TNX-801 is up to 100,000-fold less virulent than live smallpox vaccine strains and a single dose provides robust immunogenicity and protection against mpox and rabbitpox (more than one year) in animals Subcutaneous administration of TNX-801 yielded equivalent protection to the traditional percutaneous administration CHATHAM, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of develo ...

Core Insights - The combination treatment of mTNX-1700 with anti-PD1 antibody has shown increased survival and decreased metastases in animal models of gastric cancer compared to anti-PD1 treatment alone [1][3] - mTNX-1700 activates cancer-killing CD8+ T cells and limits neutrophil-mediated immune evasion, indicating its potential in overcoming resistance to anti-PD-1 immunotherapy [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, focusing on immunology and oncology [1][7] - The company is developing TNX-1700, a fusion protein for the treatment of gastric and colorectal cancers, under a license from Columbia University [4][5] Research Findings - The study published in Cancer Cell demonstrates that mTNX-1700 in combination with anti-PD-1 therapy shrank primary tumors, reduced liver and lung metastases, and increased survival in mouse models [2][3] - The research highlights the role of Trefoil Factor 2 (TFF2) in reducing immunosuppressive neutrophils and enhancing anti-tumoral CD8+ T cell responses [3][4] Future Development - Tonix Pharmaceuticals aims to further develop TNX-1700 to address the challenges of anti-PD-1 resistant cancers, with ongoing studies to identify potential clinical biomarkers [2][3] - The collaboration with Columbia University is expected to enhance understanding of TFF2's role in the tumor microenvironment and its impact on immunotherapy resistance [3][4]

CHATHAM, N.J., June 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biotechnology company, today announced that it will be added to the broad-market Russell 3000® Index, with automatic inclusion in the small-cap Russell 2000® Index, after the open of U.S. equity markets today, June 30, 2025, as part of the 2025 Russell indexes reconstitution. The annual reconstitution of the Russell US indexes captures the 4,000 largest US stocks as ...

Investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense Topline results from the trial are expected in the second half of 2026 CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with market ...

FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund o ...

CHATHAM, N.J., April 16, 2025 (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 the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company's presentation will be available under the Scientific P ...

Core Viewpoint - The collaboration between Tonix Pharmaceuticals and Makana Therapeutics aims to utilize Tonix's TNX-1500 monoclonal antibody in conjunction with Makana's genetically engineered pig organs to enhance organ compatibility and reduce rejection in xenotransplantation [1][2]. Group 1: Collaboration Details - Tonix and Makana have established a research agreement to study TNX-1500 in combination with Makana's human-compatible organs for organ failure treatment [1]. - The collaboration will support preclinical studies for kidney, heart, and islet cell transplant programs, aiming for regulatory filings for potential human use [1][2]. - The goal is to submit an investigational new drug application (IND) to the FDA for compassionate use in patients undergoing xenotransplantation [1]. Group 2: Product and Technology Insights - TNX-1500 is an investigational humanized monoclonal antibody targeting CD40L, which plays a crucial role in immune system activation and transplant immunomodulation [2][8]. - Makana's genetically engineered pigs, particularly the SLA DR knockout pig, have shown improved compatibility and potential for producing viable organs for transplantation [2][3][4]. - The collaboration aims to leverage the best-in-class pharmacokinetics and pharmacodynamics of TNX-1500, which has demonstrated effectiveness in preventing rejection in animal studies [2][7]. Group 3: Industry Context - The field of xenotransplantation faces challenges in organ compatibility and rejection, making this collaboration significant for advancing clinical applications [2][5]. - Makana's focus on antigen discovery and deletion, rather than relying on transgenic modifications, positions it favorably for future commercialization of xenotransplantation products [6][5]. - The partnership is expected to streamline the development of safer and more effective transplantation solutions, addressing the critical shortage of available human organs [2][4].