New Constellations 2019 | Page 8

CANCER BUILDING A BETTER CAR More than anything else in cancer therapy in half a century, the chimeric antigen receptor stands poised to alter the entire treatment paradigm. But it’s not there yet. From a treatment perspective, the chemotherapy regimen for acute lymphoblastic leukemia, or ALL, is impressively effective. “It’s got a cure rate of 85 percent,” says pediatric hematologist and immunologist Terry Fry, MD, one of the world’s preeminent investigators of cancer immunotherapy. “To be clear, that’s not remission. That’s five years out. It is by all standards probably the most effective chemotherapy regimen out there. In trials, it achieved an astonishing 89 percent remission rate. That’s in just 4 months of treatment, compared to the nearly 3 years of traditional chemotherapy ALL patients typically undergo — with none of the harsh, painful effects. “Traditional chemotherapy is effective but toxic,” says pediatric oncologist Michael Verneris, MD, another primary investigator of the CD19 CAR. “And in many cases, it’s not effective.” We want to change the practice of medicine.” MICHAEL VERNERIS, MD Director, Bone Marrow Transplant and Cellular Therapy, The Barton Family Endowed Chair for Bone Marrow Transplant “There are certainly unmet needs, but really we’re doing pretty well,” he continues. “So it’s interesting that this field is where we’ve developed this new therapy.” That new therapy would be the CD19-targeted chimeric antigen receptor, or CAR, the world’s first commercially available cancer gene and immunotherapy, approved by the FDA in 2017. 6 As Director of Bone Marrow Transplant and Cellular Therapy at Children’s Colorado, Dr. Verneris sees that firsthand — not just in the 15 percent of ALL patients chemotherapy fails, but in patients with worse prognoses: neuroblastomas, sarcomas, metastatic and secondary cancers. Even for kids cured, he’s seen the scars chemo leaves in its wake. “We want to change the practice of medicine,” says Dr. Verneris. not be T cells. They may not even come from the patient. Bigger applications Starting with induced pluripotent stem cells, Dr. Verneris’s lab is working to grow and engineer natural killer cells in the same way patient cells are modified now. Leveraging the human leukocyte antigen matching techniques of blood and marrow transplant, his lab could potentially grow CAR cell lines that could treat a wide variety of patients. Still, CAR therapy is not without problems. By a year out, the 89 percent remission rate drops in half. The modified T cells die off. Leukemia cells mutate to resist them. The cancer returns. “We’re working on the guts of how the CAR activates the T cell,” says Dr. Fry. “We’re using the patient’s own cells as the material to make the CAR, and sometimes you get a bad cell. With CD19 you can overcome that in many patients. But once we start applying it to other cancers, the quality of the cell is going to be a real issue.” Dr. Fry is already working to apply it to other cancers. Acute myeloid leukemia, or AML, is a logical next step — and his lab is developing a CAR to target CD33, a protein myeloid cells express. He’ll be kicking off a multisite clinical trial starting at the National Cancer Institute and expanding to five other sites, including Children’s Colorado, this year. His lab also continues to expand its arsenal for ALL, aiming to improve durability. For that, they’re rolling out novel CARs targeting both CD19 and CD22, as well as a cytokine receptor expressed on a high-risk subset of ALL known as TSLPR. Those trials, too, will kick off this year. Meanwhile, Dr. Verneris’s lab is on a mission to adapt CARs for solid tumors. They don’t work for that currently, he says, because they can’t penetrate tumors. “You get a cut on your finger, there’s 10 thousand things that happen,” Dr. Verneris observes. Cascades of signals draw cells and agents to the area to destroy bacteria, stop the bleeding and close up the wound. With manipulation, CAR cells could feasibly be programmed to co-opt those normal immune mechanisms to migrate toward and into tumor tissue. Those future CARs, says Dr. Verneris, may “You could take them right off the shelf,” he says. Bigger access Those next-generation CARs, Dr. Fry says, will grow not from a single lab or even one institution, but out of collaborations that span the globe. As part of the “Pediatric Cancer Dream Team,” funded by Stand Up to Cancer and St. Baldrick’s Foundation, Dr. Fry’s lab works directly with the cancer genomics and immunology players pushing the front lines of treatment. And as a Cancer Immunotherapy Trials Network site, Children’s Colorado will bring those new developments to the clinic. Pediatric cancer immunologist Terry Fry, MD, works with pediatric bone marrow transplant expert Mark Kohler, MD, under the hood. They’re working to develop new targets for CAR-T cells to improve durability and expand the scope of treatment. Dr. Fry holds the Robert J. and Kathleen A. Clark Endowed Chair for Pediatric Cancer Therapeutics. NEW CONSTELLATIONS 7