Loxo Oncology Shares Volatile, Now Largely Unch Following News Co.'s LOXO-101 Showed Encouraging Initial Results from Ongoing Phase 1a Study

Loxo Oncology, Inc.

, a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, today announced the presentation of initial Phase 1a safety and pharmacokinetic data for LOXO-101, the only selective inhibitor of the TRK family of tyrosine kinase receptors in clinical development, in a poster session at the American Association for Cancer Research (AACR) 2015 Annual Meeting in Philadelphia, PA. The poster, entitled "Pharmacokinetics (PK) of LOXO-101 during the first-in-human Phase I study in patients with advanced solid tumors: Interim update," will be presented in the Experimental and Molecular Therapeutics session today from 1:00 PM - 5:00 PM ET in poster section 32. The poster is also available at www.loxooncology.com. "We are very pleased with the initial clinical data for LOXO-101 and are excited about the drug's pharmacokinetics so far," said Jennifer Low, M.D., Ph.D., Chief Medical Officer of Loxo Oncology. "LOXO-101 has been well tolerated with systemic exposures that exceed our preclinical predictions for these dose cohorts. At doses tested thus far, drug levels of LOXO-101 are already at biologically relevant concentrations and support the therapeutic potential of this highly selective inhibitor of TRKA, TRKB, and TRKC. We look forward to turning our focus towards TRK-altered patients." Key findings from the poster presentation include: * As of the data cut-off for the poster, March 26, 2015, 15 patients have been enrolled across three dose cohorts: 50mg QD (n=4), 100mg QD (n=5), and 100mg BID (n=6), including one soft tissue sarcoma patient with an NTRK1 fusion enrolled on March 10, 2015 * Pharmacokinetics show good systemic exposure of LOXO-101 after oral dosing, with higher exposures observed than those predicted in nonclinical studies * LOXO-101 was generally well tolerated with the most common adverse events being Grade 1 and 2 fatigue, dizziness and anemia; no study drug related serious adverse events (SAEs) have been reported; the maximum tolerated dose (MTD) has not yet been reached. In the second half of 2015, Loxo will provide an update on its clinical development plans for LOXO-101. LOXO-101 was developed in collaboration with Array BioPharma.