Molecular Partners released positive Phase 1/2a trial data for MP0533, a tetraspecific T-cell engager targeting relapsed/refractory acute myeloid leukemia (AML). An accelerated step-up dosing regimen in cohort 8 resulted in a clinical response rate exceeding 30% after the first cycle, with one patient maintaining a response beyond six months. This data supports further dose optimization to maximize the therapeutic benefit of MP0533.
These findings are crucial for AML patients, particularly those with relapsed/refractory disease who have limited treatment options. The improved response rates and duration observed with the adjusted dosing regimen suggest MP0533 could become a valuable new therapy for this challenging disease. This positive development also validates Molecular Partners’ DARPin platform technology, potentially opening doors for further advancements in targeted cancer therapies.
Cohort 8, employing a higher starting dose and additional dosing day compared to earlier cohorts, showed improved exposure to MP0533 within the predicted therapeutic range. This resulted in a longer duration of relevant exposure and a higher blast reduction in several patients. While prior cohorts demonstrated initial blast reductions, responses were limited due to shorter exposure to therapeutic doses. Cohort 9, now underway, implements further dosing adjustments including faster escalation to therapeutic levels, increased dosing frequency, and anti-CD20 premedication to minimize exposure loss.
This positive data readout signals progress in developing a potentially effective treatment for relapsed/refractory AML. The optimized dosing regimen in cohort 9 is anticipated to further enhance response rates and duration. Future combination studies with azacitidine/venetoclax hold promise for additional therapeutic benefit, suggesting a potentially bright future for MP0533 in addressing the unmet medical needs of AML patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
