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SHP648
- Development stage
- Phase 2
- Lead developer
- Takeda
- Modality
- Gene Addition/Replacement → Gene Therapies, Gene Editing → Gene Therapies, Gene Silencing → Gene Therapies
- Administration
- Intravenous
01
Overview
SHP648 (also known as TAK-748 or AskBio009) is an investigational gene therapy developed for the treatment of hemophilia B. It utilizes a self-complementing adeno-associated virus serotype 8 (AAV8) vector to deliver a codon-optimized gene encoding the high-activity Factor IX (FIX) Padua variant (R338L) to the liver. The therapy is designed to provide sustained endogenous production of Factor IX following a single intravenous infusion, thereby reducing or eliminating the need for regular prophylactic factor replacement therapy. Originally developed by Chatham Therapeutics and Asklepios BioPharmaceutical (AskBio), the program transitioned through Baxter, Baxalta, and Shire, and is currently under development by Takeda following its acquisition of Shire.
- Other names
- AAV8-FIX Padua gene therapyAAV-8-FIX Padua gene therapyAAV 8-FIX Padua gene therapyAskBio009AskBio-009AskBio 009
02
Targets
F9 (Coagulation Factor IX)AAV8-HSRG (Hepatocyte surface receptors and glycans mediating adeno-associated virus 8 entry)
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