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Corporation","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"SWITZERLAND","productType":"Cell & Gene Therapy","year":"2021","type":"Inapplicable","leadProduct":"Tisagenlecleucel","moa":"B-lymphocyte antigen CD19","graph1":"Oncology","graph2":"Approved FDF","graph3":"Novartis Pharmaceuticals Corporation","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Novartis Pharmaceuticals Corporation \/ Undisclosed","highestDevelopmentStatusID":"15","companyTruncated":"Novartis Pharmaceuticals Corporation \/ Undisclosed"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Perelman School of Medicine","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"SWITZERLAND","productType":"Cell & Gene Therapy","year":"2022","type":"Inapplicable","leadProduct":"Tisagenlecleucel","moa":"B-lymphocyte antigen 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CD19","graph1":"Oncology","graph2":"Approved FDF","graph3":"Oxford Biomedica","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Oxford Biomedica \/ Novartis Pharmaceuticals Corporation","highestDevelopmentStatusID":"15","companyTruncated":"Oxford Biomedica \/ Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"SWITZERLAND","productType":"Cell & Gene Therapy","year":"2020","type":"Inapplicable","leadProduct":"Tisagenlecleucel","moa":"B-lymphocyte antigen CD19","graph1":"Oncology","graph2":"Approved FDF","graph3":"Novartis Pharmaceuticals Corporation","amount2":0,"highestDevelopmentShortName":"Approved FDF","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Novartis Pharmaceuticals Corporation \/ 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Find Clinical Drug Pipeline Developments & Deals for Tisagenlecleucel

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                          01

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : Citius intends to use proceeds for the pre-clinical and clinical development of Lymphir (denileukin diftitox), a recombinant fusion protein combining interleukin-2 and diphtheria toxin.

                          Product Name : Lymphir

                          Product Type : Protein

                          Upfront Cash : Undisclosed

                          April 26, 2024

                          Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          Sponsor : H.C. Wainwright & Co

                          Deal Size : $15.0 million

                          Deal Type : Private Placement

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                          02

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : Lymphir™ (denileukin diftitox) in combination with FDA-approved CAR-T products like tisagenlecleucel or lisocabtagene maraleucel is being investigated for relapsed or refractory B-cell lymphomas.

                          Product Name : Lymphir

                          Product Type : Protein

                          Upfront Cash : Inapplicable

                          April 11, 2024

                          Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : Tisagenlecleucel is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Lymphoma, Follicular.

                          Product Name : Undisclosed

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          June 05, 2023

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Undisclosed

                          Product Type : Protein

                          Upfront Cash : Inapplicable

                          November 04, 2022

                          Lead Product(s) : Efineptakin Alpha,Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : Tisagenlecleucel is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Precursor B-Cell Lymphoblastic Leukemia-Lymphoma.

                          Product Name : Undisclosed

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          July 15, 2022

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Novartis Pharmaceuticals Corporation

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Kymriah

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          June 12, 2022

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved FDF

                          Sponsor : Perelman School of Medicine

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Kymriah

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          May 27, 2022

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Kymriah

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          May 04, 2022

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Kymriah

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          March 25, 2022

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          The MedTech Conference
                          Not Confirmed
                          The MedTech Conference
                          Not Confirmed

                          Details : 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.

                          Product Name : Kymriah

                          Product Type : Cell & Gene Therapy

                          Upfront Cash : Inapplicable

                          December 14, 2021

                          Lead Product(s) : Tisagenlecleucel

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved FDF

                          Sponsor : Undisclosed

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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