TC BioPharm (NASDAQ:TCBP) began dosing the first three patients in its Phase 2b ACHIEVE clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating acute myeloid leukemia (AML).
The initial five patients in the trial are deemed a “safety cohort,” spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues. The company expects to complete the safety cohort before the end of 2022.
This safety cohort is in line with TC’s step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
In a statement, Bryan Kobel, CEO of TC BioPharm, said the next step in the study is a 19-patient interim review, which would allow the company to review dosing and increase dosing to a higher level for efficacy or maintain the current dosing level.
“We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the U.S. in the first half of 2023,” he added.
The ACHIEVE trial expects to enroll about 37 AML patients who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes (MDS), conditions that can occur when the blood-forming cells in the bone marrow become abnormal.