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Orgenesis & Excella-Bio Announce Breakthrough Manufacturing Process for Bioxomes™ (Proprietary Synthetic Exosomes/Extracellular Vesicles); Patented Process Results in Uniform, Scalable Production & Ability to Deliver Specific Cargo to Targeted Cells

On March 31, 2020, Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a pioneering, global biotech company committed to lowering costs, accelerating commercialization, and transforming the delivery of cell and gene therapies (CGTs), announced that it has developed a breakthrough and patented manufacturing process for Bioxomes™ (synthetic exosomes/extracellular vesicles), through its collaboration and licensing agreement with Excella-Bio Ltd. Exosomes, or extracellular vesicles (EVs), are small vesicles that can transfer DNA, RNA, and proteins from the cell of origin to other, often targeted cells, thereby enabling alteration of the function of the targeted cells. It is belieed that exosomes can provide the same therapeutic benefit of whole cells, without the risks and difficulties of administering entire cells to patients. Together, Orgenesis and Excella-Bio have developed Bioxomes, which are synthetic exosomes/EVs. Until now, exosome/EV production has been based on conventional ultracentrifugation or ultrafiltration. These are both complex and costly techniques. Bioxomes are engineered and produced through a patented method as membrane nanoparticles isolated from cell cultures of various sources. Orgenesis and ExcellaBio have now demonstrated the optimization and scale-up of Bioxomes™, while generating consistent and repeatable results, including uniform particles sizes. These Bioxomes have demonstrated the ability to fuse with cell membranes and deliver an intracellular cargo, in a similar manner to that of natural exosomes. Bioxomes can be sourced effectively from various cell cultures. These include mesenchymal stem cells, immortalized cells, immune cells, and epithelial cells. When loaded with pre-designated genetic material, proteins, signaling molecules and/or drugs, Bioxomes can carry selected therapeutic cargo inside the target cells, mimicking the natural membrane fusion capacity of EVs. Ms. Vered Caplan, CEO, President, and Director of Orgenesis, said, “Orgenesis and Excella-Bio developing this new process represents a true breakthrough in the field of cell and gene therapy. It provides the ability to produce robust yields in only a few steps. We believe this process may unlock the potential for large-scale production of Bioxomes for a variety of therapeutic applications based on the natural intracellular trafficking abilities of exosomes/ EVs. In particular, we are aiming to develop promising new therapies, where we can deliver intracellular antiviral payloads, among dozens of other potential cell and gene therapies.”

ORGENESIS

Headquartered in Germantown, Maryland, Orgenesis is a pioneering global biotech company which is dedicated to unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life-changing treatments at the point-of-care to large numbers of patients at low cost.

The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific know-how; (b) POCare Technologies, a suite of proprietary and in-licensed technologies that are engineered to create customized processing systems for affordable point-of-care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care.

By combining science, technologies, and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently, and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: www.orgenesis.com.

EXCELLA-BIO

Headquartered in New York City, Excella-Bio was founded by principal investigators, medical monitors, oncologists, and regulatory specialists, in order to take projects to the next level. The company’s expertise is focused on advancing product candidates from conception through the clinic by reducing manufacturing risks, shortening the time to regulatory approval, and lowering the overall costs of a clinical development program that meet applicable quality standards.

The company’s management team has extensive and unique experience in regulated cell therapy development, including contract research, development, and manufacturing across a broad range of science, technologies, and process operations. Members of the Excella-Bio scientific advisory team are leaders in the fields of immunology, virology, cell biology, clinical immunotherapy, and regulatory and data management.

Excella-Bio collaborates with leading academic institutions to turn early-stage innovations into medicinal products. Its highly dedicated team embraces the challenges that the field of cellular therapies presents. With patient benefits at the forefront of its activities, the company believes it can overcome the considerable challenges through collaboration and the will to succeed.

[Press release] [Orgenesis] [Excella-Bio]