Top-line results are expected in the third quarter of 2024.Planning phase 2 trial to prevent kidney transplant rejection
Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation, including autoimmune diseases: potential product pipeline
Sanofi recently published results on flexaliumab, an Fc-modified humanized anti-CD40L mAb for multiple sclerosis, in the New England Journal of Medicine.1
CHATHAM, N.J., February 28, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corporation (NASDAQ: TNXP), a biopharmaceutical company with a pipeline of commercially available products and development candidates, announced today announced that it was completed. 1. Single escalating dose escalation study of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy volunteers. TNX-1500 is being developed to prevent rejection in solid organ and bone marrow transplants and to treat autoimmune diseases.
“Despite advances in the field of solid organ transplantation, there is significant demand for new treatments with improved activity and tolerability,” said Seth Lederman, MD, CEO of Tonix Pharmaceuticals. “The need still exists.” “Anti-CD40L may modulate T-cell function and promote tolerance in transplanted organs. We are pleased to have completed the Phase 1 clinical phase of TNX-1500, a third generation Fc-modified anti-CD40L mAb designed CD40L monoclonal antibody. Preclinical studies in non-human primates No thrombotic complications occurred, indicating that the protein engineering of the Fc region of TNX-1500 achieved its design goals.”
Dr. Lederman continued, “Sanofi recently reported positive clinical data with another CD40L blocker using the Fc-modified humanized anti-CD40L mAb flexaliumab in the treatment of relapsing multiple sclerosis.2 Eledon Pharmaceuticals is developing tegopulvert, a non-covalent dimeric antibody without heavy/light chains or inter-heavy chain disulfide bridges, to prevent rejection of kidney transplants.3”
Dr. Lederman said, “We believe TNX-1500 has the potential to reduce the long-term toxic burden of current immunosuppressive therapies, prevent organ transplant rejection, and improve graft survival.” concluded. Additionally, TNX-1500 has the potential to address multiple other indications, including several autoimmune diseases. We look forward to the results of this Phase 1 trial, expected in the third quarter of this year, and the continued development of his TNX-1500 as a promising candidate in an important therapeutic area. ”
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with CD40 ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT), and treatment of autoimmune diseases . The first-in-human Phase 1 trial of TNX-1500 began in the third quarter of 2023. The primary objective of the phase 1 trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous administration (iv) TNX-1500. Eligible participants enrolled in the Phase 1 study were divided into three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and were evaluated periodically over a 120-day period after dosing. . This first-in-human clinical trial is intended to support dosing in a planned Phase 2 study in kidney transplant recipients.Her two articles published in American Transplant Journal TNX-1500, as a single agent or in combination with other agents, has been shown to prevent rejection, prolong survival, and preserve graft function in non-human primate kidney and heart allografts. It’s proven.Four,Five
About anti-CD40L therapeutics under development
Anti-CD40L mAbs are not approved in any jurisdiction. In addition to TNX-1500, flexaliumab, and tegopulvert, a tn03 fusion protein, dazodarivep, is being developed by Amgen (formerly Horizon Therapeutics Public Limited Company) for the treatment of Sjogren’s syndrome.6,7 Dapirorizumab pegol, an anti-CD40L pegylated Fab, is being developed by UCB for the treatment of systemic lupus erythematosus.8
*TNX-1500 is a new, investigational biologic and is not approved for any indication.
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Vermersch P. et al. N English J Medicine. 2024. 390(7):589-600 https://doi.org/10.1056/nejmoa2309439
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Sanofi press release. May 31, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-05-31-05-00-00-2678991 (Accessed August 2023)
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Eredon press release. November 2, 2023. https://ir.eledon.com/news-releases/news-release-details/eledon-reports-updated-data-oncoming-phase-1b-trial-evaluating (Accessed February 2024)
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Lassiter G., et al. Am J transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
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Tetsuya Miura et al. Am J transplant. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
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biospace. September 12, 2022. https://www.biospace.com/article/releases/horizon-therapeutics-plc-announces-phase-2-trial-evaluating-dazodalibep-for-the-treatment-of-sjoegren-s-syndrome-meets -primary-endpointt (Accessed February 2024)
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biospace. January 18, 2023. https://www.biospace.com/article/horizon-bags-second-phase-ii-win-in-sjoegren-s-syndrome (Accessed February 2024)
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https://www.ucb.com/our-science/pipeline (Accessed August 2023)
Tonix Pharmaceuticals Holding Co., Ltd.*
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit his new drug application (NDA) to the FDA for Tonmya in late 2024.1, a product candidate that has completed two positive Phase 3 trials for the management of fibromyalgia. TNX-102 SL is being developed to treat acute stress reactions and fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine addiction that received Breakthrough Therapy designation. Tonix’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40 ligand (CD40L or CD154), which is being developed for the prevention and treatment of allograft rejection. It consists of biologics that address reactions, autoimmunity, and cancer. Autoimmune disease. Tonix also has product candidates in development in the areas of rare diseases and infectious diseases.Our commercial subsidiary, Tonix Medicines, sells his Zembrace® thin touch® (sumatriptan injection) 3mg and Toshimura® (Sumatriptan Nasal Spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and are not approved for any indication.
1Tonmya™ has been conditionally approved by the U.S. Food and Drug Administration (FDA) as the trade name for TNX-102 SL for the management of fibromyalgia. Tonmya is not approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are the property of their respective owners.
This press release and more information about Tonix can be found at: www.tonixpharma.com.
Forward-looking statements
Certain statements in this press release are forward-looking statements 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 “expects,” “believes,” and “anticipates.” “estimate,” “expect,” “intend,” etc. These forward-looking statements are based on Tonix’s current expectations and actual results may differ materially. There are a number of factors that could cause actual events to differ materially from those indicated in such forward-looking statements. These factors include, without limitation, risks associated with failure to obtain FDA clearance or approval and noncompliance with FDA regulations; risks related to the lack of successful marketing of our products; risks related to the timing and progress of clinical development of our product candidates; the need for additional financing; Patent Protection and Litigation Uncertainty. uncertainty of government or third-party payor reimbursements; limited research and development efforts and dependence on third parties; and substantial competition. As with any pharmaceutical product under development, the development, regulatory approval and commercialization of new products involves significant risks. Tonix undertakes no obligation to update or revise any forward-looking statements. Investors are advised of the information contained in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2023, and periodic reports filed with the Securities and Exchange Commission (“SEC”). You should read the risk factors listed. After that date he will contact the SEC. All Tonix forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information contained herein speaks only as of its date.
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peter vozzo
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