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Orca Bio
Orca Bio makes precision-engineered versions of donor stem cell transplants for blood cancers, sorting the donor cells so that patients get the cells that fight cancer and rebuild the immune system with fewer of the cells that cause graft versus host disease. Its first product, TREGZI, was approved in the US in June 2026.
Also called: Orca BiosystemsOrca Biosystems, Inc.orca-biosystems
Overview
Orca Bio is a commercial-stage cell therapy company based in Menlo Park, California, whose high-precision platform sorts and reconstitutes allogeneic donor grafts. TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq, formerly Orca-T) was approved by the FDA on 30 June 2026 for use in matched-donor haematopoietic stem cell transplantation with a myeloablative regimen, to support reconstitution and improve chronic graft-versus-host disease-free survival in adults with haematological malignancies. In the pivotal Precision-T study, patients receiving TREGZI were twice as likely to be alive without chronic GVHD at one year compared with conventional allogeneic transplant. Orca-Q, a second precision cell therapy for high-risk haematological malignancies, holds RMAT designation. Orca has manufacturing on both US coasts. An SEC Form D shows about $192 million of equity sold in an offering that began in November 2019.
Headquarters
Menlo Park, CA, US
Scorecard
All companies#295of 1244 companies, score 14
- approved products +6
- modalities +2
- regions +1
- 24-month regulatory events +2
- registry trials +3
1 approved, 0 in phase 3, 0 earlier, 0 targets, 2 registry studies. Formula on the scorecards page.
Funding
All startupsGrowth stage
Investors not recorded; see the round sources.
Rounds on record
| Round | Year | Amount | Source |
|---|---|---|---|
| Form D offering · Equity offering by Orca BioSystems Inc, first sale 29 November 2019, filed July 2020 | 2020 | $192M | sec.gov |
Amounts only where the cited source states them. Rounds without a public source are not listed.
Type
Stage
Growth stage
Website
ApprovedPrecision-sorted allogeneic stem cell graft with regulatory T cells
Tregzi, formerly Orca-T, is a donor stem cell transplant sorted with high precision and given with regulatory T cells, so that patients with blood cancers keep the graft's anti-cancer effect while being protected from chronic graft-versus-host disease. The FDA approved it on 30 June 2026 for adults having a matched-donor transplant.
Notes
top- Series letter and investors for the 2019 to 2020 offering not sourced; later financings not sourced. Stage set to growth because the company is private and commercial-stage. Cancer ids are approximations for 'haematological malignancies'.
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cancers
fronts
technologies
drugs
ApprovedPrecision-sorted allogeneic stem cell graft with regulatory T cells