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Details:
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.
Lead Product(s): Denileukin Diftitox,Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Lymphir
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2024
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.
Lead Product(s): Efineptakin Alfa,Tisagenlecleucel
Therapeutic Area: Oncology Product Name: NT-I7
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2022
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Perelman School of Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2022
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2022
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2021
Details:
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 13, 2021
Details:
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.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
Details:
Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion. Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology Virtual Scientific Meeting.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2021
Details:
Kymriah, the first chimeric antigen receptor T-cell (CAR-T) therapy approved in Singapore, is indicated as a one-time treatment manufactured individually for each patient.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
This IND clearance allows NeoImmuneTech (NIT) to initiate a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard-of-care Kymriah CAR T-cell therapy.
Lead Product(s): Efineptakin alfa,Tisagenlecleucel
Therapeutic Area: Oncology Product Name: NT-I7
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
Details:
Novartis has entered into an agreement with Cell Therapies to manufacture Kymriah at their production facility within the Peter MacCallum Cancer Centre in Melbourne.
Lead Product(s): Tisagenlecleucel
Therapeutic Area: Oncology Product Name: Kymriah
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 28, 2020
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