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Loxo Oncology Announces Lead Program, a Highly Potent, Selective Trk Kinase Inhibitor

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Company Benefits from Array Biopharma’s Multi-year Discovery Effort; Licenses Diverse Chemical Matter that Selectively Inhibits the Trk Family While Sparing Off-targets Such as JAK, ALK and VEGF One of Company’s Compounds Featured in Scientific Paper Published Online in Nature Medicine on October 27

NEW YORK–(BUSINESS WIRE)–October 28, 2013–

Loxo Oncology, Inc., a biopharmaceutical company focused on targeted cancer therapies for genetically-defined populations, announced today that its lead clinical program is a potent and selective inhibitor of the Trk family of receptor tyrosine kinases. Loxo Oncology acquired rights to this program from Array Biopharma (NASDAQ:ARRY), which had pursued a multi-year discovery effort to design purpose-built compounds that spare structurally similar kinase targets, such as ALK, JAK and VEGF.

“After years of debate, it seems clear that highly specific kinase inhibitors have won the day in oncology,” said Keith Flaherty, M.D., director of the Henri and Belinda Termeer Center for Targeted Therapies at Massachusetts General Hospital and chair of Loxo Oncology’s Scientific Advisory Board. “We have learned that maximal target inhibition leads to measurably better clinical outcomes. Limitations of dose, because of off-target mediated toxicity, prevent us from realizing the full therapeutic potential of a target. We were fortunate to have access to chemical matter rationally designed to inhibit Trk to maximal effect in patients”

Loxo Oncology’s lead candidate has been optimized to preserve low nanomolar potency in both enzymatic and cell based assays, while demonstrating compelling pharmacology through oral dosing. The company remains on track to launch its Phase 1 study in 2014.

Research suggests that Trk has therapeutic potential in many tumor types. In a recent article, “Oncogenic and drug-sensitive NTRK1 rearrangements in lung cancer,” published online in Nature Medicine, Doebele and colleagues describe new findings implicating Trk in lung cancer. The work includes results showing potent growth inhibition with one of the many Trk inhibitors licensed to Loxo Oncology in cell lines harboring a translocation, or rearrangement, of Trk. Several other translocations, including ALK, ROS1 and RET, have been studied as oncogenic drivers in lung cancer and have been associated with robust objective response rates in the clinic.

About Loxo Oncology

Loxo Oncology was incorporated in Delaware in May 2013 and was founded by Josh Bilenker, M.D., a partner at Aisling Capital. Loxo Oncology is committed to bringing targeted cancer therapies rapidly into the clinic that have an opportunity for outsized clinical effects in genetically-defined patient populations. The company signed a multi-target, multi-year collaboration agreement with Array Biopharma (NASDAQ:ARRY) wherein the companies will collaborate to bring drugs through preclinical development. Loxo Oncology is responsible for clinical development and commercialization. Loxo Oncology derives its company name from an attendant of the Greek goddess Artemis, who represented the concept of trajectory in the sport of archery.

For Loxo Oncology
Julie Normart, 415-946-1087
jnormart@wcgworld.com


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