On January 11, 2021 EXUMA Biotech Corp., a clinical-stage biotechnology company discovering and developing chimeric antigen receptor (CAR)-T products and delivery solutions for liquid and solid tumors, reported that the company has entered into a strategic collaboration with Moffitt Cancer Center to develop EXUMA’s first rapid point-of-care, or "rPOC", subcutaneous (SC) product for the treatment of B cell malignancies (Press release, EXUMA Biotechnology, JAN 11, 2021, https://exumabio.com/news/2021/01/exuma_moffitt_collaboration/ [SID1234573808]). EXUMA’s first product using rPOC technology targeting CD19 and CD22 has the potential to complete treatment within a six-hour time frame from blood draw to injection, without preparative chemotherapy. Moffitt will provide regulatory support, gene product characterization, and analytical testing to support first-in-human studies.
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"For cancer’s most vulnerable patients, the time it takes to receive CAR-T is often the first hurdle. We look forward to our new collaboration with Moffitt Cancer Center, and the development of our rPOC CAR-T product. 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," said Sid Kerkar, M.D., Vice President Oncology R&D at EXUMA Biotech.
The collaboration enables EXUMA and Moffitt to further characterize and validate the rPOC technology and qualify analytical testing for product and patient screening to support IND submission. EXUMA will tech transfer its rPOC gene vectors to Moffitt’s Cell Therapy Facility. Moffitt will then perform engineering runs using blood from healthy donors and validation runs using blood from lymphoma patients. Moffitt will also participate in FDA meetings with EXUMA, assist with CMC documentation, and perform product characterization.
EXUMA’s rPOC Platform
EXUMA’s next-generation rapid point-of-care, or "rPOC", platform is being developed for subcutaneous CAR-T administration in a matter of hours following blood draw, with the potential to make same-day autologous CAR-T a reality for cancer patients. The long-term vision is for rPOC to be administered in the community oncology infusion clinic without the need for lymphodepleting chemotherapy or long-term immunosuppression.