Orgenesis and Kurve Therapeutics Announce Pre-Clinical Study Results for a Cell-Based Oncolytic Virus Bearing Product Demonstrating Over 50% Reduction in a Murine Glioblastoma Model

GERMANTOWN, Md., Dec. 20, 2022 (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, and Kurve Therapeutics, a next-generation medtech and drug formulation company, today announced positive preclinical study results for intranasal administration of a cell-based oncolytic virus bearing product. The results demonstrated over 50% tumor reduction in a murine glioblastoma model.

The study was conducted by an independent pre-clinical research organization. In the study, the cell-based product was successfully delivered into the brain of mice via intranasal administration utilizing Kurve Therapeutics’ patented Controlled Particle Dispersion® technology as a novel approach to bypass the blood-brain barrier. Historically, the blood-brain barrier has been a primary roadblock in delivering therapies, especially for larger molecules and cellular therapies, directly to the brain.

Orgenesis, through its newly formed POCare services subsidiary, provides clinical grade manufacturing of the product to one of its customers, a premier cell therapy development company. The product has been administered to patients intravenously in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid, Spain. The production is performed at the hospital utilizing the Orgenesis Mobile Processing Units and Lab (OMPUL) to supply clinical grade batches.

Glioblastoma Multiforme (GBM) is a highly aggressive cancer with an estimated five-year survival rate of 5%. The global glioblastoma multiforme treatment market size was valued at USD $2.14 billion in 2020 and is expected to increase at a compound annual growth rate of 8.8% from 2021 to 2028. For glioblastoma patients, currently only a few treatment options exist. These current treatment options frequently present safety concerns, limit re-administration options, and carry a significant treatment burden. One of the reasons for the lack of effective treatments is due to suboptimal penetration of the blood-brain barrier for potential drug candidates into the central nervous system. This results in both poor distribution and efficacy.

“This is encouraging initial pre-clinical data, which demonstrates the potential of cell-based products combined with Kurve’s Controlled Particle Dispersion^® technology to improve the administration of CNS-related treatments,” said Vered Caplan, CEO of Orgenesis. “Orgenesis, through its newly formed POCare services subsidiary, has commenced clinical grade production, in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid for the supply of clinical grade batches of the cell-based product intended for intravenous administration. The nasal delivery of the cell-based product has only been tested in animal models thus far. Changing the administration route of a cell-based therapy, as with any drug product, requires rigorous testing and is considered a different therapy requiring a set of pre-clinical and clinical testing according to applicable regulatory guidelines. We appreciate the tremendous support of Hospital Infantil Universitario Niño Jesús in Madrid. We also look forward to expanding our collaboration with Kurve Therapeutics.”

Marc Giroux, CEO, Kurve Therapeutics said, “By delivering stem cells to the brain through the blood-brain barrier, a significantly broader array of treatments could potentially be non-invasively administered. This could open a host of opportunities to treat a multitude of central nervous system (CNS)-related disorders. Over 100 CNS-related clinical trials with stem cells are ongoing or planned to start near term. Our partnership with Orgenesis and the combination of the technologies has delivered very exciting recent pre-clinical results, which could expand the possibilities for more effective stem-cell-based therapies if future clinical trials are successful.”

About Kurve Therapeutics
Kurve Therapeutics is a medtech and drug formulation company, as well as a developer of the Controlled Particle Dispersion® (CPD) intranasal drug delivery technology. This next-generation technology creates a focused, turbulent flow that navigates the curved pathways of the nasal cavity, allowing access to the olfactory region. The technology is designed to advance treatments for neurodegenerative diseases, including therapies with complex molecules such as monoclonal antibodies and larger peptides, by allowing medication to cross the blood-brain barrier and access the most penetrable part of the blood-brain barrier at the top of the nasal cavity. Led by a team of experienced entrepreneurs with successful track records in biotech, pharmaceuticals, and device technology, the company’s mission is to pave the way in treating complex CNS disorders, including Alzheimer’s disease, cognitive aging, Lewy body dementia, Parkinson’s disease, and ALS. Kurve’s patented technology has been featured in 18 peer-reviewed publications in leading medical journals. Controlled Particle Dispersion® (CPD) technology has been used in five double-blind placebo-controlled Phase II studies and is ready for Phase III with Alzheimer’s patients. Visit kurvetx.com to learn more about how Kurve is turning the tide on cognitive aging and neurodegenerative disease.

About Hospital Infantil Universitario Niño Jesús
Niño Jesús University Children’s Hospital, birthplace of pediatrics in Spain, has been a national benchmark in pediatric healthcare since it was founded in 1877. It is leading the field of ATMPs for childhood and adolescent diseases in Spain, including cancer, transplantation, neuropediatrics and orthopedics, through an ambitious program of research, development, and manufacturing. It has the only authorized GMP facility for both gene and cell therapies in a medical center in Spain.

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 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. 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 and OMPUL business, 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 COVID-19 pandemic, 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, 2021, 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
Orgs@crescendo-ir.com

Communications Contact for Orgenesis
IB Communications
Neil Hunter / Michelle Boxall Tel +44 (0)20 8943 4685
[email protected] / [email protected]