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Details:
Under the terms of the agreement, Pierre Fabre gains U.S. and remaining global commercial markets for tab-cel (tabelecleucel), an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy.
Lead Product(s): Tabelecleucel
Therapeutic Area: Infections and Infectious Diseases Product Name: Tab-cel
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: $640.0 million Upfront Cash: $30.0 million
Deal Type: Partnership November 01, 2023
Details:
tab-cel (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Lead Product(s): Tabelecleucel
Therapeutic Area: Infections and Infectious Diseases Product Name: tab-cel
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 September 18, 2023
Details:
Ebvallo™ (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Lead Product(s): Tabelecleucel
Therapeutic Area: Infections and Infectious Diseases Product Name: Ebvallo
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Atara Biotherapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
Details:
Ebvallo (tabelecleucel) is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Ebvallo
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: HealthCare Royalty
Deal Size: $31.0 million Upfront Cash: $31.0 million
Deal Type: Agreement December 20, 2022
Details:
Ebvallo™ (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Ebvallo
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 19, 2022
Details:
Ebvallo (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Lead Product(s): Tabelecleucel
Therapeutic Area: Infections and Infectious Diseases Product Name: Ebvallo
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 October 14, 2022
Details:
Under the amended terms, Atara will receive a milestone payment upon Tab-cel (tabelecleucel) EC approval and subsequent filing of the MAA transfer to Pierre Fabre in exchange for reduced tab-cel® royalties and supply price mark-up for Pierre Fabre.
Lead Product(s): Tabelecleucel
Therapeutic Area: Oncology Product Name: Tab-cel
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: $365.0 million Upfront Cash: $45.0 million
Deal Type: Collaboration September 28, 2022
Details:
Of 16 EBV+ PTLD patient, 15 received at least one dose of tab-cel. Overall, nine out of 15 tab-cel (tabelecleucel) treated patients achieved a response as assessed by treating physician, six CRs and three PR. Of nine responses, eight were observed of tab-cel.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
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 June 04, 2022
Details:
FUJIFILM will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its promising pipeline, including tabelecleucel (tab-cel®), ATA188, and allogeneic CAR T therapies.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Atara Biotherapeutics
Deal Size: Undisclosed Upfront Cash: $100.0 million
Deal Type: Partnership April 04, 2022
Details:
Under the agreement with FUJIFILM, will acquire Atara’s T-Cell Operations and Manufacturing facility. Atara with access to the flexible capacity needed to manufacture clinical and commercial stage allogeneic cell therapies for its pipeline, including tabelecleucel (tab-cel®).
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Fujifilm Diosynth Biotechnologies
Deal Size: $100.0 million Upfront Cash: $100.0 million
Deal Type: Partnership January 26, 2022
Details:
Patients who achieved a PR with tab-cel derived similar OS benefit to those who achieved a CR. Treatment was well tolerated in refractory and immunocompromised patients and there were no fatal events reported related to tab-cel.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
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 December 13, 2021
Details:
Under the terms of the agreement, Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in EBV-driven cancers.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: $365.0 million Upfront Cash: $45.0 million
Deal Type: Collaboration October 04, 2021
Details:
Phase 2 results validate potential life-saving benefit of treatment with tab-cel® in seriously ill patient population with no approved therapeutic options. Overall tab-cel® survival benefit demonstrated across previous treatment subgroups.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
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 June 07, 2021
Details:
Poster on key characteristics of tabelecleucel (tab-cel®) that help elucidate the product’s proposed mechanism of action (MOA) and a poster presenting an innovative assay to detect and quantify non-engineered allogeneic T cell therapies such as ATA188, will be presented.
Lead Product(s): Tabelecleucel
Therapeutic Area: Immunology Product Name: Tab-cel
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 January 19, 2021
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