Orgenesis Announces Positive Results From a Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ Acute Lymphoblastic Leukemia

Orgenesis' CD19 CAR-T therapy, ORG-101, had a complete response (CR) of 82% in adults and 93% in pediatric patients with the incidence of severe Cytokine Release Syndrome (CRS) of 2% in adult patients and 6% in pediatric patients in a real-world study

Data indicate a potentially favorable safety profile with a lower incidence of Cytokine Release Syndrome

Encouraged by the positive data, Harley Street Healthcare Group along with its partners intends to commit resources to set up a Global Cancer Initiative with a focus to democratize Advanced Therapies and support further clinical development sharing the risks and rewards

GERMANTOWN, Md., Aug. 29, 2024 (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 (CGT) in order to improve access and outcomes in healthcare, today announced positive clinical trial results for a real-world study of CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL). Harley Street Healthcare Group intends to set up a Global Cancer Initiative through its joint venture with Orgenesis, with a focus to democratize Advance Therapies and support further clinical development.

The top-line efficacy and safety data from the study had a complete response (CR )of 82% in adult patients and 93% in pediatric patients. Moreover, the incidence of severe Cytokine Release Syndrome (CRS), a common safety concern associated with CAR-T therapies, was found to be low, 2% in adult patients and 6% in pediatric patients, compared to currently approved treatments. This suggests a favorable safety profile for ORG-101. CRS is a systemic reaction caused by an exaggerated immune response to immunotherapy, which is a significant safety issue in conventional CAR-T treatments. The data, derived from 233 patients originated from a real-world study at a leading hematology center in China (additional details can be found in the Company's scientific presentation to be filed as an exhibit to a Form 8-K).

Orgenesis is leveraging its recently acquired GMP-Validated Platform to implement the CAR-T therapy, which has been adapted to a decentralized production model. This model is designed to expedite capacity setup, enhance production efficiency, and reduce treatment costs. The production data as well as the cost analysis provide additional confirmation that the Orgenesis decentralized approach is a potential alternative cost-efficient way to provide access to Advanced Therapies.

ORG-101 utilizes a third-generation lentiviral vector with a proprietary CAR construct, coupled with streamlined and decentralized onsite production and analytic testing. This approach offers a highly affordable solution compared to traditional CAR-T therapies that are produced in centralized facilities.

The Company has held meetings with the FDA in the U.S., the Israeli MOH and the Paul-Ehrlich-Institute in Germany in regard to ORG-101. The Company is now preparing to initiate its own Phase 1/2 clinical multicenter study with an initial clinical site at the General University Hospital of Patras in Greece, supported by its Enterprise Greece Grant, with the goal of expanding to additional locations of the Orgenesis network of hospital partnerships.

Vered Caplan, CEO of Orgenesis, commented, "We believe that these clinical results combined with our GMP-Validated Platform are a significant step forward for our strategy to combine our strong capabilities in decentralized cell therapy production with our regional partnerships. Not only has the product shown initial signs of positive clinical outcomes, but our production data also validated that Orgenesis' cost-effective decentralized cell processing has the potential to improve access to this treatment and reduce costs. We remain committed to bringing this and other potentially life-saving treatments to patients in need worldwide."

Sanjeev Kumar, Chief Visionary Officer at Harley Street Healthcare Group, discussed the plans for the Global Cancer Initiative: "Cancer is increasingly affecting younger populations. We expect that our Global Cancer Initiative will be based on contributions from varies partners fully committed in making cancer therapies more affordable globally with a focus to democratize Advance Therapies and will strategically support our biobanking partnership and Orgenesis' decentralized solutions to lower the cost and increase access to these therapies."

About Orgenesis

Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger numbers of patients more cost effectively and with better outcomes through great science and decentralized production. Additional information about the Company is available at: www.orgenesis.com.

About Harley Street Healthcare Group

Harley Street Healthcare Group (HSHG), including its brands and subsidiaries, the Harley Club and HARLEY of LONDON, provides integrated health & wellness services to its global client base by bringing together the best of modern medicine, state-of-the-art technological innovations wrapped around the resourcefulness of ancient healing systems. Based in London with a growing global presence, HSHG is focused on being an invested partner in the health & wellness journey of its customers through a proactive, personalized and preventative approach to delivering healthcare, moving away from the current industrial sick care system.

More information on the group is available at:

www.theharleyclub.com, www.harleyoflondon.co.uk

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. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines and the initial safety and efficacy profiles of ORG-101 are forward-looking statements. 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, uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials, the timing of and our ability to initiate and successfully enroll future trials; our ability to obtain FDA clearance of our future IND submissions and commence and complete clinical trials on expected timelines, or at all, 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, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, 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, risks relating to legal proceedings against us 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, 2023, 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.

IR contact for Orgenesis:

Crescendo Communications, LLC

Tel: 212-671-1021

[email protected]

Communications contact for Orgenesis

IB Communications

Neil Hunter / Michelle Boxall

Tel +44 (0)20 8943 4685

[email protected] / [email protected]