Organovo to Present New Preclinical Data on 3D Bioprinted Human Liver Tissues for the Treatment of Tyrosinemia I

 

SAN DIEGO...October 15, 2018 -- Organovo Holdings, Inc. (NASDAQ:ONVO) ("Organovo"), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today announced it will present data on the performance of its liver therapeutic tissue in an animal model of hereditary tyrosinemia Type 1 ("HT-1") at the Liver Meeting 2018® (American Association for the Study of Liver Diseases or "AASLD") being held November 9-13, 2018 in San Francisco.  The Company will also have a poster presentation comparing the performance characteristics of liver cells in an in vitro setting between non-diseased and non-alcoholic fatty liver disease ("NAFLD") donors.  The abstracts are available in the Online Planner on the AASLD website.

Organovo implanted its 3D bioprinted human liver tissue patches onto the livers of FRG knockout mice, and is presenting data from promising early studies in this established model for HT-1, an inborn error of metabolism ("IEM") characterized by severe liver damage due to increased tyrosine levels.  The liver tissue patches are composed of human hepatocytes and select non-parenchymal cells.  Serum and histopathologic evaluation of the implanted therapeutic tissue showed engraftment, retention and functionality through at least 35 days post-implantation, while also demonstrating the sustained presence of key human liver proteins such as albumin in the animal bloodstream.  Importantly, treated animals showed an improvement in the median survival rate versus non-treated control animals.

"We're encouraged that our 3D bioprinted liver tissues continue to show retention and functionality in a range of animal disease models, including Alpha-1-antitrypsin deficiency and HT-1, where there is critical unmet need and a potentially significant impact on patient outcomes because of the dire shortage of liver transplants," said Taylor J. Crouch, CEO, Organovo.  "In each case, our objective in implanting a healthy tissue patch is to restore function or offset the deficiency of a specific enzyme abnormality, with the ultimate goal of delaying or reducing the need for a transplant.  We remain on track for our first IND submission in calendar 2020."

Referring to the poster presentation, Dr. Sharon Presnell, chief scientific officer, Organovo, commented, "As we continue to build our library of healthy and diseased liver tissues and isolated primary cells, we are uncovering key functional and genetic features of cells that correlate with specific donor and disease-state attributes.  The data to be presented at AASLD highlights Samsara's leadership in the isolation and specialized characterization of NAFLD/NASH-origin primary human liver cells, contributing to a better understanding of liver disease and its potential treatments."

The Company's poster(s) and oral presentation are as follows:

Title:           The Performance Characteristics of Isolated Human Liver Cells Correlate
            with Donor Attributes in a Cohort of Tissues from Non-Diseased and
            NAFLD Donors
Date:           Saturday, November 10, 2018, 2:00 pm PT – Moscone Center North/South
            Building, Hall C
Publication:           1305
             
Title:           Long-Term Performance of Implanted Bioprinted Human Liver Tissue in a
            Mouse Model of Tyrosinemia I (Oral Presentation)
Date:            Sunday, November 11, 2018, 11:30 am PT – Moscone Center North/South
            Building, Room 214/216
Publication:            0083

About Organovo Holdings, Inc.
Organovo is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality.  The Company is pursuing multiple IND-track programs to develop its NovoTissues® to address a number of serious unmet medical needs in adult and pediatric populations, initially focusing on liver disease.  Organovo's first IND-track program for Alpha-1-antitrypsin deficiency recently received orphan drug designation from the FDA, and the Company expects to file its first IND in 2020.  In order to support its plan to initiate multiple IND-track programs, the Company is providing access to its ExVive™ in vitro tissue disease modeling platform to facilitate high value drug discovery and development collaborations.  Organovo's wholly-owned subsidiary, Samsara Sciences, provides the Company and its clients with high quality human liver and kidney cells for research applications.  Organovo is changing the shape of life science research and transforming medical care.  Learn more at www.organovo.com.


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