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Chemistry

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Drugs in Development

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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.


Lead Product(s): Denileukin Diftitox,Tisagenlecleucel

Therapeutic Area: Oncology Brand Name: Lymphir

Study Phase: Phase IProduct Type: Large molecule

Sponsor: H.C. Wainwright & Co

Deal Size: $15.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement April 26, 2024

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : H.C. Wainwright & Co

Deal Size : $15.0 million

Deal Type : Private Placement

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.

Brand Name : Lymphir

Molecule Type : Large molecule

Upfront Cash : Undisclosed

April 26, 2024

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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 relapsed or refractory B-cell lymphomas.


Lead Product(s): Denileukin Diftitox,Tisagenlecleucel

Therapeutic Area: Oncology Brand Name: Lymphir

Study Phase: Phase IProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 11, 2024

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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.

Brand Name : Lymphir

Molecule Type : Large molecule

Upfront Cash : Not Applicable

April 11, 2024

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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 Brand Name: NT-I7

Study Phase: Phase IProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 04, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Lead Product(s) : Efineptakin Alfa,Tisagenlecleucel

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

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.

Brand Name : NT-I7

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 04, 2022

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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 Brand Name: Kymriah

Study Phase: ApprovedProduct Type: Cell and Gene therapy

Sponsor: Perelman School of Medicine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 12, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

Lead Product(s) : Tisagenlecleucel

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Perelman School of Medicine

Deal Size : Not Applicable

Deal Type : Not Applicable

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.

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

June 12, 2022

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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 Brand Name: Kymriah

Study Phase: ApprovedProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
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.

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

May 27, 2022

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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 Brand Name: Kymriah

Study Phase: ApprovedProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
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.

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

May 04, 2022

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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 Brand Name: Kymriah

Study Phase: Phase IIProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 25, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
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.

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

March 25, 2022

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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 Brand Name: Kymriah

Study Phase: ApprovedProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 14, 2021

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
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.

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

December 14, 2021

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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 Brand Name: Kymriah

Study Phase: ApprovedProduct Type: Cell and Gene therapy

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 13, 2021

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Oxford Biomedica

United Kingdom
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SupplySide West 2024
Not Confirmed

Oxford Biomedica

United Kingdom
arrow
SupplySide West 2024
Not Confirmed

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 fo...

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Undisclosed

December 13, 2021

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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 Brand Name: Kymriah

Study Phase: Phase IIProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2021

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10

SupplySide West 2024
Not Confirmed
SupplySide West 2024
Not Confirmed

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...

Brand Name : Kymriah

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

October 27, 2021

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01

Brand Name : Kymriah

Tisagenlecleucel

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SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
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SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Oncology

Currency : USD

2020 Revenue in Millions : 474

2019 Revenue in Millions : 278

Growth (%) : 71

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02

Brand Name : Kymriah

Tisagenlecleucel

arrow
SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
arrow
SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Oncology

Currency : USD

2021 Revenue in Millions : 587

2020 Revenue in Millions : 474

Growth (%) : 24

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03

Brand Name : Kymriah

Tisagenlecleucel

arrow
SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
arrow
SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Hematology

Currency : USD

2022 Revenue in Millions : 536

2021 Revenue in Millions : 587

Growth (%) : -9

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04

Brand Name : Kymriah

Tisagenlecleucel

arrow
SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
arrow
SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 508

2022 Revenue in Millions : 536

Growth (%) : -5

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05

Brand Name : Kymriah

Tisagenlecleucel

arrow
SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
arrow
SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Oncology

Currency : USD

2018 Revenue in Millions : 76

2017 Revenue in Millions : 6

Growth (%) : 1167%

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06

Brand Name : Kymriah

Tisagenlecleucel

arrow
SupplySide West 2024
Not Confirmed

Brand Name : Kymriah

Switzerland
arrow
SupplySide West 2024
Not Confirmed

Tisagenlecleucel

Main Therapeutic Indication : Oncology

Currency : USD

2019 Revenue in Millions : 278

2018 Revenue in Millions : 76

Growth (%) : 266

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