Swedish biotech company Akiram Therapeutics has achieved a significant milestone in its first clinical trial of AKIR001, a targeted radiopharmaceutical designed to treat aggressive solid tumors. The company announced completion of the first patient cohort in its Phase I study with no safety concerns reported, enabling progression to the next stage of the trial.
The study is being conducted at Karolinska University Hospital in Stockholm, Sweden, which also serves as the trial sponsor. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of AKIR001 in patients with advanced, difficult-to-treat solid tumors.
Novel Radiopharmaceutical Approach
AKIR001 represents a targeted radiotherapy approach that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumor types—with the therapeutic radioisotope lutetium-177. This mechanism allows radiation to be delivered directly to tumor cells while minimizing impact on surrounding healthy tissue.
The drug candidate was developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for tumor types with high CD44v6 expression.
Trial Progress and Safety Profile
All patients planned for the first dose cohort have now been enrolled, with no dose-limiting toxicities or other safety concerns observed. "Completing the first cohort marks an important milestone for AKIR001. Our goal is to develop a treatment that reaches tumors with high selectivity and has a favorable safety profile. These initial clinical data support the next step in development," said Marika Nestor, CEO of Akiram Therapeutics.
Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital, added that "the completion of cohort 1 without unexpected side effects represents an important step forward. The results suggest that the drug is well tolerated at the doses tested so far, and we are pleased to proceed as planned."
Target Patient Population
The trial is enrolling patients with several challenging cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer. In the next phase, additional patients will be included to gather further data on dose response, safety, and early signs of efficacy.
Collaborative Research Initiative
The study represents a successful national collaboration between leading clinical and academic institutions in precision oncology. The project has received support from multiple Swedish organizations, including the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden's Innovation Agency.
The trial is registered at ClinicalTrials.gov under identifier NCT06639191, reflecting the company's commitment to transparency in clinical development. With the potential for AKIR001 to be classified as an orphan drug and recognized as first-in-class, Akiram Therapeutics continues to advance research in targeted radioimmunotherapy for conditions that currently lack effective treatments.
