CanariaBio Inc Completes Enrollment for Phase 2 Study of Oregovomab with Chemotherapy in Advanced Ovarian Cancer

SEOUL, South Korea – CanariaBio Inc., a prominent biotechnology company in the advanced stages of development, has announced the successful enrollment of 88 patients in their Phase 2 clinical trial. This study, which aims to evaluate the efficacy of oregovomab combined with chemotherapy agents paclitaxel and carboplatin, is directed at patients recently diagnosed with advanced epithelial ovarian cancer.

The clinical trial, designated FLORA-6 (NCT05605535), is a rigorous Phase 2, double-blinded, placebo-controlled, multi-centered study. Its primary focus is on assessing the 12-month progression-free survival (PFS) rate among the participants. Additionally, the study will measure overall survival (OS), the rate of disease control, and the immunological and early humoral response to the combined treatment of oregovomab and chemotherapy.

Ovarian cancer is characterized by a high rate of recurrence, which complicates the quest for effective treatments. Various clinical trials have encountered obstacles such as treatment resistance and toxicity, leading to limited success in developing specific and efficacious therapies. In this challenging context, oregovomab shows potential as a promising immunotherapeutic agent.

Oregovomab is a murine monoclonal antibody that targets CA 125, a biomarker frequently associated with ovarian cancer. The strategy of indirect immunization with oregovomab leverages its interaction with the immune-modulating properties of paclitaxel and carboplatin, resulting in synergistic clinical benefits. This synergy was observed in a previous Phase II trial, as reported in the journal Gynecology Oncology in 2020 (Volume 156, Pages 523-529). Currently, oregovomab is undergoing several clinical trials for ovarian cancer treatment in different settings, including a Phase 3 study (NCT04498117, NCT05605535, NCT05335993, NCT05407584, NCT04938583).

CanariaBio Inc. is a South Korean biopharmaceutical company dedicated to developing and commercializing immunotherapies for cancer. The company's technology platform encompasses a range of tumor antigen-specific monoclonal immunoglobulins that target markers such as CA-125, MUC1, PSA, and Her2/neu. CanariaBio is investigating the therapeutic potential of these antibodies as indirect immunizers. When combined with other immune-modulating drugs or drug combinations, these antibodies aim to address unmet medical needs within oncology.

The successful completion of patient enrollment in the FLORA-6 trial marks a significant achievement for CanariaBio. It underscores the company's commitment to advancing cancer immunotherapy and improving outcomes for patients with advanced epithelial ovarian cancer. As the trial progresses, further data will be collected and analyzed to determine the full potential of oregovomab in this setting, providing hope for more effective treatment options in the future.

By focusing on innovative immunotherapy approaches and conducting rigorous clinical trials, CanariaBio Inc. continues to position itself at the forefront of cancer treatment development. The ongoing research and forthcoming results from the FLORA-6 trial are eagerly anticipated by the medical community and patients alike, as they hold the promise of significant advancements in the fight against ovarian cancer.

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