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Find Clinical Drug Pipeline Developments & Deals by Gamida Cell

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Highbridge Capital Management

            Deal Size: $75.0 million Upfront Cash: Undisclosed

            Deal Type: Financing February 16, 2021

            Details:

            These capital infusions will be used to support manufacturing, regulatory and commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 09, 2021

            Details:

            The results of this global Phase 3 study of omidubicel in patients with hematologic malignancies show that omidubicel resulted in faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital.

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 11, 2021

            Details:

            The Phase 3 study for omidubicel evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 14, 2020

            Details:

            Feedback from FDA supports proceeding to BLA Submission for omidubicel with additional manufacturing requirements; the company plans to submit full BLA in second half of 2021.

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            Lead Product(s): GDA-201

            Therapeutic Area: Oncology Product Name: GDA-201

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2020

            Details:

            Updated data from the ongoing Phase 1 clinical study of GDA-201, an investigational, NK cell-based cancer immunotherapy for the treatment of patients with non-Hodgkin lymphoma, will be presented in an oral presentation at the American Society of Hematology Annual Meeting.

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 06, 2020

            Details:

            Phase 3 study of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant, met all three of its secondary endpoints.

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: NiCord

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).

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            Lead Product(s): Omidubicel

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Piper Sandler

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Public Offering May 18, 2020

            Details:

            Gamida Cell intends to use the net proceeds from this offering to fund the preparation of a Biologics Licensing Application for omidubicel in high risk hematologic malignancies and the continued clinical development of other product candidates.