• Pharmacokinetics show good systemic exposure of LOXO-101 after oral dosing, with drug levels approaching therapeutic ranges
  • LOXO-101 has been well tolerated; dose escalation is ongoing
  • The Phase 1b study, examining proof of concept exclusively in patients with NTRK alterations, is expected to begin in the second half of 2015

STAMFORD, Conn., April 21, 2015 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), 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.

About LOXO-101

LOXO-101 is a potent, oral, selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules. The TRK family (TRKA, TRKB, and TRKC) has been implicated in diverse tumor types such as lung cancer, head and neck cancer, melanoma, colorectal cancer, sarcoma, and breast cancer. LOXO-101 was built specifically to inhibit TRK and is currently the only selective TRK inhibitor in the clinic. LOXO-101 is currently being evaluated in a Phase 1 dose escalation trial for patients with advanced solid tumors.

About Loxo Oncology

Loxo Oncology is committed to the discovery, development, and commercialization of targeted cancer therapies with best-in-class potential. Our diverse pipeline reflects the convergence of proven therapeutic technologies with emerging insights into the underlying susceptibilities of cancer and drug resistance. We partner with leaders in academia and industry, allowing our management team to focus on clinical-regulatory execution in well-defined patient populations. www.loxooncology.com.

Forward Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, statements we make regarding our future financial performance, business plans and objectives, partnerships, timing and success of our clinical trials, our ability to obtain regulatory approval, the potential therapeutic benefits and economic value of our lead product candidate or pipeline candidates, potential growth opportunities, financing plans, competitive position, industry environment and potential market opportunities. Further information on potential risk factors that could affect our business and its financial results are detailed in our Annual Report on Form 10-K for the period ended December 31, 2014, filed with the Securities and Exchange Commission on March 27, 2015, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


Company: Jacob S. Van Naarden Vice President, Corporate Development and Strategy jake@loxooncology.com

Investors: Peter Rahmer The Trout Group, LLC 646-378-2973 prahmer@troutgroup.com

Media: Dan Budwick Pure Communications, Inc. 973-271-6085 dan@purecommunicationsinc.com