Developing Tomorrow’s Therapies
Caladrius leverages the manufacturing expertise of its subsidiary, PCT, a leading development and manufacturing partner to the cell therapy industry. Caladrius develops selected potentially disruptive cell therapies through preclinical or early-stage clinical studies to their next clinical milestone (likely proof-of-concept). These therapies are identified based on the Company’s constant exposure to new developments in the industry through PCT. Upon acheiving proof-of-concept, Caladrius intends to seek partners or out-license the technologies for execution of the remainder of the their development. In so doing, Caladrius hopes to promote revenue growth at PCT as the preferred cGMP manufacturing partner for cell therapy developers whose product are ready for later-stage clinical studies and commercialization.
CLBS03: Candidate for the Treatment of Recent-Onset Type 1 Diabetes
Caladrius is currently focused on developing an autologous T-regulatory (Treg) cell-based therapy (CLBS03) for the treatment of recent-onset type 1 diabetes mellitus (T1DM). CLBS03 is being investigated in an on-going Phase 2 clinical study in strategic collaboration with Sanford Research. The candidate has received international regulatory recognition including Fast Track and Orphan Drug designation for the treatment of T1DM from the FDA and Advanced Therapeutic Medicinal Product (ATMP) classification from the European Medicines Agency. Learn more.