Cancer-focused biotech 2seventy Bio Inc. (Nasdaq: TSVT) and Seattle Children's have paused a study after a patient died.
The company, which partnered with Seattle Children's on the study, said on Wednesday it had notified the Food and Drug Administration of the death, and the company is investigating the root cause of the death and its potential relationship to the drug.
The patient, who was being treated for acute myeloid leukemia, was the first to receive the drug at the second dose level in the phase 1 trial.
"I’d like to offer that our thoughts are with the family during this time. The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data," Steve Bernstein, chief medical officer at 2seventy, said in a news release.
A 2seventy spokesperson said in a statement that the company share more information after its investigation and once regulators have agreed on the path forward.
Seattle Children's is also the regulatory sponsor of the now-paused study. The treatment, called SC-DARIC33, is aimed at relapsed or refractory pediatric acute myeloid leukemia. The study was the first-in-human investigation of the treatment, according to 2seventy.
2seventy is headquartered in Cambridge, Massachusetts, and has an office in Seattle. The company also has a drug aimed at non-Hodgkin lymphoma in clinical trials, as well as a number of treatments that are pre-clinical. 2seventy has a commercial product called Abecma aimed at relapsed or refractory multiple myeloma.
2seventy spun out of Bluebird Bio in 2021. The company had about 415 employees as of February, according to the Boston Business Journal, a sister publication.
