Akiram Therapeutics, a Swedish biotech company specialising in targeted radiotherapy, has enrolled the first patient in the Phase I clinical trial of its drug candidate 177Lu-AKIR001.

The trial is being conducted at Karolinska University Hospital, which also acts as the study sponsor, and marks an important milestone in Akiram’s efforts to develop a new targeted treatment for difficult-to-treat cancers.

This is the first-in-human trial with AKIR001 and aims to evaluate the drug’s safety, tolerability, and pharmacokinetic profile. The trial follows a dose-escalation design and targets patients with advanced, difficult-to-treat tumours.

Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumour types—with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered directly to tumour cells while minimising damage to surrounding healthy tissue.

The trial is enrolling patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynaecological squamous cell carcinoma, and non-small cell lung cancer. It is expected to run for 18-24 months with patients recruited on a rolling basis. As the sponsor, Karolinska University Hospital is responsible for conducting the trial in accordance with applicable regulations and with patient safety as a top priority.

“The launch of the clinical trial with AKIR001 marks the beginning of a new chapter for Akiram. Our vision has always been to develop a treatment that can offer new opportunities for patients with difficult-to-treat cancers, where treatment options are often limited. Seeing our drug candidate now being evaluated in collaboration with Karolinska University Hospital—one of Europe’s leading cancer centres—is a major milestone and a strong motivator for our continued work,” said Marika Nestor, CEO of Akiram.

“The enrolment of the first patient means that we have now initiated dose escalation and systematic evaluation of AKIR001’s safety and potential. This is an important first step in understanding how the drug behaves clinically and the potential role a CD44v6-targeted therapy could play in tumour types where treatment options today remain limited,” added Dr Luigi De Petris, Principal Investigator at Karolinska University Hospital.

Megan Thomas, Multimedia Editor, DDW