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Impact Biomedicines presented a case review on fedratinib, a selective oral small molecule JAK2 kinase inhibitor that is being developed for the treatment of myelofibrosis (MF) and polycythemia vera (PV), in a poster session at the 59thAmerican Society of Hematology (ASH) Annual Meeting, taking place on December 9-12, 2017 in Atlanta, GA. The poster titled “Case Series of Potential Wernicke Encephalopathy in Patients treated with Fedratinib,” demonstrated that patients treated with fedratinib in clinical trials did not experience a decrease in thiamine levels, and the prevalence of Wernicke Encephalopathy (WE) in the trials was less than originally perceived for patients with myeloproliferative neoplasms. Results presented in the poster included a retrospective analysis of clinical reports showing that thiamine levels and MRI results from the 8 subjects suspected to have WE clearly supported a diagnosis of WE in only 1 of 877 treated subjects. The diagnosed patient entered the fedratinib clinical trial with >10% weight loss and had preceding protracted nausea and vomiting, suggesting this as a contributing factor to malnutrition and thiamine deficiency. This patient was treated with IV thiamine and WE was considered resolved 2 months later. In JAKARTA-1, a completed international Phase 3 pivotal trial for the treatment of myelofibrosis, fedratinib met its primary and secondary endpoints by reducing spleen size in 47% of patients by =35% at 24 weeks (p<0.0001) and improving symptom score in 36% of patients by =50% at 24 weeks (p< 0.0001)1. Comparable responses were seen in patients with normal or low platelet counts and thrombocytopenia was similar between placebo and the target dose of 400mg. In JAKARTA-2, a study in patients who were unresponsive to all other available therapies, including patients who were either Jakafi® (ruxolitinib) resistant or intolerant, fedratinib showed similar activity2. In that study, 55% of patients who had failed or were intolerant to ruxolitinib experienced a spleen size reduction of =35% with fedratinib. Notably, responses were noted in 63% of patients intolerant to ruxolitinib and 61% of patients who had lost ruxolitinib response. Currently, ruxolitinib is the only drug approved by the FDA to treat patients with MF and PV. The most common adverse events for fedratinib were hematological (anemia) and gastrointestinal (nausea, diarrhea and vomiting). The results of these trials have been published in peer-reviewed journals.

Impact Biomedicines announced the expansion of its management team to include Randy Adams as Senior Vice President of Commercial Operations and Jeff Barker as Senior Vice President of Global Technical Operations. Randy has over 20 years of commercial experience in the specialty pharmaceutical and medical device industries. Previously, Mr. Adams was Executive Vice President and Partner at Carling Communications, where he was instrumental in building a global strategic consulting and medical communications agency and was strategic lead on multiple specialty product launches. Mr. Adams currently serves on the board for the American Eye Cancer Association. Jeff Barker brings over 23 years of Chemistry, Manufacturing, and Controls (CMC) development experience to the company. Prior to joining Impact, Mr. Barker served as the principle consultant for Strategic CMC Consulting LLC, where he supported two emerging oncology biotech companies in developing their NDA submissions. Prior to consulting, Mr. Barker served as the Vice President of Pharmaceutical Sciences at Trius Therapeutics where he was responsible for all CMC development including the development and commercialization of SIVEXTRO, an oxazolidinone-class antibiotic.