Akiram Therapeutics, a Swedish clinical-stage biotech company specializing in molecular radiotherapy, announces that the first clinical data from the ongoing Phase I trial of its lead drug candidate 177Lu-AKIR001 will be presented at the EANM 2026 Congress in Vienna, October 17-21. Preliminary results show a favorable safety profile within the investigated activity range and sustained tumor retention, supporting continued dose escalation and further clinical evaluation of AKIR001.
UPPSALA, Sweden, October 13 2026 /PRNewswire/ — The abstract presenting the first clinical results from the ongoing first-in-human trial has been selected as a Top Rated Oral Presentation (TROP) at EANM 2026. The study is evaluating 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. No dose-limiting toxicities were observed, and 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.
“These first clinical results represent an important milestone for AKIR001. We are encouraged by the safety profile and sustained tumor retention observed so far. It is particularly encouraging that patients have been able to receive repeat treatment, which is an important consideration as development progresses,” says Marika Nestor, CEO of Akiram Therapeutics.
A second study involving Akiram’s CD44v6-targeting platform has also been selected as a Top Rated Oral Presentation at EANM 2026. This preclinical study evaluates AKIR001 and a derived scFv antibody format for theranostic applications in bladder cancer, extending the evaluation of Akiram’s approach to a new tumor type and antibody format.
Presentations at EANM 2026
- Oral Presentation (Top Rated)
Title:Preliminary results from the ongoing first-in-human clinical trial of anti-CD44v6 agent [¹⁷⁷Lu]Lu-AKIR001
Presentation No.: OP-172
Date & Time: October 18, 4:20 PM
Location: Hall C
Speaker: Joachim Nilsson
- Oral Presentation (Top Rated)
Title:Preclinical Evaluation of 177Lu-Labelled CD44v6-Targeted Full-Length and scFv Antibodies for Bladder Cancer Radioimmunotherapy
Presentation No.: OP-599
Date & Time: October 20, 10:05 AM
Location: Hall E2
Speaker: Iris Adriana Maria Lodewijk
AKIR001 is a targeted radiopharmaceutical drug candidate 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.
EANM in brief
The annual EANM Congress brings together experts, researchers and industry representatives in nuclear medicine to present and discuss scientific and clinical developments in the field. For more information, visit eanm26.eanm.org.
For more information, please contact:
Marika Nestor, CEO
Email: marika.nestor@akiramtherapeutics.com
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The following files are available for download:
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Akiram Therapeutics: First clinical results from AKIR001 to be presented at EANM 2026 |
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Akiram-Therapeutics-EANM-2026-first-clinical-results-AKIR001 |
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SOURCE Akiram Therapeutics
