Akiram, ITM sign Lutetium-177 supply agreement
Akiram Therapeutics, a Swedish clinical-stage biotech company specialising in molecular radiotherapy, and leading radiopharmaceutical biotech ITM Isotope Technologies Munich SE (ITM) have announced a supply agreement for non-carrier-added (n.c.a.) Lutetium-177 (Lu-177 or 177Lu) to support the development of 177Lu-AKIR001 (AKIR001), a targeted antibody-radionuclide conjugate with first-in-class potential, currently in clinical testing for the treatment of CD44v6-expressing solid tumours.
Under the terms of the agreement, ITM will provide its high-quality n.c.a. Lu-177 for use in Akiram’s ongoing clinical trial for AKIR001, the company’s lead radiopharmaceutical candidate. Lu-177 is one of the most widely used medical radioisotopes in targeted radionuclide therapy and serves as the active payload in AKIR001.
Additional details of the agreement have not been disclosed.
AKIR001 is a targeted radiopharmaceutical drug candidate that combines the therapeutic radioisotope n.c.a. Lu-177 with a proprietary antibody targeting CD44v6, a cancer marker associated with several aggressive tumour types. The approach is designed to deliver radiation selectively to tumour cells while limiting exposure to healthy tissue.
AKIR001 is currently being evaluated in a Phase I clinical trial at Stockholm’s Karolinska University Hospital in patients with irresectable or metastatic CD44v6-positive solid tumours, including lung, head and neck, thyroid, and gynaecological cancers. Akiram progressed into a third dose-escalation cohort earlier this year after continued demonstration of favourable safety and selective tumour uptake.
Marika Nestor, Akiram’s CEO, commented: “This agreement helps secure an important component for the continued development of AKIR001 and marks a significant step in advancing the programme designed to address a primary driver of aggressive cancers.”
Dr Andrew Cavey, CEO of ITM, added: “We are pleased to support the continued clinical development of AKIR001 through our manufacturing expertise and consistency of supply, and we wish Akiram every success as they advance this promising therapy.”
The announcement comes just over a week after the news that the US FDA had sent a complete response letter (CRL) to Germany-based ITM, saying there were deficiencies in its chemistry, manufacturing and controls (CMC) in its New Drug Application (NDA) for ITM-11 (177Lu-edotreotide), a somatostatin receptor-targeting therapy for gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
We’ve been following ITM’s journey for a while: from a video interview at ESMO 2025 to a more recent podcast episode with Dr Cavey, discover more about this radiopharmaceutical company today.
