Akiram Therapeutics, a Swedish biotech company, has announced that its drug candidate, 177Lu-AKIR001, has been cleared by the Swedish Medical Products Agency to begin a Phase 1 clinical trial. This trial marks a significant step in the development of a novel cancer treatment aimed at providing new options for patients with difficult-to-treat tumors.
A Novel Approach to Targeted Radioimmunotherapy
177Lu-AKIR001 represents a new class of targeted radioimmunotherapy. It is designed to target and deliver radiation directly to tumor cells expressing the CD44v6 marker. Preclinical studies have indicated its potential as a first-in-class treatment for various cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer.
Phase 1 Trial Details
The Phase 1 trial, registered on ClinicalTrials.gov as NCT06639191, will be conducted by Karolinska University Hospital. The primary objective is to evaluate the safety and tolerability of 177Lu-AKIR001 in patients with advanced solid tumors expressing CD44v6. Patient recruitment is expected to commence in the fall of 2024 and continue for two years. Funding for the study is provided by grants from the Sjöberg Foundation, the Erling Persson Foundation, and the Swedish Cancer Society. Akiram Therapeutics will supply the drug candidate for the trial.
Expert Perspectives
"177Lu-AKIR001 has the potential to transform how we treat hard-to-treat tumors and could represent a major advancement in precision medicine," said Renske Altena, Senior Physician and Primary Investigator at Karolinska Comprehensive Cancer Center. "By targeting the radiation specifically at the cancer marker CD44v6, we hope to achieve greater precision and higher efficacy than current treatment options, especially for patients whose tumors no longer respond to existing therapies."
Altena added, "For patients with aggressive and treatment-resistant cancer types, we hope this innovation can bring about a real change in their treatment plans and quality of life. A successful tailored treatment would be a significant step forward in oncology and precision medicine."
CD44v6 as a Therapeutic Target
177Lu-AKIR001 was developed using antibody phage display and affinity maturation to target the CD44v6 cancer marker. The therapy combines lutetium-177, a radioactive isotope, with a molecule designed to specifically bind to CD44v6-expressing cancer cells. Preclinical data suggest that this approach could offer a promising new radiopharmaceutical therapy for cancers with high CD44v6 expression.
Akiram's Vision
"The start of the Phase 1 clinical trial is a significant milestone for Akiram and an important step forward in molecular radiation therapy," said Marika Nestor, CEO and co-founder of Akiram Therapeutics. "We are excited to collaborate with Karolinska University Hospital and are confident in AKIR001's potential to improve treatment outcomes for patients."
