OncoVent Announces Breakthrough Phase IIb Clinical Trial Results for Oregovomab in First-Line Ovarian Cancer at China Medical Innovation and Investment Conference
From September 21 to 23, 2019, the 4th China Pharmaceutical Innovation and Investment Conference was successfully held at the beautiful Jinji Lake International Conference Center in Suzhou. At the invitation of the conference organizing committee, Dr. Shi Yuenian, Co-founder and General Manager of Shenzhen OncoQuest Biopharmaceutical Technology Co., Ltd., attended the conference and delivered a keynote address on the first day. He publicly announced for the first time to attending industry representatives, investors, and media journalists the breakthrough progress made by Oregovomab, OncoQuest’s core therapeutic vaccine product for first-line treatment, in its international multicenter Phase IIb clinical trial.
Experimental Design
The Phase IIb clinical trial enrolled 50 patients in the experimental arm (SOC + Oregovomab) and 50 patients in the control arm (SOC, standard chemotherapy regimen for ovarian cancer). Inclusion criteria were: stage III/IV disease, partial tumor resection, and baseline serum CA125 levels >50 U/mL. Patients were followed for 36 months to assess progression-free survival (PFS) and overall survival (OS).
Oregobomab antibody was administered concurrently with chemotherapy during the 1st, 3rd, and 5th cycles at a dose of 2 mg per patient per administration, with an additional dose given after the completion of the final cycle, resulting in a total cumulative dose of 8 mg per patient. Patients were then observed for 36 months without further dosing.
Experimental Results
Clinical results showed no serious adverse events related to the investigational drug. The progression-free survival (PFS) in the experimental group was 41.8 months, nearly 3.5 times that of the control group (12.2 months). Oregovomab demonstrated highly significant efficacy.
Comparison with Current Ovarian Cancer Therapeutic Agents
Next Steps
Dr. Shi Yuenian, Co-founder and General Manager of OncoVent, stated: “The top-line data from the global, multicenter Phase IIb clinical trial of Oregovomab, a first-line treatment vaccine for primary ovarian cancer, are highly positive. At the 36-month clinical endpoint, the progression-free survival (PFS) in the experimental arm (standard of care [SOC] + Oregovomab) reached 41.8 months, nearly 3.5 times that of the control arm (PFS 12.2 months). This represents the best clinical efficacy to date for first-line treatment of primary ovarian cancer. We will initiate the global Phase III clinical trial next year, aiming to bring this drug to market as soon as possible to benefit patients worldwide.”
About Oregovomab
Oregovomab is a high-affinity monoclonal antibody (Mab B43.13) that binds to the tumor-associated antigen CA125 (MUC16) and initiates a cascade immune response against this glycoprotein. CA125 is expressed on the surface of ovarian cancer epithelial cells and can be shed into the bloodstream.
About Shenzhen OnMicro
Shenzhen OncoVent Biopharmaceutical Technology Co., Ltd. (OncoVent) is a clinical-stage biopharmaceutical company. OncoVent, together with its partner OncoQuest, is dedicated to the global development of cancer immunotherapeutics, particularly next-generation therapeutic tumor vaccines. OncoVent’s technology platform includes monoclonal antibodies targeting tumor-specific antigens, such as IgG and IgE monoclonal antibodies against CA125, MUC1, PSA, and HER2/neu.
The company’s most advanced product is Oregovomab, licensed by OncoQuest, with exclusive commercial rights in the Greater China region. It has completed an international, multicenter, randomized controlled Phase II clinical trial for first-line treatment of advanced primary ovarian cancer. A Phase III study targeting first-line treatment of primary ovarian cancer is imminent. Oregovomab is also currently being investigated in multi-stage Phase II clinical trials for relapsed/recurrent ovarian cancer, including combination therapy with the PD-1 inhibitor Opdivo.
Another clinical-stage asset of OncoVent, the monoclonal antibody BrevaRex, is a novel immunotherapeutic agent for the treatment of MUC1-expressing malignant tumors. In completed FDA Phase I clinical trials, BrevaRex demonstrated favorable tolerability in patients with advanced MUC1-expressing malignancies and showed the ability to activate MUC1-specific T cells. Phase Ib/II clinical trials of BrevaRex as an immunotherapy for pancreatic cancer were scheduled to commence simultaneously in 2019 in both the United States (at Memorial Sloan Kettering Cancer Center) and China. The company’s next-generation product consists of antigen-specific monoclonal IgE antibodies licensed from the University of California, Los Angeles (UCLA), Stanford University, and Advanced Immune Therapeutics, Inc., and is currently in preclinical development. For more information, please visit www.oncovent.com.