Teplizumab

NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. Howard L. Weiner, M.D., Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham healthcare system stated, “I am excited to treat this first patient with moderate AD with nasal foralumab as early as July. These patients have no other treatment options including newly approved anti-amyloid drugs and continue to deteriorate. Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient. We will work closely with FDA to evaluate the treatment responses in this patient with moderate AD while we initiate our Phase 2 study Alzheimer’s Disease in patients with early symptomatic disease.” Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “In addition to our previously announced IND clearance of the Phase 2a early symptomatic Alzheimer’s Disease study, this additional FDA clearance allows Tiziana to also study intranasal foralumab in patients with moderate Alzheimer’s Disease who do not qualify for approved therapies.” Gabriele Cerrone further commented, “Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.” About Foralumab Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety pro clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information please visit our website: For further inquiries: Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379 email: info@tizianalifesciences.com Investors: Irina Koffler LifeSci Advisors, LLC 646.970.4681 ikoffler@lifesciadvisors.com [1] [2]

NEW YORK, June 25, 2024 /PRNewswire/ -- Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, gathered with researchers, diabetes professionals, and other leaders in T1D at the American Diabetes Association's (ADA) 84th Scientific Sessions, where Breakthrough T1D scientists, clinicians, and Breakthrough T1D-funded researchers presented research results that will improve outcomes for people with T1D. Held June 21-24 in Orlando, Florida, the ADA Scientific Sessions is one of the largest diabetes conferences in the world. Breakthrough T1D-supported research has been highlighted at this annual event since the organization started funding research in the 1970s. This year, researchers presented more than 180 studies—with Breakthrough T1D funding at present or in the past—that are paving the way for more life-changing T1D breakthroughs. "As we drive toward cures, Breakthrough T1D connects and funds the brightest minds to help accelerate cures, advance treatments, and improve access to care for those who live with type 1 diabetes all over the world. The research presented at the ADA Scientific Sessions demonstrates the incredible progress being made in the space," said Aaron Kowalski, Ph.D., Breakthrough T1D CEO. "Breakthrough T1D is thrilled to lead and support the innovation and cutting-edge research that are accelerating life-changing breakthroughs for people with type 1 diabetes." A key highlight of this year's conference was the presentation and publication of the first-ever international consensus guidance for monitoring early-stage T1D. Convened and led by Breakthrough T1D, the guidance was developed in conjunction with over 60 international experts representing 10 countries and endorsed by 11 national and international organizations and societies. It provides guidance for monitoring children, adolescents, and adults who test positive for T1D autoantibodies, along with recommended frequencies of monitoring and actions for health care professionals when risk of progression towards symptomatic T1D is high. Notably, the guidance also includes recommendations for educational and psychosocial support. "Early detection of type 1 diabetes is a priority for Breakthrough T1D, and the development of this guidance provides clarity and next steps for individuals, caregivers, and health care professionals following a positive autoantibody test," said Sanjoy Dutta, Ph.D., Breakthrough T1D chief scientific officer. "Clear monitoring guidance create a pathway to realize the benefits of early detection of T1D, including significant reduction in incidences of diabetic ketoacidosis at diagnosis, opportunities to participate in clinical trials, access to therapies that can delay onset of T1D, and time to prepare for a diagnosis. The ADA Scientific Sessions was an ideal place to present this guidance to the broader T1D scientific and professional communities." Other highlights from the sessions include: Vertex Pharmaceuticals gave a highly anticipated update on the phase I/II clinical trial of VX-880, their stem cell-derived islet cell therapy. Today, all participants who have had the therapy for at least five months have an HbA1c below 7.0% and are above target time-in-range, 11 of 12 participants have reduced or eliminated the need for external insulin, and all three individuals who received the therapy at least 12 months ago have eliminated hypoglycemic events and are fully off external insulin—meeting the primary and secondary endpoints. This research was made possible by years of funding by Breakthrough T1D and the T1D Fund to Doug Melton, Ph.D., and Semma Therapeutics—a biotech company founded by Melton to develop a stem cell-derived islet therapy for T1D—which was acquired by Vertex Pharmaceuticals. Kevan Herold, M.D., presented a secondary analysis of the phase III PROTECT clinical trial . In October 2023, Tzield™ (teplizumab-mzwv) showed that it can slow the loss of beta cells and preserve beta cell function in newly diagnosed (stage 3 T1D) children and adolescents ages eight to 17. This analysis demonstrated that, in addition to slowing down the loss of beta cells in new-onset T1D, Tzield can decrease insulin dose and improve time-in-range. This reinforces our commitment to supporting therapies that preserve beta cells at onset, which is important for the prevention of complications and improvement in new-onset clinical factors. Dr. Herold has been supported by Breakthrough T1D since the late 1980s. In his research, he showed that he could prevent autoimmune diabetes with an immune-modifying antibody (which later, became a humanized version, teplizumap) and was the lead on the clinical trial that demonstrated that teplizumab could delay the onset of T1D in people almost certain to develop the disease. In November 2022, teplizumab was approved by the FDA to delay the onset of the disease in at-risk individuals eight and older. In a Breakthrough T1D-funded study, Peter Calhoun, Ph.D., gave a fascinating talk on how continuous glucose monitors (CGMs) can predict who will move onto Stage 3 T1D earlier. He took a dataset from five screening programs—TrialNet, ASK (Autoimmunity Screening for Kids), DAISY (Diabetes Autoimmunity Study in the Young), DIPP (Type 1 Diabetes Prediction and Prevention), and BDR (Belgium Diabetes Registry)—and was able to show that incorporating CGM metrics into individual characteristics had the best predictive performance to classify individuals of the impending clinical onset of T1D. More information about Breakthrough T1D-funded research and presentations can be found on Breakthrough T1D's website. About Breakthrough T1D, Formerly JDRF As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. Contact: Casey Fielder 509-651-0087 [email protected] SOURCE JDRF International