Eric Michael David, M.D., J.D., chief strategy officer, and executive vice president of Organovo’s preclinical development, said, “With a critical shortage of donor organs and few alternatives to transplantation, Organovo is using its 3D bioprinting technology to develop novel therapeutic tissues for direct surgical implantation. Our preclinical data show rapid vascularization and tissue engraftment, and evidence of function and durability of our 3D bioprinted human liver tissue over several weeks. Most importantly, we see evidence of stable production of key human liver proteins in the animal bloodstream, and tissue staining for key human metabolic enzymes. The presence of these enzymes provides an important first step in demonstrating the capability of this tissue to treat inborn errors of metabolism, a key indication we are targeting.”
The bioprinted tissues were able to stay intact on the animal livers, and the mice tolerated them well. Both of these facts support continuing preclinical development of Organovo’s 3D bioprinted liver tissue for therapeutic use, and Organovo plans to submit an Investigational New Drug application to the US Food and Drug Administration (FDA) for its therapeutic liver tissue in a few years. The application will focus on acute-on-chronic liver failure and pediatric inborn errors of metabolism, both of which could could be helped using the therapeutic benefits from a bioprinted liver patch. Organovo will first pursue other opportunities, like breakthrough therapy designation and clinical development outside of the United States, to help accelerate the time to market for its valuable 3D bioprinted tissue. This makes sense, as the total market opportunity for the initial technology in the US exceeds $3 billion.
Organovo’s general manager, Paul Gallant, said, “We’re committed to expanding our customer footprint in Asia, as four of the world’s Top 25 global pharmaceutical companies are located in Japan. Cosmo Bio is an ideal distribution partner for our liver and kidney tissue testing services because of their deep network, strong customer relationships and excellent track record selling the products and services of leading research tool companies.”
This is different than Organovo’s research agreement with Merck Sharp & Dohme Corp. Cosmo Bio was established to sell and distribute biological reagents and services for the purposes of medical research. In order to get important, direct access to customers and other support projects in Japan’s biopharmaceutical industry, Organovo will be working with their Drug Discovery Services team. Discuss in the Organovo forum at 3DPB.com.