BAX 826 / Xenetic Biosci, Takeda - LARVOL DELTA

Xenetic Biosciences' (XBIO) CEO Scott Maguire on Q1 2017 results - Earnings call transcript (SeekingAlpha) - "Shire continues to advance this important program which is completing its Phase 1/2 study and as Scott noted, we expect top-line data from Shire this quarter. So to be clear Xenetic has not had any access to this data, so we are waiting like everyone else. When we do we will promptly announce the results and hopefully plan for Shire to proceed into a Phase 3 study this year."

New P3 trial • P1/2 data • Hemophilia • Parkinson's Disease

Baxalta to initiate a first-in-human clinical trial of BAX 826, an investigational, extended half-life FVIII treatment targeting weekly dosing for hemophilia A (Businesswire) - "Baxalta Incorporated...today announced the submission of a Clinical Trial Application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a first-in-human clinical trial to evaluate the safety and efficacy of BAX 826....The open-label, dose-finding study of BAX 826 aims to enroll 30 patients; Baxalta expects to begin treating participants in the study by early 2016."

Anticipated new trial • Anticipated target enrollment • Hemophilia

Evaluation of factor VIII polysialylation: Identification of a longer-acting experimental therapy in mice and monkeys. (PubMed, J Pharmacol Exp Ther) - "The favorable profile and mechanism of this novel experimental therapeutic demonstrated all the requirements for an EHL-rFVIII candidate, and thus BAX 826 was entered into clinical assessment for the treatment of hemophilia A. SIGNIFICANCE STATEMENT: Prolongation of FVIII half-life aims to reduce the burden of prophylaxis and to improve treatment outcomes in patients with hemophilia. This study shows that polysialylation of PSArFVIII resulted in prolongations of rFVIII circulation time and procoagulant activity, together with a favorable non-clinical safety profile of the experimental therapeutic."

Journal • Preclinical

Xenetic Biosciences, Inc. announces publication of data from Partner's phase 1/2 study evaluating program leveraging Polyxen(R) platform technology (Xenetic Press Release) - "Xenetic Biosciences, Inc....announced today that data from the completed Phase 1/2 clinical study of SHP656 ('PSA-recombinant Factor VIII', 'PSA-rFVIII') sponsored by its license partner Takeda Pharmaceuticals Company Limited ('Takeda') has been published in the journal Haemophilia....'We are pleased that this study published in the peer-reviewed journal Haemophilia has demonstrated that our PolyXen platform successfully extended the circulating half-life of rFVIII with no treatment-related adverse events.' "

P1/2 data