[Corrected 8/11/15, 9:57 am. See below.] Loxo Oncology, the Stamford, CT-based biopharmaceutical company developing targeted cancer therapies, announced last week that it has appointed veteran life sciences executive (and Detroit Xconomist) Tim Mayleben to its board of directors.
Mayleben is president and CEO of Ann Arbor, MI’s Esperion Therapeutics, and he has a long history of guiding biotech startups to commercialization. He served as COO for the original Esperion Therapeutics—founded by Roger Newton, co-developer of the blockbuster cholesterol drug Lipitor—before Pfizer bought the company for $1.3 billion in 2004. [Paragraph updated to clarify the role of the original Esperion Therapeutics in developing Lipitor, and correct Tim Mayleben’s title there.]
“Because Tim won’t flatter himself, I will,” said Jacob Van Naarden, vice president of corporate development and strategy for Loxo. “He has a proven track record of building value and generating high-quality data with relatively small capital. We were excited there was mutual interest.”
Van Naarden said Loxo is attempting to capitalize on the rise of personalized medicine, where treatments are tailored to specific genetic targets. “Loxo designs drugs from the ground up to do one thing and one thing only,” he explained.
In 2013, Loxo signed a licensing agreement with Array BioPharma, giving Loxo rights to Array’s tropomyosin receptor kinase (TRK) program, along with other oncology targets. TRK is an oncogene that is activated in certain types of cancer.
As part of the arrangement, Van Naarden said Array handles early-stage research while Loxo manages the clinical and diagnostic strategies. Loxo has commercial rights to each program; when a drug takes off and starts making money, Array is compensated through milestones, royalties, and partial ownership of Loxo.
What Loxo aims to do is treat cancer by inhibiting the genetic alterations that allow tumors to grow. The company’s lead drug, LOXO-101, is the only selective TRK inhibitor currently in clinical development. Late last month, Loxo, in partnership with the University of Colorado Cancer Center, published a research brief in Cancer Discovery that described what happened to the first patient with a TRK fusion cancer in the LOXO-101 trials.
After multiple unsuccessful treatments, the 41-year-old woman with tumors in her lungs enrolled in the LOXO-101 study. Within four weeks, she had a “very dramatic response,” and a CT scan confirmed her tumors were shrinking. After four months of therapy, subsequent scans showed the tumors had almost entirely disappeared with no adverse side effects attributed to Loxo’s drug.
“We need to see this in more than one patient and test for durability over time, but I think, for the kinds of targets we choose, genetic alteration may be more important than tumor type,” Van Naarden said. “The key is working with our diagnostic partners to find patients.”
Mayleben is similarly optimistic about Loxo’s findings. “The brain trust they’ve assembled when it comes to genetic targeting and target selection—it’s a brilliant management team augmented by a world-leading scientific board,” he said.
Van Naarden said that board, packed with translational oncologists with lab experience, helps Loxo choose which products from its pipeline to promote. “The board is very involved in the company,” he added. “We put academic biologists in the same room with chemists and drug developers. And with our partnership with Array, we’re poised to accelerate our programs quickly.”
“President Obama talked about the promise of precision medicine, and there’s very broad interest among people in the U.S.,” Mayleben said. “So many prescription drugs that are developed don’t work in everybody. What Loxo is doing is really on the cutting edge of precision medicine, using the brightest clinicians to develop molecules that are very precision-oriented. It’s companies like Loxo that are successful.”
Loxo, which has 17 employees, plans to begin Phase 2 of the LOXO-101 trial before the end of the year.