Akiram, Swedish Hospital Enter Radiotherapy Mfg. Pact

Akiram Therapeutics, a biotech company specializing in targeted radiotherapy, has entered into an agreement with Karolinska University Hospital in Solna, Sweden for the manufacturing of 177Lu-AKIR001, a radiopharmaceutical designed to treat solid tumors. A Phase I first-in-human study is planned to start in 2024.

Karolinska will supply Akiram with services related to 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 in an upcoming study.

Akiram Therapeutics has developed a new type of targeted radioimmunotherapy, 177Lu-AKIR001. The therapy has 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.

“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,” said Marika Nestor, CEO, and co-founder of Akiram Therapeutics. “We are very excited and strongly motivated to progress this important project in close collaboration with our clinical colleagues at Karolinska University Hospital.”