Developing innovative therapies for unmet medical needs
Kadmon is a fully integrated biopharmaceutical company engaged in the discovery, development and commercialization of small molecules and biologics for unmet medical needs. Our product pipeline is focused on autoimmune, inflammatory and fibrotic diseases as well as immuno-oncology.
We are developing oral small molecule inhibitors of Rho-associated coiled-coil kinase (ROCK) for the treatment of autoimmune, inflammatory and fibrotic diseases. Research by Kadmon and several academic institutions has demonstrated that ROCK inhibition can regulate aberrant immune responses and fibrotic processes.
Our most advanced product candidate, KD025, is a selective ROCK2 inhibitor in an ongoing registration clinical trial for the treatment of patients with chronic graft-versus-host disease (cGVHD), a complication arising from allogeneic hematopoietic stem cell transplantation. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KD025 for the treatment of cGVHD. We also plan to initiate a Phase 2 clinical trial of KD025 in systemic sclerosis, an immune and fibrotic disorder sharing several pathological complications with cGVHD, in the first half of 2019.
We are also developing a ROCK inhibitor, KD045, for the treatment of fibrotic diseases. We expect to complete an IND submission and initiate a clinical trial of KD045 in the second half of 2019.
In addition to our ROCK inhibitors, we have a biologics platform focused on the development of fusion proteins containing IL-115 that we believe will be an important addition to the next generation of immuno-oncology therapeutics. Our lead candidate from this effort, KD033, is an anti-PD-L1/IL-15 fusion protein. We expect to complete an IND submission and initiate a clinical trial of KD033 in the second half of 2019