At ASCO 2021 in June last year, SQZ Biotech presented an overview of its unorthodox cell therapy manufacturing technology. And on Wednesday, the Watertown, MA company announced that its first-generation system exhibited performance comparable to or better than a conventional cleanroom manufacturing process.
The study was non-clinical. Clinical trials are expected by the first half of 2023.
SQZ’s device opens a temporary window by squeezing cells to deliver cargo to the cells. Its average processing time was less than six hours per batch, more than half the time of conventional methods. The company plans to use the technology in its first red blood cell-derived program for celiac disease. This IND is expected to be submitted in the first half of 2023, the company said.
“We are extremely excited about the cell therapy production data from our prototype point-of-care manufacturing system, which has the potential to produce cell therapies using a range of cell types,” said CSO Howard Bernstein. in a press release. “Our current clinical manufacturing process takes less than 24 hours, which is comparatively faster than other cell therapy manufacturing approaches. Our integrated point-of-care platform represents a step further with faster production in a closed system that could eliminate the need for an ISO 7 clean room.”
Patients with celiac disease could benefit enormously from scalable, decentralized treatment through a more efficient process. The number of human hours required for the manufacturing process has been reduced from 150 to 15 hours, according to SQZ. The system could also produce the red blood cell-derived candidate to treat HPV16-positive solid tumors.