Anti-thymocyte Globulin (Rabbit)

Planning to initiate an open-label Phase 2 study of TNX-1500 under an investigator-initiated IND to evaluate safety and activity in the first half of 2026 Novel immunomodulatory regimen designed to reduce calcineurin inhibitor exposure and improve outcomes Dimeric Fc-modified mAb TNX-1500 selectively targets cell-associated CD40L with once-monthly dosing CHATHAM, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial biotechnology company, today announced a collaboration with Massachusetts General Hospital (MGH), a founding member of Mass General Brigham (MGB) to conduct a Phase 2 clinical trial evaluating monoclonal antibody (mAb) TNX-1500 in kidney transplant recipients. The investigator-initiated study will be led by Ayman Al Jurdi, M.D., at MGH and is designed to assess the safety, tolerability and activity of Fc-modified anti-CD40L mAb TNX-1500 in preventing kidney transplant rejection while significantly minimizing the dose of conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects and various metabolic derangements. The CD40 ligand (CD40L) is also known as CD154. Study initiation is contingent on institutional review board (IRB) approval and FDA clearance of an investigator-initiated investigational new drug application (IND). “TNX-1500 represents a differentiated approach that is designed to block the function of cell-associated CD40L,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Collaborating with MGH, one of the nation’s leading transplant research centers, allows us to advance this promising candidate in patients who need safer therapies with better long-term outcomes. The Fc-modified TNX-1500 has shown activity and has been well tolerated in animals1,2 and in a Phase 1 pharmacodynamic (PD) and pharmacokinetic (PK) study that supports monthly dosing. Ultimately, our goal is to establish TNX-1500 as a monotherapy, with the potential to transform the landscape of organ transplant management.” “The ability to modulate the immune system without the toxicities associated with prolonged standard dose CNIs is one of the most pressing unmet needs in transplantation,” said Ayman Al Jurdi, M.D., Principal Investigator at MGH. “Studying TNX-1500 in this Phase II trial will allow us to explore its potential to improve long-term outcomes for kidney transplant recipients.” Pending IRB approval and IND clearance, the open-label, single-center study will enroll five adult kidney transplant recipients at MGH. Patients will receive induction therapy with anti-thymocyte globulin, TNX-1500, tacrolimus, and corticosteroids. The corticosteroids will be tapered and discontinued by Day 33 post-transplant. TNX-1500 will be continued for 12 months (to the primary endpoint) with an option to continue treatment beyond 12 months. Tacrolimus at standard dose will be continued for six months, at which point tacrolimus will be decreased to low dose with the expectation of discontinuing tacrolimus after 12 months. The primary endpoint is the incidence of adverse and serious adverse events at 12 months. Secondary endpoints include graft survival, renal function, biopsy-proven acute rejection, and incidence of donor-specific antibodies. The study is expected to be initiated in the first half of 2026. About TNX-1500 TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 PD/PK study of TNX-1500 was completed and topline reported in first quarter 2025 to support dosing in a planned Phase 2 trial in kidney transplant recipients. The primary objective of the Phase 1 trial was to assess the safety, tolerability, PD and PK of single-dose intravenous (i.v.) TNX-1500 at 3 mg/kg, 10 mg/kg, and 30 mg/kg. Two published articles in the peer-reviewed American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in animal renal and heart allografts.1,2 1Lassiter G, et al. Am J Transplant. 2023;23(8):1171-1181.2Miura S, et al. Am J Transplant. 2023;23(8):1182-1193. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated commercial biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s rare disease portfolio includes TNX-2900, intranasal potentiated oxytocin with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have 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 the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, 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. Investor ContactsJessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 799-8599 Brian Korb astr partners (917) 653-5122 brian.korb@astrpartners.com Media Contact Mary Ann OndishTonix Pharmaceuticals investor.relations@tonixpharma.com (862) 799-8599 Ray Jordan Putnam Insights ray@putnaminsights.com INDICATIONTONMYA is indicated for the treatment of fibromyalgia in adults.CONTRAINDICATIONSTONMYA is contraindicated:In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.In patients with hyperthyroidism.WARNINGS AND PRECAUTIONSEmbryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.ADVERSE REACTIONSThe most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.DRUG INTERACTIONSMAO inhibitors: Life-threatening interactions may occur.Other serotonergic drugs: Serotonin syndrome has been reported.CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.Tramadol: Seizure risk may be enhanced.Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.USE IN SPECIFIC POPULATIONSPregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.Pediatric use: The safety and effectiveness of TONMYA have not been established.Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.Please see additional safety information in the full Prescribing Information.To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

北京 2025年6月19日 /美通社/ -- 2025年第30届欧洲血液学协会年会（EHA 2025）于6月12日~15日在意大利米兰盛大召开。作为欧洲血液学领域规模最大的学术盛宴，大会每年都吸引着来自全球100多个国家的 知名 血液学专家参会，本届大会以"加速血液学创新转化"为主题，吸引全球逾万名学者参与。 陆道培医学团队凭借8项前沿研究成果再度亮相，内容涵盖CAR-T细胞治疗、造血干细胞移植优化、罕见白血病分子机制等热点领域。其中，陆道培医院医疗执行院长、团队学术带头人陆佩华院长的口头报告（oral）以突破性通用型CAR-T技术临床实践成果引发在场专家学者的广泛关注，7项墙报展示（Poster）则凸显团队多维度科研实力。 当地时间11:45，陆佩华院长口头报告了通用型抗CD7 CAR-T疗法相关研究，报告题目：CDT402: A Universal Anti-CD7 Chimeric Antigen Receptor T-Cell Therapy for Patients With Relapsed or Refractory (R/R) T-cell Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma (T-ALL/LBL)［CTD402：一种用于治疗复发或难治性（R/R）T 细胞急性淋巴细胞白血病/淋巴母细胞淋巴瘤（T-ALL/LBL）患者的通用型抗 CD7 嵌合抗原受体T细胞疗法，摘要号：S283］。 陆佩华院长表示，针对R/R T-ALL/LBL患者生存率极低（5年OS率＜20%）且缺乏有效疗法的临床困境，CTD402通过三重基因编辑（敲除TCR、CD7及HLA-II类分子），成功解决了通用型CAR-T的"自相残杀"、移植物抗宿主病（GvHD）及宿主免疫排斥三大难题。临床试验显示完全缓解（CR）率达78%，CRS发生率79%且93.9%为轻中度（1-2级），仅1例出现2级GvHD，证实其高效性与可控风险，为既往无药可治的患者提供了希望。 陆佩华院长演讲结束后，现场反响热烈，多位国际学者就回输后免疫重建、供体选择与制备效率、最佳移植桥接时机等临床关注焦点问题进行提问交流，认为此研究有望为临床进一步转化奠定基础。本环节主席，细胞免疫治疗领域权威专家、美国宾夕法尼亚大学Marco Ruella教授主动与陆佩华院长合影，并高度评价该项研究。另一位主席、西班牙巴塞罗那大学Nuria Martinez-Cibrian教授，亦对陆佩华院长的报告表现出浓厚兴趣，会后与多位与会学者追询研究细节，并就通用型抗CD7 CAR-T疗法相关研究展开深入探讨。 此外，团队的7项墙报展示聚焦CAR-T细胞治疗、造血干细胞移植、分子机制研究等多个领域，同样吸引大批临床专家学者驻足交流。本届大会，陆道培医学团队入选的8项研究成果，覆盖从靶点机制解密到临床路径优化的全链条创新，彰显中国学者在血液肿瘤领域的创新领导力，累计超1.15万例造血干细胞移植（亲缘半相合占比超70%）及逾2500例CAR-T细胞治疗的庞大临床规模，稳居全球血液病单中心前列，这一独一无二的"道培数据池"，为团队突破性的研究提供了坚实支撑。 多年来，陆道培医学团队坚持以患者为中心，从临床实际出发，聚焦血液肿瘤患者需求，构建了从精准分层，个体化治疗到全程管理的精准诊疗体系。未来，其将继续通过不断地创新和努力，提升诊疗水平，为血液肿瘤患者带来更精准、高效的治疗方案，推动中国血液病事业的持续发展。 陆道培医疗团队 EHA2025 成果一览 口头报告 摘要号：S283 第一作者：陆佩华，通讯作者：任江涛 题目：CDT402: A Universal Anti-CD7 Chimeric Antigen Receptor T-Cell Therapy for Patients With Relapsed or Refractory (R/R) T-cell Acute Lymphoblastic Leukemia / Lymphoblastic Lymphoma (T-ALL/LBL) 墙报展示 摘要号：PF392 第一作者：卢岳，通讯作者：卢岳 题目：Comparison of Different Doses of Rabbit Anti-Thymocyte Globulin (ATG-T) and Anti-T-lymphocyte Globulin (ATLG) in TBI-Based Myeloablative Conditioning for Haploidentical Transplantation in Acute Lymphoblastic Leukemia Patients 摘要号：PF457 第一作者：周晓苏，通讯作者：刘红星 题目：Epidemiology, Clinical Features, and Molecular Basis of TTMV::RARA driven Acute Promyelocytic Leukemia 摘要号：PF948 第一作者：张弦，通讯作者：张弦 题目：Single center analysis of autologous hematopoietic stem cell transplantation followed by CD19/CD22 CART for the treatment of refractory and relapsed highly aggressive B-cell lymphoma 摘要号：PF1044 第一作者：何海，通讯作者：孙瑞娟 题目：Outcomes of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With NUP98-Rearranged Acute Myeloid Leukaemia: A Single-Center Large-Sample Cohort Study 摘要号：PS1388 第一作者：王彤，通讯作者：王彤 题目：Genetic Characteristics of BCR::ABL1-Positive B-Acute Lymphoblastic Leukemia with Multi-Lineage Involvement and Survival Analysis after allo-HSCT 摘要号：PS2039 第一作者：张铭楠，通讯作者：孙瑞娟 题目：Efficacy Analysis of Allogeneic Hematopoietic Stem Cell Transplantation in 140 Pediatric Patients with KMT2A Rearrangements Acute Myeloid Leukemia 摘要号：PS2083 第一作者：马薇，通讯作者：曹星玉 题目：Single-Center Retrospective Analysis of the Prognosis of Allogeneic Hematopoietic Stem Cell Transplantation for MLL::AF6 Fusion Gene Positive Acute Myeloid Leukemia 注：上述研究成果按摘要号排序