Akiram Therapeutics has signed a supply agreement with ITM Isotope Technologies Munich SE for non-carrier-added lutetium-177 to support clinical development of AKIR001, a targeted radiopharmaceutical being studied for CD44v6-expressing solid tumors.
Under the agreement, ITM will supply its non-carrier-added, or n.c.a., lutetium-177 for Akiram’s ongoing clinical trial of 177Lu-AKIR001. Financial terms and other details of the agreement were not disclosed.
Lutetium-177 is the radioactive payload in AKIR001 and is used in targeted radionuclide therapy. Akiram said dependable access to the isotope is important for continued clinical development of the program.
AKIR001 combines n.c.a. lutetium-177 with Akiram’s proprietary antibody targeting CD44v6, a cancer marker associated with several aggressive tumor types. The approach is designed to direct radiation selectively to tumor cells while limiting exposure to healthy tissue.
The candidate is being evaluated in a Phase I study at Karolinska University Hospital in Stockholm. The trial is enrolling patients with unresectable or metastatic CD44v6-positive solid tumors, including lung, head and neck, thyroid and gynecological cancers.
Akiram is a Swedish clinical-stage biotechnology company focused on molecular radiotherapy. The company describes AKIR001 as its lead radiopharmaceutical candidate and said the program has first-in-class potential.
Marika Nestor, Akiram’s chief executive officer, said the agreement helps secure a component needed for the program’s continued development. She said the candidate is intended to address a primary driver of aggressive cancers.
ITM is a radiopharmaceutical biotechnology company and a global producer and supplier of n.c.a. lutetium-177. ITM Chief Executive Andrew Cavey said the company’s manufacturing expertise and consistency of supply will support Akiram’s clinical trials and research.
Cavey said ITM is focused on enabling the development of radiopharmaceuticals for difficult-to-treat cancers. He said the company will provide a dependable, high-quality source of lutetium-177 as Akiram advances the AKIR001 program.
The companies did not provide a timeline for the Phase I study, expected enrollment, potential next development steps or plans for subsequent clinical trials.
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