Some of the hottest areas in biotech that are emerging and driving growth and investment are in the field of regenerative medicine and cell and gene therapy. There have been several acquisitions over the past year that really got the ball rolling with hopes to advance immunotherapies. Despite the curative potential, these therapies come with a hefty price tag and complex challenges. With the first immunotherapies to win regulatory approval in the United States, CCRM, a leader in developing and commercializing cell and gene therapies and regenerative medicine technologies, hosted a panel to discuss how we can bring these therapies to Canada.
The panel represented a wealth of knowledge covering regulatory and hands on approaches to the subject. It was moderated by Michael May, president and CEO of CCRM, and consisted of Donna Wall, MD, section head, Blood and Marrow Transplant/Cell Therapy Program, The Hospital for Sick Children (SickKids); Justin Shakespeare, executive director, Oncology Business Unit, Amgen; Patrick Bedford, senior manager, Clinical Translation and Regulatory Affairs, CCRM; and Aaron Dulgar-Tulloch, PhD, director of Bridge, GE Healthcare Cell Therapy.
There have been many decades of work in people trying variations of immunotherapy approaches and not getting a clinical signal. It was after researchers figured out T-cell biology and that they needed to bring not only the patients’ T-cells right up against the tumour cell but also that they had to get the T-cell excited and activated to go into cell division.
“The first successful patient was only about six years ago. No question that the treatment can cure, as long as you take six years as to how long to treat a number of patients who otherwise have untreatable leukemia,” says Wall. “That’s the first type of patients that we have when we have a new treatment. We take the patients where we have nothing else to offer. A number of patients do not make it to the treatment because it takes a while to engineer the cells; a number of patients may not have a response to the treatment; and a number of them who go into remission may end up relapsing. But for the first time, there are many who are responding positively to treatment and are not showing signs of leukemia.”
