"We all recognize the limitations of an autologous product," said Litten, who has spent the last five years working to advance cell therapy in oncology. As the industry looks to move to "off-the-shelf" allogeneic CAR T cell products, he contends there are a number of important scientific and regulatory challenges that will need to be overcome.
Litten, who spoke to ScienceBoard.net at the 2022 Biotechnology Innovation Organization (BIO) International Convention in San Diego, noted that with allogeneic therapies there is the opportunity to give multiple doses while autologous products "are limited in that way."
Although allogeneic T cells present many advantages over autologous T cells, which must be generated from each patient's cells, they also come with specific challenges that need to be overcome to reach clinical success, including manufacturing them at scale.
"My interactions with regulatory bodies have suggested that while [allogeneic] may be ready for the clinic from a clinical and scientific standpoint, the manufacturing has not yet been refined to a place where the agency is ready to approve it as a therapeutic," Litten said. "That is the first, second, and third challenge of bringing new cell and gene therapies to the clinic."
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