Nov. 24 Quick Takes: Pfizer’s vupanorsen meets in Phase IIb

Lipid-lowering antisense therapy vupanorsen from Pfizer Inc. (NYSE:PFE) met the primary endpoint of reducing non-HDL-C at 24 weeks in a placebo-controlled Phase IIb study. The ANGPTL3-targeting treatment also met a secondary endpoint of lowering triglycerides. Pfizer, which holds vupanorsen’s rights under a 2019 deal with Ionis Pharmaceuticals Inc. (NASDAQ:IONS), is still determining next steps in the therapy’s development. If approved, vupanorsen would compete against PCSK9-targeting Leqvio inclisiran from Novartis AG (SIX:NOVN; NYSE:NVS), which is approved in the EU and is under FDA review. The PCSK9 category also includes mAbs Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) and Praluent alirocumab from Sanofi (Euronext:SAN; NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).

Selecta Biosciences Inc. (NASDAQ:SELB) said it will work with FDA to resolve a newly issued clinical hold on SEL-302. The agency is seeking additional information regarding the gene therapy’s CMC. Selecta has not yet begun a Phase I/II trial of the gene therapy to treat the metabolic disorder methylmalonic acidemia. SEL-302 consists of MMA-101, an adeno-associated viral (AAV) therapy to which Selecta obtained rights from the Asklepios BioPharmaceutical Inc. division of Bayer AG (Xetra:BAYN), combined with Selecta’s ImmTOR immune tolerance platform. Selecta’s shares slipped 15% in after-hours trading Wednesday...