FDA Lifts Clinical Hold on Selecta Biosciences’ Gene Therapy Program

The FDA has removed a clinical hold on Selecta Biosciences’ SEL-302 gene therapy in development for treating patients with methylmalonic anemia, a rare metabolic disorder.

In November 2021, the company received a letter from the FDA placing a hold on the program and requesting additional information on the product’s chemistry, manufacturing and controls.

The agency’s decision immediately halted plans for a phase 1/2 study evaluating SEL-302 for treating methylmalonic anemia. At the time, the company said the FDA’s letter did not contain any clinical or preclinical questions.

The phase 1 study is now slated to begin in the second half of 2022.