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, USA I August 29, 2024 I 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
SOURCE: Orgenesis
Post Views: 982
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, USA I August 29, 2024 I 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
SOURCE: Orgenesis
Post Views: 982
