Uppsala, Sweden-based Akiram Therapeutics reported first clinical results for its lead drug candidate lutetium-177 (Lu-177)-labelled AKIR001 at the European Association of Nuclear Medicine (EANM) congress in Vienna.
The first-in-human ongoing phase I trial is evaluating Lu-177 AKIR001 in patients with irresectable or metastatic CD44v6-positive solid tumors who have no remaining standard treatment options. Eight patients had been treated so far, with no dose-limiting toxicities and treatment-related adverse events limited to grade 1 and 2, according to the company. Four patients received repeat treatment.
Quantitative imaging showed sustained tumor retention of Lu-177-AKIR001, with clearance from blood and normal tissue, Akiram said. Low CD44v6 expression on immunohistochemistry (IHC) was associated with low absorbed tumor doses. The firm said this finding highlights the potential of IHC as a valuable tool for patient stratification and optimized patient selection prior to treatment.
