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Orgenesis Selects Therapeutics, Inc. as CRO to Support Development and Planned Phase 2 Clinical Study of Ranpirnase for the Treatment of External Genital Warts

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GERMANTOWN, Md., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), has entered into a Services Agreement with Therapeutics, Inc., a premier U.S. Clinical Research Organization (CRO) dedicated to dermatology product development. Under the agreement, the parties will collaborate for the development of Orgenesis’ Ranpirnase topical drug formulation for the treatment of external genital warts (EGW) caused by human papilloma virus (HPV) in advance of an investigational new drug (IND) submission. Once those studies are underway, the teams will investigate enhanced intracellular targeting of Ranpirnase using Orgenesis’ Bioxomes™ technology.

Ranpirnase is a member of the pancreatic ribonuclease (RNase A) enzyme family and has demonstrated a broad spectrum of antiviral applications. The parties plan to seek FDA guidance for a Phase 2 clinical study of topical Ranpirnase for EGW in early 2021. The study will build on existing safety and efficacy data from a placebo-controlled phase 1/2 clinical study with 75 subjects with EGW. In that study, topical Ranpirnase applied twice daily for 8 weeks showed a significant reduction in the lesion area compared to placebo and was shown to be generally safe and well-tolerated without any additional adverse effects versus placebo.

“EGW is one of the most common sexually transmitted diseases with approximately 400,000 new cases annually in the US alone. In a phase 1/2 clinical study, topical Ranpirnase was well tolerated and demonstrated signals of efficacy against HPV via a unique mechanism of action (MOA) that appears to eradicate the virus and modulate the immune system. With this work underway, we look forward to commencing our Phase 2 study, as well as exploring other indications for Ranpirnase across our Point of Care (POCare) Platform. Ranpirnase has already demonstrated preclinical activity against a variety of viruses such as cytomegalovirus (CMV), influenza, HIV, and SARS,” said Vered Caplan, CEO at Orgenesis.

“We are excited to partner with Orgenesis for this important work on the EGW application of Ranpirnase, and conduct further exploratory work using Bioxomes for enhanced payload delivery into cells,” commented Daniel J. Piacquadio, MD, President & CEO of Therapeutics, Inc. “As a CRO, our business is built on supporting customer goals with thoughtfully integrated solutions that help to bring viable drug candidates through each development phase and into commercialization.”

Bioxomes are synthetic exosomes/extracellular vesicles that have demonstrated the ability to fuse with cell membranes and deliver an intracellular cargo in a similar manner to natural exosomes without the risks and difficulties of administering entire cells to patients. Orgenesis has developed a breakthrough manufacturing process for Bioxomes with distinct advantages over natural exosomes, which is designed to optimize scale up and reduce costs, while generating consistent and repeatable results, including uniform particles sizes.

About Therapeutics
Therapeutics, Inc. The Dermatology CRO, designs, creates, and executes turn-key development programs for regulatory registration of topical, oral and injectable dermatology drugs, biologics and devices. The company distinguishes itself as a full service provider from concept to commercialization; providing program management, non-clinical, clinical, regulatory affairs and CMC capabilities and support for its clients. Therapeutics’ full service perspective provides their clients a “development advantage” independent of the engagement; be it a focused Phase 1-4 clinical trial program or a full service engagement starting with an API. Therapeutics, Inc. is committed to moving products from concept to bench top to proof-of-concept followed by all aspects of development to achieve regulatory review and approval. Additional information is available at: http://www.therapeuticsinc.com/

About Orgenesis
Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format. The Orgenesis Point of Care (POCare) Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing at www.orgenesis.com.

Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, the development of our POCare strategy, the sufficiency of working capital to realize our business plans; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31 2019, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021