Akiram Therapeutics Advances CD44v6-Targeted Radiotherapy AKIR001 with Cohort 2b Clearance and Journal Publication
Key Insights
Akiram Therapeutics (search) completed cohort 2a of its Phase I trial for 177Lu-AKIR001, a CD44v6 (search)-targeted radiopharmaceutical, with no dose-limiting toxicities observed and encouraging tumor uptake demonstrated.
The Safety Review Committee approved initiation of cohort 2b, which will increase the protein dose while maintaining the same activity level to optimize dosing for future development.
Preclinical data supporting AKIR001's development were published in The Journal of Nuclear Medicine, showing high tumor selectivity, favorable safety profile, and clear dose-dependent antitumor activity.
Swedish biotech company Akiram Therapeutics (search) has completed cohort 2a of its Phase I clinical trial evaluating 177Lu-AKIR001, a CD44v6 (search)-targeted radiopharmaceutical, and received clearance to advance to cohort 2b. The milestone comes alongside publication of supporting preclinical data in The Journal of Nuclear Medicine, reinforcing the scientific foundation for this targeted radiotherapy approach.
Phase I Trial Progress Shows Favorable Safety Profile
The Phase I dose-escalation trial, conducted at Karolinska University Hospital (search), has successfully completed enrollment of all planned patients in cohort 2a, which investigated a higher activity dose than the initial run-in cohort. According to Akiram, no dose-limiting toxicities or other safety concerns were observed, with results aligning with earlier findings and demonstrating continued favorable safety and encouraging tumor uptake.
Following review of the cohort 2a data, the Safety Review Committee approved initiation of cohort 2b. This next phase of the dose-escalation stage will increase the protein dose while maintaining the same activity level used in cohort 2a, aiming to identify the most favorable protein dose for remaining cohorts and future clinical development.
"Completing cohort 2a marks solid and steady progress in our dose-escalation strategy," said Marika Nestor, CEO of Akiram Therapeutics (search). "The consistency of the safety profile together with encouraging tumor uptake provides confidence as the study advances into the next step of the dose-escalation stage and confirms that development remains on track."
Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital (search), added: "Following a thorough safety assessment, we are pleased to now proceed to cohort 2b."
Mechanism and Target Population
177Lu-AKIR001 combines a CD44v6 (search)-directed antibody with the therapeutic radioisotope lutetium-177, enabling selective and precise delivery of radiation to tumor cells while limiting exposure to healthy tissue. The drug candidate was developed through antibody phage display and affinity maturation targeting the cancer marker CD44v6.
The trial enrolls patients with advanced, difficult-to-treat solid tumors, specifically those with anaplastic and iodine-refractory thyroid cancer (search), head and neck squamous cell carcinoma (search), gynecological squamous cell carcinoma (search), and non-small cell lung cancer (search). The study's primary objectives include assessing safety, tolerability, and pharmacokinetics in this patient population.
Preclinical Validation Published in Leading Journal
Supporting the clinical development, Akiram announced that preclinical data on AKIR001 have been published in The Journal of Nuclear Medicine. The article, titled "Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6 (search)-Targeted Radiotherapeutic Entering First-in-Human Trials," presents foundational data demonstrating the candidate's favorable tumor-to-organ profile.
The published study shows that 177Lu-AKIR001 exhibits sustained retention in tumors and low uptake in normal tissue, key characteristics for effective radiopharmaceuticals. The combined findings from biodistribution, dosimetry and specificity analyses confirm clear and selective targeting of CD44v6 (search)-expressing tumors.
The preclinical data revealed clear dose-dependent antitumor activity and low uptake in normal tissues across several preclinical systems, providing scientific validation for Akiram's CD44v6 (search)-targeted approach and supporting the ongoing first-in-human trial.
"These results bring together years of systematic development around our CD44v6 (search) platform—spanning antibody engineering, dosimetry, in vivo studies and safety assessments," Nestor explained. "Having the work peer-reviewed adds an extra layer of confidence as the drug is now being evaluated in patients at Karolinska University Hospital (search)."
Development Support and Future Outlook
The AKIR001 project represents a collaborative effort between leading clinical and academic institutions in precision oncology, with support from the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden's Innovation Agency.
With potential for orphan drug classification and first-in-class recognition, Akiram is positioning AKIR001 to address conditions that currently lack effective treatments. The protein-dose optimization in cohort 2b is described as central to preparing for subsequent stages of evaluation as the company advances its targeted radioimmunotherapy platform.