ATMI is making a $1.3 million investment in Orgenesis and will supply it with a complete disposable manufacturing process toward its therapeutic technology for treating diabetes, under which a patient's liver cells are converted into functioning insulin-producing cells, the companies said today.
Under a process development agreement signed by subsidiaries of ATMI and Orgenesis, ATMI will supply its Integrity® Xpansion™ technology to Orgenesis. The compact bioreactor is a multi-plate, single-use system based on 10 to 200 stacked plates made from polystyrene, the same plastic material as multiple-tray stacks.
According to ATMI, a single Xpansion bioreactor can replace up to 200 traditional stacked trays. The system is designed to produce a sufficient amount of autologous insulin-producing cells for transplantation back to the patient's liver.
"The Integrity Xpansion multiplate single-use bioreactor technology was specially developed by ATMI for addressing the scaling-up challenges of cell therapy manufacturing processes. This fully industrial technology platform is very suitable for adherent fragile cell culture applications, such as the adult liver cells,” Mario Philips, svp and GM of ATMI LifeSciences, said in a statement.
The companies say conversion of patient tissue into insulin-producing cells enhances diabetes treatment by overcoming two problems seen in the traditional method of pancreatic islet cell transplantation—donor shortages, and the risk of transplant rejection. “If successful, this could mean the end of diabetes as we now know it,” Orgenesis declares on the homepage of its website.
The agreement is for a period of six months unless terminated by either party with 30 days advance written notice to the other party, Orgenesis disclosed today in a Form 8-K filing with the U.S. Securities and Exchange Commission.
ATMI also purchased 1,526,718 units of Orgenesis stock at $0.8515 per unit. Each unit consists of one share of Orgenesis’ common stock and a common share purchase warrant that can be exercised over the next two years at $1.
Orgenesis aims to develop its technology to clinical stage, designed to enable normal glucose-regulated insulin secretion, via cell therapy. The company licenses technology developed by its CSO and founder Sarah Ferber, Ph.D. While head of the Molecular Endocrinology research unit at Tel Hashomer’s Center for Regenerative Medicine, Stem Cells, and Tissue Engineering, she established a proof of concept for the technology, which seeks to substitute malfunctioning organs with new functional tissues created from the patient's own existing organs.
“We intend to dedicate most of our capital to research and development with no expectation of revenue from product sales in the foreseeable future,” Orgenesis stated last month in its 10-Q first quarter filing.