Stem Cell Therapeutics Corp. has announced the signing of an agreement with University Health Network ("UHN"), through its commercialization agent MaRS Innovation ("MI"), both of Toronto.
The agreement provides Stem Cell Therapeutics ("SCT") with an option to an exclusive world-wide license to an innovative cancer stem cell program.
Based on Dr. Aaron Schimmer's award-winning research, the technology has provided 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.
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," commented David Allan, Executive Chairman of SCT.
Allan continued, "He is following in the steps and traditions of other world-renowned Canadian stem cell researchers such as Drs. Ernest McCulloch, James Till and John Dick. 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.
"This opportunity, emerging from Dr. Schimmer's research, targets an unmet medical need in leukemia therapy and is a compelling example of MaRS Innovation's critical role in bridging the technology gap for promising early-stage assets from our members through translational funding and strategic guidance," said Dr. Raphael Hofstein, president and CEO of MaRS Innovation. "We are pleased to have collaborated with UHN and partner with Stem Cell Therapeutics on this exciting project."
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.
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.
Dr. Christopher Paige, Vice President, Research at UHN, stated "We are very pleased to have created this partnership with the emerging Canadian biotechnology company, Stem Cell Therapeutics Corp. This is an excellent example of how research hospitals such as the UHN can work with MaRS Innovation and receptor companies to translate cutting-edge Canadian research discoveries into the prospect for important benefits to patients."