On November 9, 2020 Quest PharmaTech Inc. (TSXV: QPT) reported that OncoQuest Pharmaceuticals, Inc., Seoul, South Korea (078590.KQ) ("OQP") has begun dosing patients in the USA for the Phase 3 clinical trial of its immunotherapeutic drug candidate oregovomab (Press release, Quest PharmaTech, NOV 9, 2020, View Source [SID1234570653]). This global pivotal trial is expected to enroll 602 patients from 140 clinical sites in 17 countries.
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The Phase 3 clinical trial called FLORA-5/GOG-3035, is a double-blind, placebo-controlled, multicenter clinical study to compare the safety and efficacy of oregovomab versus placebo when administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin) for the treatment of newly diagnosed patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma, in conjunction with optimal debulking surgical resection. The primary and secondary endpoints, for both the adjuvant and neoadjuvant cohorts of this trial, are progression free survival and overall survival, respectively.
The FLORA-5 trial is being conducted in collaboration with the Gynecologic Oncology Group Foundation in the US and IQVIA (a clinical research organization). Greater China area clinical trials are conducted in collaboration with OncoVent, a Shenzhen Hepalink Pharmaceuticals Group Company in China, which is also the commercialization license holder of oregovomab for China. "OncoVent is glad to enter into a Clinical Trial Collaboration Agreement with OncoQuest Pharmaceuticals and participate in this global Phase 3 clinical trial" said Dr. Yuenian Eric Shi, CEO of OncoVent.
Information on the clinical trial can be found on www.clinicaltrials.gov with the identifier: NCT04498117.
OQP also announces the appointment of Dr. Sunil Gupta as Chief Medical Officer. Dr. Gupta, MBBS, FRCPC has over 30 years of senior leadership experience in clinical development, medical and regulatory affairs focussed on oncology drug development.
Prior to joining OQP, Dr. Gupta was with Agenus Inc. for 2 years as Vice President of Regulatory and Pharmacovigilance. Prior to joining Agenus, Dr. Gupta was with Sanofi and legacy company Rhone-Poulenc Rorer for 22 years. Dr. Gupta has led several clinical trial programs in oncology that led to regulatory approvals with FDA, EMA and other agencies worldwide during his pharmaceutical industry career. In a leadership role he has secured registration of 2 molecules, Eloxatin (oxaliplatin) for colorectal cancer and Jevtana (cabozitaxel) for advanced prostate cancer, with successful FDA, EMA, and other health agency interactions worldwide. Dr. Gupta obtained his medical education in India followed by an internal medicine residency and oncology fellowship at the Ottawa University Hospitals, Ottawa, Canada. He completed an additional year of advanced fellowship at the Indiana University Purdue University Medical Center at Indianapolis.
"We are pleased to welcome Dr. Gupta to our clinical development team and to have started the Phase 3 trial" said Dr. Madi Madiyalakan, Chairman of OncoQuest Pharmaceuticals, Inc. and CEO of Quest PharmaTech Inc. "We are grateful to so many individuals who have helped us get to this milestone, including Dr. Eliel Bayever, our former Chief Medical Officer who recently left OQP to pursue other opportunities".
A summary of the company’s work to date on Ovarian Cancer can be found at www.oncoquestinc.com
About Oregovomab.
Oregovomab is a murine IgG monoclonal antibody 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 a recently completed randomized Phase 2 clinical trial of 97 patients. In this Phase 2 clinical trial, treatment with oregovomab demonstrated a highly clinically significant outcome for both progression-free survival and overall survival favoring the addition of oregovomab to a standard of care chemotherapy combination of paclitaxel and carboplatin. 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 Gynecology Oncology 2020 156:523-529) and Cancer Immunology and Immunotherapy 2020 69: 383-397, respectively.