Norwegian University of Life Sciences

HALETHORPE, Md., Sept. 24, 2024 /PRNewswire/ -- Fzata, Inc. is pleased to announce a five-year UG3/UH3 non-dilutive grant (UG3NS135350) of up to $7 million, plus in-kind contributions, awarded by the NIH National Institute of Neurological Disorders and Stroke (NINDS). Grant participants include Fzata and the University of Maryland, Baltimore (UMB). The grant supports development of BioPYM™ drug candidate FZ006 as a safe and effective oral treatment for chronic visceral pain associated with inflammatory bowel syndrome (IBS). Work under the grant will include IND-enabling studies, GLP toxicology, cGMP manufacturing, phase 1 trial design, IND submission, and Phase 1a clinical trial. Continue Reading Fzata's FZ006 drug candidate is in development as an effective, safe, non-addictive option to treat chronic abdominal pain. Dr. Zhiyong Yang, President and CEO of Fzata, commented, "Chronic visceral pain associated with IBS is a serious unmet need. Ten to 15 percent of Americans suffer with severe pain, but treatment options are often inadequate. The most effective opioid treatments come with a high risk of addiction, a national problem. FZ006 will be the first effective, safe, non-addictive option to treat chronic abdominal pain. We are excited to work with the outstanding team we assembled, including labs at UMB and NINDS, to bring a real game-changer to IBS patients and their families." "This NIH award presents a wonderful opportunity for Fzata, one of UMB's startup portfolio companies, to advance development of their platform technology for an important medical need. It's gratifying that the funded work will be in collaboration with UMB scientists," said Phil Robilotto, DO, MBA, associate vice president of technology transfer at UMB and director of UM Ventures, Baltimore. "We are excited by Fzata's continued pipeline advancements, including ("FZ002") for C. difficile infections, which is based on technology licensed from UMB and expected to start first-in-human clinical trials in 2025." About Fzata, Inc . The Company has innovated and developed a next-generation therapeutics platform called Bioengineered Probiotic Yeast Medicines (BioPYM™) for oral live biotherapeutics. BioPYM enables probiotic yeast to function as a micro-factory within the gut, producing therapeutics on site where disease pathologies occur. The "plug and play" platform accepts any gene to make biotherapeutic proteins including monoclonal antibodies, enzymes, cytokines, and hormones. Leveraging BioPYM, the Company has a pipeline of proprietary drug candidates to treat a wide variety of gastrointestinal diseases and gut-health axis disorders. Learn more at or follow us on LinkedIn. For investment opportunities, licensing, or collaboration inquiries, please contact: Elizabeth Smith, PhD, MBA, Chief Business Officer, Fzata E-mail: [email protected] SOURCE Fzata, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The largest long-term standardized camera-trap survey to date finds that human activity impacts tropical mammals living in protected areas and sheds light on how different species are affected based on their habitat needs and anthropogenic stressors. By 2030, if the 30 by 30 initiative supported by more than 100 countries is successful, 30% of our land and ocean ecosystems will be designated protected areas meant to safeguard biodiversity and help limit the impacts of climate change. However, a study by Rice University ecologist Lydia Beaudrot and collaborators reports for the first time that tropical mammals living inside protected areas are not spared the effects of human activity even when it occurs outside of the protected boundaries. Based on the largest long-term camera-trap wildlife survey of its kind to date, the research sheds light on how anthropogenic stressors such as human population density and habitat fragmentation impact 159 mammal species in 16 protected areas across three biogeographic regions. The study, published in Nature Ecology and Evolution, could inform biodiversity policymaking decisions by 30 by 30 participants. Composed of millions of images collected over multiple years from over 1,000 camera-trap sites, the data set was assembled by a large-scale network of research stations that agreed to implement a consistent data-collection protocol as part of a partnership between Conservation International, the Wildlife Conservation Society and the Smithsonian Institution. "This data set is just phenomenal -- it was a herculean effort unlike anything attempted before," said Beaudrot, an assistant professor of biosciences. The study found that specialist species -- which occupy specific habitats only -- thrive when habitat fragmentation is low and are generally more susceptible to the negative impacts of human activities like hunting and land use than generalist species, which are able to live in more diverse habitats. Thus, a white-bellied pangolin living in the Bwindi Impenetrable National Park in Uganda should shuffle closer to its center, since specialists are likely to fare better the farther inward they are from the edge of a protected area. "Habitats are more varied at the edge of the protected area," said Asunción Semper-Pascual, a postdoctoral researcher at the Norwegian University for Life Sciences and the lead author on the study. "There is usually this difference between forest cover and open landscape, such as an area used for agriculture, etc. Some generalist species thrive in this kind of diverse setting because it provides access to different resources." Generalist species, such as the tayra -- a dog-sized omnivore in the weasel family that is at home both under forest cover and in grasslands or cropland, only thrive near the edge of protected areas if human population density there is low. Understanding species-specific responses to different anthropogenic stressors can help set conservation priorities and guide protected-area management -- locally by focusing on the most vulnerable species in a region and globally by highlighting how landscape-scale factors impact biodiversity beyond the protected perimeter. "We have to think about the situation holistically," Beaudrot said. "Conservation is going to work best when it's tackled in specific contexts and in concert with the people who live there so as to create win-win situations for both the people and the wildlife." "As more protected areas are created, we need to think carefully about the factors both within and outside protected areas that influence biodiversity," Semper-Pascual said. The Research Council of Norway (NFR301075) and the National Science Foundation (2213568) supported the research.

Research Study to Assess the Role of TNX-1500 in the Prevention of Heart Xenograft Rejection Preclinical Xenotransplantation Studies are Expected to Support Regulatory Filings for TNX-1500 CHATHAM, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-15001, an Fc-modified humanized monoclonal antibody directed against CD40-ligand. UMB’s preclinical studies will utilize genetically-modified porcine hearts supplied by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS, Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine. “We are excited to collaborate with the University of Maryland and Dr. Mohiuddin on the development of TNX-1500 for the prevention of rejection in xenograft transplantation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a third generation anti-CD40L monoclonal antibody that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. Previous preclinical studies in non-human primates demonstrated that TNX-1500 showed activity in preventing allograft and xenograft organ rejection and was well tolerated. A positive result from this study would potentially help support an Investigational New Drug (IND) application and human clinical studies.” “Despite exciting advancements in the field of xenotransplantation, better therapeutics are needed to prevent xenograft organ rejection,” said Dr. Mohiuddin. “Several lines of research indicate that anti-CD40L is required for long term xenograft acceptance. We are excited to collaborate in support of developing an effective immunosuppression regimen for patients requiring xenograft transplantation.” The primary objective of the preclinical research study is to study the activity of TNX-1500 in preventing cardiac xenograft rejection in animals to support an IND application for human studies. About TNX-1500 TNX-1500 (Fc-modified anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), which is also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the treatment of autoimmune diseases and for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease FcγRII binding and to reduce the potential for thrombosis. In June 2022, Tonix announced data from three oral presentations at the 2022 American Transplant Congress of animal studies found that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. In those studies, blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate models of cardiac and kidney allograft transplantation without clinical thrombosis. Copies of the presentations are available under Scientific Presentations on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com. 1TNX-1500 is a biologic at the pre-IND stage of development and has not been approved for any indication Tonix Pharmaceuticals Holding Corp.* Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023. *All of Tonix’s product candidates are investigational new drugs or biologics 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 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, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, 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 Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182 Olipriya Das, Ph.D. (media)Russo PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588 Peter Vozzo (investors)ICR Westwickepeter.vozzo@westwicke.com(443) 213-0505