Uppsala – October 13, 2026 -- Akiram Therapeutics reported no dose-limiting toxicities among the eight patients treated so far with its lead radiopharmaceutical candidate 177Lu-AKIR001 in a Phase I trial, with treatment-related adverse events limited to grade 1-2.
The Swedish clinical-stage biotech will present the first clinical data at the EANM 2026 Congress in Vienna, October 17-21. The abstract was selected as a Top Rated Oral Presentation (TROP).
Sustained tumor retention supports continued dose escalation
The first-in-human study is evaluating 177Lu-AKIR001 in patients with irresectable or metastatic CD44v6-positive solid tumors who have no remaining standard treatment options. At data cut-off, eight patients had been treated, and four of them received repeat treatment after the first administration.
Quantitative imaging showed sustained tumor retention of the drug, with clearance from blood and normal tissues. Preliminary results indicate a favorable safety profile within the investigated activity range, which supports continued dose escalation and further clinical evaluation.
Immunohistochemistry emerges as a patient selection tool
Low CD44v6 expression, as determined by immunohistochemistry (IHC), was consistently associated with low absorbed tumor doses. Akiram says this points to IHC as a tool for patient stratification and optimized selection before treatment.
CEO Marika Nestor said the ability of patients to receive repeat treatment is an important consideration as development progresses.
Second TROP abstract extends platform into bladder cancer
A second study of Akiram's CD44v6-targeting platform was also selected as a Top Rated Oral Presentation. The preclinical work evaluates AKIR001 and a derived scFv antibody format for theranostic applications in bladder cancer, extending the approach to a new tumor type and antibody format.
Presentation schedule at EANM 2026
The clinical data (OP-172) will be presented by Joachim Nilsson on October 18 at 4:20 PM in Hall C. The bladder cancer study (OP-599) will be presented by Iris Adriana Maria Lodewijk on October 20 at 10:05 AM in Hall E2.
AKIR001 combines the radioisotope lutetium-177 with a proprietary antibody targeting CD44v6, a tumor-associated antigen expressed in several solid tumor types. The Phase I trial (NCT06639191) is running at Karolinska University Hospital.