Akiram Therapeutics and University Hospital Agree on Cancer Therapy Manufacturing
Biotech firm Akiram Therapeutics has entered into an agreement with a leading Swedish university hospital for the GMP manufacturing of its radiopharmaceutical 177Lu-AKIR001, paving the way for its first-in-human study.
Uppsala, Sweden – Akiram Therapeutics, a Swedish biotechnology company, has finalized an agreement with a prominent Swedish university hospital for the Good Manufacturing Practice (cGMP) production of its novel radiopharmaceutical, 177Lu-AKIR001. This collaboration marks a critical step towards initiating the planned Phase I first-in-human study, scheduled for 2024.
The radiopharmaceutical, 177Lu-AKIR001, is designed as a targeted radioimmunotherapy to treat patients with solid tumors. Developed by Akiram, the therapy utilizes a targeting molecule coupled with therapeutic radioactivity directed at the cancer marker CD44v6. Preclinical studies have shown potential for the drug candidate as a first-in-class treatment for various cancers, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer.
Under the terms of the agreement, the university hospital will provide essential manufacturing services for the radiopharmaceutical, ensuring it meets stringent clinical standards. The hospital will also be responsible for the radiolabeling process and preparing the drug for patient administration in the upcoming clinical trial. CEO Marika Nestor stated that with GMP production secured, the company is now poised to apply for the first-in-human study authorization.
Akiram Therapeutics specializes in developing targeted radioimmunotherapies for cancer. The company leverages expertise in radiation science, precision medicine, and drug development to advance treatments for cancers with limited therapeutic options.