South San Francisco-based Nodality has spent five years honing an enabling technology for personalized medicine, which could help patients avoid wasteful treatments and improve the success rate in new drug R&D. Now it has persuaded New York-based Pfizer (NYSE: PFE), the world’s biggest drugmaker, to buy into its vision.
Nodality, which raised $15 million of venture capital last month from Kleiner Perkins Caufield & Byers, TPG Biotech, Maverick Capital and Pfizer Ventures, has struck an important new collaboration with Pfizer to come up with better drugs for autoimmune diseases. Terms of the alliance aren’t being disclosed, but instead of typical diagnostic industry fee-for-service contract terms, the deal is structured more like a small biotech/ Big Pharma drug partnership, says Dan Dornbusch, Nodality’s vice president of business development. The multi-year deal provides Nodality with upfront cash, and the potential for milestone payments based on success in development. Besides helping Pfizer pick the right patients for clinical trials, Nodality also could end up developing companion diagnostic products that help doctors do a better job selecting the right drug for the right patient in real-world use.
The new deal with Pfizer is the second major pharma partnership Nodality has inked this year, following one it formed in February with Belgium-based UCB. It’s the latest vote of confidence in Nodality’s technology approach, which uses high-speed cell counting machines, called flow cytometers, to look at tissue samples from individual patients. That process gives Nodality a window into specific patterns in the biological pathways of a diseased tissue, giving doctors a more detailed idea of what’s going wrong at the molecular level. Information like that, the thinking goes, ought to help physicians select the best drug or combination of drugs that is more likely to work for an individual patient.
For Pfizer, the interest in such technology is clear. Autoimmune diseases, in which the immune goes haywire and attacks healthy tissue as if it were an invading pathoge, tend to cause chronic pain, fatigue, and disability. Scientists don’t know what causes most of these conditions, don’t know how to diagnose them very well, and don’t know how to select patients likely to benefit in the clinic. There have been a few big successes in treating autoimmunity—Abbott Laboratories’ adalimumab (Humira) recently dethroned Pfizer’s atortastatin (Lipitor) as the world’s top-selling prescription drug—but many autoimmune conditions lack effective treatments, prompting Pfizer and other Big Pharma companies to pour billions of dollars into autoimmune R&D. There are an estimated 14 million to 24 million patients in the U.S. alone with autoimmune disorders, according to the National Institutes of Health.
The Nodality/Pfizer collaboration will specifically focus on one autoimmune condition, lupus, in the beginning. The plan is to seek to understand the way various drug candidates work, and how they might match up with the underlying biology of the disease from patient to patient.
“We think this collaboration will generate novel insights into how the disease works, which will let Pfizer develop their current products, and open up some new pathways, some new therapeutic targets, and new ways to treat lupus,” Nodality’s Dornbusch says. “For us, it will generate a large amount of knowledge on how the disease works, so we can more efficiently develop products.”
Pfizer’s Jose-Carlos Gutierrez-Ramos, the company’s senior vice president of biotherapeutics R&D, said in a statement that, “Our partnership with Nodality exemplifies Pfizer’s commitment to Precision Medicine by providing us with earlier insight into a compound’s potential clinical profile, which can help reduce attrition rates, accelerate development and improve patient targeting. There is a tremendous patient need for new medicines that can impact the pathophysiology of autoimmune diseases.”
Nodality currently has about 40 employees, and expects to hire another 10 people or so in the coming months to carry out its R&D work, Dornbusch says.
The partnerships with Pfizer and UCB represent a shift in strategy at Nodality over the past year or so. The company, which I profiled here in September 2010, was looking at commercializing its own personalized test to help doctors select the right treatments for acute myeloid leukemia. Nodality has since backed away an attempt to commercialize the product on its own, and instead has been searching for a partner with an established sales force to pitch the product. Nodality has continued to amass evidence to support its test for acute myeloid leukemia, and also chronic lymphocytic leukemia, which it plans to release in December at the American Society of Hematology meeting, says Shakti Narayan, the company’s senior director of business development.
“Our company is 90 percent R&D, and what we’re best at is developing tests, a real pipeline of tests and assays for multiple partners,” Dornbusch says. “That’s how we think we can create the most value for patients.”
Nodality has developed what you could call a two-pronged business strategy. It got an important lab certification this summer, which is a basic step it needed to complete before processing patient samples for commercial diagnostic purposes. Once a partner’s sales force has persuaded a doctor to order the test, Nodality hopes to make money by delivering useful information back to the doctor who treats acute myeloid leukemia, chronic lymphocytic leukemia, and potentially other malignancies. The other main source of cash flow could come from Big Pharma companies like Pfizer, who are looking for information like this to help them improve their success rates in drug development.
Nodality certainly isn’t the only company that thinks it has a hot platform for enabling personalized medicine, but Dornbusch says it doesn’t have to be. The company, which started based on work at Garry Nolan’s lab at Stanford University, uses its technology to look at a wide variety of proteins that carry out basic functions in cells. The technology is supposed to be sensitive enough to look at a biological sample in all its complexity, and detect a single cell with a protein pathway that’s out of whack. Other platforms like high-speed gene sequencers, instruments that look at gene expression, or profiles of RNA in cells, can also be very sensitive and useful to physicians or drug developers, Narayan says. “We’re building our technology and applications to be complementary,” he says.