TNXP Tonix Pharmaceuticals Holding Corp.

0.6
-0.01  -2%
Previous Close 0.61
Open 0.6
52 Week Low 0.3902
52 Week High 13
Market Cap $32,639,099
Shares 54,534,835
Float 54,507,489
Enterprise Value $2,778,633
Volume 4,854,142
Av. Daily Volume 8,963,414
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Upcoming Catalysts

Drug Stage Catalyst Date
TNX-102 SL (Tonmya)
Fibromyalgia
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data has been delayed - June 19, 2020. No updated timeline.
TNX-601
PK trial
Phase 1
Phase 1
Efficacy trial to commence in 2020.
TNX-102 SL (Tonmya)
Post-traumatic stress disorder (PTSD)
Phase 3
Phase 3
Phase 3 trial halted due to insufficient efficacy - July 27, 2018.
TNX-1300 (RBP-8000)
Cocaine intoxication
Phase 2
Phase 2
In-licensed - noted May 23, 2019.
TNX-201
Episodic tension-type headache
Phase 2
Phase 2
Phase 2 data released February 2016 did not meet primary endpoint

Latest News

  1. Topline Results Expected Fourth Quarter 2020 Due to Faster than Previously Projected Enrollment

    Completion of Trial Enrollment Anticipated Early Third Quarter 2020

    Interim Results from the First 50 Percent of Participants Continue to be Expected in September 2020

    NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that due to faster-than-expected enrollment, the Company anticipates topline Phase 3 RELIEF results in the fourth quarter of 2020, rather than the first quarter of 2021 as previously guided. RELIEF is a potential pivotal study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid…

    Topline Results Expected Fourth Quarter 2020 Due to Faster than Previously Projected Enrollment

    Completion of Trial Enrollment Anticipated Early Third Quarter 2020

    Interim Results from the First 50 Percent of Participants Continue to be Expected in September 2020

    NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that due to faster-than-expected enrollment, the Company anticipates topline Phase 3 RELIEF results in the fourth quarter of 2020, rather than the first quarter of 2021 as previously guided. RELIEF is a potential pivotal study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia. An optional interim analysis of the first 50 percent of randomized participants that are evaluable for efficacy will be conducted, with results expected in September 2020.

    "We are pleased to announce that we will achieve our recruitment goal ahead of schedule. We have worked diligently to ensure the safe and timely recruitment of the RELIEF trial before and during the COVID-19 pandemic," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "Fibromyalgia affects millions of adults globally and we believe that TNX-102 SL has the potential to offer a new, non-addictive treatment option for patients seeking relief from this disorder."

    About the Phase 3 RELIEF Study

    The RELIEF study is a double-blind, randomized, placebo-controlled adaptive design trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg in fibromyalgia. The trial is expected to enroll approximately 470 participants across approximately 40 U.S. sites. For the first two weeks of treatment, there is a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. After the first two weeks, all participants have the dose increased to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint is daily diary pain severity score change from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.

    Additional details about the RELIEF study are available at www.theRELIEFstudy.com or clinicaltrials.gov (NCT04172831).

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of 2020. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the fourth quarter of 2020.  TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) stage. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600 (triple reuptake inhibitor) , a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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 partices; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505 

    Primary Logo

    View Full Article Hide Full Article
  2. TNX-1700 (Stabilized Recombinant Trefoil Factor 2) (rTFF2-CTP) Enhances Anti-tumor Activity of PD-1
    blockade in Mouse Models of Colorectal Cancer

    NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of TNX-1700 are being presented in a poster at the American Association of Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held online June 22-24, 2020. The poster can be found on the Scientific Presentations page of Tonix's website.

    A poster, titled "Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal…

    TNX-1700 (Stabilized Recombinant Trefoil Factor 2) (rTFF2-CTP) Enhances Anti-tumor Activity of PD-1

    blockade in Mouse Models of Colorectal Cancer

    NEW YORK, June 22, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of TNX-1700 are being presented in a poster at the American Association of Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held online June 22-24, 2020. The poster can be found on the Scientific Presentations page of Tonix's website.

    A poster, titled "Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer," includes data from a preclinical study which investigated the role of PD-L1 in colorectal tumorigenesis and evaluated the utility of targeting myeloid-derived suppressor cells (MDSCs) in combination with PD-1 blockade in mouse models of colorectal cancer. The data show that anti-PD-1 monotherapy was unable to evoke anti-tumor immunity in this model of colorectal cancer, but TFF2-CTP augmented the efficacy of anti-PD-1 therapy. Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice. Tonix is developing TNX-1700 (rTFF2-CTP) for the treatment of gastric, colon and pancreatic cancers under a license from Columbia University. The studies conducted were performed by scientists at Columbia University under the direction of Timothy Wang, M.D., Chief of the Division of Digestive and Liver Diseases at Columbia University Irving Medical Center.

    "Colorectal cancer is notoriously unresponsive to anti-PD1 treatment, which has revolutionized the treatment of other cancers and is known as immuno-oncology. Much research has been focused on trying to turn anti-PD1 unresponsive tumors into anti-PD1 responsive tumors," said Seth Lederman, M.D., Chief Executive Officer of Tonix.

    "The data from this preclinical trial demonstrate that TNX-1700 treatment converted anti-PD1 non-responsive colorectal tumors into anti-PD1 responsive tumors," said Dr. Wang. "In addition, it was shown that TNX-1700 inhibits the MDSCs which contribute to the toxic element of the tumor microenvironment. Therefore, whether a tumor is anti-PD1 non-responsive or responsive may relate to the tumor microenvironment rather than the tumor itself."

    "We believe these data warrant additional work to learn if TNX-1700 modifies the toxic tumor microenvironment in humans and will make colorectal cancer responsive to anti-PD-1 therapy," added Dr. Lederman.

    About TNX-1700

    TNX-1700 is a stabilized recombinant version of Trefoil Factor 2 (TFF2).  TFF2 is a small secreted protein, encoded by the TFF2 gene in humans that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms.

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based. Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the first quarter of 2021. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix's programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600 (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners

    rsllc.com

    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

    View Full Article Hide Full Article
  3. Plan to Produce Blueprint of How the Human Immune System Responds to Infection Caused by SAR-CoV-2, the Virus that Causes COVID-19

    Results Expected to Support Tonix's Anticipated Regulatory Filings for TNX-1800, a Live Replicating Virus Vaccine Designed to Elicit T Cell Immunity in Addition to Antibodies

    NEW YORK, June 18, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration…

    Plan to Produce Blueprint of How the Human Immune System Responds to Infection Caused by SAR-CoV-2, the Virus that Causes COVID-19

    Results Expected to Support Tonix's Anticipated Regulatory Filings for TNX-1800, a Live Replicating Virus Vaccine Designed to Elicit T Cell Immunity in Addition to Antibodies

    NEW YORK, June 18, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19.  The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix's TNX-1800, which is a live replicating virus vaccine designed to protect against COVID-19.  The data will support the interpretation of animal trial results with TNX-1800, which are expected in the fourth quarter of 2020 and subsequent human trials.

    "More than 200 years of vaccine experience, beginning with Dr. Edward Jenner's landmark discoveries with horsepox and cowpox vaccines, have shown that T cell eliciting vaccines are particularly effective against viruses," said Seth Lederman, M.D., President and CEO of Tonix.  "We believe that protective vaccines against the SARS-CoV-2 virus will be similar in that regard.  The data we plan to collect from recovered and asymptomatic COVID-19 volunteers will inform vaccine development on how to safely provide to vaccine recipients the same immune responses that others got from recovering from actual CoV-2 infection.  If approved by the U.S. Food and Drug Administration (FDA) for use in healthy, non-pregnant adults without moderate or severe eczema, TNX-1800 would feature single-dose immunity without the use of adjuvants, ease of manufacturing on readily available systems, and glass-sparing distribution since we believe 100 doses of TNX-1800 could be packaged in a single vial. Our goal with TNX-1800 is to develop a vaccine that is well tolerated, produces strong, long-lasting immunity, and can be rapidly and broadly deployed."

    Dr. Lederman, a former tenured professor at Columbia Medical School, who has made original contributions to immunology and virology, continued, "Tonix's TNX-1800 is based on a virus that we believe is closely related to Dr. Jenner's first vaccine.  Vaccines that descended from Dr. Jenner's vaccine were used to eradicate smallpox globally, the only virus ever successfully eradicated. Smallpox was spread through the respiratory route, but it was eradicated with a vaccine administered in the arm.  Tonix's lead COVID-19 vaccine candidate, TNX-1800, is designed to elicit a predominant T cell response, with some antibody response, while three other early candidates in the Company's vaccine portfolio are designed to elicit almost pure T cell responses."  Dr. Lederman added, "The features of a protective immune response to SARS-CoV-2 remain unknown.  But since SARS-CoV-2 is a virus, we believe that T cell responses, in particular T Helper Type 1, or TH1 responses, will play an important if not dominant role in protecting against serious illness from COVID-19. These studies will provide us with a blueprint for interpreting the results of planned animal and human studies with TNX-1800."

    Raj Kalkeri, Ph.D., from Southern Research and technical lead for this study, said, "This is groundbreaking research with regards to COVID-19.  As scientists, we know that the most successful vaccines mimic and potentiate how the immune system responds to an invader. This additional work we are doing with Tonix will add focus to that objective. We are looking forward to a timely completion of this study, utilizing readouts from a variety of assays that can provide information about TH1 or other types of immunity."

    An expert team of scientists from Southern Research, including Raj Kalkeri, Ph.D., Elizabeth Wonderlich, Ph.D., John Farmer, Ph.D. and Fusataka Koide, Director of Virology, is working on this collaboration.

    About TNX-1800, TNX-1810, TNX-1820, TNX-1830 and TNX-801*

    TNX-1800 is a live modified horsepox virus vaccine for percutaneous administration that is designed to express the Spike protein of the SARS-CoV-2 virus that causes COVID-19 and to elicit a predominant T cell response.  TNX-1810, TNX-1820 and TNX-1830 are modified horsepox viruses that are designed to express different SARS-CoV-2 proteins than Spike and to elicit almost pure T cell responses.  TNX-801 is a live horsepox virus vaccine 1.  Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor.  Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice1.  TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge2.  Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production.

    1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453

    2Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference  - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf )

    *TNX-801 and TNX-1800 are in the pre-IND stage and have not been approved for any indication

    About Southern Research

    Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across four divisions: Drug Discovery, Drug Development, Engineering, and Energy & Environment. SR supports the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Cancer Institute, National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA, major aerospace firms, utility companies, and other private and government organizations. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR is developing 18 drugs to combat various forms of cancer, ALS, Alzheimer's, diabetes, kidney disease, Parkinson's and tuberculosis, among others.  SR has developed 20 other drugs, including seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Wilsonville, Alabama; Frederick, Maryland; Cartersville, Georgia; and Houston, Texas.

    Further information about SR can be found at https://southernresearch.org

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the first quarter of 2021.  TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600 (triple reuptake inhibitor) , a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

    View Full Article Hide Full Article
  4. NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of TNX-1700 (rTFF2) will be presented in a poster at the American Association of Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held June 22-24, 2020.

    Details of poster presentation at AACR 2020:

    Title:  Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer

    Authors: Woosook Kim, Na Fu, Phaneendra Duddempudi, Zinaida Dubeykovskaya, Steven Almo, Chandan Guha, Seth Lederman, and Timothy Wang

    Poster Session: Combination Immunotherapies…

    NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of TNX-1700 (rTFF2) will be presented in a poster at the American Association of Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held June 22-24, 2020.

    Details of poster presentation at AACR 2020:

    Title:  Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer

    Authors: Woosook Kim, Na Fu, Phaneendra Duddempudi, Zinaida Dubeykovskaya, Steven Almo, Chandan Guha, Seth Lederman, and Timothy Wang

    Poster Session: Combination Immunotherapies 4

    Date and Time:  Monday, June 22, 2020, 9:00 a.m. - 6:00 p.m. ET

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix's lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the first quarter of 2021.  TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix's preclinical pipeline includes TNX-1600 (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

    *TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners



    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

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  5. NEW YORK, June 11, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix will acquire the migraine and pain treatment technologies of Trigemina, Inc., and will assume the license for some of the technologies from Stanford University. The lead asset, TNX-1900 (formerly TI-001, oxytocin solution for intranasal delivery), is a proprietary, patented enhanced formulation of nasal oxytocin, with demonstrated activity in several non-clinical studies in pain including migraine prophylaxis and neuropsychiatric models and with safety data from non-U.S. studies.

    "Tonix is excited to develop intranasal oxytocin as a non-addictive…

    NEW YORK, June 11, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix will acquire the migraine and pain treatment technologies of Trigemina, Inc., and will assume the license for some of the technologies from Stanford University. The lead asset, TNX-1900 (formerly TI-001, oxytocin solution for intranasal delivery), is a proprietary, patented enhanced formulation of nasal oxytocin, with demonstrated activity in several non-clinical studies in pain including migraine prophylaxis and neuropsychiatric models and with safety data from non-U.S. studies.

    "Tonix is excited to develop intranasal oxytocin as a non-addictive treatment for migraine and craniofacial pain," said Seth Lederman, M.D., President and Chief Executive Officer. "The preclinical data that we have seen to date are promising and show that oxytocin, a natural hormone, is capable of blocking the release of the neurotransmitter calcitonin gene-related peptide (CGRP) in the brain coverings and trigeminal ganglia, thus potentially preventing a key step in the causation of migraine.  It has been shown that intra-nasally delivered oxytocin selectively reaches the trigeminal ganglia with low systemic absorption.  Overall, we believe that TNX-1900 has the potential to be a safe, natural, non-addicting, non-constipating and easy to administer alternative to opioids to treat migraine and craniofacial pain."

    "We are excited that Tonix will continue to advance the progress Trigemina has made with these assets and look forward to potentially facilitating their development," said Shashidar H. Kori, M.D., Chief Medical Officer, Trigemina Inc. "This agreement further validates our previous development work and its continued potential."

    About TNX-1900

    TNX-1900, Tonix's patented intranasal oxytocin formula, is currently being studied as a candidate for prophylaxis of chronic migraine.  TNX-1900 is in the pre-Investigational New Drug (IND) stage and has not been approved for any indication.  TNX-1900 is based on a proprietary formulation of oxytocin and is being developed first for the treatment of migraine. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is approved by the U.S. Food and Drug Administration (FDA) as Pitocin®, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor.  An intranasal form of oxytocin was marketed by Novartis to assist in nursing as Syntocinon®, but the product was withdrawn and the New Drug Application (NDA) has been discontinued.  In clinical and preliminary research, it has been observed that low oxytocin levels in the body can lead to increase in headache frequency, and that increased oxytocin levels can relieve headaches.  Certain other chronic pain conditions are also associated with decreased oxytocin levels.  Oxytocin when delivered via the nasal route, results in enhanced binding of oxytocin to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals.  Intranasal oxytocin has been well tolerated in several clinical trials and established in adults and children.  Intranasal oxytocin has been shown in animals that it can also block CGRP release, a pathway known to be critical to the pathogenesis of migraine attacks.  In preclinical research, nasally applied TNX-1900 selectively inhibits the activity of trigeminal pain-sensing nerve cells and blocks the release of CGRP.  TNX-1900 is believed to interrupt pain signals at the trigeminal ganglia by suppressing electrical impulses, a potentially different activity than drugs that just block CGRP.  Migraine attacks are caused, in part, by the release of CGRP from pain-sensing nerve cells that are part of the trigeminal system.  The CGRP binds to receptors on other nerve cells and starts a cascade of events that eventually results in a severe headache.  This, in turn, reduces various kinds of trigeminal nerve associated pain and prevents CGRP from acting at receptors in the central nervous system that are involved in migraine.  Targeted delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects which could potentially occur with systemic CGRP antagonists. For example, CGRP has roles in dilating blood vessels in response to ischemia, including in the heart. We believe targeted delivery of oxytocin could translate into selective blockade of CGRP release in the trigeminal ganglion and not throughout the body, which could be a potential safety advantage over systemic CGRP inhibition.  In addition, daily dosing is more quickly reversible, in contrast to monthly or quarterly dosing, giving physicians and their patients greater control. 

    Pitocin® is a trademark of Par Pharmaceutical, Inc.

    Syntocinon® is a trademark of BGP Products Operations GmbH

    About Tonix Pharmaceuticals Holding Corp.

    Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing drugs and biologics to treat and prevent human disease and alleviate suffering. Tonix's current portfolio includes biologics to prevent infectious diseases, and small molecules and biologics to treat pain, psychiatric and addiction conditions. In 2020, Tonix announced a program to develop a potential vaccine, TNX-1800* (live modified horsepox virus vaccine for percutaneous administration) to protect against the novel coronavirus disease emerging in 2019, or COVID-19. TNX-1800 is based on Tonix's proprietary horsepox vaccine platform and is molecularly designed to express the Spike protein of the SARS-CoV-2 virus that causes COVID-19.  TNX-801* (live horsepox virus vaccine for percutaneous administration) is in development to protect against smallpox and monkeypox. Tonix's most advanced drug development programs are focused on delivering safe and effective long-term treatments for fibromyalgia, or FM, and posttraumatic stress disorder, or PTSD. Tonix's most advanced product candidate, TNX-102 SL**, is in Phase 3 development as a bedtime treatment for FM and PTSD. The Company is enrolling participants in the Phase 3 RELIEF trial in FM and expects results from an unblinded interim analysis in September of 2020 and topline data in the first quarter of 2021.  The Phase 3 RECOVERY trial (P302) for TNX-102 SL (trade name Tonmya***) in PTSD has stopped enrollment based on the Independent Data Monitoring Committee's recommendation to stop the study for futility following an interim analysis of the first 50% of enrolled participants. Topline data for RECOVERY are expected in the second quarter of 2020. TNX-102 SL is also in development for agitation in Alzheimer's disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy Designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is in development as a daytime treatment for depression as well as PTSD and corticosteroid-induced cognitive dysfunction. The first efficacy study will be in the treatment of major depressive disorder. TNX-1600 (a triple reuptake inhibitor) is a pre-clinical new molecular entity (NCE) being developed as a treatment for PTSD. Tonix's preclinical pipeline includes TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers. TNX-1200* (live vaccinia virus vaccine for percutaneous administration) is in development to protect against smallpox and monkeypox. Finally, TNX-701 (undisclosed small molecule) to prevent radiation effects is being advanced as a medical countermeasure to improve biodefense.

    *TNX-1800, TNX-801, TNX-1200 and TNX-1300 are investigational new biologics and have not been approved for any indication.

    **TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

    ***Tonmya has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL for the treatment of PTSD.

    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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; 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, 2019, as filed with the Securities and Exchange Commission (the "SEC") on March 24, 2020, 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.

    Contacts

    Jessica Morris (corporate)

    Tonix Pharmaceuticals



    (212) 688-9421

    Travis Kruse (media)

    Russo Partners

     

    (212) 845-4272

    Peter Vozzo (investors)

    Westwicke



    (443) 213-0505

    Primary Logo

    View Full Article Hide Full Article
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