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STTR Grant Helps Zen-Bio, LSU’s Pennington To ID Metabolic Disease Drug Candidates

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Contract research organization Zen-Bio and the Pennington Biomedical Research Center of the Louisiana State University system have been awarded a one-year, approximately $229,000 Phase I Small Business Technology Transfer grant to look for natural compounds to prevent and treat metabolic disease and obesity.
 
The collaboration will use a library of natural botanical extracts developed by PBRC’s Botanical Research Center, which is a collaboration between PBRC and New Jersey’s Rutgers University.
 
This structure means that PBRC, the LSU system, and Rutgers stand to benefit from any licensing revenues that may arise if BRC and Zen-Bio, either on their own or with a larger industrial partner, can commercialize any of the compounds into treatments for obesity, diabetes, or other metabolic diseases, officials said this week.
 
Any revenue of this kind is at least a few years away, however, as the researchers are set to begin work under the STTR grant next week.
 
Under the grant, Zen-Bio will use its proprietary high-throughput, human cell-based assays for lipogenesis, lipolysis, and adipogenic gene-expression profiling to screen a library of thousands of botanical extracts developed by researchers at the BRC, a National Institutes of Health-funded research center of PBRC and Rutgers’ Biotechnology Center for Agriculture and the Environment.
 
Jeffrey Gimble, professor of stem cell biology at the Pennington Biomedical Research Center, is principal investigator on the STTR grant, which was awarded to Zen-Bio by the National Institute of Diabetes and Digestive and Kidney Diseases. According to Gimble, the underpinnings of the research project were created when he was an employee of Research Triangle Park, NC-based Zen-Bio in the late 1990s.
 
After joining PBRC, Gimble applied for an STTR grant in which PBRC and Zen-Bio would collaborate to use the adipose-derived stem cells Gimble had worked with at his former company to screen chemical compounds that might affect how human cells differentiate fat.
 
“We had a couple of grant applications that went in that had the intent of using a commercial library of chemical compounds,” but the NIH did not fund the project as proposed, Gimble told BTW this week. “After we went through several rounds with that, we thought, ‘What do we have unique here at Pennington?’”
 
It turns out that PBRC colleague William Cefalu together with Rutgers researcher Ilya Raskin had established the BRC under the NIH Botanical Research Centers Program in order to investigate how natural botanical extracts influence metabolic syndromes.
 
“I knew that they had this library of botanical extracts, and we set up an alternative project where we would use the same paradigm of using these pre-adipocyte cells from human fat to screen the botanical extract library against that,” Gimble said. “That was much better received at the NIH as a project that was worth exploring” under the STTR mechanism.
 

“There are some things that are easier to do in a company format than in an academic setting, and I think screening is one of those at this point.”

Ben Buehrer, vice president of Zen-Bio, told BTW that the company stayed in close contact with Gimble after his departure in order to keep an eye on potential collaborations.
 
“There are some things that are easier to do in a company format than in an academic setting, and I think screening is one of those at this point,” Buehrer said. “[Gimble] contacted us in particular about this approach because … he thought they could do a much higher throughput in different assays that we already have established for adipocytes. We’re also developing these assays for skeletal muscle, which goes straight into the idea of metabolic disease.”
 
Gimble said that out of the several hundred thousand compounds the research team will screen it hopes to identify “one to two percent that are outliers with respect to either promoting fat formation and making cells form fat faster, better, and easier; and maybe an equivalent number of compounds that are going to inhibit fat formation in a manner that is actually at the mechanism level of fat formation.”
 
Such an accomplishment would represent successful completion of the Phase I STTR grant and, the researchers hope, trigger a Phase II grant, which could be worth as much as $750,000 over two years.
 
Gimble said a Phase II project would attempt to characterize toxicity, dose-dependency, and in vivo efficacy of lead compounds identified in Phase I.
 
“If we could achieve those goals in Phase II, then we would be in a position to start saying this has some legs and might have some value as a therapeutic — either as a neutraceutical or pharmaceutical,” Gimble said. “Then some larger partner and other source of funding would be necessary. You’d be looking at either venture firms, large pharma, or some larger biotech entity.”
 
Zen-Bio will eventually look to add the screening methods developed to its contract research repertoire, but at this point is “not taking a stake in any intellectual property that might come out,” Buehrer said. He added that Zen-Bio will retain the right to in-license any promising compounds that are discovered.
 
“That doesn’t mean that going forward, if we see a good opportunity, we can’t make sure that both entities profit in the process,” Buehrer stressed. “We have in the past had interest in developing compounds. We’re not averse to that, but a lot of times that can slow down the process if you try to take too much up front.”
 
Zen and the Art of the Deal
 
If the collaboration produces promising lead compounds for metabolic diseases, and either Zen-Bio or another biotech or pharma company licenses them for further development, Rutgers, PBRC, and the LSU system under which PBRC operates would stand to benefit.
 
Anne Jarrett, director of IP and legal and regulatory affairs for PBRC, told BTW that in an arrangement involving multiple parties, IP based on discoveries made solely by Pennington researchers would be assigned exclusively to Pennington; and likewise with Rutgers and Zen-Bio.
 
“However, it is hard to write into the contract at this point how it will be distributed because we don’t know what might be discovered during the course of the collaboration,” Jarrett said.
 
Of any licensing or royalty revenues garnered by PBRC, 10 percent go to the LSU system, 40 percent are split by the inventors, and 50 percent go to PBRC. “Each campus in the [LSU system] has different designations for how to assign” its share of licensing revenues, she added.
 
Rutgers’ stake comes from the fact that the botanical extracts library was primarily developed by its researchers and made available to PBRC’s BRC through a materials transfer agreement. This original agreement did not include sub-transfer rights so Zen-Bio is currently putting the finishing touches on a separate MTA with Rutgers for the library, Buehrer said.
 
It is unclear how that might translate into an IP-ownership stake for Rutgers if one of the compounds is licensed for commercialization.
 
“I assume it’s a pretty liberal agreement because Rutgers and PBRC have established the BRC as a collaborative center between the two institutions,” Buehrer said.
 
Rutgers’ Office of Corporate Liaison and Technology Transfer could not be reached for comment prior to publication of this article.

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