Affibody has received a recommendation from the Trial Review Committee (TRC) to proceed to the second part of the Phase 1 study with the radiotherapy candidate ABY-271 in HER2-positive metastatic breast cancer. This is according to a press release.

The recommendation is based on a series of data from the first cohort of patients.

"The initial results from the study with ABY-271 are very promising. We have observed a favorable safety profile and biodistribution, which supports the study moving on to the next step," says Associate Professor Oscar Wiklander at Karolinska University Hospital, coordinating investigator in the study.

"I am very pleased that these first clinical results with ABY-271 reflect the preclinical data and dosimetry calculations so well. I am particularly pleased with the low renal uptake," said David Bejker, CEO of Affibody.

The second part of the study, part B, involves the evaluation of higher radioactivity levels and additional protein mass doses.

Affibody is said to be in line with TRC's recommendation to submit a protocol amendment to the European Medicines Agency (EMA) to speed up the transition to the second part of the study, which is expected to start in the first half of 2026. The first results are expected in the second half of 2026.

Investors Patricia Industries is the main owner of Affibody.