The therapy would use pancreatic beta cells derived from induced pluripotent stem cells (iPSCs). iPSCs can be derived from adult human tissue cells yet share the developmental potentials of embryonic stem cells.
Currently, Japan has 6 ongoing clinical trials utilizing this technology, but the rest of the world is now joining the movement with 4 clinical trials initiated outside of Japan in the past year.
Since 2009, Allele Biotechnology has been developing clinically compatible technologies to produce high-quality iPSCs and tissue-specific cells from iPSCs.
The pancreatic beta-cell program is powered by Allele’s core capabilities, including proprietary methods utilizing mRNA for generation and differentiation of iPSCs, and a state-of-art, commercialization-ready cGMP facility in San Diego, Calif.
“We are excited to have a partnership with SCM Lifescience, which has years of experience in cell therapy clinical trials,” says Dr. Jiwu Wang, founder, and CEO of Allele Biotechnology. “This collaborative project will help us quickly generate first-in-human results in the fast-moving field of iPSC-based therapies.”
The purpose of the collaboration is to confirm the therapeutic applicability of Allele’s iPSC-derived pancreatic beta cells for diabetes and related indications.
The initial efforts will be focused on developing an autologous product for certain forms of Type 3c Diabetes (T3cDM), that are inherently non-autoimmune in nature.
Allele Biotechnology also envisages alternative, off-the-shelf allogeneic therapeutic products for other types of diabetes, taking advantage of its growing bank of cGMP-grade footprint-free iPSCs, and gene editing technologies.
SCM Lifescience currently has a number of allogeneic mesenchymal stem cell therapies in its pipeline, indications include chronic graft versus host disease, acute pancreatitis, severe atopic dermatitis, and liver cirrhosis.