OvaRex (oregovomab) / CanariaBio, Shenzhen Hepalink, Orient Europharma, Hikma, Specialised Therap - LARVOL DELTA

A Phase Ib Study of Indirect Immunization with Oregovomab and Toll-like-Receptor-3 Stimulation with Hiltonol® in Patients with Recurrent Platinum-Resistant Ovarian Cancer. (PubMed, Curr Oncol) - " The safety and compatibility of combining oregovomab with Hiltonol® have been demonstrated in this study. The potential to enhance activity of chemotherapy using oregovomab indirect immunization and Hiltonol® stimulation is proposed."

Journal • P1 data • Platinum resistant • Cardiovascular • Fatigue • Hematological Disorders • Hypertension • Oncology • Ovarian Cancer • Pain • Solid Tumor • Thrombocytopenia • MUC16 • TLR3

A Phase Ib Study of Indirect Immunization with Oregovomab and Toll-like-Receptor-3 Stimulation with Hiltonol in Patients with Recurrent Platinum-Resistant Ovarian Cancer (Multidisciplinary Digital Publishing Institute) - "Ten (67%) patients had disease progression, three (20%) had stable disease, and two were unevaluable. Early humoral response by week 6 was observed in seven of nine (77%) patients, median progression-free survival was 2.7 months (95% confidence interval [CI]: 2.2, 3.3), and median overall survival was 15.0 months (95% CI: 8.2–23.9)."

P1 data • Platinum resistant • Ovarian Cancer

Long-term survival analysis of a randomized phase II study of front-line chemo-immunothe-rapy with carboplatin-paclitaxel using oreg-ovomab indirect immunization in advanced ovarian cancer (QPT-ORE-002). (PubMed, Int J Gynecol Cancer) - "This study suggests that simultaneous administration of oregovomab on alternate cycles during front-line carboplatin and paclitaxel could enhance progression-free survival and long-term overall survival. This increase in median overall survival after 9 years of follow-up is meaningful in patients with optimally debulked epithelial ovarian cancer."

Journal • P2 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MUC16

QPT-ORE-004: A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: CanariaBio Inc. | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Platinum sensitive • Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • MUC16

Challenges in Endocrine Function Testing During Clinical Cancer Drug Trials: False Positives Due to Heterophilic Antibodies (ENDO 2025) - "She was referred to the Endocrinology Department for osteoporosis management, and after evaluation, she was treated with Denosumab and cholecalciferol...Two months after switching to alendronate, PTH was measured at 1171 pg/mL...Following the initiation of osteoporosis treatment, the patient participated in a clinical trial to assess the safety and efficacy of Oregovomab in combination with Paclitaxel, Carboplatin, and Bevacizumab... Heterophilic antibodies have been recognized for a long time, but caution is needed as mouse-derived antibodies are still used in early-stage research. These antibodies can cross-react with non-homologous antigens, interfere with immunoassays, and lead to inaccurate test results."

Clinical • Endocrine Disorders • Oncology • Ovarian Cancer • Pituitary Gland Carcinoma • Rheumatology • Solid Tumor

QPT-ORE-006: Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=88 | Active, not recruiting | Sponsor: CanariaBio Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ Sep 2027 | Trial primary completion date: Sep 2024 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

FLORA-4: Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery (clinicaltrials.gov) - P3 | N=615 | Active, not recruiting | Sponsor: CanariaBio Inc. | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Long-term survival analysis of a randomized phase II study of front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer (QPT-ORE-002). (ASCO 2025) - P2 | "This study suggests that simultaneous administration of oregovomab on alternate cycles during front-line carboplatin and paclitaxel leverages CP associated temporal change in the tumor microenvironment permitting an immune treatment effect to enhance PFS and long-term OS. This increase in median overall survival after 9 years of follow up is particularly clinically meaningful in patients with optimally debulked EOC."

Clinical • Metastases • P2 data • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Oregovomab in combination with non-platinum chemotherapy for the treatment of PARP inhibitor– and platinum-resistant ovarian cancer: A two-cohort, single-arm phase 2 study (OPERA/KGOG3065/APGOT-OV6). (ASCO 2025) - P2 | "Oregovomab plus weekly paclitaxel chemotherapy demonstrated encouraging activity and safety in heavily pre-treated PARPi- and platinum-resistant EOC."

Combination therapy • P2 data • Platinum resistant • Anemia • Epithelial Ovarian Cancer • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor

CanariaBio Inc Announces Enrollment Completion of randomized Phase 2 study of Oregovomab in combination with chemotherapy as neo-adjuvant treatment of patients with Advanced Ovarian Cancer (PRNewswire) - "CanariaBio Inc...announces the successful completion of enrollment of 88 patients in a randomized Phase 2 study of oregovomab in combination with chemotherapy (paclitaxel and carboplatin) as neo-adjuvant treatment of patients with newly diagnosed advanced epithelial ovarian cancer. This trial, known as FLORA-6 (NCT05605535) is a Phase 2, double-blinded, placebo-controlled, multi centered clinical trial in neo-adjuvant setting in patients with newly diagnosed advanced epithelial ovarian cancer. The study will assess 12 months progression free survival (PFS) rate, PFS, overall survival (OS), disease control rate, the immunological and early humoral response of concomitant oregovomab and chemotherapy."

Enrollment closed • Ovarian Cancer

OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer. (PubMed, Future Oncol) - P2 | "Herein, we described the rationale and design of OPERA/KGOG 3065/APGOT-OV6, a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi/platinum-resistant ovarian cancer. The primary end point was the objective response rate, according to RECIST 1.1.Clinical Trial Registration: NCT05407584 (ClinicalTrials.gov)."

Journal • P2 data • Oncology • Ovarian Cancer • Solid Tumor

Phase 2, single arm clinical trial to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer: FLORA-4 study. (ASCO 2024) - P3 | "Combination oregovomab and niraparib in patients with platinum sensitive EOC was well tolerated with no new safety signals. Translational research is ongoing to assess biomarkers of early humoral response."

Clinical • P2 data • Anemia • Cardiovascular • Dermatology • Hematological Disorders • Hypertension • Immunology • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia • Urticaria • MUC16 • STING

The OVAREX study: Establishment of ex vivo ovarian cancer models to validate innovative therapies and to identify predictive biomarkers. (PubMed, BMC Cancer) - P=N/A | "This clinical study aims at generating PDX and ex vivo models (PDTO, ADS, and explants) from tumors or ascites of ovarian cancer patients who will undergo surgical procedure or paracentesis. We aim at demonstrating the predictive value of ex vivo models for their potential use in routine clinical practice as part of precision medicine, as well as establishing a collection of relevant ovarian cancer models that will be useful for the evaluation of future innovative therapies."

Biomarker • Journal • PARP Companion diagnostic • Preclinical • Colorectal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

High Parathyroid Hormone (PTH) due to Immunoassay Interference (ENDO 2024) - "Due to a history of advanced ovarian cancer, the patient was taking Oregovomab, a murine monoclonal antibody, as therapy for her advanced disease...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Endocrine Disorders • Oncology • Ovarian Cancer • Renal Disease • Solid Tumor

CanariaBio recommended to halt phase 3 study of ovarian cancer drug candidate (Korea Biomedical Review) - "CanariaBio said the Data and Safety Monitoring Board (DSMB) recommended halting its global phase 3 clinical trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients. The company said that the recommendation was made due to the trial not achieving the necessary statistical value (p-value) in the futility analysis."

Trial termination • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Front-line chemoimmunotherapy for treating epithelial ovarian cancer: Part II promising results of phase 2 study of paclitaxel-carboplatin-oregovomab regimen. (PubMed, Taiwan J Obstet Gynecol) - "In the 97 EOC patients after optimal debulking surgery (residual tumor <1 cm or no gross residual tumor), patients treated with CIT had a dramatical and statistically significant improvement of both progression-free survival (PFS) and overall survival (OS) compared to those treated with chemotherapy alone with a median PFS of 41.8 months versus 12.2 months (hazard ratio [HR] 0.46, 95 % confidence interval [CI] 0.28-0.7) and OS not yet been reached (NE) versus 42.3 months (HR 0.35, 95 % CI 0.16-0.74), respectively. The current review as Part II will explore the possibility of using CIT as front-line therapy in the management of advanced-stage EOC patients after maximal cytoreductive surgery based on the evidence by many phase 2 studies."

Journal • P2 data • Review • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • MSLN

Front-line chemo-immunotherapy for treating epithelial ovarian cancer: Part I CA125 and anti-CA125. (PubMed, Taiwan J Obstet Gynecol) - "The current standard therapy of epithelial ovarian cancer (EOC) is the combination of surgery (primary cytoreductive surgery or interval cytoreductive surgery) and platinum-based chemotherapy (mainly using paclitaxel and carboplatin either by neoadjuvant chemotherapy and/or by postoperative adjuvant chemotherapy) with/without adding targeted therapy (mainly using anti-angiogenesis agent- bevacizumab)...It is well-known that overexpression of CA125 has been associated with attenuated cellular apoptosis, platinum chemotherapy resistance, tumor proliferation and disease progression, suggesting that anti-CA125 may play a role in the management of patients with EOC. The current review is a Part I which will focus on development of anti-CA125 monoclonal antibody, hoping that alternation of the front-line therapy by chemo-immunotherapy will be beneficial for prolonged survival of patients with EOC."

IO biomarker • Journal • Review • Oncology • Ovarian Cancer • Solid Tumor • MUC16

A DOUBLE-BLIND PLACEBO-CONTROLLED PHASE III CHEMOIMMUNOTHERAPY (PACLITAXEL-CARBOPLATIN-OREGOVOMAB [PCO]) VS CHEMOTHERAPY (PACLITAXEL-CARBOPLATIN-PLACEBO [PCP]) IN PATIENTS WITH NEWLY DIAGNOSED, ADVANCED EPITHELIAL OVARIAN CANCER (EOC): FLORA-5/GOG-3035 STUDY (IGCS 2023) - "The primary objective is PFS determined by RECIST 1.1 criteria. Current Trial Status: At the time of abstract submission, 618 patients were enrolled and target enrolment Cohort 1 (378) and Cohort 2 (240) was achieved."

Clinical • IO biomarker • Metastases • P3 data • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

PHASE 2, SINGLE ARM CLINICAL TRIAL TO EVALUATE THE SAFETY AND ACTIVITY OF OREGOVOMAB AND NIRAPARIB IN SUBJECTS WITH PLATINUM SENSITIVE RECURRENT OVARIAN CANCER: FLORA-4 (IGCS 2023) - "In a randomized phase II study in patients with previously untreated EOC, immunization with oregovomab in a schedule-dependent combination with paclitaxel and carboplatin (PC) demonstrated significant improvement in mPFS (months) 41.8 for PCO and 12.2 for PC (p = 0.0027, HR 0.46) and mOS has not yet been reached (NE) for PCO and was 43.2 months for PC (p = 0.043, HR 0.35). This study will assess DCR, ORR, early humoral response, and safety of concomitant administration of oregovomab and niraparib. Current Trial Status: At the time of abstract submission, 10 subjects were enrolled, and the target enrollment was completed."

Clinical • P2 data • Oncology • Ovarian Cancer • Solid Tumor

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II CHEMOIMMUNOTHERAPY (PACLITAXEL-CARBOPLATINOREGOVOMAB) VS CHEMOTHERAPY (PACLITAXEL-CARBOPLATINPLACEBO) AS NEOADJUVANT THERAPY IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PERITONEAL CARCINOMA (IGCS 2023) - "Introduction: Oregovomab, a murine IgGκ monoclonal antibody binds to tumor-associated antigen, CA125, rendering target antigen CA125 more immunogenic through enhanced antigen processing and presentation to specific T cells, bypassing tumor-associated suppression and resulting in enhanced efficacy of chemotherapy. Secondary objectives include investigator assessed ORR and DCR by RECIST v1.1, PFS, OS, Response to surgery, safety and tolerability. Current Trial Status: Of the 88 patients enrolment target of the study, 31 patients have been enrolled from 14 centers at the time of submission."

Clinical • Metastases • P2 data • Oncology • Peritoneal Cancer • Solid Tumor

Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer (clinicaltrials.gov) - P1b/2 | N=54 | Recruiting | Sponsor: CanariaBio Inc. | Trial primary completion date: Apr 2023 ➔ Apr 2024

Combination therapy • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Specialised Therapeutics signs exclusive license agreement with CanariaBio for new ovarian cancer therapy (PRNewswire) - "Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) has signed a license deal with Korea-based CanariaBio Inc., acquiring the exclusive license to a new monoclonal antibody therapy for patients with ovarian cancer in Australia, New Zealand and in select Southeast Asian countries. The therapy, known as oregovomab, is currently in a pivotal phase III international clinical trial known as the FLORA-5 study....Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territories of Australia, New Zealand, Singapore, Thailand, Vietnam, Brunei and Malaysia. CanariaBio will be responsible for the manufacture and supply of oregovomab to ST....The Phase 3 FLORA-5 study is fully enrolled and ongoing. Final results are expected in 2025."

Enrollment closed • Licensing / partnership • P3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

CanariaBio and Hikma announce the signing of distribution and license agreement for oregovomab in MENA Region (PRNewswire) - "CanariaBio Inc. and Hikma MENA FZE, part of Hikma Pharmaceuticals PLC...today announced the signing of distribution and license agreement for oregovomab in the Middle East and North Africa (MENA) region."

Licensing / partnership • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

QPT-ORE-004: A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer. (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: CanariaBio Inc. | Trial completion date: May 2024 ➔ Oct 2024 | Trial primary completion date: Sep 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • MUC16

CanariaBio Announces Enrollment Completion of Phase 2 study of Oregovomab in combination with niraparib. (EIN News) - "CanariaBio...announces the successful enrolment 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."

Enrollment closed • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor