Quest PharmaTech Inc, a pharmaceutical company developing and commercializing products for the treatment of cancer, has completed a critical review of the development status for its recently acquired therapeutic antibody platform, conducted in association with external consultants and leading international experts in cancer therapeutics and immunology. Advances in the understanding of immune regulatory pathways and immune activation suggest that a revised strategy for these agents has substantial therapeutic benefit potential.
More specifically, the company believes that combinatorial immunotherapy which necessarily takes advantage of immune modulating effects of selected cytotoxic agents, normally used as part of standard chemotherapy regimens, as well as the use of specific immunoadjuvants will lead to important commercial application of this immunology platform in the treatment of cancer.
Quest's technology platform includes a series of antibodies that target several different cancer markers and have potential for development in multiple indications. Taking advantage of the availability of clinical grade oregovomab (anti CA125 antibody), Quest will conduct three carefully planned and executed proof-of-concept clinical trials to establish these principles to ultimately lead to the design of a definitive combinatorial product registration.
An 80 patient multicentre Italian cooperative trial will establish evidence for the clinical benefit associated with enhanced specific T cell immunity achievable by combining oregovomab with carboplatin and paclitaxel in the initial treatment of advanced ovarian cancer. Concurrent to this effort, a 30 patient Canadian clinical trial will evaluate the ability of a TLR-3 agonist to enhance the strength of the oregovomab immune response generated in the 'maintenance' setting in advanced ovarian cancer patients following front-line chemotherapy. The third clinical trial to be conducted in the U.S. will use gemcitabine, another cytotoxic agent, in a cohort of patients with CA125 associated resectable pancreatic cancer in combination with oregovomab.
All the clinical efforts are supported by preclinical and clinical data in the published works of Dr. Christopher Nicodemus, M.D., FACP, who will help implement the strategy by chairing Quest's Clinical Advisory Board.
"Successful completion of our clinical strategy will lead to a product for one or all treatment phases of advanced ovarian cancer, starting with front line treatment followed by watchful waiting and finally retreatment or initial treatment of recurrent disease. Hopefully, the label could be expanded to include any CA125 associated malignancy," said Dr Madi R Madiyalakan, chief executive officer of Quest. The global ovarian cancer market is anticipated to reach US$ 1.65 billion by 2016.
The additional antibodies in the platform (anti-MUC1, anti-PSA, anti-CA19.9 and anti-TAG 72) will undergo continuing preclinical development in anticipation of rapid clinical development once the initial oregovomab studies establish the validity of the combination therapy premise.
The oregovomab clinical development strategy also includes a 24 month program to define an optimal registration path for the product or combination in CA125 associated malignancy and also to implement a new manufacturing plan for the product. The Company is in advanced discussion with several companies to help implement the overall strategy; but is not in a position to announce details of these discussions at this time.
Quest PharmaTech is developing the high affinity monoclonal antibody oregovomab (MAb B43.13) for the treatment of ovarian cancer. Oregovomab targets the circulating tumour-associated antigen CA125.
Quest is a publicly traded, Alberta-based biotechnology company committed to the development and commercialization of oncology product candidates.