Forming a PACT to Treat Cancer Patients with Cutting-Edge Cell Therapies
One and a half years into his time at the UW Carbone Cancer Center, Jacques Galipeau, MD, (pictured left) sees 2018 as the year the Cancer Center and other UW Health groups will begin treating patients with new advanced cell technologies available for the first time in the US.
“I was recruited so that the incredible discoveries in the cell technology space bubbling all through the science at UW can get ‘MacGyvered’ into promising high-tech treatments that are accessible through UW Health to Wisconsinites,” Galipeau, a hematologist and the inaugural assistant dean for therapeutics discovery and development in the UW School of Medicine and Public Health, said. He is also director of the Program for Advanced Cell Therapy, or PACT, and tasked with advancing these technologies to treat human diseases.
From conducting the nation’s first bone marrow transplant 50 years ago to leading the way with stem cell research, UW and cell therapy discoveries go hand in hand.
“Fast forward to 2017, 2018, and not a single human subject in Madison has been treated with one of these advanced cell therapy innovations that are coming out of UW,” Galipeau said. “There’s a large and vibrant cell therapy community here, driving discovery. The field is ready for the next step: first-in-human clinical trials. And that’s the gap I was recruited to fill.”
What are these advanced cell technologies? In the language of the Food and Drug Administration, which regulates them, they are cells that are “more than minimally manipulated.” In other words, advanced cell technologies are those in which the cells used in the therapy are grown, enriched or genetically modified before being given to the patient. Compared to the standard bone marrow transplant, where the cells are simply collected and purified but not grown, advanced cell technologies are FDAregulated to ensure that infectious contaminants are not also grown in the process.
“There are three things we want to do,” Galipeau said. “The first is to develop and deploy the genius ideas currently on campus in the cell technology space. Second, we want to scour international best practices that we can readily adopt but will need an FDA license to be done here. And third, we want to work with industries that are operating in this space that are looking for institutions that have the capacity to support a human study that involves cell technologies.”
As both a proof-of-concept and because it has the best chance at success, Galipeau and his PACT team – including director of cell manufacturing Rupa Pike, PhD and medical director Inga Hofmann, MD – are already working on the second task, looking to reduce a complication from bone marrow transplants. Nearly all adults have been infected with CMV, an often symptomless viral infection that usually remains dormant for life in those infected. However, in very immune suppressed people – including those undergoing bone marrow transplants – CMV can reawaken, leading to serious and sometimes deadly complications.
“There’s a technology developed in Germany over a decade ago where you take T cells, a type of immune cell, from a related donor who has anti-CMV immunity and give them to the patient that has the reactivated virus to cure them,” Galipeau said. “They’re using this in Germany and it works beautifully, but here, because it’s more than minimally manipulated, it’s considered experimental. So this is going to be the first trial we roll out, led by Dr. Hofmann, and we expect it to be available this year.”
But that is just the first developmental therapy Galipeau and PACT are pursuing. He wants UW to become a leader in developing even more cell therapies to treat even more diseases. For one, he knows that the pre-clinical research being conducted here has the capacity to become in-human therapies. Also, he wants the technologies developed at UW spun off into start-up companies in Madison.
“Rather than us creating this new intellectual property and putting it out there and hoping an established company will gobble it up, we want to take ownership of moving it forward,” Galipeau said. “Our vision is to create a frictionless pathway to be able to take these new ideas to the next step.”
Date Published: 03/05/2018