Affibody Takes New Steps with Phase 1 Study of ABY-271
Affibody AB has recently made significant progress in its clinical research, moving the Phase I study for its promising treatment candidate, ABY-271, to the next stage. This decision reflects a positive recommendation from the Trial Review Committee (TRC) based on initial patient data and safety information.
Significant Findings from Initial Patient Data
The TRC reviewed comprehensive data from the early patient cohort, which showcased the treatment's safety and tolerability. These findings indicated that ABY-271 is not only targeting tumors effectively, but it also presents a favorable profile with minimal uptake in critical organs like the kidneys.
Expert Insights on ABY-271
According to Dr. Oscar Wiklander, a coordinating investigator at the Karolinska University Hospital, the initial data from ABY-271 offers promising insights into its behavior in patients. "The results are significant as they align with our expectations from preclinical studies, prompting us to proceed with confidence into the next phase of this study," he stated.
Affibody's CEO, David Bejker, expressed his enthusiasm about the confirmed early clinical results. He emphasized that the therapy's promising safety profile is crucial for the future of the treatment and the company as a whole.
About ABY-271 and Its Clinical Study
ABY-271 is designed to specifically target HER2-positive tumors using the radioisotope lutetium-177, known for emitting beta radiation that damages tumor cells. The ongoing Phase 1 study aims to evaluate ABY-271’s safety and biodistribution in patients, with both involved in the trial being those with HER2-positive metastatic breast cancer.
Structure of the Clinical Trial
The study is structured in two parts. Part A includes evaluating the drug’s uptake in up to six patients, while Part B will introduce higher doses of radioactivity and additional protein mass doses to a total of 15 patients. This comprehensive approach is aimed at building a robust understanding of the treatment's efficacy and safety profile.
Future Directions and Regulatory Steps
With the TRC's recommendations, Affibody will soon submit changes to the clinical protocol to the European Medicines Agency (EMA) aimed at accelerating the transition to Part B of the study. The next phase is anticipated to kick off in early 2026, with initial results expected by mid-year.
About Affibody
Affibody is a pioneering company focused on developing advanced radiopharmaceuticals, primarily targeting various cancers. Their efforts target the intersection of innovative molecule discovery and a deep understanding of radioligand therapies, creating a robust pipeline specifically in oncology.
Beyond ABY-271, Affibody is exploring other indications within immunology and inflammation, propelled by strategic partnerships that enhance its scope.
Contacting Affibody for More Information
For those interested in learning more about Affibody, details about their research and upcoming developments can be obtained by reaching out directly to their divisions:
David Bejker (CEO) - +46 706 454 948
Peter Zerhouni (CFO and CBO) - +46 706 420 044
Frequently Asked Questions
What is ABY-271 designed to treat?
ABY-271 is developed for the treatment of HER2-positive metastatic breast cancer.
What are the key findings from the Phase 1 study?
The initial phase of the study reported positive safety data and effective tumor targeting.
When does the next phase of the study start?
The next phase is projected to commence in early 2026, pending regulatory approval.
What is the significance of lutetium-177 in ABY-271?
Lutetium-177 is a radioisotope that emits beta radiation aimed at damaging tumor cells selectively.
How can I contact Affibody for more information?
Interested parties can contact Affibody's CEO or CFO for further details regarding their studies and developments.
