Swedish biotech company Akiram Therapeutics has announced significant progress in its first clinical trial of AKIR001, a radiopharmaceutical intended to treat aggressive solid tumours. The company confirmed completion of the first patient cohort in its phase 1 study, with no safety concerns reported, allowing the trial to continue to its next stage.
The study is taking place at Karolinska University Hospital in Stockholm, Sweden, which is also acting as sponsor. It aims to evaluate the safety, tolerability and pharmacokinetics of AKIR001 in patients with cancers that are difficult to treat, including thyroid, head and neck, gynaecological and lung cancers.
AKIR001 combines an antibody directed against CD44v6 – a marker found on several aggressive tumour types – with the radioactive isotope lutetium-177. This approach allows radiation to be delivered directly to tumour cells, potentially limiting damage to surrounding healthy tissue.
“Completing the first cohort marks an important milestone for AKIR001. Our goal is to develop a treatment that reaches tumours with high selectivity and has a favourable safety profile,” said Marika Nestor, CEO of Akiram Therapeutics.
Luigi De Petris, principal investigator at Karolinska University Hospital, added that the results “suggest that the drug is well tolerated at the doses tested so far and we are pleased to proceed as planned.”
The trial will now expand to additional patients to gather further data on dosage, safety and early signs of effectiveness.
