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Tonix Pharmaceuticals Announces AI Collaboration with X-Chem to Develop Broad-Spectrum Antivirals

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Tonix Pharmaceuticals (Nasdaq: TNXP) has announced an AI and ML research collaboration with X-Chem to accelerate the development of oral broad-spectrum antivirals. The collaboration focuses on Tonix's TNX-4200 antiviral program, which aims to develop oral CD45 phosphatase inhibitors with broad-spectrum activity against various viral families.

Tonix has been awarded a contract with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the TNX-4200 program, including an IND submission and a Phase 1 clinical study. The collaboration with X-Chem is expected to optimize the physicochemical properties, pharmacokinetics, and safety attributes of Tonix's drug candidates.

Tonix plans to leverage its research facilities, including a BSL-3 lab and an ABSL-3 facility at its research and development center in Frederick, Md., to support the development of these host-directed broad-spectrum antiviral programs.

Tonix Pharmaceuticals (Nasdaq: TNXP) ha annunciato una collaborazione di ricerca in IA e ML con X-Chem per accelerare lo sviluppo di antivirali orali a ampio spettro. La collaborazione si concentra sul programma antivirale TNX-4200 di Tonix, che mira a sviluppare inibitori della fosfatasi CD45 orali con attività a ampio spettro contro diverse famiglie virali.

Tonix ha ricevuto un contratto dal Dipartimento della Difesa degli Stati Uniti, Defense Threat Reduction Agency (DTRA) per un massimo di 34 milioni di dollari per avanzare il programma TNX-4200, incluso un'invio di IND e uno studio clinico di Fase 1. La collaborazione con X-Chem dovrebbe ottimizzare le proprietà fisico-chimiche, la farmacocinetica e le caratteristiche di sicurezza dei candidati farmacologici di Tonix.

Tonix prevede di sfruttare le proprie strutture di ricerca, inclusi un laboratorio BSL-3 e una struttura ABSL-3 presso il suo centro di ricerca e sviluppo a Frederick, Md., per supportare lo sviluppo di questi programmi antivirali a largo spettro diretti all'ospite.

Tonix Pharmaceuticals (Nasdaq: TNXP) ha anunciado una colaboración de investigación en IA y ML con X-Chem para acelerar el desarrollo de antivirales orales de amplio espectro. La colaboración se centra en el programa antiviral TNX-4200 de Tonix, que tiene como objetivo desarrollar inhibidores de la fosfatasa CD45 orales con actividad de amplio espectro contra varias familias virales.

Tonix ha recibido un contrato del Departamento de Defensa de los Estados Unidos, Defense Threat Reduction Agency (DTRA) por hasta 34 millones de dólares para avanzar en el programa TNX-4200, incluyendo una presentación de IND y un estudio clínico de Fase 1. Se espera que la colaboración con X-Chem optimice las propiedades fisicoquímicas, la farmacocinética y las características de seguridad de los candidatos a fármacos de Tonix.

Tonix planea aprovechar sus instalaciones de investigación, incluyendo un laboratorio BSL-3 y una instalación ABSL-3 en su centro de investigación y desarrollo en Frederick, Md., para apoyar el desarrollo de estos programas antivirales dirigidos al huésped de amplio espectro.

Tonix 제약 (Nasdaq: TNXP)은 X-Chem과 AI 및 ML 연구 협력을 발표하여 경구 광범위 항바이러스제 개발을 가속화하고 있습니다. 이 협력은 Tonix의 TNX-4200 항바이러스 프로그램에 초점을 맞추고 있으며, 다양한 바이러스 계열에 대한 광범위한 활동을 가진 경구 CD45 탈인산효소 억제제를 개발하는 것이 목표입니다.

Tonix는 미국 국방부 방어 위협 감소국(DTRA)에서 최대 3,400만 달러의 계약을 수여받아 TNX-4200 프로그램을 발전시키고 있으며, 여기에는 IND 제출 및 1상 임상 연구가 포함됩니다. X-Chem과의 협력은 Tonix의 약물 후보의 물리화학적 특성, 약동학 및 안전 특성을 최적화할 것으로 예상됩니다.

Tonix는 메릴랜드주 프레더릭에 있는 연구 개발 센터의 BSL-3 연구소 및 ABSL-3 시설을 포함한 연구 시설을 활용하여 이러한 숙주 지향 광범위 항바이러스 프로그램의 개발을 지원할 계획입니다.

Tonix Pharmaceuticals (Nasdaq : TNXP) a annoncé une collaboration de recherche en IA et ML avec X-Chem pour accélérer le développement d'antiviraux oraux à large spectre. La collaboration se concentre sur le programme antiviral TNX-4200 de Tonix, qui a pour objectif de développer des inhibiteurs de la phosphatase CD45 oraux avec une activité à large spectre contre diverses familles virales.

Tonix a reçu un contrat du Département de la Défense des États-Unis, Defense Threat Reduction Agency (DTRA) à hauteur de 34 millions de dollars pour faire avancer le programme TNX-4200, y compris une soumission IND et une étude clinique de phase 1. La collaboration avec X-Chem devrait optimiser les propriétés physico-chimiques, la pharmacocinétique et les caractéristiques de sécurité des candidats médicaments de Tonix.

Tonix prévoit d'exploiter ses installations de recherche, y compris un laboratoire BSL-3 et une installation ABSL-3 dans son centre de recherche et développement à Frederick, Md., pour soutenir le développement de ces programmes antiviraux à large spectre dirigés contre l'hôte.

Tonix Pharmaceuticals (Nasdaq: TNXP) hat eine Forschungspartnerschaft in KI und ML mit X-Chem bekannt gegeben, um die Entwicklung oraler Breitbandantiviren zu beschleunigen. Die Zusammenarbeit konzentriert sich auf Tonix' TNX-4200 Antivirenprogramm, das darauf abzielt, orale CD45-Phosphatase-Hemmer mit breiter Wirkung gegen verschiedene Virusfamilien zu entwickeln.

Tonix erhielt einen Vertrag von der US-Verteidigungsministerium Defense Threat Reduction Agency (DTRA) über bis zu 34 Millionen USD, um das TNX-4200-Programm voranzutreiben, einschließlich einer IND-Einreichung und einer Phase-1-Studie. Es wird erwartet, dass die Zusammenarbeit mit X-Chem die physikochemischen Eigenschaften, die Pharmakokinetik und die Sicherheitsmerkmale der Wirkstoffkandidaten von Tonix optimiert.

Tonix plant, seine Forschungseinrichtungen, einschließlich eines BSL-3-Labors und einer ABSL-3-Einrichtung in seinem Forschungs- und Entwicklungszentrum in Frederick, Md., zu nutzen, um die Entwicklung dieser wirtsgerichteten Breitbandantivirenprogramme zu unterstützen.

Positive
  • Collaboration with X-Chem to accelerate development of oral broad-spectrum antivirals using AI and ML technology
  • Awarded a contract with U.S. Department of Defense for up to $34 million to advance TNX-4200 program
  • Access to state-of-the-art research facilities, including BSL-3 and ABSL-3 labs
Negative
  • None.

Insights

This collaboration between Tonix Pharmaceuticals and X-Chem represents a significant step forward in the development of broad-spectrum antivirals. The use of AI and ML in drug discovery could potentially accelerate the process and improve the quality of drug candidates.

Key points to consider:

  • The $34 million contract with the U.S. Department of Defense adds credibility and funding to Tonix's TNX-4200 program
  • Focus on host-directed antivirals could lead to drugs effective against multiple viral families, addressing a critical need in biodefense and public health
  • The collaboration may enhance Tonix's competitive position in the antiviral market
  • Tonix's in-house BSL-3 and ABSL-3 facilities provide a strategic advantage for this type of research

While promising, investors should note that drug development is a long and risky process. The success of this collaboration and its impact on Tonix's financial performance remain to be seen. The market cap of $20.9 million suggests the company is still in early stages, making this a speculative investment.

The collaboration between Tonix and X-Chem exemplifies the growing trend of AI integration in drug discovery. This partnership has several promising aspects:

  • X-Chem's AI/ML technology could significantly reduce the time and cost associated with traditional drug discovery methods
  • The focus on optimizing physicochemical properties, pharmacokinetics and safety attributes through AI could lead to more efficient lead compound selection
  • Integration of laboratory data with in silico technology may result in more accurate predictions and better drug candidates

However, it's important to note that while AI can accelerate certain aspects of drug discovery, it doesn't guarantee success in clinical trials or regulatory approval. The real test will be in the translation of these AI-assisted discoveries into effective and safe therapeutics. Investors should monitor the progress of the TNX-4200 program, particularly the upcoming IND submission and Phase 1 clinical study, as these will be critical milestones in validating this AI-driven approach.

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures

Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families

Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral program TNX-4200

CHATHAM, N.J., Oct. 08, 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, today announced that it has entered into an AI and ML research collaboration with X-Chem, Inc. (X-Chem), a leader in small molecule drug discovery, to accelerate development of Tonix’s oral broad-spectrum antivirals.

Tonix’s TNX-4200 antiviral program focuses on the development of oral CD45 phosphatase inhibitors, with broad-spectrum activity against a range of viral families. As previously disclosed, Tonix entered into a contract with the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the development of Tonix’s TNX-4200 broad-spectrum oral antiviral program for medical countermeasures, including an Investigational New Drug (IND) submission and a first-in-human Phase 1 clinical study.

“We are excited to enter into this research collaboration with X-Chem, which we believe will expand our capabilities, and deepen our understanding of host-targeted small molecule therapeutics for a variety of targets,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “With the support of X-Chem’s drug discovery AI/ML technology, we expect to optimize the physicochemical properties, pharmacokinetics, and safety attributes of our drug candidates.”

"We are excited to partner with Tonix in their pursuit of such important programs in human health, at the intersection of laboratory and in silico technology. This collaboration highlights how integrative work continues to leverage the creation of target-specific high-quality data to drive AI drug discovery,” said Erin Davis, Ph.D., Chief Technology Officer of X-Chem.”

The DTRA contract awarded to Tonix is expected to help fund and accelerate the development of the Company’s lead oral host-directed TNX-4200 broad-spectrum antiviral program. The TNX-4200 program aims to reduce viral load and to 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 to optimize lead compounds for therapeutic intervention of biothreat agents.

For the oral broad-spectrum antiviral programs, including TNX-4200, Tonix is utilizing its state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center (RDC) 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.

About X-Chem, Inc.

X-Chem, Inc. is a leader in small molecule drug discovery services for pharmaceutical and biotech companies. As pioneers of DNA-encoded chemical library (DEL) technology and its integration with proprietary AI technology and computational sciences, X-Chem can accelerate all steps in the discovery process. The company leverages its unique AI/ML approach, market-leading DEL platform, and computationally-driven medicinal chemistry expertise to discover novel small molecule leads against challenging, high-value therapeutic targets. Integrated with X-Chem’s extensive chemistry and computational technologies, project teams can deliver clinical candidates with unmatched speed. X-Chem also provides libraries, reagents, and informatic tools to allow DEL operators to get the most of their DEL platform. X-Chem empowers its partners to effectively build drug pipelines from target to clinical candidate, enhanced with AI and extensive data packages.

Further information about X-Chem can be found at www.x-chemrx.com.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in October of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL was generally well tolerated in the Phase 3 program. 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. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract 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. The company’s Good Manufacturing Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture TNX-801 and the GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 and infectious disease. 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’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.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432


FAQ

What is the purpose of Tonix Pharmaceuticals' collaboration with X-Chem for TNXP stock?

The collaboration aims to accelerate the development of oral broad-spectrum antivirals using AI and ML technology, focusing on Tonix's TNX-4200 antiviral program which develops oral CD45 phosphatase inhibitors with broad-spectrum activity against various viral families.

How much funding did Tonix Pharmaceuticals (TNXP) receive from the U.S. Department of Defense for its antiviral program?

Tonix Pharmaceuticals was awarded a contract with the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA) for up to $34 million to advance the development of its TNX-4200 broad-spectrum oral antiviral program.

What is the TNX-4200 antiviral program developed by Tonix Pharmaceuticals (TNXP)?

The TNX-4200 program is Tonix's lead oral host-directed broad-spectrum antiviral program that aims to develop oral CD45 phosphatase inhibitors with broad-spectrum activity against various viral families. It aims to reduce viral load and allow the adaptive immune system to mount a protective response.

Where are Tonix Pharmaceuticals' (TNXP) research facilities located for the antiviral program?

Tonix Pharmaceuticals has state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility, located at its research and development center in Frederick, Maryland, within the 'I-270 biotech corridor'.

Tonix Pharmaceuticals Holding Corp.

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