By Michal Clements W’84
As part of Penn’s Year of Health, Chicago area Penn alumni gathered on February 18, 2015 for a captivating presentation by Dr. Bruce Levine, C’84, my Penn undergraduate classmate, and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the Perelman School of Medicine.
The engaging topic was “Designing and Building Targeted Immunity from Patient’s Own Cells: Treating Untreatable Cancers.” The meeting was sponsored by the Perelman School of Medicine and the Penn Club of Chicago.
Nine highlights of the lively presentation were:
1. Penn was granted Breakthrough Therapy Designation for Gene Immunotherapy by the FDA (similar to the TSA Pre Check line for FDA approval). (http://www.uphs.upenn.edu/news/News_Releases/2014/07/ctl019/)
2. As of 2014, the Penn team (Abramson Cancer Center of the University of Pennsylvania) treated over 150 patients with CLL, ALL, Lymphoma, and myeloma with their own engineered T cells designed to kill their cancer. To qualify, all patients must have relapsed following two other treatments. The overall complete response rate for the ALL subgroup is 90%; Moreover, 70% of this group have failed stem cell transplant prior to receiving their investigational T cell therapy.
3. Penn’s program and research is expanding to treat a broad range of cancers, beyond CLL, ALL and Lymphoma, including breast cancer, pancreatic cancer, ovarian cancer, mesothelioma, glioblastoma and others. More information is available here: www.penncancer.org/Tcelltherapy and at http://somapps.med.upenn.edu/pbr/cvpf/
4. Penn’s medical campus footprint has increased seven to ten fold since the early 1980’s when Dr. Levine and I were undergraduates. The new Center for Advanced Cellular Therapeutics http://www.uphs.upenn.edu/news/News_Releases/2014/09/cact/ center will open in 2016.
5. This treatment is for patients who have not succeeded with other courses of treatment. Cell and Regenerative Medicine may become the next pillar of cancer therapy (after surgery, chemotherapy, radiation). It’s possible that this will relegate stem cell transplants to history.
6. The clinical trial patients are “like astronauts” because they are take the step into the unknown. Pediatric patient, Emily Whitehead, serves as one example. Emily’s treatment been profiled in the short documentary by Ross Kauffman “Fire with Fire” https://vimeo.com/54668275 and in the upcoming PBS Ken Burns’ special “Cancer: The Emperor of All Maladies”, episode 6. The PBS special will air on PBS on March 30th- April 1st.
7. In August 2012, Penn Medicine entered into a partnership with Novartis to tap into their global research and regulatory expertise. In December 2012, Novartis bought a manufacturing facility. Penn’s program is differentiated from other Gene Immunotherapy programs through this operational capability and expertise (along with the Penn team). At present, manufacturing the CAR T Cells is a very manual process, since each lot is unique- made from the patient’s own cells. Work continues to CAR T Cell make the process more automated.
8. It took approximately 30 years for stem cell transplants to reach the 1 million mark,, a target is that CAR T Cell might accomplish this in half that time.
9. Philanthropy from the Alliance for Cancer Gene Therapy and others funded the initial research. Interested Penn alumni can contribute directly at https://giving.apps.upenn.edu/giving/jsp/fast.do?program=MC&fund=602548
Dr. Levine provided ample bonus material, including recommendations for more the upcoming PBS special, and the Fire with Fire VIMEO. On behalf of the Penn Club of Chicago, I want to thank Dr. Levine again and also the Perelman School of Medicine for co-sponsoring the event. Seeing this progress made renewed my sense of pride in Penn!
More info on designation is here: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm
Putting it in perspective, this is the first for an academic institution, the FDA has previously granted Breakthrough Therapy to only four other biologic agents and this is the first personalized cell therapy for cancer to obtain it. From October 2013 through June 30, 2014 the FDA received 20 applications and only 3 were approved, the previous year, 10 of 11 applications were not approved.