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Loxo Oncology gets FDA clearance for gene-defined cancer drug application

May 30, 2017

Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the United States Food and Drug Administration cleared the Investigational New Drug (IND) application for LOXO-195, Loxo Oncology’s next-generation TRK inhibitor. LOXO-195 was developed to treat patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as larotrectinib.

“We hope that LOXO-195 can extend the period of durable disease control for patients with TRK fusion cancers,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “Today, there are patients receiving larotrectinib in ongoing clinical trials who have ongoing clinical responses. We have an obligation to these patients, and all patients with TRK fusion cancers, to be ready when they need a new treatment option.”

Informed by internal research and the medical literature, LOXO-195 was designed to address anticipated mechanisms of acquired resistance in cancers exposed to a prior TRK inhibitor, including “solvent front” mutations (e.g. NTRK1 G595R, NTRK3 G623R), which are not well-addressed by existing investigational agents. LOXO-195 will be developed as a sequential treatment, to follow larotrectinib or another TRK inhibitor, to extend the total time of benefit from TRK inhibition.

LOXO-195 will initially be studied in a multi-center Phase 1/2 trial. The primary objective of the trial is to determine the maximum tolerated dose or recommended dose for further study. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Objective Response Rate and Duration of Response, as determined by RECIST v1.1). The trial will include a dose escalation phase and dose expansion phase.


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