[{"orgOrder":0,"company":"Cell Therapies","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kymriah\u00ae To Be Manufactured at Cell Therapies Pty Ltd, Marking Australia\u2019s First On-Shore Commercial Production of CAR T therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kymriah\u00ae Receives FDA Regenerative Medicine Advanced Therapy Designation in Follicular Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"NeoImmuneTech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1b Study of NT-I7 and Kymriah in Relapsed\/Refractory Large B-Cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Receives Approval for Kymriah by Health Sciences Authority as Singapore\u2019s First Commercially Approved CAR-T Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Oxford Biomedica","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Oxford Biomedica In License and Supply Deals With Novartis and Arcellx","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Cell and Gene therapy","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kymriah\u00ae Pivotal Trial Demonstrates Strong Response 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Find Clinical Drug Pipeline Developments & Deals for Tisagenlecleucel
Citius currently intends to use the net proceeds for pre-clinical and clinical development of its product candidates, including Lymphir (denileukin diftitox), a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin.
Lymphir™ (denileukin diftitox) in combination with FDA-approved CAR-T products like tisagenlecleucel or lisocabtagene maraleucel is being investigated for the treatment of relapsed or refractory B-cell lymphomas.
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit.
44% of patients who experienced remission within three months of infusion were still in remission at the five-year mark, demonstrating the long-term benefit and curative potential of one-time Kymriah (Tisagenlecleucel) infusion.
The approval of Kymriah (Tisagenlecleucel) is based on data from the Phase II ELARA trial, a single-arm, open-label trial, in which 90 patients were evaluated for efficacy with a median follow-up of approximately 17 months.
Approval based on the Phase II ELARA trial showing Kymriah (tisagenlecleucel) demonstrated high response rates in heavily pretreated patients, including an 86% overall response rate and a 69% complete response.
CHMP opinion based on Phase II global ELARA trial for Kymriah, demonstrating high response rates in heavily pretreated patients; 69% experienced a complete response, with an 86% overall response rate and a remarkable safety profile.
CAR T-cell therapy tisagenlecleucel (tisa-cel) was not found to improve event-free survival over what was seen with standard of care as a second-line treatment for patients with aggressive non-Hodgkin lymphoma.
Under the terms of the agreement, Oxford Biomedica will receive payments related to the development and manufacturing of lentiviral vectors for use in clinical trials with also allowing for payments for the manufacture and supply of lentiviral vectors for commercial use.
Kymriah (tisagenlecleucel) is an autologous, immunocellular cancer therapy which involves reprogramming a patient's T-cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing cells. It is administered as intravenous infusion.
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