Celgene set to obtain Impact Biomedicines to develop Fedratinib

Celgene Corporation and Impact Biomedicinessigned and agreement that entails acquisition of Impact Biomedicines enabling development of fedratinib  for myelofibrosis and polycythemia vera.

Fedratinib, a highly selective JAK2 kinase inhibitor, was assessed in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial (JAKARTA-1) for patients with treatment-naïve myelofibrosis, fedratinib exhibited remarkable improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, improvements were marked irrespective of  a patient’s baseline platelet count.

Nadim Ahmed, President, Hematology and Oncology for Celgene said “We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets.”

Phase II trial (JAKARTA-2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor. JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration (FDA) after potential cases of Wernicke’s encephalopathy (WE) were reported in eight out of 877 patients receiving one or more doses (less than one percent of treated patients). The FDA removed the clinical hold in August 2017.

Based on the benefit risk profile of edratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in myelofibrosis are set to commence in the middle of 2018.