Orgenesis announces agreement to acquire assets of Tamir Biotechnology, Inc. including broad spectrum antiviral platform

Strategy to combine ranpirnase antiviral platform with Bioxome(TM) technology

Germantown, MD, US, April 13, 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), announces it has entered into an agreement to acquire the assets of Tamir Biotechnology, Inc. (“TamirBio”), including ranpirnase, TamirBio’s broad spectrum anti-viral platform. The acquisition will be completed for total stock and cash consideration valued at approximately USD 16.8 million.  Orgenesis plans to combine ranpirnase with its co-developed Bioxome(TM) technology for enhanced payload delivery directly to cells.

TamirBio is a clinical stage anti-viral therapeutics company engaged in the discovery and development of a new class of prophylactic and therapeutic drugs for the treatment of viruses and other pathological conditions.  TamirBio’s lead asset, ranpirnase, a ribonuclease (RNase), is a member of the superfamily of enzymes that catalyze the degradation of RNA, and mediate several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death. Therefore, it is a potential candidate for the development of therapeutics for life-threatening diseases, including viral and autoimmune diseases, that require anti-proliferative and apoptotic properties.

TamirBio’s first target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. The company’s lead asset, topical ranpirnase, was evaluated in a phase I/II clinical trial targeting genital warts. The phase I/II study demonstrated clear clinical effect of ranpirnase. Additional clinical trials are currently being planned.

Orgenesis and TamirBio plan to combine ranpirnase with Bioxomes, which have demonstrated the ability to fuse with cell membranes and deliver an intracellular cargo, in a similar manner to natural exosomes. Bioxomes can carry selected therapeutic cargo inside the target cells when loaded with predesignated genetic material, proteins, signaling molecules and drugs, as these mimic the natural membrane fusion capacity of exosomes. Orgenesis and TamirBio believe the combination of the two platforms will result in enhanced efficacy and anti-viral results.

Vered Caplan, CEO of Orgenesis, said, “Combining TamirBio’s broad antiviral platform, ranpirnase, with Bioxomes could result in an enhanced payload delivery into cells. In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials.  Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway. We believe combining ranpirnase with the Bioxome platform has the potential to become a potent and powerful combination given the natural intracellular trafficking abilities of Bioxomes. We look forward to testing a variety of additional anti-viral therapies in the near future.”

“We are honored to combine forces with Orgenesis to advance this powerful platform,” stated, Jamie Sulley, President of TamirBio.  “Ranpirnase has already demonstrated preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS. Not only do we believe Orgenesis will help advance ranpirnase through the clinic using their global development platform, but by combining ranpirnase with the Bioxome technology, we believe we can deliver ranpirnase through a more effective delivery mechanism.”

About Orgenesis

Orgenesis is a pioneering global biotech company which is 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 knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which 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.