CanariaBio Inc. announced 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.