6:28 PM
Mar 08, 2018
 |  BC Innovations  |  Product R&D

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

CompanyProductsCell source
AxoSim Technologies LLCNerve-on-a-ChipPrimary or induced pluripotent stem (iPS) cells
CN Bio Innovations Ltd.Single and multi-organ chips, including brain, gut, heart, kidney and liverPrimary human cells; iPS cells; cell lines
Emulate Inc.Human Emulation System including Brain-Chip, Intestine-Chip, Liver-Chip, Lung-ChipiPS cells
Hepregen Corp. HepatoPac Microliver TechnologyPrimary hepatocytes
Hesperos Inc.Single and multi-organ chips, including bone marrow, brain, endocrine system, gut, heart, kidney, liver, pancreas and skinPrimary cell culture; iPS cells
Hurel Corp.Hurelhuman and seven other species of hepatic modelsPrimary hepatocytes
Mimetas B.V.OrganoPlate models of blood-brain barrier (BBB), gut, kidney, neurons, vasculature and some cancersMultiple 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 interactionPrimary cells; iPS cells
Tara Biosystems Inc.Biowire II cardiovascular modeliPS cells
TissUse GmbHMulti-organ chips including adipose tissue, bone marrow, brain, gut, hair follicle, heart, kidney, liver, lung, lymph node, pancreas, skin and vasculatureCell lines; primary cells; iPS cells; commercial models; patient biopsies; tissue slices

NIH’s National Center for Advancing Translational Sciences (NCATS) has its own program and also plans to publish before year end.

NCATS and the U.S. Defense Advanced Research Projects Agency (DARPA) each had collaborations with FDA from 2012-17 on $75 million funding initiatives to foster organ-on-chip development.

The early data show promise. Three stakeholders from industry and NIH told BioCentury some types of data from the models, such as drug accumulation or data on toxicity mechanisms, could soon be included in INDs.

“I’d be surprised if we didn’t see organ-on-a-chip data in regulatory submissions within the next 18-24 months,” said Emma Sceats, CEO of CN BIO Innovations Ltd. CN BIO makes organ-on-chips for pharmas.

“My guess is that it’s most likely to be on programs involving human-specific modalities, where the translational relevance and/or cost of traditional preclinical models is a problem,” she said.

According to Sceats, those programs could include gene editing therapies where the target sequences are not highly conserved from mouse to human, or human mAbs that can’t be tested in mice.

Brian Berridge,...

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