Akiram Therapeutics and University Hospital Agree on Cancer Therapy Manufacturing
Swedish biotech firm Akiram Therapeutics has secured a manufacturing agreement with a university hospital for its 177Lu-AKIR001 cancer therapy. The deal paves the way for Phase I human trials planned for 2024.
Akiram Therapeutics, a Swedish biotechnology company, has finalized a manufacturing agreement with a prominent Swedish university hospital for its targeted radiotherapy drug candidate, 177Lu-AKIR001. This accord represents a significant step towards initiating the first-in-human Phase I clinical study, scheduled for 2024.
The radiopharmaceutical, 177Lu-AKIR001, is designed to treat patients with solid tumors. Akiram Therapeutics has developed this novel targeted radioimmunotherapy with the potential to serve as a first-in-class treatment for multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer.
The agreement establishes a collaboration with Karolinska University Hospital. Under the terms, the hospital will provide services for the current Good Manufacturing Practice (cGMP) production of 177Lu-AKIR001, ensuring the radiopharmaceutical is ready for patient administration in the upcoming study. This includes the critical radiolabeling process.
"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," stated Marika Nestor, CEO and co-founder of Akiram Therapeutics.
Preclinical studies have demonstrated the potential of 177Lu-AKIR001, which targets the CD44v6 cancer marker using an antibody combined with lutetium-177 (177Lu), as a promising therapy for cancers expressing high levels of CD44v6.