Preliminary Results Show Favorable Safety and Tumor Retention for 177Lu-AKIR001

Akiram Therapeutics, a Swedish clinical-stage biotech company specializing in molecular radiotherapy, is set to present preliminary clinical data from its lead drug candidate, 177Lu-AKIR001, at the EANM 2026 Congress in Vienna, scheduled from October 17 to 21. The company’s first-in-human Phase I trial of 177Lu-AKIR001, which is being conducted at Karolinska University Hospital, has shown a favorable safety profile and sustained tumor retention within the investigated activity range.

The abstract presenting the initial results of the trial has been selected as a Top Rated Oral Presentation (TROP) at the congress. The study evaluates 177Lu-AKIR001 in patients with irresectable or metastatic CD44v6-positive solid tumors who have no remaining standard treatment options. At the data cut-off, eight patients had been treated, with no dose-limiting toxicities observed. Treatment-related adverse events were limited to grade 1-2. Four patients received repeat treatment after the first administration.

Quantitative imaging revealed sustained tumor retention of 177Lu-AKIR001, with clearance from blood and normal tissues. Low CD44v6 expression, as determined by immunohistochemistry (IHC), was consistently associated with low absorbed tumor doses. These findings highlight the potential of IHC as a valuable tool for patient stratification and optimized patient selection prior to treatment.

A second study, also selected as a Top Rated Oral Presentation, evaluates the preclinical application of 177Lu-labelled CD44v6-targeted full-length and scFv antibodies for bladder cancer radioimmunotherapy. This study is part of Akiram's broader CD44v6-targeting platform and was presented at the congress on October 20, 10:05 AM, in Hall E2.

The lead drug candidate, 177Lu-AKIR001, is a targeted radiopharmaceutical that combines the therapeutic radioisotope lutetium-177 with a proprietary antibody targeting CD44v6, a tumor-associated antigen expressed in several solid tumor types. The approach is designed to deliver radiation selectively to tumor cells while limiting exposure to healthy tissue. AKIR001 is currently being evaluated in a first-in-human Phase I clinical trial (NCT06639191) at Karolinska University Hospital.

At the data cut-off, eight patients had been treated, with no dose-limiting toxicities observed. Treatment-related adverse events were limited to grade 1-2. Four patients received repeat treatment after the first administration. Quantitative imaging showed sustained tumor retention of 177Lu-AKIR001, with clearance from blood and normal tissues. Low CD44v6 expression, as determined by immunohistochemistry (IHC), was consistently associated with low absorbed tumor doses. These findings highlight the potential of IHC as a valuable tool for patient stratification and optimized patient selection prior to treatment.

A second study, also selected as a Top Rated Oral Presentation, evaluates the preclinical application of 177Lu-labelled CD44v6-targeted full-length and scFv antibodies for bladder cancer radioimmunotherapy. This study is part of Akiram's broader CD44v6-targeting platform and was presented at the congress on October 20, 10:05 AM, in Hall E2.