Orca Bio has disclosed $250 million in funding, flooding its balance sheet with cash to buoy preparations for the commercialization of a blood cancer cell therapy.
California-based Orca filed for FDA approval of its allogeneic T-cell immunotherapy Orca-T last year. Using purified donor regulatory T cells, Orca-T is designed to prevent graft-versus-host disease (GvHD) with less immunosuppression than is required for conventional allogeneic hematopoietic stem cell transplantation (alloHSCT).
The FDA is set to decide by April 6 whether to approve the drug candidate as a treatment for hematological malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes.
Orca has been gearing up for commercialization in anticipation of approval. Friday, the biotech said it has raised $250 million across two rounds, including a series F financing that closed last month, and that it secured up to $100 million in credit from Silicon Valley Bank.
An Orca spokesperson said the capital raised was comparable between the two rounds. The previously undisclosed series E round completed in 2024, the spokesperson said.
Orca disclosed its $192 million series D round in a Securities and Exchange Commission filing in 2020, but no entries appear for the two subsequent rounds.
Orca will use the money to scale up for commercialization, including by adding manufacturing capacity on the East Coast to complement its existing operations in California. The biotech put Steve Gavel in charge of commercial activities in June. However, Gavel, who worked on the Carvykti launch at Legend Biotech, lasted just a few months at Orca before joining Cabaletta Bio in October.
Mike Hirschmann, who joined Orca as senior vice president of U.S. commercial, stepped up to the chief commercial officer role when Gavel departed. Like Gavel, Hirschmann worked at Legend before joining Orca.
If Orca-T wins approval, the commercial team will need to persuade physicians to use the product over existing methods for preventing GvHD. A phase 3 trial linked Orca-T to significantly better survival free from moderate-to-severe chronic GvHD in patients with hematological malignancies than conventional alloHSCT with tacrolimus and methotrexate. The combination of tacrolimus and methotrexate is one way physicians try to prevent GvHD in these patients.
Other trials found that antithymocyte globulin (ATG) and cyclophosphamide (PTCy) are better at preventing GvHD than tacrolimus and methotrexate. A retrospective analysis of patients in a phase 1b trial of Orca-T yielded evidence that the therapy may have advantages over PTCy. Yet the researchers who wrote up Orca’s phase 3 data said a randomized trial versus PTCy or ATG may be needed to reach a definitive conclusion.