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

SI03-11. Navigating the T1D Journey Screen – Monitor – TZIELD Considerations for Specialty Care (ENDO 2025) - "The Endocrine Society thanks the following supporters: Funded Sanofi Expanded information on T1D patient journey with emphasis on disease management, monitoring pre-symptomatic T1D, and care coordination."

Latent EBV enhances the efficacy of anti-CD3 mAb in Type 1 diabetes. (PubMed, Nat Commun) - "In parallel, signaling impairment is greater in adaptive than innate immune cells following teplizumab treatment in EBV-seropositive individuals. Our data thus indicate that EBV can impair signaling pathways in immune cells to modulate their responses in the context of type 1 diabetes."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8

The Use of Continuous Glucose Monitoring to Diagnose Stage 2 Type 1 Diabetes. (PubMed, J Diabetes Sci Technol) - "Metrics such as time above range >140 mg/dL could indicate progression risk, and artificial intelligence (AI)-based modeling may enhance predictive capabilities. Further research is needed to establish CGM-based diagnostic criteria and refine screening strategies to improve T1D detection and intervention."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Application of Teplizumab to delay type 1 diabetes stage 3: generalizability of the TN-10 study to a European population (DDG 2025) - "The time up to the progression of T1D stage 2 to stage 3 was similar between TN-10-placebo arm and people from the FR1DA study. Those with and without T1D FDR in FR1DA also showed a similar progression from T1D stage 2 to stage 3. The results of the TN-10 study, which show that Teplizumab can delay the beginning of T1D stage 3, can be generalized to European populations with or without T1D FDR."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Protect Per Protocol analysis: Conservation of β-cell function in children and adolescents with a newly diagnosed type 1 diabetes stage 3 (DDG 2025) - P3 | "The participants treated with Teplizumab showed a better preservation of the β cell function and clinically relevant metabolic results, including lower insulin doses and more tir vs. PBO. Encore submission."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Safety of Teplizumab for type 1 diabetes in stage 2 and stage 3: Integrated analysis of clinical studies (DDG 2025) - P=N/A, P2, P2/3, P3 | "This analysis offers a comprehensive overview of the Teplizumab security profile. Most undesirable events were predictable and mechanism-based, with temporary and self-limited effects that were manageable. Encore submission."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Prevention in diabetes mellitus type 1 and 2 from different perspectives (DDG 2025) - "Where are the advantages where the disadvantages when it comes to the use of the monoclonal antibody teplizumab approved by the FDA...How is the current status in Germany in particular with regard to the cluster division of high-risk patients? Does digitization offer new opportunities for departure here?"

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

The Role of the Diabetes Care and Education Specialist in Screening and Monitoring for Type 1 Diabetes. (PubMed, Sci Diabetes Self Manag Care) - "By working within the ADCES7 Self-Care Behaviors Framework®, DCESs can help individuals and their families understand and navigate the complexities of early-stage T1D to ensure timely care and reduce the risk of DKA. This article emphasizes the critical role the DCES plays in improving access to care, enhancing health outcomes, and supporting the quality of life for individuals with early-stage T1D."

Journal • 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

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

Teplizumab: a promising intervention for delaying type 1 diabetes progression. (PubMed, Front Endocrinol (Lausanne)) - "A promising new intervention in this field is Teplizumab, the first approved disease-modifying therapy for T1D. Teplizumab is designed to delay progression to stage 3 T1D in adults and children aged 8 years and older who are diagnosed with stage 2 T1D."

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

An Exploratory Cost-Effectiveness Analysis of Immune Therapy in Delaying the Initiation of Automated Insulin Delivery Systems in Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - "In the absence of randomized clinical trials for ATG in the prevention space, findings in this study assume that ATG is at least half as efficacious as teplizumab. The optimal prevention-treatment strategy will ultimately depend on payers' ability to negotiate prices for teplizumab and further evidence on efficacy of ATG in preventing T1D."

Clinical • HEOR • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Anti-CD3 mAb treatment reshapes CD8+ T cells in the islets in autoimmune diabetes (IMMUNOLOGY 2025) - "Description The humanized FcR non-binding anti-CD3 mAb, teplizumab, delays or prevents type 1 diabetes (T1D) by modulating the immune mediated destruction of beta cells...In sum, our findings described alterations in the islets of NOD mice with long remission after anti-CD3 treatment. Islet-infiltrating CD8+ T cells have a more diverse repertoire with a less differentiated transcriptome, whereas islet beta cells are reshaped to a more differentiated state.Keywords: Animals Rodent; Cells T Cells T Cells, Cytotoxic; Diseases Autoimmunity; Techniques/Approaches Molecular Biology"

Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • TCF7

Latent EBV enhances the efficacy of teplizumab in Type 1 diabetes (IMMUNOLOGY 2025) - "Impairments in function of adaptive immune cells were enhanced by teplizumab treatment in EBV seropositive individuals. Our data indicate that EBV can impair signaling pathways in immune cells, that broadly redirect cell differentiationKeywords: Animals Human; Cells B Cells T Cells; Diseases Autoimmunity Diabetes"

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8

Polymeric Nanocarriers Delay the Onset of Type 1 Diabetes in Nonobese Diabetic (NOD) Mice (IMMUNOLOGY 2025) - "Description Introduction: Teplizumab (Anti-CD3) is the first FDA-approved therapy to delay the onset of type 1 diabetes (T1D) and prolong insulin independence...We have previously demonstrated that rapamycin-loaded polymersome nanoparticles (rPS) induce immune antigen-specific tolerance towards transplanted fully-MHC mismatched islets via a costimulation blockade... rPS is a promising early-intervention therapy to delay the onset of T1D. Our prior work demonstrates that rPS leverages antigen presenting cells to reprogram T cells for antigen-specific islet tolerance and can mitigate adverse events of chronic, nonspecific immunosuppression.Keywords: Animals Rodent; Cells Dendritic Cells T Cells; Diseases Diabetes; Processes Tolerance/Suppression/Anergy"

Preclinical • Diabetes • Hematological Disorders • Leukopenia • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus

Paediatric screening in Italy as a gateway to secondary prevention in type 1 diabetes. (PubMed, Diabetes Res Clin Pract) - "Furthermore, the anti-CD3 + T cell monoclonal antibody teplizumab, which may be considered at present for compassionate use only, represents a step forward in delaying T1D onset in stage 2 patients...The screening will also advance our understanding of T1D disease pathogenesis and progression. These insights advocate for tailored prevention strategies, thus improving the design of clinical trials."

Journal • Review • Celiac Disease • Diabetes • Immunology • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Teplizumab for Type 1 Diabetes in Children: A Paradigm Shift in Treatment (ESPE-ESE 2025) - "Despite the approval of teplizumab, the main challenges remain the need for widespread screening programs for early- stage T1DM diagnosis in children and the identification of individuals at high risk within the general population. Keywords TIDM, children, , Teplizumab immunotherapy"

Clinical • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8

Teplizumab: Not all that glitters is gold. (PubMed, Diabetes Obes Metab) - No abstract available

Journal

Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in autoimmune type 1 diabetes in Canada (Sanofi Press Release) - "Health Canada has issued a Notice of Compliance (NOC) for Tzield (teplizumab), a first-in-class disease-modifying therapy for autoimmune type 1 diabetes (T1D), that delays the onset of Stage 3 T1D in adult and pediatric patients 8 years of age and older currently living with Stage 2 type 1 diabetes...The Health Canada approval for Tzield is based on positive results from the initial Phase 2 TN-10 trial, evaluating the use of Tzield to delay the onset of Stage 3 T1D in adults and children aged 8 years of age and older with Stage 2 T1D."

Canada approval • Type 1 Diabetes Mellitus

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