Selecta Biosciences and AskBio Announce Updates to Methylmalonic Acidemia (MMA-101) Program
– Methylmalonic Acidemia (MMA) program to become wholly-owned by Selecta –
– Selecta to postpone IND submission until at least the fourth quarter of 2021 –
– Empty capsid (SEL-399) study remains on track –
WATERTOWN, Mass. and RESEARCH TRIANGLE PARK, N.C., April 29, 2021 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB) and Asklepios BioPharmaceutical, Inc. (AskBio), today announced an update to the companies’ collaboration to evaluate gene therapy candidate MMA-101 and ImmTOR™ for the treatment of methylmalonic acidemia (MMA). Selecta will assume all rights to the MMA program and will continue to progress the MMA-101 and ImmTOR combination through clinical development. AskBio’s decision to give all rights to Selecta is based on an internal strategic review and prioritization of its portfolio.
“Obtaining exclusive rights to the MMA program further strengthens Selecta’s wholly-owned gene therapy portfolio,” said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. “We are grateful to the AskBio team for their partnership in progressing MMA-101 through IND-enabling studies and look forward to taking advantage of this opportunity to independently advance the program through clinical development. Additionally, we are pleased with the progress made to date in our first-in-human trial of ImmTOR for gene therapy with the empty capsid study, which remains a collaborative effort with AskBio.”
Due to a manufacturing issue we believe is related to a component sourced from a third-party, Selecta now expects that submission of the IND for MMA-101 and ImmTOR will be delayed until at least the fourth quarter of 2021. A detailed assessment of the manufacturing process is currently being conducted, and the Company expects to provide an update on program timelines as they are clarified. ImmTOR manufacturing continues to proceed smoothly, and there is no impact to any of Selecta’s ImmTOR programs.
The dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no DNA combined with ImmTOR, is currently underway and progressing as expected. The study, being conducted in healthy volunteers at the SGS Life Sciences Clinical Pharmacology Unit in Antwerp, Belgium, is designed to evaluate the safety and preliminary efficacy of ImmTOR in gene therapy. Selecta and AskBio intend to provide topline data in the fourth quarter of this year.
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