Affibody AB has announced that its Trial Review Committee (TRC) has recommended progressing the Phase I clinical study of the Radioligand Therapy (RLT) candidate ABY-271 in HER2-positive metastatic breast cancer to its second phase, which will explore higher radioactivity levels. This decision follows promising safety and biodistribution data from the initial patient cohort, indicating effective tumor targeting and a favorable safety profile with minimal kidney uptake.
Assistant professor Oscar Wiklander, coordinating investigator at Karolinska University Hospital, expressed optimism about the initial findings, which align with preclinical expectations. The TRC’s endorsement is a critical milestone, not only for the ABY-271 program but also for the broader Affibody platform, which is designed to develop next-generation targeted radiotherapeutics.
The ongoing study, conducted across specialized sites in Sweden and Germany, aims to assess the safety and efficacy of ABY-271, which utilizes the radioisotope lutetium-177 to deliver cytotoxic beta radiation directly to HER2-expressing tumors. As metastatic breast cancer poses significant treatment challenges, the advancement of this trial could pave the way for innovative therapeutic options in a field with high unmet medical needs.
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