DJ Selecta Biosciences, Partner Get FDA Rare-Pediatric Designation for MMA-101
By Colin Kellaher
Selecta Biosciences Inc. and Asklepios BioPharmaceutical Inc. on Tuesday said the U.S. Food and Drug Administration granted rare-pediatric-disease designation to MMA-101, the gene therapy they are developing for a rare metabolic disorder.
Selecta, a Watertown, Mass., clinical-stage biotechnology company, and privately held Asklepios said the designation covers MMA-101 for the treatment of isolated methylmalonic acidemia due to methylmalonyl-CoA mutase gene mutations.
The companies said they expect to initiate a phase 1 clinical trial of MMA-101 with Selecta's ImmTOR immune tolerance platform in the first half of 2021.
The FDA awards priority-review vouchers to drugmakers upon approval of drugs that are granted the rare-pediatric-disease designation. Those vouchers can be used to obtain priority review for another drug or sold to other companies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 20, 2020 08:55 ET (12:55 GMT)
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