The move to human development comes based on “strong results” from preclinical animal model studies, the San Diego, Calif.-based company said. The company expects to pursue a formal preclinical development program.
“We’re excited to introduce an implantable bioprinted liver tissue as the first preclinical candidate in our therapeutic tissue portfolio, and see the early results as extremely promising. The scientific and commercial progress we have already made with ExVive Human Liver Tissue in drug toxicity testing has given us a firm foundation upon which to build a larger tissue for transplant. Advancing our first therapeutic tissue into preclinical development is an important milestone for Organovo, and it speaks to the power of our technology platform in addressing multiple applications, including preclinical safety, disease modeling and tissue replacement products for surgical implantation. We believe that 3D bioprinted tissues have an opportunity to provide options for patients who suffer from liver disorders,” CEO Keith Murphy said in a press release.
Organovo said it plans to submit an investigational new drug application to the FDA within 3 to 5 years for the new tissue, as well as pursuing a breakthrough therapy designation to accelerate time to market.
“Organovo’s approach is designed to overcome many of the challenges that cell therapies and conventional tissue engineering have struggled to address, including limited engraftment and significant migration of cells away from the liver. In our preclinical studies, we deliver a patch of functional tissue directly to the liver, which integrates well, remains on the liver and maintains functionality. We believe our tissues have the potential to extend the lives of patients on liver transplant lists, or those who do not qualify for transplants due to other factors,” chief strategy officer Dr. Eric David said in a prepared statement.
Approximately 17,000 patients are on the U.S. liver transplant waiting list, Organovo said, with only 6,000 transplants performed each year.
The company said it plans to pursue clinical solutions with the tissue for treating both acute-on-chronic liver failure and pediatric metabolic liver diseases. Organovo said the total addressable market opportunities for both of those indications exceeds $3 billion.
“Supply issues are a constant and growing challenge in transplant medicine and liver has the second highest transplant need among all organs. New solutions in development, such as 3D bioprinted human tissues, have the potential to create tissues that could augment and extend organ function to give more time to those patients on transplant waiting lists. Moreover, we are continuing to push the boundaries and understand how to scale 3D bioprinting and tissue engineering to develop larger tissues,” Dr. David Gerber of the UNC School of Medicine said in prepared remarks.
Organovo said it is continuing to conduct early research on other tissues for therapeutic use in direct surgical applications.
“There are many conditions in areas such as liver, kidney, gastrointestinal, vascular, and lung disease where supplying a tissue patch may be curative, or bridge a patient a few more years before they need a transplant. The promise of 3D bioprinting human tissues to address these unmet needs is significant,” Dr. John Geibel of Yale University said in a prepared release.