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Loxo Oncology Announces First Quarter 2016 Financial Results

Loxo Oncology, Inc. LOXO, -1.92% a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today reported financial results for the first quarter ended March 31, 2016. Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

"With cash runway well into 2018, we are nicely positioned to bring our programs through new and meaningful milestones," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In the first half of 2016, we were able to show continued and durable efficacy for LOXO-101 in TRK fusion cancer patients as part of our Phase 1 update at AACR. For the remainder of the year, we will continue to focus on Phase 2 enrollment, moving our highly selective RET inhibitor into the clinic, and advancing our TRK resistance program towards an IND filing. We look forward to providing an update on our Phase 2 enrollment progress by the end of the year."

Recent Highlights

Presented Data from Phase 1 Study of LOXO-101 at the American Association for Cancer Research (AACR) Annual Meeting

In April, Loxo Oncology presented updated data from the Phase 1 trial at the 2016 AACR Annual Meeting in New Orleans. Key findings from the presentation included:

  • As of the March 25, 2016 data cutoff date, six patients with TRK fusion cancers had been evaluated for response across five different tumor types; all six had demonstrated significant tumor regressions, with five achieving a confirmed response by standard RECIST criteria.
  • No TRK fusion patients had progressed, with one patient in cycle 14, two patients in cycle 10, and three patients in cycle 7, as of the data cutoff date (1 cycle = 28 days).
  • Five of the six patients, all of whom remain on study, are being treated at or below the Phase 2 dose of 100mg BID.
  • Adverse events reported regardless of attribution to study drug were generally consistent with those previously presented. Adverse events included fatigue (33 percent), constipation (23 percent) and dizziness (23 percent). Grade 3 adverse events included fatigue, constipation, anemia, increased liver enzymes, dyspnea, abdominal pain, hypertension, hyperkalemia, delirium, pleural effusion and syncope.

Published Case Report of First Pediatric Response to LOXO-101 in the Journal Pediatric Blood and Cancer

In April, Loxo Oncology published a case report in the online edition of the peer-reviewed journal Pediatric Blood and Cancer, co-authored with Nemours Children's Hospital, Northwestern University and St. Jude Children's Research Hospital, describing a partial response in the first patient with a TRK fusion cancer enrolled in the pediatric Phase 1 dose-escalation trial of LOXO-101. Key highlights include:

  • The report describes a 16-month old female patient with advanced infantile fibrosarcoma (IFS), a rare pediatric cancer. Genetic testing revealed an ETV6-NTRK3 fusion, which is frequently found in IFS.
  • At the end of cycle 1 (day 28), imaging of the brain and neck showed tumor regression of more than 90 percent from baseline.
  • Repeat scans at the end of cycle 2 showed a continued decrease in tumor volume. During the preparation of the manuscript, the patient was in study cycle 5 (~5 months), with a confirmed partial response by standard RECIST criteria
  • The patient experienced no adverse events related to LOXO-101...