Monoclonal Antibody for Treatment of Inhalation Anthrax

治疗吸入性炭疽的单克隆抗体

• 批准号: 6845421
• 负责人: Vincent Strout
• 金额: $ 500万
• 依托单位: ELUSYS THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6845421
• 关键词: Macaca fascicularis; anthrax; anthrax toxin; bioterrorism /chemical warfare; clinical research; clinical trial phase I; cooperative study; dosage; drug screening /evaluation; human subject; human therapy evaluation; immunologic substance development /preparation; immunotherapy; laboratory rat; monoclonal antibody; neutralizing antibody; nonhuman therapy evaluation; patient oriented research; pharmacokinetics

DESCRIPTION (provided by applicant): Elusys Therapeutics is actively developing a novel, ultra high-affinity monoclonal antibody (Mab) to neutralize the lethal effects of anthrax toxin. Elusys's Mab, ETI-204, is directed against Protective Antigen (PA) of B. anthracis and is being developed for both prophylactic and therapeutic treatment of anthrax infections resulting from a bioterrorist attack. Anthrax is currently considered by the federal government to be the number one biowarfare threat. In both mouse and rabbit studies, ETI-204 has protected 100% of treated animals from death following exposure to anthrax toxin or inhaled spores. As a result of this compelling data, the Company is rapidly pursuing a well defined clinical development program with input from meetings with both the Office of Counterterrorism (OCTAP) and the FDA. This application is for funding to complete the final animal efficacy testing, human safety testing and pharmaceutical manufacturing necessary to apply for FDA approval of ETI-204 for treatment of anthrax infection in both pre- and post exposure situations. The specific aims of this application are: (1) to develop a scaleable ETI-204 manufacturing process; (2) to complete definitive efficacy testing in a primate spore challenge model: (3) to produce clinical-grade ETI- 204; and (4) to complete human safety trials. Due to the urgent national need for an effective anthrax therapeutic, Elusys, with funding from DoD, has already initiated and will have completed several additional animal efficacy and PK studies to further ensure the success of ETI-204's continued development as outlined in this application. Funding provided under this application would greatly facilitate and expedite the final development work necessary to validate the safety and efficacy of a much needed anthrax antidote to protect both military and civilian personnel.

描述（由申请人提供）：Elusys Therapeutics 正在积极开发一种新型超高亲和力单克隆抗体 (Mab)，以中和炭疽毒素的致命作用。 Elusys 的 Mab ETI-204 针对炭疽芽孢杆菌的保护性抗原 (PA)，正在开发用于生物恐怖袭击引起的炭疽感染的预防性和治疗性治疗。炭疽目前被联邦政府视为头号生物战威胁。在小鼠和兔子研究中，ETI-204 已保护 100% 的接受治疗的动物在接触炭疽毒素或吸入孢子后免于死亡。由于这些令人信服的数据，公司正在迅速制定明确的临床开发计划，并根据与反恐办公室 (OCTAP) 和 FDA 的会议提供的意见。该申请旨在资助完成最终的动物功效测试、人体安全测试和药品生产，以申请 FDA 批准 ETI-204 用于治疗暴露前和暴露后的炭疽感染。 该应用的具体目标是：（1）开发可扩展的ETI-204制造工艺； (2) 在灵长类孢子激发模型中完成明确的功效测试： (3) 生产临床级 ETI-204； (4)完成人体安全试验。 由于国家迫切需要有效的炭疽治疗剂，Elusys 在 DoD 的资助下，已经启动并将完成几项额外的动物功效和 PK 研究，以进一步确保 ETI-204 的持续开发取得成功，如本申请中所述。本申请提供的资金将极大地促进和加快最终开发工作，以验证保护军事和文职人员急需的炭疽解毒剂的安全性和有效性。