|
|
|
|
|
SEOUL, S.KOREA, Aug 8, 2023 - (JCN Newswire) - 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.
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. 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.
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.
Contact Information
Jacquelyn Choi
PR Manager
ipr@canariabio.com
Topic: Press release summary
Source: CanariaBio Inc
Sectors: BioTech, Healthcare & Pharm
https://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| |
Latest Press Releases
Telangana Rising 2047 Vision Document to Be Released on Dec 8-9, 2025, at Global Summit in Bharat Future City
Dec 6, 2025 07:00 HKT/SGT
|
|
|
Wear the Speed, Live the Convenience: Tappy Technologies Powers the Launch of High Performance Payment Bands in Collaboration with First Abu Dhabi Bank and Mastercard
Dec 5, 2025 18:53 HKT/SGT
|
|
|
Leapfrog Acquisition Corp Announces Pricing of $125,000,000 Initial Public Offering
Dec 5, 2025 17:50 HKT/SGT
|
|
|
Bank Indonesia Unveils Five-Point Strategy to Boost Indonesia's Economic Resilience
Dec 5, 2025 16:00 HKT/SGT
|
|
|
Business of IP Asia (BIP Asia) Forum and Entrepreneur Day open today
Dec 5, 2025 15:41 HKT/SGT
|
|
|
Immortal Dragons Backs Etheros Pharmaceuticals: Targeting Aging-Related Disease with Breakthrough Catalytic Antioxidants
Dec 5, 2025 15:00 HKT/SGT
|
|
|
Doubleview Extends High-Grade Domains at Hat: H099 Returns 438m of 0.40% CuEq Including 52m of 1.02% CuEq, Expanding Mineralization Envelope Around Conceptual Pit Vertically and Laterally
Dec 4, 2025 21:59 HKT/SGT
|
|
|
CaoCao Unveils '100 Cities, 100 Billion in 10 Years' Robotaxi Strategy, Officially Launches World's First 'Green Intelligent Mobility Hub'
Dec 4, 2025 21:00 HKT/SGT
|
|
|
The Gourmet's Guide: Using Your TravelKon eSIM to Hunt for Japan's Best Ramen, Sushi, and Street Food
Dec 4, 2025 17:45 HKT/SGT
|
|
|
Spritzer Celebrates Global and Regional Brand Excellence 2025
Dec 4, 2025 12:45 HKT/SGT
|
|
|
|
|
More Press release >> |
|
|
|
