Grifols' GigaGen Receives FDA Clearance Of IND Application For Phase 1 Trial Of Recombinant Polyclonal For HBV Treatment, GIGA-2339
Grifols' GigaGen Receives FDA Clearance Of IND Application For Phase 1 Trial Of Recombinant Polyclonal For HBV Treatment, GIGA-2339
SAN CARLOS, Calif. , July 31, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company's first recombinant polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024
GIGA-2339是第一個用於治療和功能性治癒慢性乙型肝炎病毒（HBV）感染的重組多克隆療法，在2024年第4季度預計開始試驗。
Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body's natural immune response
GIGA-2339含有超過1,000種全人重組抗-HBV抗體，重現人體的自然免疫反應。
GigaGen's recombinant polyclonals are part of Grifols' robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare professionals
GigaGen的重組多克隆體是基立福強大創新策略和爲患者和醫療保健專業人員提供下一代抗體藥物承諾的一部分。
SAN CARLOS, Calif. , July 31, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company's first recombinant polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.
加州聖卡洛斯，2024年7月31日（環球新聞線）--GigaGen公司是基立福的子公司，是一家生物技術公司，致力於推進用於免疫缺陷、傳染病和檢查站耐藥癌症的變革性抗體藥物。宣佈美國食品和藥物管理局（FDA）已批准其新藥申請（IND），以評估該公司的第一款重組多克隆藥物GIGA-2339用於治療乙型肝炎病毒（HBV）感染的一期試驗。
