By GRAHAM HICKS
University of Alberta experimental oncologist Dr. John Lewis has worked on “delivery platforms” at the nano scale — i.e. incredibly tiny — to carry drugs or gene therapies to exactly where they are supposed to go in the body in a safe and timely manner.
Consider the delivery platform to be Star Wars’ Luke Skywalker and his X-wing fighter, attacking the mighty but diseased Death Star molecule: Finding, attacking, gaining entry, and deeply penetrating The Death Star to find the exact target to blow it all to kingdom come.
After decades of experimentation, Dr. Lewis’s company Entos Pharmaceuticals has developed its Fusogenix drug-transport mechanism (i.e. the X-wing fighter) to carry cancer, autoimmune, inflammatory and anti-aging drugs/therapies to precise locations in the body, to penetrate resistant molecules and drop off the drug payload exactly where needed within the molecule.
An experimental new drug is being tested by Entos in partnership with an unnamed (for competitive reasons) global biopharmaceutical firm. The drug and the delivery platform will be tested in human trials — the most difficult and final stage in the drug approval process.
This is high drama, carried out in slow motion.
It’s about getting drugs and micro-therapies precisely positioned within the body to do their jobs without toxic side effects, a Holy Grail the bio-medical world has yet to accomplish.
The stakes are high. Globally, medical researchers are developing and testing nano-sized drug delivery platforms. Whoever “wins” will not only gain admittance to the medical hall of fame, but will also create a medical technology worth billions of dollars. As the finish line looms, Entos’ Fusogenix drug-delivery system is a front runner.
High-risk venture capital firms are placing their platform-delivery bets, says Entos advisor Jason Ding of Deloitte Corporate Finance. Whoever “wins” will reap huge returns. Others will see millions of dollars flushed down the toilet.
Should Dr. Lewis’s platform and the mystery drug prove effective and safe in humans, Entos could earn up to $109 million in future royalties.
That could be just the start. The Entos delivery platform has the potential to deliver hundreds of nano-drugs and DNA gene manipulators — to precisely the right locations within the body.
The platform could also be the delivery system for CRISPR technology. which is revolutionizing genomic disease treatment and is raising fears about unregulated genetic modification.
“The body is really good at stopping anything from getting into cells and changing DNA,” explains Dr. Lewis. “It copes with viruses that mutate on a daily basis, always trying to get in.”
For every improvement in nano-delivery platforms — new generations of the X-wing fighter — the targeted Death Star molecule fights back. “Tamed” viruses — stuck on the platforms — can sneak through the body’s defenses, but only once. The body’s immune system wastes no time “reading” and then blocking new viruses.
A platform made from a lipid (fat) particle can snuggle up against the Death Star, but is no good at finding an entrance. When the lipid particle was engineered to punch through the Death Star’s membrane, toxins within the molecule spewed into the bloodstream, overwhelming the liver’s blood-cleansing properties. The cure was worse than the disease.
Dr. Lewis’s delivery platform is re-useable, a lipid particle coated with the tiniest of viruses (to evade the immune system) that can fight its way into the Death Star without unleashing toxins into the bloodstream. The delivery platform itself can be nano-manufactured here in the city, at the University of Alberta’s Cell Therapy Manufacturing facility.
In the laboratory, the Fusogenix platform has delivered cancer-fighting drugs into cancer-riddled cells. Tumours in mice have shrunk by 97 per cent. Quite apart from Fusogenix, Dr. Lewis is working on promising gene therapies that may stop cancers from spreading.
Don’t count your chickens before they hatch. Drug testing in humans has a bad habit of not crossing the final safety and regulatory hurdles. Dr. Lewis still doesn’t know if Fusogenix will be 100% safe and effective in human beings. Only the clinical trials will tell.
“We know it works in animals,” he says. “If our platform, in partnership with drug-development companies, proves to be active and safe in human trials, then the sky is the limit.”