Monoclonal Antibody for Treatment of Inhalation Anthrax

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死作用。Elusys的MaB，ETI-204，针对B的保护性抗原（PA）。炭疽病，并正在开发用于预防和治疗生物恐怖袭击造成的炭疽感染。炭疽目前被联邦政府认为是头号生物战威胁。在小鼠和兔子的研究中，ETI-204保护了100%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，该公司正在迅速寻求一个明确的临床开发计划，并与反恐办公室（OCTAP）和FDA举行会议。该申请旨在获得资金，以完成申请FDA批准ETI-204治疗暴露前和暴露后炭疽感染所需的最终动物功效测试，人体安全测试和药物制造。 本申请的具体目的是：（1）开发可扩展的ETI-204生产工艺;（2）在灵长类动物孢子挑战模型中完成确定性疗效测试;（3）生产临床级ETI- 204;以及（4）完成人体安全性试验。 由于国家迫切需要一种有效的炭疽治疗剂，Elusys在美国国防部的资助下，已经启动并将完成几项额外的动物疗效和PK研究，以进一步确保ETI-204的成功继续开发。在这一申请下提供的资金将大大促进和加快必要的最后研制工作，以验证急需的炭疽解毒剂的安全性和有效性，从而保护军事和文职人员。

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.