OncoQuest Lays the Groundwork for Commencement of Phase 3 Study in Frontline Ovarian Cancer

In Clinical Trials by Barbara Jacoby

Source: OncoQuest, Inc.

From: prnewswire.com

OncoQuest Inc., a privately held, cancer immunotherapy company, has retained the services of IQVIA, a company formed through the merger of IMS Health and Quintiles, to manage OncoQuest’s planned Phase 3 clinical study in frontline ovarian cancer with the company’s lead product candidate, oregovomab, an anti-CA-125 antibody. OncoQuest will collaborate with IQVIA, a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry, to provide oversight of the day-to-day study execution activities.

OncoQuest has also signed a Letter of Authorization with The GOG Foundation, Inc. (GOG-F) to provide consultation on regulatory strategy, protocol design and additional aspects of the Phase 3 study, and to coordinate participation of GOG-affiliated study sites.

The planned Phase 3 study is expected to enroll over 500 patients with newly diagnosed, advanced ovarian cancer globally. The primary endpoint will be to evaluate progression-free survival of patients treated with oregovomab plus a standard-of-care chemotherapy combination, carboplatin and paclitaxel, compared to the chemotherapy alone. Patients will also undergo tumor debulking surgery either before or halfway through the treatment.  This Phase 3 study is based on a Phase 2 study with a similar design where promising results were noted [NCT01616303].

“We are delighted to have the services and support of two well-respected and internationally recognized organizations to assist and guide our pivotal Phase 3 study of oregovomab,” said Dr. Eliel Bayever, M.B.B.Ch, M.R.C.P., Chief Medical Officer of OncoQuest, “We have chosen these two partners based on their extensive experience in global cancer studies, and, specifically with GOG-F, their focus on gynecologic cancers.”

“I am pleased that GOG-F is working with  OncoQuest on this very exciting trial to investigate whether the combination of oregovomab together with the standard-of-care chemotherapeutic regimen can demonstrate an improvement in progression-free survival in women with newly diagnosed advanced ovarian cancer,” said Bradley J. Monk, M.D., FACS, FACOG, Co‐Director of GOG Partners, Arizona Oncology (US Oncology Network), Professor, Gynecologic Oncology at University of Arizona, and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona.

About OncoQuest

OncoQuest is a subsidiary of Quest PharmaTech Inc. (TSXV-QPT) (“Quest”) and is a private biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer. OncoQuest’s technology platform includes a portfolio of tumor antigen specific monoclonal immunoglobulins including CA-125, MUC1, PSA and Her2/neu.  The company is exploring the therapeutic potential of these antibodies in combination with other immune modulating drugs or drug combinations to enhance tumor specific immunity and clinical outcomes.

OncoQuest’s lead product candidate is oregovomab, an anti-CA-125 antibody, for the treatment of ovarian cancer that has completed a Phase 2 frontline randomized controlled study. In addition, oregovomab is currently being studied in multiple Phase 2 clinical trials in the relapsed recurrent ovarian cancer setting as well. OncoQuest’s anti-MUC1 antibody program has already undergone a Phase 1 clinical trial in breast cancer patients, and its development is being led by OncoVent Co. Ltd., OncoQuest’s joint venture partner that has licensed the rights of our immunotherapeutic antibodies in the territory of Greater China. OncoQuest’s next-generation monoclonal antibodies are based on immunoglobulin E licensed from UCLA, Stanford University and Advanced Immune Therapeutics, Inc. These antigen-specific monoclonal IgE antibodies are currently in preclinical development.  To learn more, visit www.oncoquestinc.com.

About IQVIA

IQVIA (NYSE: IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With more than 58,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com

About the GOG Foundation, Inc. (GOG-F)
The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The mission of the GOG Foundation is to conduct clinical and translational research that positively impacts women through the prevention and treatment of gynecologic malignancies. To learn more, visit www.gog.org

About Quest PharmaTech Inc.
Quest PharmaTech Inc is a publicly traded, Canadian based biopharmaceutical company (QPT: TSX-V) developing products to improve the quality of life. The Company through its subsidiary, OncoQuest and its Chinese joint venture, OncoVent, is developing antibody-based immunotherapeutic products for cancer. Quest has an ownership interest in Bioceltran which is focused on SP Technology™ for transdermal delivery of drugs and photosensitizers for pharmaceutical and cosmetic purposes. Quest through its subsidiary, Madenco BioSciences, is developing pharmaceutical products for dermatology and wound healing applications.  Quest, through its ownership interest in OncoCare Therapeutics, is developing an antibody licensed from University of Nebraska, AR 9.6 mAb against truncated O-glycan on MUC16, for targeted cancer therapy applications.  To learn more, visit www.questpharmatech.com