NEW YORK – Exuma Biotech on Tuesday said it will collaborate with Moffitt Cancer Center to advance the development its point-of-care CAR T-cell product for B-cell malignancies.
The CD19- and CD22-targeting CAR T-cell product is the first therapy in Exuma's pipeline that uses its rapid point-of-care (rPOC) platform. The company claims the platform enables CAR T cells to be infused into patients within six hours after blood is drawn and doesn't require them to receive lymphodeleting chemotherapy. Exuma envisions deploying rPOC in community infusion clinics and believes the platform has the "potential to make same-day autologous CAR T a reality for cancer patients."
Moffitt will work with Exuma, both located in Florida, to further validate rPOC, conduct analytical testing, and screen patients with the goal of filing an investigational new drug application and launching first-in-human studies. The cancer center will provide regulatory support and participate in meetings with the US Food and Drug Administration. EXUMA will transfer its rPOC gene vector technology to Moffitt's Cell Therapy Facility, so the cancer center can evaluate its performance using blood samples from healthy donors and lymphoma patients.
"For cancer's most vulnerable patients, the time it takes to receive CAR T is often the first hurdle," Sid Kerkar, VP of oncology R&D at Exuma, said in a statement. "This partnership allows us to accelerate our potential treatment for cancer patients from the lab to the clinic, with our combined teams of internationally renowned scientists."
Exuma believes its point-of-care product can help improve access to CAR T-cell therapy and reduce costs. The company released preclinical data on its product in November, showing robust CAR T-cell expansion (greater than 10,000 fold) and tumor regression in animal studies.