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Risk assessment is the target of a new collaboration agreement signed by Bayer and TissUse this week. Under the agreement, TissUse will work with Bayer to apply the former's Multi-Organ-Chip technology to develop a liver-endocrine tissues multi-organ model for risk assessment. The mechanistic in-vitro assay will make it possible to determine differences between species in terms of critical toxicities for early drug development. No financial details were disclosed.
TissUse noted in a press release that in addition, “the new assay is expected to significantly contribute to the 3R principles of animal welfare,” which are replacement, reduction and refinement.
“We are thrilled to start this new collaboration which will address a fundamental area of unmet need in safety assessment,” Dr. Uwe Marx, CEO of TissUse, said in a press release. “We already have a longstanding relationship with Bayer, and this new project will enable the development of an assay with potentially great predictive power for Bayer across divisions and businesses.”
“The assessment of human relevance of certain toxicities observed in animal assays still represents a major challenge for the various areas of toxicology (human & veterinary drug candidates, agrochemicals and industrial chemicals). A recurring problem is thyroid or testicular toxicity that occurs in both crop protection, as well as human and veterinary drug development candidates. Answering whether toxicity findings in rodent lack human relevance as well as predicting human toxicities that are absent in rodent are key for risk assessment and regulatory success,” a TissUse press release continued.
Bayer and TissUse hope to develop an assay that looks at these target organs as well as the liver in an integrated microfluidic system.
This is the second partnership TissUse has announced with a big-name pharma company so far this year. Back in March, the company shared news of a cooperating agreement with Roche for the development of human-relevant in-vitro assays, also based on the Multi-Organ-Chip technology. Roche and TissUse will collaborate over three years to develop assays that can better predict safety issues of new drug candidates, specifically along the lines of pharmacokinetics and lineage-specific hematopoietic toxicity. The goal is an assay that can assess long-term repeated dose testing in a dynamic bone marrow model, with a second development phase aiming at uniting the bone marrow model with a liver model to study metabolic activation.
“We are excited to form this long-term partnership which will address fundamental aspects of antibody kinetics and organ-specific NCE toxicity by applying our Multi-Organ-Chip technology,” Marx commented at the time. “Combining several organ models in a circulatory system is the next necessary step to assess systemic toxicity and establish complex in-vitro disease models in order to bring innovative medicine faster to the patient.”
And in January, TissUse reported that it was making progress in its collaboration with AstraZeneca to develop relevant microphysiological system models based on the Multi-Organ-Chip platform. More specifically, the partners are looking into the development of a physiologically relevant, human, ex-vivo model of type 2 diabetes. Their work has produced a human microfluidic two-organ-chip model for studying pancreatic islet-liver crosstalk related to insulin and glucose regulation for up to 15 days in culture. The results were published in Nature Scientific Reports and presented at the 3D Cell Models Congress in Berlin in January.
TissUse's Multi-Organ-Chip (MOC) technology is a microfluidic microphysiological systems platform that is “capable of maintaining and culturing miniaturized organ equivalents emulating the biological function of their respective full-size counterparts over long periods,” the company notes. The platform includes Control Units that can manage up to four MOCs at once, and TissUse's currently offered organ models include liver, intestine, skin, vasculature, neuronal tissue, cardiac tissue, cartilage, pancreas, kidney, hair follicle, lung tissue, fatty tissue, tumor models and bone marrow.