Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, has entered into an agreement with a leading Swedish university hospital for the manufacturing of 177Lu-AKIR001, a radiopharmaceutical designed for treating patients with solid tumors. This agreement marks an important step towards the Phase I first-in-human study, which is planned to start in 2024.
Akiram Therapeutics has developed a new type of targeted radioimmunotherapy, 177Lu-AKIR001. The therapy holds the potential to become a first-in-class treatment in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. The drug is composed of a target recognition molecule, to which therapeutic radioactivity is coupled for effect on tumor cells.
This agreement marks the collaboration between Akiram Therapeutics and Karolinska University Hospital, one of Sweden’s premier medical institutions. Karolinska will supply Akiram with services related to the current Good Manufacturing Practice (cGMP) production of the radiopharmaceutical product 177Lu-AKIR001 for human use, along with other related services. The hospital will also establish the radiolabeling of the product and ensure that it is ready for administration to patients with cancer in an upcoming study.
“With this agreement and the GMP production of the affinity carrier in place, we have everything needed to apply for a first-in-human clinical study in 2024. We are very excited and strongly motivated to progress this important project in close collaboration with our clinical colleagues at Karolinska University Hospital,” says Marika Nestor, CEO and co-founder of Akiram Therapeutics.