Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals has announced an exclusive collaboration with Kansas State University to develop a novel zinc nanoparticle (ZNP) mRNA COVID-19 vaccine, TNX-3700, which aims to enhance temperature stability during storage and transport. This new technology could eliminate the need for ultra-cold chain logistics traditionally required by lipid-nanoparticle (LNP) based vaccines. By improving deployment capabilities, TNX-3700 may facilitate global vaccination efforts against SARS-CoV-2. The collaboration aligns with pandemic preparedness goals.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its addition to the Nasdaq Biotechnology Index, effective December 20, 2021. The Index tracks biotechnology and pharmaceutical securities listed on Nasdaq. Tonix focuses on developing therapeutics for various conditions, including COVID-19 related products and CNS disorders. Key candidates in their portfolio include TNX-102 SL, TNX-1300, and TNX-1800. However, the company faces risks such as regulatory delays and the need for further financing, which could impact development timelines.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has received FDA clearance for its Investigational New Drug (IND) application to initiate a first-in-human clinical study for TNX-2100, a skin test designed to measure T cell immunity to SARS-CoV-2. The study is expected to commence in Q1 2022. Dr. Seth Lederman emphasized the test's potential to offer personalized vaccine booster recommendations and reduce healthcare costs. Tonix is also developing TNX-1800, a live virus vaccine for COVID-19, aiming to begin Phase 1 trials in the second half of 2022.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced a research collaboration with Columbia University to develop TNX-1700, a recombinant trefoil factor family 2 (rTFF2) therapeutic for gastric and colorectal cancers. This partnership aims to enhance anti-PD1 checkpoint inhibitor therapy efficacy. The studies, led by Timothy Wang, M.D., will explore rTFF2's role in detoxifying the tumor microenvironment to activate CD8+ T cells and limit cancer cell immune evasion. Recent U.S. patent claims strengthen Tonix's position in this innovative treatment approach.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA clearance for a Phase 2 study of TNX-1900, an intranasal oxytocin formulation aimed at preventing chronic migraines. With approximately four million chronic migraine sufferers in the U.S., the drug targets oxytocin receptors to inhibit pain signals effectively. The company plans to start enrollment in the second half of 2022 and is also developing TNX-1900 for craniofacial pain and insulin resistance. TNX-2900, related to TNX-1900, is in development for Prader-Willi syndrome.

Tonix Pharmaceuticals (Nasdaq: TNXP) has published a study in JCI Insight revealing that TNX-3500 (sangivamycin) exhibits strong antiviral activity against multiple SARS-CoV-2 variants in vitro, surpassing remdesivir's efficacy. The combined use of TNX-3500 and remdesivir shows an additive effect. The company emphasizes TNX-3500's potential as a COVID-19 therapeutic following its favorable safety profile in prior studies. Tonix plans further animal studies and aims to submit an Investigational New Drug application for clinical trials.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the U.S. Patent and Trademark Office granted U.S. Patent No. 11,167,010 on November 9, 2021. This patent, which covers the TFF2-CTP polypeptide, is expected to provide exclusivity until April 2, 2033. Tonix is developing TNX-1700, a modified form of TFF2, to treat gastric and pancreatic cancers. Data from preclinical studies indicate that TFF2-CTP enhances the effectiveness of anti-PD-1 therapies in colorectal cancer models. TNX-1700 is currently an investigational new biologic and not yet FDA-approved.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Seth Lederman, President and CEO, will present at the Q4 Investor Summit on November 17, 2021, at 4:50 p.m. ET. Investors can arrange virtual meetings with management through the conference coordinator. A webcast of the presentation will be available on the Tonix website, with a replay accessible for 90 days post-event.

Tonix focuses on developing therapeutics for various diseases, including candidates for COVID-19 and fibromyalgia. Their lead vaccine candidate, TNX-1800, is expected to start human trials in late 2022.

Tonix Pharmaceuticals announced results from its Phase 1 study of TNX-601 CR, a novel treatment for major depressive disorder (MDD). The study showed that TNX-601 CR demonstrated appropriate pharmacokinetics for once-daily dosing, enhancing treatment adherence compared to immediate release tianeptine. A Phase 2 trial is expected to begin in the first half of 2022, involving approximately 260 participants. The trial aims to evaluate TNX-601 CR's efficacy and safety over six weeks. This formulation is notable as no tianeptine product has been approved by the FDA in the U.S.