Selecta Biosciences Provides Update on Phase 1/2 Clinical Trial of SEL-302 for the Treatment of Methylmalonic Acidemia
Selecta Biosciences, Inc. (SELB)
Last selecta biosciences, inc. earnings: 3/12 08:00 am
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Source: GlobeNewswire
WATERTOWN, Mass., Nov. 24, 2021 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 1/2 clinical trial of SEL-302 (which consists of MMA-101 plus ImmTOR) for the treatment of patients with methylmalonic acidemia (MMA). On November 23, Selecta received a letter from the FDA issuing a clinical hold in order to obtain additional information on the chemistry, manufacturing and controls (CMC) related to the MMA-101 product candidate. There were no outstanding clinical or pre-clinical questions in the FDA letter. This clinical trial had not yet been initiated, and no human patients will be dosed with MMA-101 until all of the FDA’s questions are resolved. Selecta intends to work closely with the FDA to address the r
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