Akiram Therapeutics, a Swedish biotech company specialising in targeted radiotherapy, announces the completion of cohort 2a in the clinical phase 1 trial evaluating the drug candidate 177Lu-AKIR001. Cohort 2a investigated a higher activity dose than the run-in cohort. The results aligned with earlier findings, demonstrating continued favourable safety and encouraging tumour uptake.
The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor. The purpose of the study is to assess safety, tolerability, and pharmacokinetics in patients with advanced, difficult-to-treat solid tumours.
Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical combining a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. This mechanism enables selective and precise delivery of radiation to tumour cells while limiting exposure to healthy tissue.
All patients planned for cohort 2a have now been enrolled, and no dose-limiting toxicities or other safety concerns have been observed. Following review of the cohort 2a data, the Safety Review Committee has approved initiation of cohort 2b. In this next step of the dose-escalation stage, the protein dose will be increased while maintaining the same activity level used in cohort 2a. Cohort 2b aims to identify the most favourable protein dose for the remaining cohorts in the Phase I trial and for further clinical development of AKIR001.
The trial enrolls patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer.
The project is the result of a successful national collaboration between leading clinical and academic institutions in the field of precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.
