NEW YORK—The goal of a collaboration and license agreementbetween Loxo Oncology Inc. and Array BioPharma Inc. is very simply stated: tobuild drugs that work in people to shrink tumors, according to Dr. JoshBilenker, Loxo's founder and CEO.
The collaboration agreement stipulates that Loxo will fundArray's preclinical research, providing access to Array's discovery platformand scientists, and be responsible for target selection and conducting clinicaltrials. Array, a biopharmaceutical company focused on the discovery,development and commercialization of targeted small-molecule drugs to treatpatients afflicted with cancer, can receive as much as $434 million inmilestone payments as well as royalties on sales of any resulting drugs. Arrayalso received shares of stock in Loxo, which is committed to bringing targetedcancer therapies with an opportunity for outsized clinical effects ingenetically defined patient populations into the clinic rapidly. The contractis multiyear and renewable by mutual agreement.
"Array has a great track record of hitting intended targets,and our job is to make smart choices about the targets to pursue, to be goodpartners to the R&D team at Array, to craft a product profile and to providea thesis through clinical trials," Bilenker adds. He anticipates human testingby midyear 2014.
"The objective is to keep the discovery engine at thecutting edge and maintain discovery capability for the future," says RonSquarer, CEO of Array, which has created 18 separate drug molecules, 15 ofwhich are in clinical development. "We are delighted to enter into thiscollaboration with the goal of rapidly bringing this exciting technology tocancer patients."
Dr. Kevin Koch, president of Array, which has a "consistentrecord of successful drug discovery with extensive capabilities inhigh-throughput lead identification, protein-structure-enabled drug design anddiverse chemistry approaches," adds, "we had identified a candidate thataddresses a clinical target in cancer, so this will be a personalized medicinestrategy that has high response rates early. It will drive value in theinvestment community by having lower regulatory hurdles and higher patientbenefits."
With several drug candidates in or about to enter Phase IIIclinical trials, Array is evolving into a late-stage development company. Itsstrong suits include chemistry approaches such as competitive, allosteric andcovalent target inhibition. Founded in 1998, the company has had partnerships withcompanies including Amgen, AstraZeneca, Celgene, Genentech, Novartis andOncothyreon.
Loxo, a biopharmaceutical company that was established inMay 2013 and funded by Aisling Capital (a life-science investment firmheadquartered in New York), will enter a multiyear license and collaborationagreement for this Array-invented preclinical development candidate and relatedintellectual property. Both companies will also collaborate on discovering anddeveloping small-molecule drugs for mutually agreed-upon novel oncologytargets. By targeting a specified novel oncogenic activating mutation, it ispossible to accelerate both preclinical and clinical development of compounds,enabling rapid clinical development and commercialization.
Loxo "was founded in collaboration with several importantand close academic partnerships in order to obtain the clinical andtranslational drug development perspective that identifies what targets, whatneeds and what methods to prove it efficiently in the clinic," according to Bilenker,who adds that the collaboration with Array "provides a world-class chemistrysolution to the most exciting emerging targets."
Dr. Keith Flaherty, the director of the Henri and BelindaTermeer Center for Targeted Therapies at Massachusetts General Hospital, willchair Loxo's scientific advisory board.
According to Squarer, "Array has partnered with a number ofventure-backed companies that continue to produce encouraging results. Theventure-financed model of drug discovery and development can cost-effectivelyidentify novel candidates and rapidly test the clinical hypothesis. Thisprocess will be as fast and efficient as possible, and the outcome will be veryvaluable to everybody concerned."
Bilenker, who believes that it is too soon to calculate thecommercial potential, concludes, "there are nice commercial surprises whendrugs work against the intended target. We feel that if we can build drugs thatwork well and that matter, commercial success will follow."