# Orca Bio

Source: https://onco.cc/companies/orca-bio/  
OnCo record `orca-bio` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Company
- Last checked: 2026-09-10
- Also known as: Orca Biosystems; Orca Biosystems, Inc.; orca-biosystems
- HQ: Menlo Park, CA
- Type: cell-therapy
- Website: https://orcabio.com/

## Notes

- 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'.

## Sources

- Official website: https://orcabio.com/
- TREGZI FDA approval (June 2026): https://orcabio.com/orca-bios-tregzi-receives-u-s-fda-approval-as-first-and-only-precision-engineered-cell-therapy-for-allogeneic-transplant-in-adults-with-hematological-malignanciesorca-bio-adds-east/
- Newsroom: https://orcabio.com/newsroom/
- Form D, July 2020: https://www.sec.gov/Archives/edgar/data/1720544/000172054420000002/primary_doc.xml
- ClinicalTrials.gov: trials led by Orca Biosystems: https://clinicaltrials.gov/search?lead=Orca%20Biosystems%2C%20Inc.

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Myelodysplastic syndromes / neoplasms (MDS)](https://onco.cc/cancers/mds/)
- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [Allogeneic (off-the-shelf) cell therapy](https://onco.cc/technologies/allogeneic-cell-therapy/)
- drugs: [Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq](https://onco.cc/drugs/tregzi/)
- trials: [Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies](https://onco.cc/trials/nct05316701/), [Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome](https://onco.cc/trials/nct07216443/)

---
JSON: https://onco.cc/api/v1/entities/orca-bio.json