BIVV001 Fusion Protein as Factor VIII Replacement Therapy for ...
2020年9月9日 · BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels. Data are lacking on the safety and...
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BIVV001, a new class of factor VIII replacement for hemophilia A …
2020年4月23日 · We have developed a new class of FVIII replacement, rFVIIIFc-VWF-XTEN (BIVV001), that is physically decoupled from endogenous VWF and has enhanced pharmacokinetic properties compared with all previous FVIII products.
BIVV001 Fusion Protein as Factor VIII Replacement Therapy for ...
2020年9月10日 · In a small, early-phase study involving men with severe hemophilia A, a single intravenous injection of BIVV001 resulted in high sustained factor VIII activity levels, with a half-life that was up to four times the half-life associated with recombinant factor VIII, an increase that could signal a ne …
Blood：BIVV001，一种新型FVIII替代品，用于A型血友病的止血控 …
Schratz等人开发了一种新的FVIII替代品，rFVIIIFc-VWF-XTEN (BIVV001)，在生理条件下，它可与内源性VWF解耦，并与既往所有FVIII产品相比，药代动力学特性增强。 BIVV001是一个独特的融合蛋白，由VWF-D？ D3结构域融合通过 免疫 球蛋白rFVIII G1 Fc结构域和两个XTEN？ 多肽与rFVIII融合组成。 BIVV001给药后，小鼠和猴子的血浆FVIII半衰期分别为25-31小时和33-34小时，提示FVIII半衰期延长了3-4倍。 本研究结果表明，考虑多方面的蛋白质工程的效果远远超过 …
BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels. Data are lacking on the safety and...
BIVV001融合蛋白作为因子Ⅷ替代品治疗A型血友病疗效显著
2020年9月14日 · BIVV001是一种新型融合蛋白，旨在克服这一半衰期上限，并维持长时间较高的因子Ⅷ活性水平。 然而，单剂量BIVV001的安全性和药代动力学尚不明确。 在这项临床1-2a期、开放标签试验中，研究组招募了16例18-65岁、先前治疗过、严重血友病（因子Ⅷ活性小于1%）男性，将其随机分组，分别接受静脉注射重组因子Ⅷ剂量25（低剂量组）或65 IU/kg体重（高剂量组）。 注射后至少有3天的洗脱期。 这些患者随后接受了相应剂量的BIVV001单次静脉注射，分 …
Efanesoctocog alfa - Sanofi - AdisInsight - Springer
Efanesoctocog alfa (previously known as BIVV 001) is a fully recombinant antihemophilic factor VIII therapy being developed by Sanofi for the treatment and
Developing BIVV001, a new class of factor VIII replacement for ...
2020年2月20日 · We have developed a new class of FVIII replacement, rFVIIIFc-VWF-XTEN (BIVV001), that is physically decoupled from endogenous VWF and has enhanced pharmacokinetic properties compared with all...
BIVV001: The First Investigational Factor VIII Therapy to Break …
2018年11月29日 · BIVV001 (rFVIII-VWF-XTEN) is a novel investigational rFVIII therapy with single-chain FVIII, the Fc domain of human immunoglobulin G1, 2 XTEN polypeptides, and the FVIII-binding D′D3 domain of VWF, designed to circulate in plasma independently of VWF, thereby breaking the VWF half-life ceiling.