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NEW YORK—The goal of a collaboration and license agreement between Loxo Oncology Inc. and Array BioPharma Inc. is very simply stated: to build drugs that work in people to shrink tumors, according to Dr. Josh Bilenker, Loxo's founder and CEO.
The collaboration agreement stipulates that Loxo will fund Array's preclinical research, providing access to Array's discovery platform and scientists, and be responsible for target selection and conducting clinical trials. Array, a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer, can receive as much as $434 million in milestone payments as well as royalties on sales of any resulting drugs. Array also received shares of stock in Loxo, which is committed to bringing targeted cancer therapies with an opportunity for outsized clinical effects in genetically defined patient populations into the clinic rapidly. The contract is 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 good partners to the R&D team at Array, to craft a product profile and to provide a thesis through clinical trials," Bilenker adds. He anticipates human testing by midyear 2014.
"The objective is to keep the discovery engine at the cutting edge and maintain discovery capability for the future," says Ron Squarer, CEO of Array, which has created 18 separate drug molecules, 15 of which are in clinical development. "We are delighted to enter into this collaboration with the goal of rapidly bringing this exciting technology to cancer patients."
Dr. Kevin Koch, president of Array, which has a "consistent record of successful drug discovery with extensive capabilities in high-throughput lead identification, protein-structure-enabled drug design and diverse chemistry approaches," adds, "we had identified a candidate that addresses a clinical target in cancer, so this will be a personalized medicine strategy that has high response rates early. It will drive value in the investment community by having lower regulatory hurdles and higher patient benefits."
With several drug candidates in or about to enter Phase III clinical trials, Array is evolving into a late-stage development company. Its strong suits include chemistry approaches such as competitive, allosteric and covalent target inhibition. Founded in 1998, the company has had partnerships with companies including Amgen, AstraZeneca, Celgene, Genentech, Novartis and Oncothyreon.
Loxo, a biopharmaceutical company that was established in May 2013 and funded by Aisling Capital (a life-science investment firm headquartered in New York), will enter a multiyear license and collaboration agreement for this Array- invented preclinical development candidate and related intellectual property. Both companies will also collaborate on discovering and developing small-molecule drugs for mutually agreed-upon novel oncology targets. By targeting a specified novel oncogenic activating mutation, it is possible to accelerate both preclinical and clinical development of compounds, enabling rapid clinical development and commercialization.
Loxo "was founded in collaboration with several important and close academic partnerships in order to obtain the clinical and translational drug development perspective that identifies what targets, what needs and what methods to prove it efficiently in the clinic," according to Bilenker, who adds that the collaboration with Array "provides a world-class chemistry solution to the most exciting emerging targets. "
Dr. Keith Flaherty, the director of the Henri and Belinda Termeer Center for Targeted Therapies at Massachusetts General Hospital, will chair Loxo 's scientific advisory board.
According to Squarer, "Array has partnered with a number of venture-backed companies that continue to produce encouraging results. The venture-financed model of drug discovery and development can cost-effectively identify novel candidates and rapidly test the clinical hypothesis. This process will be as fast and efficient as possible, and the outcome will be very valuable to everybody concerned. "
Bilenker, who believes that it is too soon to calculate the commercial potential, concludes, "there are nice commercial surprises when drugs work against the intended target. We feel that if we can build drugs that work well and that matter, commercial success will follow."