The US Food and Drug Administration (FDA) has issued a clinical hold on Selecta Biosciences’ Phase I/II clinical trial of its gene therapy candidate, SEL-302, to treat individuals with methylmalonic acidemia (MMA).
SEL-302 comprises ImmTOR in combination with MMA-101.
Utilising its proven ImmTOR platform, Selecta develops tolerogenic treatments that specifically alleviate undesirable immune responses.
The FDA notified the company of the clinical hold via a letter, which also sought further data on the chemistry, manufacturing and controls linked to the MMA-101 product candidate.
The letter had no unresolved clinical or pre-clinical issues, adding that the trial has not begun yet.
Furthermore, no human patients would review doses of MMA-101 until all the concerns of the FDA are addressed.
Selecta plans to work collaboratively with the FDA to meet further data requirements.
Selecta Biosciences president and CEO Carsten Brunn said: “Patient safety is our primary concern, and we are committed to addressing the FDA’s questions regarding CMC as expeditiously as possible.
“We look forward to working closely with the FDA to satisfy all outstanding concerns, and to providing additional updates early next year.”
In April 2021, Selecta and Asklepios BioPharmaceutical updated their partnership to assess MMA-101 plus ImmTOR for MMA treatment.
According to the collaboration, Selecta gained complete rights to the MMA programme and will advance the combination therapy clinically.
A rare metabolic ailment, MMA interferes with the ability of the body to metabolise specific amino acids and fats.
The disease is expected to cause hyperammonemia, metabolic acidosis and long-term consequences such as feeding issues, developmental delays, intellectual incapability and chronic kidney disease.
The latest development comes after the FDA put a partial clinical hold on Kura Oncology’s Phase Ib KOMET-001 trial of KO-539 in patients with acute myeloid leukaemia.
Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.
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