HμREL liver tissue co-culture to be tested by Sanofi

NORTH BRUNSWICK, N.J.—HμREL Corp., a provider of advanced tissue constructs and microfluidic cell-based assay platforms for preclinical drug development, has entered into a multiphase research and development collaboration with Sanofi US Services Inc.Sanofi, an integrated global healthcare company, discovers, develops and distributes therapeutic solutions focused on patients’ needs.

Under terms of the agreement, Sanofi US will fund a range of studies designed to evaluate the utility of HμREL’s cell-based products and technologies for preclinical drug development. Different aspects of the collaboration will be carried out in HμREL’s laboratories in North Brunswick, N.J., as well as in various Sanofi R&D locations in both the United States and Europe. HμREL and Sanofi US intend to share the results of their R&D collaboration through one or more co-authored, peer-reviewed scientific publications.

“Through collaborating with our network of internal and external partners, Sanofi R&D focuses on translating the findings of basic research more quickly and efficiently into meaningful healthcare solutions,” says Marc Bonnefoi, head of Sanofi’s North America R&D hub. “Our partnership with HμREL is an opportunity to leverage an innovative new life-sciences technology to accelerate drug development and impact the lives of patients.”

HμREL’s patent-pending HμRELhuman in-vitro liver tissue construct utilizes a proprietary co-culture of primary cryopreserved human hepatocytes (i.e., actual human liver cells) to deliver highly sensitive and accurate predictions of the liver-mediated effects of drugs on humans. Compared to other in-vitro methods, HμRELhuman is distinguished not only by its predictive accuracy and responsiveness, but also by its long endurance (maintaining its functionality over weeks instead of over the days or hours typical of most in-vitro systems in use today); the stability of the results it delivers over time; and its ease, convenience and practicality of use in industrial laboratory settings. In addition to HμRELhuman, the company offers companion products HμRELdog and HμRELrat, which enable the comparison of a drug candidate’s test results across human, large-animal and small-animal species. A future product, the HμRELflow microfluidic assay platform, is currently in its beta-test phase of development.

HμREL CEO Robert Freedman says, “We are honored and thrilled to have such a company as Sanofi choose to be our R&D collaboration partner. Sanofi anchors its approach to R&D in the conviction that new life-science technologies can be of practical value only when they can translate from the laboratory benchtop all the way to a new medicine that is demonstrably safe and of novel efficacy in humans, and that receives regulatory approval. And we are confident that HμREL’s technology constitutes the kind of game-changing translational tool for which both drug developers and the regulators have been waiting.”

Game-changing? Freedman cites three reasons to support his contention. First, he notes that the cells are “high-functioning” and “human-relevant” (the term from which the company name, HμREL, is derived), responsive, stable, long enduring and replicable. Second, Freeman points to “industrial utility, practicality and convenience. Our cell lines are rugged and easy to use. They don’t have to be teed up perfectly.” Third is the pathway ongoing R&D will provide to future products. The company started with a microfluidic assay platform from Cornell, in which the liquid culture medium containing the molecular entity under study is recirculated in a microfluidic pathway, analogously to how the bloodstream recirculates through the various organs of the body.

The initial phase of the R&D collaboration will aim to validate HμREL’s HμRELhuman 3D liver tissue co-culture for use across an array of ADME-T studies that are typically addressed during the preclinical phase of drug discovery and development. Subsequent phases of the collaboration are planned to broaden the range of validated applications, as well as to cover the HμRELflow microfluidic platform.