Tzield (teplizumab-mzwv) / MacroGenics, Sanofi, Ligand - LARVOL DELTA

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Immunomodulatory agents and cell therapy for patients with type 1 diabetes. (PubMed, Arch Endocrinol Metab) - "Teplizumab, a humanized monoclonal antibody that binds to CD3, was recently approved in the USA to delay Stage 3 T1D in individuals ≥ 8 years of age...Stem cell-derived islet replacement therapy is promising for patients with long- standing T1D, especially with asymptomatic hypoglycemia not resolved by technology. This review aimed to provide updated information on the main immunomodulatory agents and cell therapy options for type 1 diabetes."

Journal • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Immunotherapy as a treatment for type 1 diabetes mellitus in children and young adults: A comprehensive systematic review and meta-analysis. (PubMed, PLoS One) - "This meta-analysis aimed to assess the effectiveness of immunotherapy in treating T1DM by examining its effects on the patients' required dose of insulin, C-peptide, and HbA1c levels. While some studies failed to show desired results, the overall effect was an increase in C-peptide levels and a decrease in HbA1c levels. However, the study did not achieve statistical significance for insulin dosing. The main study's strength is its focus on randomized clinical trials which is considered among the highest levels of epidemiological evidence. Therefore, further research is required to minimize the gaps and to explore immunotherapy-based drugs as potential treatments for T1DM."

Clinical • Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

M120 Risk Score Improves Identification of Children at High Risk of Developing Clinical Type 1 Diabetes and Reports Short-Term Response to Preventive Immunotherapy. (PubMed, Diabetes Care) - "M120 improves risk stratification and identifies early effects of immunotherapy. It could be applied to increase prevention trial efficiency and guide treatment decisions in the clinic."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Teplizumab for Type 1 Diabetes in Children: A Paradigm Shift in Treatment (ESPE-ESE 2025) - No abstract available

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Assessing the Adverse Drug Reactions for TZIELD (Teplizumab) in Type 1 DM Patients—A Pharmacovigilance Study (ADA 2025) - No abstract available

Adverse drug reaction • Adverse events • Clinical • Metabolic Disorders • Type 1 Diabetes Mellitus

TN-10 Extension Study—Teplizumab following Stage 3 Type 1 Diabetes Diagnosis in Participants from the TN-10 Trial (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Assessing the Adverse Drug Reactions for TZIELD (Teplizumab) in Type 1 DM Patients—A Pharmacovigilance Study (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Adverse drug reaction • Adverse events • Clinical • Metabolic Disorders • Type 1 Diabetes Mellitus

Assessing Caregivers' Knowledge and Opinions on T1D Antibody Screening and Teplizumab Infusions (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Metabolic Disorders

Pharmacotherapeutic strategies to promote regulatory T cell function in autoimmunity. (PubMed, Curr Opin Immunol) - "We discuss how co-stimulatory blockade with CTLA-4 immunoglobulin affects tolerogenic environments and consider whether lymphodepleting therapies, such as antithymocyte globulin and teplizumab, might be needed to condition the environment for better Treg-promoting effects. We focus on the potential application of Treg-promoting drugs in type 1 diabetes and draw on evidence from transplantation. With multiple pharmacotherapeutic strategies to optimize Tregs in vivo, there is significant promise for new approaches to effectively and durably induce autoimmune disease remission."

Journal • Review • Diabetes • Immunology • Metabolic Disorders • Oncology • Transplantation • Type 1 Diabetes Mellitus • IL2 • TNFA • TYK2

Type 1 diabetes risk factors, risk prediction and presymptomatic detection: Evidence and guidance for screening. (PubMed, Diabetes Obes Metab) - "With the recent approval of teplizumab as a therapy to delay disease progression, attention has increasingly focused on diagnosing individuals with Stage 1 and Stage 2 type 1 diabetes...The authors discuss additional tests that can help predict how soon a diagnosed individual may require insulin treatment. Finally, the paper highlights ongoing challenges in optimizing screening for wider application and the complexities of integrating research-based screening into routine clinical practice."

Journal • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

TEPLI-REAL: Description of Patients With Type 1 Diabetes Treated With Teplizumab (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Sanofi

New trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Anti-diabetic Biologicals: Exploring the Role of Different Analytical Techniques. (PubMed, Crit Rev Anal Chem) - "These biological products, derived from natural sources via extraction, semi-synthesis, or recombinant DNA technology, include insulin and its analogs, GLP-1 receptor agonists, amylin analogs, and the recently approved monoclonal antibody teplizumab...In doing so, it highlights their advantages and limitations, offering valuable insights for researchers and regulatory professionals involved in selecting suitable methods for QC assessment and understanding the complexities of ADBs evaluation. Furthermore, the article discusses the paramount importance of QC and future perspectives, emphasizing the transition to advanced versions of current techniques driven by the need for efficiency and reliability in quality testing."

Journal • Review • Diabetes • Metabolic Disorders

Effect of Teplizumab on time in range in newly diagnosed type 1 diabetes: A PROTECT study per-protocol analysis (ATTD 2025) - P3 | "For both treatment groups, mean time in hypoglycemia range (teplizumab: ≤2.80%; placebo: ≤2.82%) and severe hypoglycemia range (teplizumab: ≤0.83%; placebo: ≤0.69%) was consistently low.Teplizumab in stage 3 T1D is associated with increased time in target glycemic range with no increased time in hypoglycemia range. This study and medical writing, provided by Ann E. Todd at IMPRINT Science, were funded by Sanofi."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

No, we should use only active (approved) control (ATTD 2025) - "Will we completely stop doing PCTs in type 1 diabetes? No, but adaptive trial designs can be done in a rigorous way, and the approval of teplizumab for stage 2 type 1 diabetes in the U.S. will give us the impetus to implement them."

Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

1440 - PARALLEL SESSION 37: DEBATE: ADAPTIVE TRIALS IN THE POST- TEPLIZUMAB ERA: TO PLACEBO OR NOT TO PLACEBO? (ATTD 2025) - No abstract available

Clinical

Pharmacotherapy of type 1 diabetes - part 2 Today. (PubMed, Expert Opin Pharmacother) - "Type 1 diabetes has now been redefined as an autoimmune disease which may be diagnosed purely from presence of anti-beta cell antibodies with no abnormality of glucose levels. The future will see intensification of efforts to combat the immune process which destroys beta cells."

Journal • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus

Precision medicine in stage 2 type 1 diabetes (ATTD 2025) - "The time lapse also opens the opportunity for intervention with disease modifying therapies and recently, the first of these therapies has been introduced into the clinic: teplizumab, with many clinical trials on next generation therapies following. Combining the precision biomarkers with tailored interventions opens the path for precision medicine in T1D and arresting the disease."

Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Early expansion of TIGIT+PD1+ effector memory CD4 T cells via agonistic effect of alefacept in new-onset type 1 diabetes. (PubMed, J Immunol) - "The persistent increase of TIGIT+PD1+ effector memory CD4 T cells was specific to alefacept treatment; 2 other T cell depleting therapies, teplizumab and anti-thymocyte globulin, induced only a transient increase in this CD4 population. Our data suggest that the expanding TIGIT+PD1+ effector memory CD4 T cell population represents a promising biomarker of early treatment effects of alefacept. The nondepleting effects on proliferation and cytokine production also suggest agonistic activity by this CD2 targeted therapy."

IO biomarker • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD2 • CD4 • CD58 • CD8 • PD-1 • TIGIT

Update on efforts to interdict type 1 diabetes (ATTD 2025) - "In the prevention space (delaying progression from stage 2 to stage 3 T1D) the outcome is more discrete, and a T cell-directed therapy, teplizumab, has received FDA approval...What is clear, a single administration or short course of an immunotherapy is unlikely to provide sustained freedom from exogenous insulin. In this talk, recent successful and unsuccessful immune targeting therapies in T1D and ongoing trials with future areas of immunotherapy innovation will be reviewed."

Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Pharmacotherapy of type 1 diabetes - part 3: Tomorrow. (PubMed, Expert Opin Pharmacother) - "Very recently teplizumab, a CD3 inhibitor, has been approved to delay onset of hyperglycemia in these individuals. The future will see progress in immunosuppression, possibly using specific CAR-Treg cells directed at the beta cell antigens which trigger the immune process. In parallel, stem cell derived beta cells may eventually make it possible to replace lost beta cells, resulting in a true cure for type 1 diabetes."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Transplantation • Type 1 Diabetes Mellitus • SLC51B

Immunotherapies for prevention and treatment of type 1 diabetes. (PubMed, Immunotherapy) - "There has long been an interest in altering the immune response in T1D to prevent or cure T1D across its various stages with limited efficacy. This review highlights immunomodulatory approaches over the years including the anti-CD3 monoclonal antibody teplizumab which is now approved to delay onset of T1DM and other interventions under current investigation."

Journal • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Early diagnosis of type 1 diabetes : a step towards precision medicine (PubMed, Rev Med Suisse) - "Many of these genetic risk regions are also linked to other autoimmune diseases. Early diagnosis enables secondary prevention strategies, notably with teplizumab, the first approved drug for delaying T1D onset, already in use for stage 2 patients in the USA."

Journal • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Real-world experiences of adult individuals or caregivers of children who received teplizumab treatment in stage 2 type 1 diabetes. (PubMed, Diabetes Obes Metab) - "Type 1 diabetes (T1D) happens when the body destroys cells in the pancreas that make insulin. This ultimately causes high blood sugar. People with T1D often worry about the long-term effects of the disease. Teplizumab is the first FDA-approved treatment that delays the onset of high blood sugar in people in the early stages of T1D-when there are signs of cell damage and mild increases in blood sugar. We surveyed adults (N = 30) and caregivers (N = 17) of children treated with teplizumab about their journey before and after treatment. More than half of adults were initially told they might have a different type of diabetes, usually type 2, before being accurately diagnosed with early-stage T1D. Doctors specializing in diabetes were most often the ones who recommended screening for T1D. The most common reason to screen was a chance for more time before the onset of high blood sugar. Greater than 80% of people were grateful they or their child had the opportunity to receive..."

Journal • Real-world evidence • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Immunotherapy in Type 1 Diabetes: Emerging Therapies and Future Directions. (PubMed, J Pak Med Assoc) - "This brief review highlights key immunomodulatory therapies, including teplizumab, which has demonstrated the ability to delay the onset of T1D, and rituximab, known for preserving β-cell function, though its effects tend to be transient. However, significant challenges remain, including high costs, long-term safety concerns, and the need for personalized care. As this therapeutic landscape evolves, further research is critical to optimizing these strategies and moving closer to a potential cure for T1D."

Journal • Review • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus