Uppsala, Sweden, October 13, 2026
Akiram Therapeutics, a Swedish clinical-stage biotechnology company specializing in targeted molecular radiotherapy, has announced that the first clinical results from its investigational cancer treatment ¹⁷⁷Lu-AKIR001 will be presented at the European Association of Nuclear Medicine (EANM) 2026 Congress in Vienna, Austria. The preliminary findings come from an ongoing first-in-human Phase 1 clinical trial evaluating the radiopharmaceutical in patients with unresectable or metastatic CD44v6-positive solid tumors who have no remaining standard treatment options. The abstract has been selected as a Top Rated Oral Presentation, highlighting the scientific interest in the candidate’s early clinical findings. As of the data cutoff, eight patients had received treatment, with no dose-limiting toxicities observed and treatment-related adverse events limited to Grade 1–2. Imaging results also demonstrated sustained retention of the investigational drug in tumor tissue, supporting continued dose escalation and further clinical evaluation.
Phase 1 Trial Shows Encouraging Early Safety Findings
The ongoing Phase 1 study is evaluating the safety, tolerability and pharmacokinetic properties of ¹⁷⁷Lu-AKIR001 in patients with advanced solid tumors expressing the CD44v6 cancer-associated marker. These patients have limited treatment options, creating a need for investigational approaches that can selectively target cancer cells. In the preliminary analysis, all eight treated patients were evaluated for early safety findings, and researchers reported no dose-limiting toxicities within the activity levels investigated. Treatment-related adverse events were limited to Grade 1–2, indicating that the reported events were mild to moderate in severity. In addition, four patients received repeat treatment following their initial administration. Although these observations are encouraging for continued clinical development, the small patient population and early stage of the study mean that the findings cannot establish the treatment’s overall safety or effectiveness. Further dose escalation, additional patient enrollment and longer follow-up will be required to characterize potential risks and determine whether the candidate can deliver meaningful clinical benefits.
Targeted Radiopharmaceutical Combines Antibody and Lutetium-177
¹⁷⁷Lu-AKIR001 is an investigational targeted radiopharmaceutical that combines a proprietary antibody directed against CD44v6 with lutetium-177 (¹⁷⁷Lu), a therapeutic radioisotope used in molecular radiotherapy. CD44v6 is a tumor-associated antigen expressed in several types of solid cancers, making it a potential target for antibody-based treatment strategies. The antibody component is designed to recognize the target on tumor cells and deliver radioactive material to the tumor tissue. Lutetium-177 emits radiation that can damage cancer-cell DNA, potentially leading to cell death. The treatment strategy aims to concentrate radiation exposure at the tumor while limiting exposure to healthy tissues. Quantitative imaging from the preliminary clinical study showed sustained tumor retention alongside clearance from blood and normal tissues. Researchers also observed that low CD44v6 expression, measured using immunohistochemistry (IHC), was consistently associated with lower absorbed tumor doses. This finding suggests that IHC testing may help guide patient selection and identify individuals more likely to receive sufficient radiation exposure at the tumor site. However, the clinical value of this approach will require further investigation.
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EANM 2026 Presentation Highlights Development Progress
The first clinical results will be presented on October 18, 2026, at 4:20 p.m. in Hall C, during the EANM 2026 Congress in Vienna. The presentation, titled “Preliminary results from the ongoing first-in-human clinical trial of anti-CD44v6 agent [¹⁷⁷Lu]Lu-AKIR001,” will be delivered by Joachim Nilsson. Akiram has also secured a second Top Rated Oral Presentation for preclinical research evaluating its CD44v6-targeting platform in bladder cancer. That presentation will examine lutetium-177-labelled full-length and single-chain variable fragment (scFv) antibody formats for potential radioimmunotherapy applications. Together, the presentations demonstrate the company’s ongoing work to investigate targeted radiation approaches across different tumor types and antibody formats. The clinical trial is being conducted at Karolinska University Hospital and remains in the early stages of development. Future studies will need to establish the appropriate dose, characterize safety across larger patient populations and assess evidence of antitumor activity. The preliminary findings provide an initial basis for further evaluation but do not establish clinical efficacy or regulatory approval.
Akiram Therapeutics’ progress with AKIR001 reflects continuing research into precision oncology and targeted radiopharmaceutical treatments. By combining antibody-based tumor recognition with therapeutic radiation, the company aims to develop an alternative approach for patients with difficult-to-treat solid tumors. Further clinical evidence will determine whether AKIR001 can translate its early safety and imaging findings into meaningful patient benefits.
Source: Akiram Therapeutics press release
