Orca Bio’s T-cell therapy shows promise in haematological malignancies

The company is preparing to submit the results to the FDA this year

Orca Bio has shared promising results from a late-stage study of its investigational allogeneic T-cell immunotherapy in patients with haematological malignancies.

The phase 3 Precision-T trial has been evaluating the candidate, Orca-T, in patients with acute myeloid leukaemia, acute lymphoblastic leukaemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukaemia.

Patients were randomised to receive either Orca-T plus single-agent tacrolimus (TAC) or a conventional allogeneic haematopoietic stem cell transplant (alloHSCT) plus TAC methotrexate.

The study met its primary endpoint, with Orca-T demonstrating a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD). At one year, the rate for patients who received Orca-T was 78% compared to 38% for those in the alloHSCT arm.

Patients in the Orca-T group also achieved an estimated overall survival of 94% compared to 83% in the alloHSCT cohort at one year, and the cumulative incidence of moderate-to-severe cGvHD was 13% and 44% in the Orca-T and alloHSCT arms, respectively.

Orca Bio said it is now preparing to submit the results to the US Food and Drug Administration (FDA) this year.

Ivan Dimov, Co-Founder and Chief Executive Officer at Orca Bio, said:  “We are working closely with the FDA and expect to submit a Biologics License Application this year. These results support the validity of our high-precision platform as we continue to advance our… pipeline of allogeneic cell therapies for the treatment of haematologic malignancies, autoimmune diseases and beyond.”