A Chinese company has presented early clinical data on two CAR-T therapies in patients with kidney cancer, and it plans to decide by the end of the year whether to expand the therapies’ development to Europe or the US.

Exuma Biotechnology – which is headquartered in the Cayman Islands and operates primarily in the Chinese cities of Shanghai and Shenzhen – announced Tuesday the presentation of first-in-human data for its CAR-Ts, CCT301-38 and CCT301-59, in seven patients with recurrent or refractory metastatic Stage IV renal cell carcinoma (mRCC) at the Association for Cancer Immunotherapy’s 2019 meeting in Mainz, Germany.

The main difference between the CAR-T’s is that they respectively target the antigens AXL and ROR2, but they were both included in an “umbrella” clinical trial that randomized patients to receive one or the other depending on which antigen their tumors expressed. The data showed that six of seven patients remained alive, with a median follow-up of 140 days, with stable disease as the best response. The trial is currently taking place at the Shanghai Public Health Clinical Center.

The company is planning to extend the study to other hospitals in China by the end of the summer, and it has already had initial discussions with oncologists with regard to the possibility of initiating studies in the US, said Gregory Frost, founder of Exuma and managing director of biotech venture capital firm F1 BioVentures, in a phone interview. However, given the differences in standard of care for mRCC between China, the US and Europe, Frost said an “umbrella” trial design would be unlikely outside of China, and the company would instead use either the AXL or ROR2 therapy.

“There obviously will be differences in frontline therapy,” Frost said. “If you take patients in Europe versus the US, those therapy lines will vary to a certain extent.”

One aspect of CAR-T production where the company has devoted considerable focus is on logistics, especially chain of custody. Because autologous CAR-Ts like Exuma’s are tailor-made for patients using their own cells, it’s of particular importance to ensure a patient does not inadvertently receive the cells of another patient. Such an incident occurred in the fall of 2016, when two patients in a clinical trial nearly received each other’s CAR-T doses, resulting in the products being rendered unusable, GlobalData – formerly BioPharm Insight – reported in October 2017. Chain of custody will become especially important as hospitals administer multiple cell therapy products.

Exuma developed its own electronic batch record (EBR) system from the ground up. The system, which uses QR codes, is designed to minimize delays as the trial becomes a multi-center study and has resulted in a 12-day “vein to vein” production process, Frost said.

Photo: Alaric DeArment, MedCity News

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