Latest Hotspot

Orgenesis Announces Positive Results from ORG-101 CAR-T Study in CD19+ Acute Lymphoblastic Leukemia

4 September 2024
4 min read

Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a global biotechnology enterprise dedicated to advancing the potential of cell and gene therapies (CGT) to enhance healthcare accessibility and outcomes, revealed encouraging results from a real-world clinical trial of its CD19 CAR-T therapy, ORG-101, in patients suffering from CD19+ Acute Lymphoblastic Leukemia (B-cell ALL). Harley Street Healthcare Group plans to establish a Global Cancer Initiative in collaboration with Orgenesis, aimed at democratizing Advanced Therapies and fostering further clinical advancements.

👇Explore more about this drug by clicking the image below. Gain detailed insights into its R&D Status, Core Patent, Clinical Trials and Global Approval Status. Stay informed and updated.

图形用户界面, 应用程序

描述已自动生成

The recent efficacy and safety data for the study reveal an impressive complete response (CR) rate of 82% in adult subjects and 93% in pediatric subjects. Additionally, the occurrence of severe Cytokine Release Syndrome (CRS)a significant safety concern in CAR-T therapieswas found to be minimal, with rates of just 2% in adults and 6% in children, which is lower compared to existing treatments. This indicates a strong safety profile for ORG-101. 

CRS is a systemic response caused by an excessive immune reaction to immunotherapy and poses a significant safety challenge in traditional CAR-T treatments. The findings, involving 233 patients from a real-world study at a prominent hematology center in China, support this safety profile. Further specifics are available in the company’s scientific presentation to be included as an exhibit in a Form 8-K filing.

Orgenesis is using its newly acquired GMP-Validated Platform to deploy the CAR-T therapy, adapting it to a decentralized manufacturing model. This model is intended to speed up capacity establishment, improve production efficiency, and lower treatment costs. The production data and cost analysis reinforce that Orgenesis’ decentralized approach offers a cost-effective alternative for accessing Advanced Therapies.

ORG-101 employs a third-generation lentiviral vector featuring a proprietary CAR construct, along with streamlined, decentralized onsite manufacturing and testing. This strategy presents a substantially more affordable option compared to traditional CAR-T therapies produced at centralized facilities.

The company has engaged in discussions with the FDA in the U.S., the Israeli Ministry of Health, and the Paul-Ehrlich-Institute in Germany regarding ORG-101. It is now gearing up to launch its own Phase 1/2 multicenter clinical trial, beginning at the General University Hospital of Patras in Greece and supported by its Enterprise Greece Grant, with plans to expand to additional sites within the Orgenesis network of hospital partnerships.

Vered Caplan, CEO of Orgenesis, stated, “We believe that these clinical results, combined with our GMP-Validated Platform, represent a significant advancement in our strategy to integrate our capabilities in decentralized cell therapy production with our regional partnerships. The product has not only demonstrated initial signs of positive clinical outcomes, but our production data also confirm that Orgenesis’ cost-effective decentralized cell processing can potentially enhance access to this treatment and reduce costs. We are committed to delivering this and other potentially life-saving treatments to patients globally.”

Sanjeev Kumar, Chief Visionary Officer at Harley Street Healthcare Group, outlined the objectives for the Global Cancer Initiative: “Cancer is increasingly affecting younger demographics. Our Global Cancer Initiative aims to gather contributions from various committed partners to make cancer therapies more affordable globally, focusing on democratizing Advanced Therapies. This initiative will strategically support our biobanking partnership and Orgenesis’ decentralized solutions to reduce costs and increase access to these therapies.”

👇Explore the most recent advancements in drug research, indications, organizations, clinical trials, results, and patents related to this target by clicking the image link below. Dive in to gain deeper insights!

图形用户界面, 文本, 应用程序, 表格

描述已自动生成

According to the data provided by the Synapse Database, As of September 3, 2024, there are 762 investigational drugs for the CD19 target, including 264 indications, 495 R&D institutions involved, with related clinical trial reaching 1327, and as many as 43209 patents.

The drug ORGCAR19 (CD19 CAR-T) is a Chimeric Antigen Receptor T-cell (CAR-T) therapy that targets the CD19 antigen. It is being developed by Orgenesis, Inc. and is intended for the treatment of neoplasms, immune system diseases, and hemic and lymphatic diseases. The active indications for ORGCAR19 include acute lymphoblastic leukemia and lymphoma. CAR-T therapy involves modifying a patient's T cells to express chimeric antigen receptors that specifically target cancer cells. CD19 is a protein found on the surface of certain types of B-cell malignancies, making it an ideal target for CAR-T therapy in the treatment of hematologic cancers.

图形用户界面, 文本, 应用程序

描述已自动生成

Johnson & Johnson Seeks Initial Approval for Nipocalimab in Treating Broad-Spectrum Myasthenia Gravis
Latest Hotspot
3 min read
Johnson & Johnson Seeks Initial Approval for Nipocalimab in Treating Broad-Spectrum Myasthenia Gravis
4 September 2024
Johnson & Johnson aims for initial approval of nipocalimab to treat a wide range of patients with antibody-positive generalized myasthenia gravis.
Read →
Exploring the Mysteries of Chemical Modifications in Small Nucleic Acid Drugs: The Efficient Retrieval Pathway of Patsnap Bio
Bio Sequence
6 min read
Exploring the Mysteries of Chemical Modifications in Small Nucleic Acid Drugs: The Efficient Retrieval Pathway of Patsnap Bio
3 September 2024
Patsnap Bio, with its chemical modification search function, provides users with a powerful tool for exploring multidimensional nucleotide sequence information.
Read →
Merck Releases Progress Report for Phase 3 Studies: KEYNOTE-867 & KEYNOTE-630 Clinical Trials
Latest Hotspot
4 min read
Merck Releases Progress Report for Phase 3 Studies: KEYNOTE-867 & KEYNOTE-630 Clinical Trials
3 September 2024
Merck has recently divulged advancements pertaining to two pivotal Phase 3 clinical trials, designated as KEYNOTE-867 and KEYNOTE-630.
Read →
Cardiovascular Mortality Risk Reduced by 16%! Bayer Announces Latest Analysis Data from Finerenone FINE-HEART Study
Hot Spotlight
8 min read
Cardiovascular Mortality Risk Reduced by 16%! Bayer Announces Latest Analysis Data from Finerenone FINE-HEART Study
3 September 2024
at the ESC Congress, Bayer published the pooled analysis of the Phase III FINE-HEART study on finerenone, along with the latest data from the FINEARTS-HF trial.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.