Ridgeback Biotherapeutics LP announces publication of mAb114 results in the New England Journal of Medicine

Ridgeback在《新英格兰医学杂志》发表 抗体鸡尾酒ZMapp治疗埃博拉新手段

2019-11-29 09:25:31 CISION


Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the results for the Pamoja Tulinde Maisha  clinical trial have been published in the New England Journal of Medicine.  The PALM study was organized by an international research consortium coordinated by the World Health Organization . It is led and funded by the DRC's National Institute for Biomedical Research and Ministry of Health, and the National Institute of Allergy and Infectious Diseases , part of the U.S. National Institutes of Health.  The study was designed to compare mortality among patients who received one of three investigational Ebola drugs with that from a control group of patients who received the investigational monoclonal antibody cocktail ZMapp, developed by Mapp Biopharmaceutical, Inc.  Mortality rates were lower for mAb114 treated patients: 35% (61/174) of patients in the mAb114 treatment group vs 50% (84/169) for the control arm (p=0.007).  The Mortality rate for mAb114 treated patients with low viral load (CT>22) was 10%.  "This landmark study will permanently change the outlook for Ebola patients.  Ebola is a disease that can be treated, especially if patients are treated early in the course of the disease.  The PALM trial coordinators were able to accomplish a feat which many said could not be done – conduct a scientifically rigorous clinical trial in the midst of a complicated and ever-changing Ebola outbreak.  The results published today demonstrate the incredibly robust impact that mAb114 has on this devastating and deadly disease.  The heroes behind this discovery are the patients, their families and the extraordinary PALM study team – their contributions will forever change the trajectory of this brutal disease," said Wendy Holman, CEO of Ridgeback Biotherapeutics. Ridgeback Biotherapeutics licensed mAb114 from NIAID's Vaccine Research Center.  The company has applied for and has been granted Orphan Drug Designation and Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).  Ridgeback Biotherapeutics is in the process of filing a Biologics License Application for mAb114 with the FDA and is manufacturing additional supply of mAb114 for potential use in either the current or future Ebola outbreaks.  Ridgeback Biotherapeutics has been awarded a $14 million contract by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services to manufacture mAb114 and support activities required for licensure from the FDA.     About Pamoja Tulinde Maisha (PALM): The PALM study is co-sponsored and funded by the INRB (Institut National de Recherche Biomédicale) and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health and carried out by an international research consortium coordinated by the World Health Organization (WHO).  The Ebola treatment centers in the PALM trial have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations:  the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médicins Sans Frontières (MSF).  About mAb114: mAb114 is a monoclonal antibody — a protein that binds to a single target on a pathogen — isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. Nancy Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID's Vaccine Research Center (VRC), and her team, in collaboration with researchers from the National Institute of Biomedical Research (INRB) in the DRC and the Institute for Research in Biomedicine and Vir Biotechnology, Inc.'s subsidiary Humabs BioMed, both based in Bellinzona, Switzerland, discovered that the survivor retained antibodies against Ebola 11 years after infection. They isolated the antibodies and tested the most favorable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising. Professor Jean-Jacques Muyembe, director general of INRB and one of the scientists involved in the original detection of the Ebola virus in 1976, played a key role in discovering mAb114. About Ridgeback Biotherapeutics LP: Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman owned biotechnology company focused on orphan and infectious diseases.  Initial funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals committed to investing in and supporting technologies that will make the world a better place.  The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. SOURCE Ridgeback Biotherapeutics LP Related Links www.ridgebackcap.com/
生物技术公司 Ridgeback Biotherapeutics LP 今天宣布, Pamoja Tulinde Maisha 临床试验的结果已经发表在《新英格兰医学杂志》上。PALM 研究是由世界卫生组织协调的一个国际研究财团组织的。它由 DRC 的国家生物医学研究所和卫生部以及美国国立卫生研究院下属的国家过敏和传染病研究所领导和资助。 该研究旨在比较接受三种研究埃博拉(Ebola)药物之一的患者与接受研究单克隆抗体鸡尾酒疗法 ZMapp 的对照组患者的死亡率。Inc .接受 mAb114治疗的患者死亡率较低: mAb114治疗组35%(61/174)患者,对照组50%(84/169)( p =0.007)。mAb114治疗病毒载量低( CT >22)的患者死亡率为10%。 这项具有里程碑意义的研究将永久改变埃博拉(Ebola)患者的前景。埃博拉(Ebola)是一种可以治疗的疾病,特别是如果患者在疾病早期接受治疗。PALM 试验协调员能够完成许多人说不能做到的一项壮举——在埃博拉(Ebola)疫情复杂且不断变化的情况下进行一项科学严谨的临床试验。今天公布的结果表明 mAb114对这种破坏性和致命疾病的影响是难以置信的强大。Ridgeback Biotherapeutics 首席执行官温迪•霍尔曼( Wendy Holman )表示:“这一发现背后的英雄是病人、他们的家人以及 PALM 研究团队的杰出代表——他们的贡献将永远改变这种残酷疾病的发展轨迹。” Ridgeback Biotherapeutics 授权 NIAID 疫苗研究中心的 mAb114。公司已向美国食品药品监督管理局( FDA )申请并获批孤儿药物指定和突破性治疗指定。Ridgeback Biotherapeutics 正在向 FDA 提交 mAb114的 Biologics License Application ,并正在制造额外的 mAb114供应,用于当前或未来埃博拉(Ebola)疫情的潜在用途。 Ridgeback Biotherapeutics 公司获得了生物医学高级研究和开发管理局( BARDA )在美国卫生和公众服务部负责准备和反应的助理部长办公室授予的价值1400万美元的合同,用于生产 mAb114和支持 FDA 许可所需的活动。 关于 Pamoja Tulinde Maisha ( PALM ): PALM 研究由 INRB (国家生物医学研究所)和美国国立卫生研究院国家过敏和传染病研究所( NIAID )共同赞助和资助,由世界卫生组织( WHO )协调的一个国际研究财团进行。PALM 试验中的埃博拉(Ebola)治疗中心由国家生物医学研究所( INRB )、刚果民主共和国卫生部以及三个医疗人道主义组织的工作人员负责监督:国际医疗行动联盟( ALIMA )、国际医疗团( IMC )和 Sans Fronti è res ( MSF )。 关于 mAb114: mAb114是一种单克隆抗体——一种与病原体单一靶标结合的蛋白质——与1995年在刚果民主共和国 Kikwait 市爆发的埃博拉(Ebola)疫情的幸存者分离。Nancy Sullivan 博士, NIAID 疫苗研究中心( VRC )生物防御研究科科长,以及她的团队,与来自刚果民主共和国国家生物医学研究所( INRB )和生物医学和病毒生物技术研究所( Institute for Research in Biomedical and Vir Biotechnology , Inc .)的研究人员合作,这两个研究所都设在贝林佐纳,瑞士发现,幸存者在感染埃博拉(Ebola)病毒11年后保留了抗体。他们分离了抗体,并在实验室和非人类灵长类动物研究中测试了最有利的抗体,并选择 mAb114作为最有前途的抗体。INRB 总干事 Jean-Jacques Muyembe 教授和1976年参与埃博拉(Ebola)病毒原始检测的科学家之一在发现 mAb114方面发挥了关键作用。 关于 Ridgeback Biotherapeutics LP : Ridgeback Biotherapeutics 总部位于弗洛里达州迈阿密,是一家私人控股的、多数女性拥有的生物技术公司,专注于孤儿和传染病。Ridgeback Biotherapeutics 的初始资金来源于 Wayne 和 Wendy Holman ;两个人致力于投资和支持将使世界变得更美好的技术。Ridgeback 的团队致力于为需要冠军的病人和疾病寻找拯救生命和改变生命的解决方案。 SOURCE Ridgeback Biotherapeutics LP 相关链接 www.ridgebackcap.com /