Chips for tox
How the first data from organs-on-chips could find their way into INDs
After several years’ pushing from FDA, NIH and DARPA for more predictive preclinical tox tests, organ-on-a-chip companies are close to demonstrating their models can detect signals missed in animals. While replacing animals is nowhere in sight, there’s a good chance the chips will become a regular part of IND packages.
In December, FDA issued its latest “Predictive Toxicology Roadmap.” Last month, the National Toxicology Program submitted a similar road map. Both documents reiterated the call for organs-on-chips and other technologies that could catch issues animal models can’t and limit use of animals in safety studies. The NTP is a coalition of 16 agencies, including FDA, run by the U.S. Department of Health and Human Services.
Companies and academics have been advancing organ-on-chip technologies with the goal of integrating the models early in drug development.
At least ten companies are making organs-on-chips, and at least three plan to publish proof-of-concept studies with pharma partners this year (see “Organ-on-a-Chip Companies”).
Table: Organ-on-a-chip companies
|AxoSim Technologies LLC||Nerve-on-a-Chip||Primary or induced pluripotent stem (iPS) cells|
|CN Bio Innovations Ltd.||Single and multi-organ chips, including brain, gut, heart, kidney and liver||Primary human cells; iPS cells; cell lines|
|Emulate Inc.||Human Emulation System including Brain-Chip, Intestine-Chip, Liver-Chip, Lung-Chip||iPS cells|
|Hepregen Corp.||HepatoPac Microliver Technology||Primary hepatocytes|
|Hesperos Inc.||Single and multi-organ chips, including bone marrow, brain, endocrine system, gut, heart, kidney, liver, pancreas and skin||Primary cell culture; iPS cells|
|Hurel Corp.||Hurelhuman and seven other species of hepatic models||Primary hepatocytes|
|Mimetas B.V.||OrganoPlate models of blood-brain barrier (BBB), gut, kidney, neurons, vasculature and some cancers||Multiple cell types, including primary, proximal tubule cells and iPS cells|
|Nortis Inc.||Chips include blood vessels, gut, heart, kidney, liver, stem cells and kidney-liver interaction||Primary cells; iPS cells|
|Tara Biosystems Inc.||Biowire II cardiovascular model||iPS cells|
|TissUse GmbH||Multi-organ chips including|