Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement 


Organovo Holdings, Inc. recently announced it has entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine (IIAM). Under the terms of the agreement, IIAM will provide Organovo with donated organs that have not been utilized for transplantation with high potential benefit for generating the cell-based building blocks for Organovo’s therapeutic liver tissue development program.

“We continue to lay the groundwork for the potential start of human clinical trials in calendar 2020, as we develop our NovoTissues to address liver disease in adult and pediatric populations,” said Taylor J. Crouch, CEO, Organovo. “IIAM is one of the world’s largest providers of organs and tissues designated for medical research and development. We’re thrilled to more closely align our groundbreaking work with IIAM. This partnership, along with our own expertise in isolating, characterizing, and utilizing specialized human liver cells, will enable us to create implantable 3D bioprinted liver tissue patches destined for patient treatment. Our clinical program expects to serve patient populations that are in desperate need of new treatment options. Where possible, we will also leverage the distribution capabilities of our Samsara subsidiary to put these valuable cells and tissues into the hands of other leading liver researchers.”

Crouch continued, “As we head into calendar 2019, we’re on track to pursue orphan designation for a second rare disease indication and to commence Investigational New Drug (“IND”) enabling studies for treating end stage liver diseases including Alpha-1-antitrypsin deficiency, ultimately culminating in a targeted IND filing for calendar 2020.”

“IIAM is excited to collaborate with Organovo and Samsara as they work toward clinical applications of liver cells as a therapy for the patient populations affected with inborn metabolic errors,” said Gina Dunne Smith, Executive Director, IIAM. “This is yet another way for donors and their families to save or improve the lives of others.  As we move forward, these are cutting edge research projects that are exciting for our entire team.”

“MTF Biologics could not be more pleased with our new agreement to support Organovo and their therapeutic endeavors,” said Joe Yaccarino, President and CEO, MTF Biologics. “As the parent company to IIAM, we are pushing to increase opportunities for biologics and clinical modalities of many tissue forms. This latest collaboration is directly in line with our mission of saving and healing lives through honoring donated gifts, serving patients and advancing science.”

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. For more information, visit www.organovo.com.

 

THE INTERNATIONAL INSTITUTE FOR THE ADVANCEMENT OF MEDICINE (IIAM) is at the forefront of providing non-transplantable organs to the medical research community for purposes of combatting and curing disease. IIAM has unprecedented collaborations in the US to source livers and other organs for therapeutic applications and pre-clinical investigations targeting a range of debilitating metabolic disorders.  As a nonprofit with more than 30 years of experience in the field, IIAM is a known and trusted partner to both organ procurement organizations and research institutions worldwide.

IIAM works closely with them to honor donor and donor family intentions to the fullest by anticipating the next frontier of research requiring human tissue.  IIAM leads the way in educating the next generation of researchers so that every donor’s legacy leaves the world a healthier place.  IIAM is a wholly-owned subsidiary of MTF Biologics, also known as Musculoskeletal Transplant Foundation, a non-profit organization based in Edison, NJ and the world’s largest tissue bank, whose mission is to save and heal lives by honoring donated gifts, serving patients and advancing science.