Aug 25, 2019

John Hood couldn’t understand why pharmaceutical Sanofi shelved a promising cancer program. So, he took action. Hood founded Impact Biomedicines in 2016 to resurrect fedratinib, a drug he co-invented years earlier to treat a deadly bone marrow cancer called myelofibrosis. His effort proved worthwhile: On Aug. 16, the U.S. Food and Drug Administration approved fedratinib. Celgene — which in early 2018 bought Impact BioMedicines for up to $7 billion — said the drug is the first new treatment for myelofibrosis patients in a decade. “It’s a huge win for patients and a great win for San Diego,” said Hood, who was the CEO of Impact Biomedicines, which was founded locally. Second Chances Impact Biomedicines isn’t alone. Other biotechs are banking on companies’ scrapped or stalled ideas, including Kura Oncology and Mirum Pharmaceuticals. After finding what were thought to be failures, these companies navigated tricky licensing negotiations and convinced skeptical investors to give programs another go. Hood believed in fedratinib so much that he put down a quarter million dollars of his money as a down payment to get the drug back, on the bet he could secure $5 million in investor cash within 120 days. He co-invented the medicine while working at TargeGen, a San Diego company that French drugmaker Sanofi acquired in 2010. But several years later Sanofi shelved fedratinib, by then a late-stage program. The pharmaceutical made the decision after the FDA slapped a clinical hold on the drug after a few patients reportedly developed the neurological condition Wernicke’s encephalopathy. Another Look at the Data With fedratinib no longer available, relapsing patients contacted Hood. He took another look at the patient data. “I thought the reasoning behind the clinical trial stoppage was spurious and incorrect,” Hood said. “I know patients suffered because of it.” Hood said a “bad confluence of events” explain Sanofi’s decision. He cited the pharmaceutical coming off clinical trial failures and fedratinib competition. “This thing had two strikes on it before it ever stepped up to the plate,” he said. Another major advocate of restarting was Catriona Jamieson, a researcher and physician at UC San Diego Moores Cancer Center who treated patients with the drug. By 2016, newly formed Impact Biomedicines advanced the drug and showed it did not increase the risk of Wernicke’s encephalopathy. The FDA hold was lifted, sparking the Celgene deal. New Jersey-based Celgene paid $1.1 billion upfront in cash. With the FDA approval Impact Biomedicines received an undisclosed payment. Factoring in royalties, the deal is worth up to $7 billion.