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Orca Bio
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Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, such as AML.


Lead Product(s): Allogeneic T-Cell Immunotherapy

Therapeutic Area: Oncology Product Name: Orca-T

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 05, 2024

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Orca-Q is an investigational allogeneic cellular therapy consisting of a single infusion containing a proprietary composition of stem and immune cells derived from peripheral blood from either related or unrelated matched, unmatched or haploidentical donors.


Lead Product(s): Orca-Q

Therapeutic Area: Oncology Product Name: OrcaGraft

Highest Development Status: Phase IProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 03, 2022

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TregGraft (Orca-T) is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors.


Lead Product(s): Orca-T

Therapeutic Area: Oncology Product Name: TregGraft

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 August 02, 2022

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TregGraft (Orca-T) , an investigational, high-precision allogeneic cell therapy derived from stem and immune cells from either related or unrelated HLA-matched donors, is intended to safely replace a patient’s compromised blood and immune system with that from healthy donor.


Lead Product(s): Orca-T

Therapeutic Area: Oncology Product Name: TregGraft

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 May 12, 2022

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Pooled data from 137 patients show Orca-T, an investigational high-precision allogeneic cellular therapy improved overall survival and reduced chronic graft versus host disease compared to standard of care.


Lead Product(s): Orca-T

Therapeutic Area: Oncology Product Name: TregGraft

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 25, 2022

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Early multi-center results indicate that Orca-T, a novel approach to HSCT, improves time-to-engraftment, markedly reduces the incidence and severity of GvHD, and significantly improved GRFS at 1 year.


Lead Product(s): TregGraft

Therapeutic Area: Oncology Product Name: Orca-T

Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2020

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Preliminary data from the Phase I/II clinical trials of Orca-T will be presented at the 62nd American Society of Hematology Annual Meeting. Data provide insights into manufacturing efficiency, logistics and early clinical outcomes of Orca-T for patients with blood cancers.


Lead Product(s): TregGraft

Therapeutic Area: Oncology Product Name: Orca-T

Highest Development Status: Phase I/ Phase IIProduct 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

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Orca-T is an allogeneic, high-precision cell therapy for patients with blood cancers who are eligible for a hematopoietic stem cell transplant. Orca-T has received ODD from the FDA for enhancing cell engraftment in patients who qualify for a hematopoietic stem cell transplant.


Lead Product(s): TregGraft

Therapeutic Area: Oncology Product Name: Orca-T

Highest Development Status: Phase I/ 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 14, 2020

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The partnership promotes complementary scientific technologies to develop next generation cell-based therapies for patients with solid cancers.


Lead Product(s): T cell therapies

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Lyell Immunopharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 02, 2020

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The financing will support the continued advancement of Orca Bio’s cell therapy pipeline and its novel manufacturing platform, which sorts blood with single-cell precision and a high level of purity and speed to create optimal therapeutic mixtures of immune and stem cells.


Lead Product(s): TRGFT-201

Therapeutic Area: Oncology Product Name: TRGFT-201

Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Lightspeed Venture

Deal Size: $300.0 million Upfront Cash: Undisclosed

Deal Type: Series D Financing June 17, 2020

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