Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : H.C. Wainwright & Co
Deal Size : $15.0 million
Deal Type : Private Placement
Citius Pharmaceuticals Announces $15 Million Registered Direct Offering
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
Lead Product(s) : Denileukin Diftitox,Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Citius Adds City of Hope to UMN’s LYMPHIR Phase 1 for B-Cell Lymphoma
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Efineptakin Alpha,Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase I
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Perelman School of Medicine
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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
Lead Product(s) : Tisagenlecleucel
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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