Collaboration in cancer stem cell research

Toronto, ON – With compelling evidence that tigecycline, an FDA-approved antibiotic, is able to selectively target leukemia cells and leukemic stem cells by shutting down their energy supply through the inhibition of mitochondrial protein synthesis, this technology, Based on Dr. Aaron Schimmer’s award-winning research, is in the first steps of commercialization.

Stem Cell Therapeutics Corp. (SCT), a life sciences company developing stem cell-related technologies, recently announced the signing of an agreement with University Health Network (UHN), through its commercialization agent MaRS Innovation (MI), both of Toronto. The agreement provides SCT with an option to an exclusive world-wide license to this innovative cancer stem cell program.

Dr. Schimmer, Associate Professor in the University of Toronto’s Department of Medical Biophysics and a clinician-scientist in the Princess Margaret Cancer Centre/Ontario Cancer Institute at University Health Network, published his findings in 2011 in the journal Cancer Cell. Based on this discovery, Dr. Schimmer received the 2012 Till & McCulloch Award presented each year by the Stem Cell Network to recognize the year’s most influential peer-reviewed article by a researcher in Canada.

“In recent years Dr. Schimmer has had a widely-recognized rise to become one of Canada’s premier clinician-scientists,” said David Allan, Executive Chairman of SCT. “We are fortunate to be the commercial partner on what we believe will be an exciting journey to new cancer stem cell-specific products. Repositioning a safe and well-tolerated antibiotic as a cancer therapeutic is an attractive business proposition for SCT, particularly when it is backed by strong science, sufficient differentiation from the original product, and strong intellectual property protecting the new utility, as we find in this opportunity.”

A Phase I multicenter dose-escalation tigecycline trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) is currently ongoing at Princess Margret Cancer Centre (UHN), University of California, Los Angeles and the University of Kansas. In addition to addressing safety and tolerability, this trial will also provide important human proof-of-concept data. Biomarkers indicative of on-target effects and inhibition of mitochondrial translation are being assessed at each dose level. Enrolment is proceeding well in this open label, 28-patient trial. Dosing is estimated to be completed in the first half of 2013. SCT projects that a Phase Ib/IIa combination trial can commence in early 2014 provided the necessary funding is secured.

In parallel with its clinical program, SCT plans to devote additional resources to amplify the preclinical R&D program to unlock the potential of tigecycline and its derivatives. The mitochondrial-targeting mechanism-of-action (MOA) could provide an opportunity for synergy with other cancer therapies, thereby expanding tigecycline’s use from AML into other types of malignancies.

SCT has been granted an option by UHN under which, and prior to April 30, 2013, SCT may conclude the exclusive license provided SCT has secured additional financing sufficient to support its product development operations. The worldwide, exclusive license agreement will contain customary provisions regarding an initial license consideration, milestones, royalties on sales and sublicensing terms.