Germantown, Maryland-based Orgenesis Inc (NASDAQ:ORGS), a developer and manufacturer of advanced cell therapies announced Wednesday that it had entered into a collaboration agreement with the New York Blood Center (NYBC), one of the largest community-based blood collection and distribution centers in the United States.
Under the terms of the agreement, NYBC will be responsible for establishing the infrastructure to collect, process, test, cryopreserve and bio-bank sampling materials, including liver biopsies. The samples are intended for use as the source of autologous insulin-producing (AIP) cells for patients that may be eligible for future clinical trials.
Through its Israeli subsidiary, Orgenesis Limited, Orgenesis is developing technology designed to successfully reprogram human liver cells into glucose-responsive, insulin-producing cells. Converting the diabetic patient's own tissue into insulin-producing cells through the groundbreaking technology has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation.
Through its Masthercell Global subsidiary, a global contract development and manufacturing organization (CDMO), Orgenesis also focuses on the development and manufacture of cell therapies for advanced medicinal products in the regenerative medicine industry. It helps cell therapy organizations speed up the arrival of their therapies onto the market.
“This agreement marks an important milestone toward initiating our US clinical activities. We have utilized human biopsy samples in a wide range of animal trials, and this agreement will now enable us to collect the biopsies from patients for potential clinical use once we receive the appropriate regulatory approvals,” said Professor Sarah Ferber, founder and Chief Scientific Officer at Orgenesis.
Orgenesis has invested significant time and effort in developing processes that include effective processing of liver biopsies and manufacturing of batch sizes that may be utilized for human clinical trials. It has leveraged the technologies developed by Ferber, a thought leader in the field of cell therapy.
She is the inventor of the company’s transdifferentiation (TD) platform technology, which direct reprograms adult cells into cells of alternate function. The technology has potential applications across multiple indications.
The first indication the company is pursuing is for the treatment of severe diabetes following Total Pancreatectomy, a surgical procedure performed to treat chronic pancreatitis when other treatment methods are unsuccessful. The company also plans to target insulin-dependent diabetes. Both these therapies involve the use of the TD technology that transforms the patient's own liver cells into functional and physiologically glucose-responsive insulin-producing cells, with the goal of providing long-term insulin independence.
“We view the New York Blood Center as an ideal strategic partner for the expansion of our activity in the US. NYBC is well equipped to provide the necessary infrastructure to collect, process and biobank materials for both our diabetes program as well as for other development programs,” said Orgenesis CEO Vered Caplan.
“They have well established relationships with hundreds of hospitals in the US, which will be valuable during both the development and the commercial phases of our programs. Moreover, this infrastructure provided by NYBC and their expert development team complements our cell collection and processing activities for research purposes in Belgium, Israel and South Korea, where we have set up similar programs,” she added.
Beth Shaz, executive vice president at NYBC, said they looked forward to leveraging both their infrastructure and hospital relationships to help “accelerate the path to market.”
“We are delighted to partner with Orgenesis in advancing these disruptive cell therapies,” said Shaz.
Shares in Orgenesis climbed 1.5% to $5.58.
Contact Uttara Choudhury at [email protected]