Our completed pipeline milestones include the effective translation of integrated mouse technology platforms and preclinical product lines to humans. This includes lead mAb development for human regulatory B10 cell depletion in vivo and the development of human regulatory B10 cell manufacturing technologies. Both product lines are advancing to manufacturing, clinical application and commercialization.
Our near-term milestone is humanization of our human B10 cell depleting mAbs prior to lead drug selection and manufacturing for IND approval and clinical trials in oncology.
Within our B cell expansion program, current milestones include the optimization and efficient implementation of scaled-up human B cell manufacturing for phase I clinical trials for two orphan diseases, severe combined immunodeficiency (SCID) post-transplant and cGVHD, following IND approval.