It’s been almost two years since Organovo (NYSE: ONVO) created a new business—using its bio-printing technology to create 3-D samples of living human liver tissue for use in testing the toxicity of pre-clinical drug candidates.
Since then, the San Diego company has built a thriving business as a contract research organization (CRO) that tests experimental drug compounds on bio-printed liver tissue. Each pea-sized sample in a 24-well tray functions (for a week or so) much like a liver in the human body, with cell-to-cell interactions occurring in a 3-D matrix.
According to Organovo CEO Keith Murphy, the technology has been validated across a broad set of safety data, and seven of the top 25 global pharmaceuticals are now customers—including Merck, Roche, Astellas, and Bristol-Myers Squibb. As Murphy put it recently, “We don’t think of ourselves as a bio-printing company any more. We look at ourselves as a human tissues company…We’ll test your compound in our lab as a service.”
Now Organovo is expanding its capabilities. The company announced this week that it has developed a similar testing service for screening pre-clinical drug candidates on living human kidney tissue. Organovo said its bio-printed human kidney tissue simulates the proximal tubule, a key part of the millions of filtering units that make up a kidney—and the primary site of renal toxicity.
The company said it has signed multiple commercial orders for its kidney drug-testing service. Organovo said it also is collaborating on scientific studies of its kidney tissue technology as part of a continuing early access program that includes two big pharma companies.
“We now have a technical capability that no CRO has,” Murphy said. “Think about how compelling it is to change the animal model testing paradigm. The potential of this is to do way better [drug] discovery.”
According to Murphy, the core value of Organovo’s technology is that its 3-D human tissue culture is a much closer approximation to tissue that scientists call in vivo-–within the body—than any conventional tissue used in drug-screening studies. Its 3-D sample facilitates cell-to-cell interactions that are more lifelike than conventional 2-D tissue samples.
With its liver model, for example, Organovo showed that its 3-D liver sample is more sensitive to the toxicity of compounds that were previously deemed to be safe in a standard battery of pre-clinical animal studies and toxicity tests.
Each bio-printed sample of kidney tissue is derived from a cadaver or donor cells, and consists of about 1 million cells. In the wells of a laboratory culture tray, each sample is opaque white and about 3 millimeters (1/8th of an inch) by a half-millimeter.
In March, Organovo CSO Sharon Presnell and other scientists presented data and findings that showed that the company’s “ExVive” Human Kidney samples can carry out a variety of renal and biological functions that are difficult to replicate in a lab sample. Organovo and others made additional presentations this week at the Eurotox 2016 scientific conference in Seville, Spain.
For example, Organovo said its bio-printed kidney tissue demonstrated “functional stability” by continuing to transport the antioxidant glutathione across the cellular membrane of its kidney cells for more than four weeks. Organovo said its kidney samples also react like a real kidney to injury caused by cisplatin, an anti-cancer drug that is a known kidney toxicant.
Murphy and other Organovo executives said the presentations drew a standing-room-only crowd of toxicologists and pharmaceutical industry scientists, and proved to be a seminal event for the company. “It was a turning point because it wasn’t just us talking about our technology,” Murphy said. “It was our customers talking about our technology.”
Murphy added, “With this data, we’re seeing an inflection point in terms of increased customer adoption.”
In a statement, the company estimates that its human kidney tissue service could generate tens of millions of dollars in annual revenue, and represents as much as $100 million in potential future revenue.