Global Cord Blood Corporation (GCBC; NYSE: CO) announced receiving Investigational New Drug (IND) approval from the US FDA for its subsidiary Cellenkos’ pipeline candidate CM0804. The FDA clearance allows Cellenkos to initiate a Phase Ib, open-label study for CM0804 as an add-on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib.
Collaboration Details
CM0804 was licensed to Incyte Corporation (NASDAQ: INCY) for development and commercialization alongside Jakafi, the JAK inhibitor ruxolitinib. This collaboration aims to address the needs of myelofibrosis patients who do not achieve optimal responses to ruxolitinib therapy.
Acquisition Background
GCBC announced the acquisition of Hong Kong-based Cellenkos on April 29, 2022, in a cash deal valued at USD 664 million. The acquisition granted GCBC full ownership of Cellenkos, excluding the rights to CK0804 and those already licensed to Incyte. Cellenkos specializes in cell therapy using umbilical cord blood to develop innovative, allogeneic, off-the-shelf cell-based therapies.
Pipeline Highlights
Cellenkos’ preclinical pipeline includes T-regulatory (T-reg) cell therapies targeting autoimmune diseases and inflammatory disorders. Another key product, CK0802, has completed a Phase I study as a treatment for COVID-19-induced acute respiratory distress syndrome (ARDS) in 45 patients.-Fineline Info & Tech
