Affibody's ABY-271 Radioligand Therapy Advances to Phase I Part B Following Positive Safety Data in HER2-Positive Breast Cancer
核心洞察
Affibody (搜索)'s Trial Review Committee recommended advancing ABY-271 Phase I trial to Part B based on favorable safety, tolerability, and biodistribution data from initial patient cohort.
The radioligand therapy demonstrated targeted tumor activity with low uptake in kidneys and other vital organs in HER2-positive metastatic breast cancer (搜索) patients.
Part B will evaluate higher radioactivity levels and additional protein mass doses in 15 randomized patients, with initiation expected in first half of 2026.
Affibody (搜索) AB has received clearance to advance its radioligand therapy candidate ABY-271 to the second part of a Phase I clinical trial in patients with HER2-positive metastatic breast cancer (搜索), following positive safety and biodistribution data from the initial patient cohort.
The company's Trial Review Committee (TRC), comprising principal investigators, medical monitor, dosimetry and nuclear medicine specialists, recommended progression to Part B of the study after reviewing safety, tolerability, dosimetry and biodistribution data from the first enrolled patients. The committee found that ABY-271 demonstrated targeted tumor activity with a favorable safety profile characterized by low uptake in kidneys and other critical organs.
Clinical Trial Design and Initial Results
The ongoing Phase I study is an open-label, two-stage, randomized trial evaluating ABY-271's safety, tolerability, and biodistribution in tumors and critical organs in subjects with HER2-positive metastatic breast cancer (搜索). The trial is being conducted at specialized centers in Germany and Sweden.
Part A of the study involved up to six sequentially enrolled patients to evaluate the uptake of ABY-271 in tumors and critical organs through single intravenous infusions. The positive results from this initial cohort have now cleared the path for Part B, which will expand to 15 randomized subjects and assess higher radioactivity levels and additional protein mass doses.
"The initial data from the ABY-271 study are very promising. We observed a favorable safety profile and encouraging biodistribution data, supporting progression of the study to the next stage," said assistant professor Oscar Wiklander at Karolinska University Hospital (搜索), who serves as the coordinating investigator in Sweden.
Mechanism of Action and Platform Validation
ABY-271 is an Affibody (搜索) molecule that targets HER2 (搜索)-expressing tumors and is labeled with the radioisotope lutetium-177, which emits cytotoxic beta radiation to deliver irreversible damage to tumor cells. The therapy represents a novel approach within the radioligand therapy field, leveraging the company's proprietary Affibody platform technology.
"I am thrilled that these early clinical results with ABY-271 mirror the preclinical findings and dosimetry predictions remarkably well. I am especially excited about the low kidney uptake," said David Bejker, CEO of Affibody (搜索). "The positive outcome not only marks an important milestone for this program but also for the Affibody platform as a powerful technology for developing next-generation targeted radiotherapeutics."
Next Steps and Timeline
Affibody (搜索) plans to submit a protocol amendment to the European Medicines Agency (搜索) (EMA) to expedite the transition to Part B of the trial. The company anticipates beginning the next phase in the first half of 2026, with initial results expected in the second half of 2026.
The advancement of ABY-271 represents a significant milestone for Affibody (搜索)'s radioligand therapy pipeline, which focuses on oncology indications with high unmet medical need. The company's approach combines decades of innovation in Affibody molecule discovery and engineering with deep understanding of the radioligand therapy field to develop highly selective tumor-targeting treatments across a wide range of cancers.