Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
Tonix Pharmaceuticals presented data on TNX-102 SL for fibromyalgia at the PDDS 2024 conference. The presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, a sublingual cyclobenzaprine HCl tablet. Key points include:
1. Patents based on TNX-102 SL's eutectic composition are expected to provide market exclusivity until at least 2034.
2. FDA New Drug Application (NDA) submission is on track for October 2024, with Fast Track designation granted.
3. The Phase 3 RESILIENT study demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and all six key secondary endpoints.
4. TNX-102 SL's formulation allows for efficient transmucosal absorption and targeting of disturbed sleep.
5. In vitro tests have been developed to support manufacturing processes and product uniformity.
Tonix Pharmaceuticals (Nasdaq: TNXP) has been issued U.S. Patent No. 12,090,139 by the United States Patent and Trademark Office for its Tosymra® (sumatriptan nasal spray) 10mg, indicated for the acute treatment of migraine in adults. The patent, titled 'Formulations Comprising Triptan Compounds', covers the pharmaceutical composition, method of treating migraine via intranasal administration, and intranasal delivery system for Tosymra®. Set to expire in 2030, this patent strengthens Tosymra®'s market position as a differentiated drug with a unique administration method. CEO Seth Lederman emphasized that this new patent enhances Tosymra®'s intellectual property protection and solidifies its market presence.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is developing TNX-801, a promising single-dose mpox vaccine candidate that aligns with the World Health Organization's (WHO) preferred target product profile. TNX-801 shows potential advantages over current FDA-approved vaccines Jynneos and ACAM2000, including better tolerability, single-dose protection, and suitability for immunocompromised individuals. The vaccine has demonstrated efficacy against the new, more lethal Clade I mpox strain in preclinical trials. TNX-801's lyophilized version can be stable at ambient temperatures, making it more accessible in regions with cold-chain infrastructure. Tonix has partnered with Bilthoven Biologics to scale up production, potentially enabling global distribution to address the urgent need for a safer, more effective mpox vaccine.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that its single-dose mpox vaccine candidate TNX-801 aligns with the World Health Organization's (WHO) newly issued preferred target product profile (TPP) for mpox vaccines. The WHO released its TPP criteria at the Mpox Research and Innovation Scientific Conference held August 29-30, 2024. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature.
TNX-801 has shown single dose protection against a lethal challenge of Clade I monkeypox virus in animal studies. It is designed for percutaneous administration using a bifurcated needle and is expected to have stability at ambient temperature, eliminating the need for ultra-cold storage. The vaccine may also be suitable for use in immunocompromised individuals.
Tonix recently announced a collaboration with Bilthoven Biologics to develop GMP manufacturing processes for its mpox vaccine. The WHO's declaration of mpox as a Public Health Emergency of International Concern (PHEIC) underscores the urgent need for new vaccines to control the outbreak.
Tonix Pharmaceuticals (Nasdaq: TNXP) has appointed Thomas Englese as Executive Vice President of Commercial Operations. Englese brings over 20 years of biopharmaceutical industry experience, specializing in commercial operations, sales, and marketing. This appointment comes as Tonix prepares to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia in October 2024.
Englese's expertise includes launching and managing major brands through all stages of commercialization. His previous roles include Chief Commercial Officer at Tris Pharmaceuticals and Aziyo Biologics, and Senior Vice President at Mallinckrodt PLC. Tonix CEO Seth Lederman expressed confidence in Englese's ability to advance the fibromyalgia program and build out the company's commercial capabilities.
Tonix Pharmaceuticals (TNXP) presented data on TNX-801, a potential mpox vaccine, at the University of Alberta. TNX-801, based on synthetic horsepox, demonstrated efficacy in protecting animals from lethal challenge with clade I monkeypox. New data showed improved tolerability in immunocompromised animals and no evidence of spreading to blood or tissues even at high doses. TNX-801 offers advantages over existing vaccines, including single-dose protection, percutaneous administration, and potential for long-lived immunity. The vaccine has been selected by NIH's Project NextGen for clinical testing. Tonix is collaborating with Bilthoven Biologics to develop GMP manufacturing processes for TNX-801. The company also highlighted the potential of TNX-801 as a viral vector platform for other infectious diseases.
Tonix Pharmaceuticals (Nasdaq: TNXP) has launched a national awareness campaign at PAINWeek about the impact of gastroparesis on oral migraine medication absorption. The campaign, titled 'Does Your Migraine Pill Work Every Time?', aims to educate patients and healthcare providers about the benefits of non-oral migraine treatments like nasal sprays and injectables.
Gastroparesis, a condition that slows stomach emptying, can delay or block the absorption of oral medications, leading to inconsistent migraine relief. Non-oral treatments bypass the digestive system, potentially offering faster relief in as little as 10 minutes. Tonix is launching a disease education website, gpmigraine.com, and supporting a webinar on September 19, 2024, to further educate patients about gastroparesis and migraine management options.
Tonix Pharmaceuticals (TNXP) presented data on TNX-102 SL for acute stress reaction (ASR) and PTSD prevention at the 2024 Military Health System Research Symposium. An investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce ASR severity and prevent PTSD is expected to begin in Q3 2024. The OASIS trial will enroll about 180 trauma survivors at emergency departments, randomizing them to receive TNX-102 SL or placebo for two weeks after motor vehicle collisions.
TNX-102 SL showed effects on sleep and PTSD symptoms in previous military-related PTSD trials. The company believes early intervention with TNX-102 SL could reduce ASR symptoms and prevent PTSD development. Tonix also presented data on an automated high-throughput assay for screening wound healing therapeutics.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented data on TNX-102 SL, a potential non-opioid analgesic for fibromyalgia, at the 2024 Military Health System Research Symposium. The Phase 3 RESILIENT study showed statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. Post hoc analyses revealed strong correlations between improvements in pain and sleep quality, supporting the concept of targeting sleep to achieve syndromal improvement in fibromyalgia.
TNX-102 SL was well-tolerated with no new safety signals. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with an FDA decision expected in 2025. The company believes TNX-102 SL could be the first new treatment option for fibromyalgia in 15 years.
Tonix Pharmaceuticals (TNXP) and Bilthoven Biologicals (BBio) have announced a collaboration to advance TNX-801, Tonix's mpox vaccine candidate. This partnership comes as the World Health Organization (WHO) declared the spread of mpox in multiple African countries a public health emergency for the second time in two years. TNX-801 is a live replicating, attenuated virus vaccine based on horsepox, currently in preclinical development to prevent mpox and smallpox.
Key points:
- TNX-801 has shown promising results in animal models, protecting non-human primates against lethal Clade 1 monkeypox virus challenge
- The vaccine is designed to be administered as a single dose, potentially improving acceptance and eliminating partial vaccination issues
- BBio, part of the Cyrus Poonawalla Group, will develop manufacturing processes for potential GMP production
- The collaboration aims to address the global need for an affordable, safe, and effective mpox vaccine