Additional Relevant Details Baxalta has dosed the first patient in its Phase 1, first-in-human clinical trial of BAX 826, a recombinant Factor VIII (rFVIII) treatment for hemophilia A that uses proprietary polysialic acid (PSA) technology to extend its circulating half-life. BAX 826 is under investigation as Baxalta’s second extended half-life treatment based on ADVATE [Antihemophilic Factor (Recombinant)], the world's most prescribed FVIII treatment.

BAX 826 is a next-generation rFVIII treatment based on the full length ADVATE. The compound is modified using proprietary polysialic acid (PSA) technology licensed from Xenetic Biosciences, Inc. (OTCQB: XBIO) to extend its circulating half-life. Baxalta has partnered with Xenetic to develop novel forms of polysialylated blood coagulation factors, including FVIII. Xenetic’s PolyXen™ technology utilizes the biopolymer PSA in order to extend the circulating half-life and potentially improve the pharmacokinetic profile of therapeutic proteins, peptides, and small molecules. Preclinical studies indicated BAX 826 offered an extended circulating half-life compared to standard rFVIII.