CARLSBAD, Calif. — Lineage Cell Therapeutics said it has received a novel induced pluripotent stem cell line containing hypoimmunity edits from Factor Bioscience, marking a milestone in the companies’ strategic collaboration to develop next-generation allogeneic cell therapies.
The gene-edited iPSC line was engineered by Factor and is intended for Lineage’s use in differentiating certain cell transplant product candidates. Lineage said the edits are designed to support applications that do not rely on immune-privileged sites or human leukocyte antigen matching and include an additional disease-specific modification intended to further differentiate the cell line from other cell therapy approaches.
Receipt and acceptance of the cell line triggered a success payment from Lineage to Factor, reimbursing Factor for its development efforts to date. Factor remains eligible for an additional payment if Lineage elects to enter into an exclusive license to use the cell line. Lineage said its decision to proceed will depend on further performance criteria and additional testing, including evaluation of the line’s compatibility with its proprietary AlloSCOPE allogeneic cell expansion manufacturing platform.
“Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies,” said Brian M. Culley, Chief Executive Officer of Lineage. “This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen®, for dry age-related macular degeneration with geographic atrophy. We look forward to leveraging the knowledge and expertise we have developed in retinal cell transplantation to additional cell therapy product candidates which may have the potential to transform the treatment of a wide range of diseases. We view the convergence of directed cell differentiation with modern gene editing technology as an exciting new branch of medicine, and we plan to continue to advance this emerging space.”
“The cells we have delivered to Lineage embody the incredible potential of Factor’s gene-editing technology and represent a major milestone in the partnership between our companies,” said Matt Angel, Ph.D., Chief Executive Officer and President of Factor. “We believe Factor’s state-of-the-art cell-engineering technologies have the potential to enable treatment of diseases in ways not previously possible. Factor and Lineage together are driving progress at the leading edge of engineered cell therapy development to benefit patients.”
Lineage and Factor entered into an exclusive option and license agreement in 2023. Under the agreement, Factor developed the hypoimmune iPSC line using a development strategy informed by subject matter experts and competitive landscape analysis. The edits include targeted deletion of the B2M gene to reduce immunogenicity by limiting rejection by CD8+ T cells, insertion of the HLA-E gene to help prevent adverse natural killer cell responses, and a third undisclosed edit intended to provide clinical differentiation and competitive advantage in selected indications.
