Monoclonal Antibody for Treatment of Inhalation Anthrax

描述(申请人提供)：Elusys治疗公司正在积极开发一种新型的、超高亲和力的单抗(Mab)，以中和炭疽毒素的致命作用。Elusys的单抗ETI-204是针对炭疽杆菌保护性抗原(PA)的，正在开发用于预防和治疗生物恐怖袭击引起的炭疽感染。炭疽病目前被联邦政府视为头号生物武器威胁。在小鼠和兔子的研究中，ETI-204已经100%保护了处理过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，该公司正在通过与反恐办公室(OCTAP)和FDA的会议提供意见，迅速实施一项定义明确的临床开发计划。这项申请是为完成最终的动物效力测试、人体安全性测试和药物制造所需的资金，以申请FDA批准ETI-204在暴露前和暴露后的情况下治疗炭疽感染。 这项申请的具体目标是：(1)开发可扩展的ETI-204制造工艺；(2)在灵长类孢子挑战模型中完成最终的疗效测试；(3)生产临床级ETI-204；以及(4)完成人体安全性试验。由于国家对有效的炭疽治疗方法的迫切需求，Elusys在国防部的资助下，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‘S继续开发的成功，如本申请所述。在这项申请下提供的资金将极大地便利和加快必要的最后开发工作，以验证一种急需的炭疽解毒剂的安全性和有效性，以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.