-U.S. FDA has issued a clinical hold on Phase 1/2 Clinical Trial of SEL-302 due to CMC related questions-
WATERTOWN, MA, USA I November 24, 2021 I 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 requests for additional information.
“Patient safety is our primary concern, and we are committed to addressing the FDA’s questions regarding CMC as expeditiously as possible,” said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. “We look forward to working closely with the FDA to satisfy all outstanding concerns, and to providing additional updates early next year.”
About MMA
MMA is a rare metabolic disease that affects the body’s ability to metabolize certain amino acids and fats. The condition may lead to metabolic acidosis, hyperammonemia and long-term complications including feeding problems, developmental delays, intellectual disability and chronic kidney disease.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
SOURCE: Selecta Biosciences
Post Views: 34
-U.S. FDA has issued a clinical hold on Phase 1/2 Clinical Trial of SEL-302 due to CMC related questions-
WATERTOWN, MA, USA I November 24, 2021 I 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 requests for additional information.
“Patient safety is our primary concern, and we are committed to addressing the FDA’s questions regarding CMC as expeditiously as possible,” said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. “We look forward to working closely with the FDA to satisfy all outstanding concerns, and to providing additional updates early next year.”
About MMA
MMA is a rare metabolic disease that affects the body’s ability to metabolize certain amino acids and fats. The condition may lead to metabolic acidosis, hyperammonemia and long-term complications including feeding problems, developmental delays, intellectual disability and chronic kidney disease.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is a clinical stage biotechnology company leveraging its ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. Selecta has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. Selecta Biosciences is headquartered in the Greater Boston area. For more information, please visit www.selectabio.com.
SOURCE: Selecta Biosciences
Post Views: 34
