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Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions, today announced the initiation of a new islet cell transplant program in Type 1 Diabetes (T1D). Specifically, the company aims to deploy its manufacturing capability to address the issue of large-scale production of islet cells, with the initial goal of establishing a production modality that can support the entire production process in a dynamic culturing system, potentially solving a major hurdle to commercialization of islet cell therapy product candidates.
"Recent and emerging evidence suggests that an islet cell transplant may be able to provide the equivalent of a functional cure for some people with diabetes. Several islet cell programs for T1D have reached phase 1 clinical trials, but to our knowledge, the manufacturing process required to supply sufficient material for a meaningful portion of the addressable patient population is a challenge that remains unsolved," said Brian M. Culley, Lineage CEO. "By building upon our recent GMP manufacturing success, we believe we have a compelling opportunity to try and reduce-to-practice an islet cell production system, capable of supporting doses in the hundreds of millions of cells per eligible patient. Our initial goal for this program is to demonstrate this capability with one of our proprietary cell lines, which parenthetically is the third cell line for which we have generated a unique master cell bank at our in-house facility. If successful, we next would seek to demonstrate system compatibility with an internally- or externally-sourced hypo-immune cell line, suitable to support a clinical campaign in T1D. Importantly, we believe we can not only reach an initial feasibility decision on this initiative with a fairly modest investment, but also apply any relevant insights or improvements to our other transplant programs, including programs we may launch in the future. Overall, if we are successful in developing a commercially-viable production modality for islet cells, we believe it will create a compelling product profile, as well as provide options to license this technology to a partner or enter the diabetes
Posted In: LCTX
