On September 1, 2021 OncoQuest Pharmaceuticals Inc., ("OncoQuest") a clinical-stage biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer, reported the first patient enrolled in each of two investigator initiated clinical trials assessing the safety and efficacy of oregovomab in a previously treated recurrent ovarian cancer setting (Press release, OncoQuest, SEP 1, 2021, View Source [SID1234587126]).
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The first study, led byProf. Jung KH, is being conducted at three centres in Korea (Korea Anam Hospital, Seoul St. Mary’s Hospital and Seoul Asan Hospital). This is a Phase 1b/2 clinical trial evaluation of the safety and efficacy of oregovomab when used in combination with bevacizumab, paclitaxel, and carboplatin in subjects with platinum sensitive recurrent ovarian cancer. Oregovomab has previously been established to augment the activity of carboplatin and paclitaxel through immune stimulation, and bevacizumab augments the activity of carboplatin and paclitaxel by inhibiting angiogenesis. The study will establish the safety and compatibility of the combination of these agents as possible approaches in patient management(ClinicalTrials.gov Identifier: NCT04938583). This study is supported by Korean Government’s K-Master program (KM-21) under the guidance of Prof. Kim YH at the Korea University Anam Hospital and Professor Park KH at Korea University College of Medicine.
The second study (ORION-02), led by Clinical Assistant Professor Jack Chan, is being conducted at a single centre in Singapore (National Cancer Centre Singapore). This is a Phase 1/2 clinical trial evaluation of the safety and efficacy of platinum-based chemotherapy, oregovomab and the PD-1 blockade agent, nivolumab, in subjects with platinum sensitive recurrent epithelial cancer of ovarian, tubal, or peritoneal origin (ClinicalTrials.gov Identifier: NCT04620954). The safety of oregovomab in combination with nivolumab has already been established in the ORION-01 study (ClinicalTrials.gov Identifier: NCT03100006).
OncoQuest has completed a Phase II study using oregovomab in combination with a TLR-3 agonist (Hiltonol) in the recurrent ovarian cancer setting (ClinicalTrials.gov Identifier: NCT03162562). Oregovomab is currently being tested in a global Phase III study in 12 countries in combination with carboplatin and paclitaxel chemotherapy in the front-line ovarian cancer setting (ClinicalTrials.gov Identifier: NCT04498117).
"We are committed to continue to work with investigators to explore the potential of oregovomab in combination therapies for treating ovarian cancer in both front line and recurrent settings. Progress in this area began in collaboration with Dr. Alan Gordon (Gynecologic Oncology2004 94:340-351) that identified potential favourable interactions between oregovomab and both carboplatin and doxorubicin in the recurrent disease setting. Those initial results led eventually to the observations recently reported by Brewer et al (Gynecologic Oncology 2020 156:523-529) that combining oregovomab with carboplatin and paclitaxel in a front-line setting improves outcomes", said Dr. Madiyalakan, Chairman of OncoQuest. OncoQuest is also in the process of initiating a clinical trial using oregovomab with niraparib in the recurrent ovarian cancer setting. "These additional clinical studies will guide us to select the optimal combinations for treatment throughout the course of this difficult disease," added Dr. Madiyalakan.
About Oregovomab.
Oregovomab is a murine IgG against CA 125. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefit as observed in this phase 2 trial. In a randomized Phase 2 clinical trial of 97 patients, treatment with Oregovomab demonstrated a highly clinically significant outcome for both progression-free and overall survival favoring the addition of oregovomab to a standard of care chemotherapy combination of carboplatin and paclitaxel. The risk of progression and of death was reduced by more than 50% when compared to placebo, and safety data showed that oregovomab did not add incremental toxicity to the chemotherapy regimen. Clinical and translational results were published in Gynecologic Oncology (2020 156:523-529) and Cancer Immunology and Immunotherapy (2020 69: 383-397), respectively.