Orca Bio Secures 250 Million USD in Funding Ahead of Cancer Cell Therapy Launch

Orca Bio has secured 250 million USD in funding across two financing rounds, significantly strengthening its balance sheet as the company prepares for the potential commercialisation of its blood cancer cell therapy candidate. The California-based biotechnology firm submitted its biologics licence application to the FDA last year for Orca-T, an allogeneic T-cell immunotherapy designed to address graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation.

The therapy utilises purified donor regulatory T cells and aims to prevent GvHD whilst requiring less immunosuppression compared to conventional allogeneic hematopoietic stem cell transplantation. The FDA has set an approval decision date of 6 April 2026 for Orca-T as a treatment for various haematological malignancies, including acute myeloid leukaemia, acute lymphoblastic leukaemia and myelodysplastic syndromes.

The funding comprises a Series F financing round that closed in December 2025 and a previously undisclosed Series E round completed in 2024. According to a company spokesperson, the capital raised was roughly evenly distributed between the two rounds. The company has also secured up to 100 million USD in credit facilities from Silicon Valley Bank. Notably, neither financing round appears in Securities and Exchange Commission filings, contrasting with the company’s 192 million USD Series D round disclosed in 2020.

Orca Bio intends to deploy the capital towards scaling its commercial operations, with a particular focus on establishing manufacturing capacity on the East Coast to complement its existing California facilities. The commercial strategy has experienced leadership changes in recent months. Steve Gavel, appointed to lead commercial activities in June 2025 following his involvement in Legend Biotech’s Carvykti launch, departed after just four months to join Cabaletta Bio in October. Mike Hirschmann, who also previously worked at Legend Biotech, assumed the chief commercial officer position following Gavel’s exit.

The commercial opportunity for Orca-T depends substantially on the therapy’s ability to demonstrate advantages over existing GvHD prevention methods. Phase 3 trial data indicated that Orca-T significantly improved survival free from moderate-to-severe chronic GvHD compared to conventional allogeneic hematopoietic stem cell transplantation combined with tacrolimus and methotrexate. The tacrolimus and methotrexate combination represents one established approach to GvHD prevention in this patient population.

However, separate clinical trials have demonstrated that antithymocyte globulin and cyclophosphamide show superior efficacy in preventing GvHD compared to the tacrolimus and methotrexate regimen. Whilst retrospective analysis of patients enrolled in a Phase 1b trial of Orca-T suggested potential advantages over cyclophosphamide, researchers who analysed the Phase 3 data acknowledged that a randomised controlled trial comparing Orca-T directly against cyclophosphamide or antithymocyte globulin may be necessary to reach definitive conclusions regarding comparative efficacy.

The absence of head-to-head trial data against current standard-of-care regimens presents a notable challenge for Orca Bio’s commercial team as they seek to establish market positioning. The competitive landscape in GvHD prevention continues to evolve, and payers will likely scrutinise the therapy’s value proposition in the absence of direct comparative evidence against the most effective existing treatments.