Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, has announced that cohort 2b in the ongoing Phase I clinical trial evaluating the drug candidate 177Lu-AKIR001 has been completed. Following the safety review, the study has advanced to cohort 3. The results continue to support a favorable safety profile, enabling further dose escalation and evaluation of higher activity levels according to the study protocol.
The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor, and is designed to evaluate the safety, tolerability, and pharmacokinetic profile of the drug candidate.
In cohort 2b, the protein dose was evaluated while maintaining the same activity level as in the previous cohort. Following review of the cohort 2b data, the Safety Review Committee approved continued dose escalation, allowing the study to proceed to cohort 3.
Across the cohorts evaluated to date, no dose-limiting toxicities have been observed, and imaging data have demonstrated selective tumor uptake and accumulation in tumor tissue in treated patients. Several patients have also received repeat treatment based on medical assessment, further supporting the tolerability, manageability, and feasibility of repeated administration. Taken together, the findings support continued clinical evaluation in the ongoing trial.
Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6 — a cancer marker associated with several aggressive tumor types — with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered selectively to tumor cells while minimizing exposure to healthy tissue.
“Advancing to cohort 3 marks an important step in our clinical development program. The results support further evaluation of dose levels, and the next stage will be central to further defining dosing parameters and treatment characteristics ahead of future stages of development,” says Marika Nestor, CEO of Akiram Therapeutics.
“The decision to proceed to cohort 3 follows a thorough safety evaluation. We look forward to continuing the study and collecting additional clinical data,” says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.
The trial enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options.
The project is the result of a successful national collaboration between leading clinical and academic institutions in 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.
The trial is registered at ClinicalTrials.gov: NCT06639191.
