Orgenesis Enters into Collaboration Agreement with the Bambino Gesù Children's Hospital in Rome to Establish Point of Care Cell and Gene Therapy Center

March 29, 2021 7:00 AM EDT
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GERMANTOWN, Md., March 29, 2021 (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, announces that it has entered a collaboration with the Bambino Gesù Children's Hospital in Rome to establish a Point of Care Cell Therapy center at the Hospital. Process work will be focused on supporting clinical trials related to therapies developed by both the Hospital and Orgenesis, joint research, development of new approaches, and validation activities for advanced cell and gene therapies.

“At the Bambino Gesù Children's Hospital, we are developing a number of cutting-edge therapies. Orgenesis’ new point-of-care center is being implemented to optimize promising therapies to potentially move into clinical trials and large-scale manufacturing, in a way that could substantially reduce overall costs. Producing therapies onsite drastically streamlines manufacturing efforts and reduce time to treatment for patients. We also look forward to working closely with Orgenesis to support efforts to advance our respective cell and gene therapies,” said Prof. Franco Locatelli, Director of the Department of Pediatric Hematology and Oncology and Cell and Gene Therapy.

Vered Caplan, CEO of Orgenesis, stated, “It is an honor to collaborate with the Bambino Gesù Children's Hospital, a pioneer Institution in the field of cell and gene therapies, which is developing life-changing therapies for children, our most vulnerable and deserving population. Further to this great work, the agreement also supports the expansion of our POCare Network capacity. We remain focused on finding exceptional partners like the Bambino Gesù Children's Hospital to rapidly expand our POCare Network across Europe, North America, Asia and other regions around the world.”

Following implementation of the Point-of-Care cell and gene therapy center, Orgenesis’ goal is to deploy its Orgenesis Mobile Processing Units and Labs (OMPULs) onsite. OMPULs serve as multi-purpose, mobile, autonomous good manufacturing practice (GMP) facilities. OMPULs are modular in nature, allowing for rapid and cost-effective scale up as production needs require. These units are a deviation from traditional centralized manufacturing processes in that they enable decentralized onsite production of cell and gene therapies within a sterile and automated mobile processing center to streamline the process of bringing advanced therapies to market.

About the Bambino Gesù Children's Hospital The Bambino Gesù Children's Hospital was established in 1869 as the first children's hospital in Italy and has now become a reference center for the health of children and adolescents from Italy and abroad and is today the largest sub-specialty children's hospital and research center in Europe. It has over 3,500 employees and collaborates with the main international organizations in the pediatric field. It is the Italian reference center of Orphanet, the largest database of rare diseases in the world, with 39 participating states. The Bambino Gesù Children's Hospital is pioneering treatment with genetically-modified somatic cells for treatment of both inherited and malignant disorders.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis 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 POCare 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 StatementsThis 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 achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the coronavirus outbreak, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, 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, 2020, 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, LLCTel: + 1 212-671-1021Orgs@crescendo-ir.com 

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Source: Orgenesis Inc.


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