Although the IIBR has operated in a very low-key, quietmode—to the extent that finding information about it online is nearlyimpossible—Crown characterizes the institute as "the world's premier serviceprovider for drug discovery in metabolic disease with its unique collection offully characterized, non-human primate models with naturally occurring diabetesand metabolic syndrome." Because of her skills and knowledge, the founder ofIIBR, Dr. Barbara C. Hansen—currently director of the Center for PreclinicalResearch and a professor of internal medicine and pediatrics at the Universityof South Florida's Tampa campus—will join Crown Bioscience as a scientificadvisor for metabolic diseases.
Based largely on 30 years' worth of research in Hansen'slibrary, the professor herself is clearly a big part of the deal, at least inthe early stages of the acquisition, and Crown Bio makes a point ofhighlighting her skills as a "leading expert in non-human primate models ofobesity, diabetes and associated metabolic syndromes" who has "demonstratedthat metabolic syndromes in non-human primate models are highly translatable tohuman disease in terms of disease natural history, mechanism and drug responses."
As such, the acquisition of IIBR and addition of Hansen tothe Crown Bio team "creates a unique opportunity for new target discovery,target validation and drug evaluation in a highly predictable model system,"according to the official announcement about the deal, and the combination ofIIBR's diabetic rhesus macaque and Crown Bio's diabetic cynomolgus monkeys areexpected to "create a powerhouse for translational research in diabetes andmetabolic syndrome."
The company had originally sought Hansen's expertise to helpcharacterize the large cynomolgus monkey colonies it possesses, which representnaturally occurring diabetes, according to Laura Sailor, vice president ofglobal business development for Crown Bio. The acquisition naturally flowed fromthere, Sailor tells ddn, with theidea that Crown Bio's capacity mixed with Hansen's expertise and deepexperience with in-vivo models "wouldenable the drug development of diabetic therapeutics and enable more predictiveand early-stage go/no-go preclinical data."
The problem as Crown Bio sees it, according to Sailor, isthat with the high cost of driving diabetes clinical trials, "even in Phase IIwith added burden of cardiovascular toxicity, many pharma players in the spacehave decided to defocus this therapeutic area for early-stage development andthe ones that want to play are putting the huge money necessary for theclinical trial patients, often with lots of post-study work required by FDA."
As pharmas shift their strategies, there will be an increasingoption for biotech to do the target discovery and early-stage preclinical work,and then backfill pharmacy pipelines, Sailor says, but one big limiting factorto biotech and small pharmas has been the lack of predictive models fordiabetes.
"Unfortunately, most of our knowledge and drug developmentprograms still depend heavily on rodent models, which have been shown to bepoorly predictive of human disease and drug response," said Dr. Yiyou Chen,chief scientific officer of Crown Bio, in the news release about theacquisition. "This contributes to the high rate of clinical failure foranti-diabetes drug development programs. With a critical mass of non-humanprimate models, we hope to enable our partners to discover new biologicalpathways and new treatments for this important disease."
"The rodent and pig models don't translate to the clinic,"Sailor reiterates. "Crown Bio had decided to provide a more predictive model innon-human primates (NHPs). With infrastructure and expertise from overseas,Crown Bio started to build out this division. Barbara Hansen is the world'sforemost and most experienced research lab in the world for natural occurringspontaneously diabetic NHP colonies. With the oldest and most-characterized NHPcolonies in the world averaging over 30 years of age, Dr. Hansen's efforts areworld-renowned and the gold standard for late-stage preclinical model testingin rhesus monkeys."
"We are delighted to join forces with Crown Bio; there isdefinitely a synergy between IIBR's expertise in disease biology and CrownBio's capability in translational research as well as operational know-how,"Hansen said in an official statement. "With 285 million patients today and 500million by 2030 worldwide, diabetes has reached pandemic proportion. There is agrowing and unmet need for new treatment for the disease and associatedcomplications."