Tonix Pharmaceuticals Publishes Technology Advancing Human Antibody Development Against SARS-CoV-2 and Other Pathogens

Tonix Pharmaceuticals Holding Corp., a fully integrated biopharmaceutical company, has made significant strides in the realm of infectious disease research through the development of a high-throughput, high-content imaging-based assay. This innovative screening method is designed to identify neutralizing antibodies in convalescent sera, targeting SARS-CoV-2 variants and potentially other pathogens. The promising research findings were published in the peer-reviewed journal Microorganisms in an article titled “High-Throughput Screening Assay for Convalescent Sera in COVID-19: Efficacy, Donor Selection, and Variant Neutralization,” authored by Kota et al.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, emphasized the importance of this technology. According to Dr. Lederman, the imaging system can pinpoint antibodies that neutralize SARS-CoV-2 and its variants, potentially offering a valuable tool for combating other infectious agents. This capability underscores Tonix's commitment to advancing their therapeutic discovery and development technologies, especially in light of rising COVID-19 infection rates and concerns over the efficacy of existing mRNA vaccines.

Beyond this novel assay, Tonix is actively engaged in various research and development initiatives aimed at preventing and treating viral diseases. Among these projects is TNX-801, a live-virus vaccine derived from horsepox, intended to protect against mpox (monkeypox) and smallpox. This vaccine serves as the foundation for their Recombinant Pox Virus (RPV) platform technology, which is being adapted to create vaccines for other viruses, including COVID-19. TNX-1800, one such adaptation, has been selected by the National Institute of Allergy and Infectious Diseases (NIAID) for inclusion in clinical trials under Project NextGen, a program designed to accelerate the development of next-generation COVID-19 vaccines.

Tonix is also developing TNX-4200, an orally available CD45 antagonist with broad-spectrum antiviral efficacy. This program has garnered substantial support from the U.S. Department of Defense's Defense Threat Reduction Agency (DTRA), which has awarded Tonix a contract worth up to $34 million. The funding will be used to establish the drug's physicochemical properties, pharmacokinetics, and safety attributes, ultimately supporting an Investigational New Drug (IND) submission and a first-in-human Phase 1 clinical study.

Tonix's research and development center in Frederick, Maryland, plays a crucial role in these endeavors. Equipped with state-of-the-art laboratories, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility, the center is strategically located within Maryland's I-270 biotech corridor, a hub of U.S. biodefense research.

Additionally, Tonix's product development pipeline extends beyond infectious diseases. The company's CNS portfolio includes TNX-102 SL, a product candidate for fibromyalgia that has completed Phase 3 trials and received Fast Track designation from the FDA. Tonix also focuses on treating acute stress reaction and other central nervous system disorders. Their immunology development portfolio targets organ transplant rejection, autoimmunity, and cancer, with TNX-1500 being a key candidate in this area.

Tonix's commercial subsidiary, Tonix Medicines, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for acute migraine treatment in adults. While all product candidates are still investigational and have not yet received regulatory approval, Tonix remains dedicated to advancing their development to alleviate human suffering and prevent disease.

In summary, Tonix Pharmaceuticals is at the forefront of infectious disease research with their innovative screening assays and diverse vaccine development programs. Their efforts, supported by substantial government contracts and cutting-edge research facilities, highlight their commitment to advancing public health and addressing unmet medical needs.