on niraparib, please visit www.gsk.com.
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.
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