Orca Bio’s T-cell immunotherapy candidate for blood cancers has more than doubled the number of patients surviving free of moderate-to-severe chronic graft versus host disease (GvHD).
The Phase III Precision-T study (NCT05316701) found that the company’s lead investigational allogeneic T-cell immunotherapy, Orca-T (TRGFT-201), saw 78% of patients avoid GvHD versus 38% in the arm using a conventional allogeneic stem cell transplant at one year.
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Chronic GvHD is when a patient’s immune system recognises donor cells as foreign and attacks them. This leads to a rejection of the stem cell transplant, which is typically used to replace damaged blood-forming cells at the root of a number of haematologic malignancies of blood cancers such as leukaemia.
The company’s randomised Phase III trial, which enrolled 174 patients with haematological malignancies, met its primary endpoint of a statistically significant improvement in survival free of chronic GvHD. It also met its key secondary endpoint with 94% of the Orca-T group achieving overall survival (OS) after one year versus 83% in the conventional stem cell transplant group.
Study author Professor Everett Meyer said: “Today, treating patients with serious blood cancers using allogeneic stem cell transplants requires a difficult risk-benefit trade-off as clinicians aim to cure the disease while avoiding potentially deadly treatment-related toxicities such as GvHD.
“The Precision-T study showed double the rate of survival free from GvHD with Orca-T versus a conventional transplant, a relapse-free survival rate of 76% and no new safety concerns. These findings are highly encouraging and provide compelling new evidence as we work to solve the critical factors contributing to the needs of this patient population.”
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By GlobalDataResearch by GlobalData’s Pharmaceutical Intelligence Center estimates that the stem cell therapy is likely to bring in $60m in sales globally by the end of 2027 if it gains approval, with that figure expected to grow to $163m by the end of 2030. Meanwhile the overall market for blood cancer therapies brought in more than $117bn in 2024, predicted to rise to $178bn by the end of the decade.
GlobalData is the parent company of Clinical Trials Arena.
Now, the company has said that it plans to file for a biologics licence application (BLA) with the US Food and Drug Administration (FDA) sometime this year.
Orca Bio co-founder Ivan Dimov said: “We are working closely with the FDA and expect to submit a BLA this year. These results support the validity of our high-precision platform as we continue to advance our robust pipeline of allogeneic cell therapies for the treatment of hematologic malignancies, autoimmune diseases and beyond.”
Elsewhere in the field of blood cancers, TC BioPharm has completed subject dosing in cohort A of the Phase IIb ACHIEVE trial of TCB008. Meanwhile, Swedish company Cantargia has enrolled the first patient in the Phase Ib/IIa trial of nadunolimab.
