AKIR001 publication in The Journal of Nuclear Medicine supports ongoing clinical development
Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces that data on its CD44v6-targeted radiotherapeutic candidate AKIR001 have been published in The Journal of Nuclear Medicine, one of the leading journals in nuclear medicine. The publication summarizes key studies underpinning the ongoing first-in-human Phase 1 trial at Karolinska University Hospital. It reports high tumor selectivity, favorable safety and dosimetry findings, and antitumor effects in multiple preclinical models.
The article, titled “Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials,” presents foundational data supporting the clinical development of AKIR001. The study shows that the candidate exhibits a favorable tumor-to-organ profile, with sustained retention in tumors and low uptake in normal tissue — key characteristics of radiopharmaceuticals. The combined findings from biodistribution, dosimetry and specificity analyses confirm that 177Lu-AKIR001 demonstrates clear and selective targeting of CD44v6-expressing tumors.
The efficacy and safety results further strengthen the rationale for clinical evaluation, with clear dose-dependent antitumor activity and low uptake in normal tissues across several preclinical systems. These findings provide important scientific validation for Akiram’s CD44v6-targeted approach and support the ongoing first-in-human trial in patients with tumors that express CD44v6.
“These results bring together years of systematic development around our CD44v6 platform—spanning antibody engineering, dosimetry, in vivo studies and safety assessments. Having the work peer-reviewed adds an extra layer of confidence as the drug is now being evaluated in patients at Karolinska University Hospital. For us, it reaffirms that we are advancing on a solid and well-supported scientific foundation,” says Marika Nestor, CEO of Akiram Therapeutics.
About the Phase 1 clinical trial
The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.
The trial is registered at ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06639191
Reference
Mortensen ACL et al. Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials. Journal of Nuclear Medicine (2025).
DOI: 10.2967/jnumed.125.270782.
Full text: https://jnm.snmjournals.org/content/early/2025/11/06/jnumed.125.270782
For more information, please contact:
Marika Nestor, CEO
Email: marika.nestor@akiramtherapeutics.com
About Akiram Therapeutics
Akiram Therapeutics is a Swedish biotechnology company in clinical phase, developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody that targets a radiation component to the cancer marker CD44v6. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s website and follow the company on LinkedIn.