Tonix Pharmaceuticals Receives First Contract Payment From U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals With the Defense Threat Reduction Agency (DTRA)
Tonix Pharmaceuticals Receives First Contract Payment From U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals With the Defense Threat Reduction Agency (DTRA)
The $34.0 million five-year contract will help fund and accelerate the development of the Company's broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix's premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.Tonix Pharmaceuticals Receives First Contract Payment from U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals with the Defense Threat Reduction Agency (DTRA)
Tonix Pharmaceuticals收到來自美國國防部的第一個合同付款，用於加速開發與國防威脅削減局（DTRA）合作的廣譜抗病毒藥物
First payment received under Tonix's contract with the Defense Threat Reduction Agency (DTRA), for up to $34 million over five years
Tonix與國防威脅削減局(DTRA)的合同下收到首筆付款，爲期五年，金額達3400萬美元
CHATHAM, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, received its first payment from the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense (DoD), to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The previously announced award from DTRA is for up to $34 million over five years.
新澤西州查塔姆，2024年10月17日(GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (納斯達克股票代碼: TNXP) (Tonix或公司)，一家擁有上市產品和開發候選產品流水線的全面整合的生物製品公司，收到了來自美國國防部(Department of Defense，DoD)旗下的國防威脅削減局(DTRA)的首筆付款，用以開發小分子廣譜抗病毒藥物，預防或治療感染，以提高在生物威脅環境中軍事人員的醫療準備就緒。此前宣佈的DTRA授予的資助爲期五年，達3400萬美元
"This award provides important validation and substantial non-dilutive funding for our ongoing research to advance our antiviral discovery program," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals "With biological adaptations and mutations happening to viruses rapidly across the globe, this research will be crucial in order to protect lives in the event biological threats are introduced onto the battlefield."
"這一獎項爲我們正在進行的抗病毒研究提供了重要的確認和大量非稀釋性資金支持，"Tonix Pharmaceuticals首席執行官席思·萊德曼博士表示。"隨着病毒在全球範圍內迅速發生生物適應性和突變，這項研究將至關重要，以保護生命，防止生物威脅進入戰場。"
The $34.0 million five-year contract will help fund and accelerate the development of the Company's broad-spectrum antiviral program, which has the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and cost-effective solution for a broad-spectrum medical countermeasure. Tonix's premise is that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.
3400萬美元五年合同將有助於資助和加速公司的廣譜抗病毒項目的發展，該項目有潛力降低病毒載量，使適應性免疫系統警覺到免疫系統的其他組成部分以啓動保護性反應。Tonix計劃利用先前關於磷酸酶抑制劑的研究，特別是針對CD45的化合物，優化用於治療生物威脅劑的首要化合物，併爲廣譜醫學對抗措施提供政府一個完整和具有成本效益的解決方案。Tonix的觀點是，部分抑制CD45將提供最佳的抗病毒保護，同時需要較低的血漿藥物濃度，較低的劑量和更好的安全性。
Tonix will utilize its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab at its research and development center (RDC) facility located in Frederick, Md., as well as experienced personnel in-house. The RDC is located in Maryland's 'I-270 biotech corridor' and is close to the center of the U.S. biodefense research community.
Tonix將利用其位於馬里蘭州弗雷德裏克市的研發中心（RDC）設施內的Biosafety Level 3（BSL-3）實驗室等先進研究實驗室能力，以及內部經驗豐富的人員。RDC位於馬里蘭州的「 I-270生物技術走廊」內，靠近美國生物防禦研究社區的中心。
About Defense Threat Reduction Agency (DTRA)
The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD) is both a Defense Agency and Combat Support Agency with two distinct yet highly integrated roles countering Weapons of Mass Destruction (WMD) and emerging threats. Its origins stretch back to World War II and the Manhattan Project, but today the agency encompasses a wide variety of strategic and operational functions that deter, prevent, and ultimately prevail against these unique threats. DTRA enables the Department of Defense (DoD), the United States Government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats. DTRA provides cross-cutting solutions to enable the Department of Defense, the United States Government, and international partners to deter strategic attack against the United States and its allies; prevent, reduce, and counter WMD and emerging threats; and prevail against WMD-armed adversaries in crisis and conflict. DTRA's continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit .
關於國防威脅削減局（DTRA）
國防-威脅減少局（DTRA）是美國國防部的一個機構，既是國防機構又是作戰支援機構，具有兩個明確而高度整合的角色，分別對抗大規模殺傷性武器（WMD）和新興威脅。其起源可以追溯到二戰和曼哈頓計劃，但今天該機構囊括了各種各樣的戰略和運營功能，以阻嚇、預防和最終戰勝這些獨特威脅。DTRA使美國國防部（DoD）、美國政府和國際合作夥伴能夠對抗和阻嚇大規模殺傷性武器和新興威脅。DTRA提供跨領域的解決方案，以使美國國防部、美國政府和國際合作夥伴能夠阻止對美國及其盟友的戰略襲擊；預防、減少和對抗WMD和新興威脅；並在危機和衝突中戰勝持有WMD的對手。DTRA繼續努力增強作戰支援任務，通過開發創新技術來保護免受生物威脅。欲了解更多信息，請訪問（網址）。
Tonix Pharmaceuticals Holding Corp.**
Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix's development portfolio is focused on central nervous system (CNS) disorders, and its priority is to progress TNX-102 SL, a product candidate for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institude of Drug Abuse and Addiction (NIDA). Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
Tonix Pharmaceuticals Holding Corp.**
Tonix是一家專注於轉化疼痛管理療法和現代化公共衛生挑戰解決方案的全面綜合生物製品公司。Tonix的研發組合專注於中樞神經系統（CNS）疾病，其重點是推進TNX-102 SL，這是一個候選產品，根據兩項統計顯著的第三期研究提交了用於治療纖維肌痛的新藥申請。FDA已授予TNX-102 SL用於治療纖維肌痛的快速通道指定。TNX-102 SL還正在開發用於治療急性應激反應和急性應激障礙的產品，該產品在北卡羅來納大學的OASIS研究中，由美國國防部（DoD）資助，根據醫師發起的IND進行研究。Tonix的CNS產品組合包括TNX-1300（可卡因酯酶），這是一個處於第二期開發階段的生物製品，旨在治療可卡因中毒，並獲得了FDA的突破性療法指定，其開發得到了美國國家濫用藥物和成癮研究所（NIDA）的資助。Tonix的免疫學研發組合包括生物製品，用於解決器官移植排斥、自身免疫和癌症問題，包括TNX-1500，這是一個尋求預防移植物排斥和治療自身免疫疾病的Fc修飾的人源化單克隆抗體，靶向CD40配體（CD40L或CD154）進行研發。Tonix還在罕見疾病領域開發產品候選者，包括用於普拉德-威利氏綜合徵的TNX-2900，以及針對傳染病、包括一種mpox疫苗的候選產品，即TNX-801。Tonix最近宣佈與美國國防部威脅減少局（DTRA）簽訂了一項合同，爲期五年，爲開發TNX-4200，一種針對CD45的小分子廣譜抗病毒製劑，以預防或治療感染，以提高軍事人員在生物威脅環境中的醫療準備。Tonix擁有並運營位於馬里蘭州弗雷德裏克市的最先進的傳染病研究設施。我們的商業子公司Tonix Medicines推廣Zembrace SymTouch（舒馬曲坦注射劑）3毫克和Tosymra（舒馬曲坦鼻噴霧）10毫克，用於成人急性偏頭痛的治療。
* Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
* Tonix製品開發候選是新型藥物或生物製品；它們的功效和安全性尚未得到確認，也未獲批准用於任何適應症。
Zembrace SymTouch和Tosymra是Tonix Medicines的註冊商標，其他所有商標均爲其各自所有者的財產。
This press release and further information about Tonix can be found at .
有關Tonix的此新聞稿和更多信息，請訪問。
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the "SEC") on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
前瞻性聲明
本新聞稿中的某些聲明屬於1995年《私人證券訴訟改革法案》範疇內的前瞻性聲明。這些語句可以通過使用諸如「預計」、「相信」、「預測」、「估計」、「預期」和「打算」等前瞻性詞語來識別。這些前瞻性語句基於Tonix的當前期望，實際結果可能存在實質性差異。存在許多因素可能導致實際事件與此類前瞻性語句所示不符。這些因素包括但不限於，與未獲得FDA清除證明或批准以及與FDA法規不符合有關的風險；與未能成功推銷我們的任何產品有關的風險；與我們的產品候選品的臨床開發的時間和進展有關的風險；我們需要額外融資的風險；專利保護和訴訟的不確定性；政府或第三方支付者的退款不確定性；有限的研發工作並依賴第三方；以及激烈的競爭。與任何處於開發階段的藥品一樣，開發、監管批准和新產品的商業化存在重大風險。Tonix不承擔更新或修改任何前瞻性聲明的義務。投資者應閱讀2023年12月31日結束的年度報告10-K，以及在2024年4月1日提交給證券交易委員會（「SEC」）的在此之後提交給SEC的定期報告中所規定的風險因素。Tonix的所有前瞻性聲明都受所有這些風險因素和其他謹慎聲明的明確限制。此處的信息僅代表其發表之日。
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
投資者聯繫方式
Jessica Morris
tonix pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
媒體聯繫人
雷喬丹
普特納姆觀點
ray@putnaminsights.com
（949）245-5432
Released October 17, 2024
2024年10月17日發佈
譯文內容由第三人軟體翻譯。
