Rawan Faramand, MD, on Evaluating Orca-T in Patients With Acute Myeloid Leukemia

“These new findings presented at ASCO show that Orca-T has the potential to offer curative therapy for patients with AML with very low rates—and in this case 0%—treatment-related mortality... In doing so, we're keeping the balance of graft versus leukemia—meaning not seeing higher rates of relapse—while still decreasing the risk of toxicities that we typically observe in an SOC stem cell transplantation. This approach hopefully has the potential to expand curative treatment to many more patients.”

Currently, allogeneic hematopoietic cell transplant (allo-HCT) is a standard of care (SOC) option for a number of hematologic malignancies. Although allo-HCT has the curative potential for some patients, it also has restrictions on eligibility and carries a number of risks, including graft versus host disease (GvHD), which can be fatal in some patients. As such, there is continued interest in the development of new treatment options for these diseases. Orca Bio is currently developing one such potential option: Orca-T, an investigational cell therapy product alternative to standardallo-HCT that consists of CD34+ stem cells, regulatory T-cells, and conventional T-cells from the peripheral blood of matched donors. The product is intended to reduce the risks associated with standard allo-HCT while maintaining the anticancer benefit of the SOC.

Orca-T has been evaluated in an ongoing phase1b clinical trial (NCT04013685) and is also now being evaluated in a phase 3 clinical trial (NCT05316701). Both trials enrolled patients with a range of hematologic malignancies. Notably, a subgroup analysis of patients with acute myeloid leukemia (AML) who were treated in the phase 1b study was recently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 to June 4, in Chicago, Illinois, by Rawan Faramand, MD, an assistant professor at Moffit Cancer Center.

Shortly before her presentation, CGTLive® spoke with Faramand to learn more about the new data from the AML subgroup analysis. Faramand went over the promising results, discussed challenges in the study, and expressed enthusiasm for the ongoing phase 3 clinical trial, data from which will be presented in the future.

REFERENCE
1. Pantin JM, Patel SS, Faramand R , et al. Treatment of acute myeloid leukemia with Orca-T. Presented at: 2024 (ASCO) Annual Meeting; May 31-June 4; Chicago, Illinois.