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

Expert insights on clinical application of immunotherapy for type 1 diabetes mellitus (2026 edition) (PubMed, Zhonghua Yi Xue Za Zhi) - "It further elaborates on the eligible patient populations, pre-treatment assessment, dosing regimens, adverse event management, and follow-up strategies for teplizumab in patients with stage 2 T1DM. This insight aims to provide clinicians with standardized references for the application of DMT and immunotherapy in clinical practice, promote precision medicine, and improve patient outcomes."

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

SIRENA protocol: an Italian, prospective, multicentre cohort study of children and adults with islet autoimmunity and early-stage type 1 diabetes. (PubMed, BMJ Open) - P | "Structured longitudinal follow-up is needed to characterise disease trajectories, reduce diabetic ketoacidosis (DKA) at diagnosis and identify candidates for emerging disease-modifying therapies such as teplizumab...SIRENA will generate real-world Italian evidence to refine follow-up strategies, strengthen paediatric-adult care integration and position Italy within the European pre-T1D Registry and the European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception infrastructure. ClinicalTrials.gov NCT07503366."

Journal • Diabetes • Endocrine Disorders • Immunology • Metabolic Disorders • Pediatrics • Preventive care • Type 1 Diabetes Mellitus

Determinants of glycemic control in children and adolescents with type 1 diabetes (T1D) in three care centers of the changing diabetes in children (CDIC) program in the northern regions of Cameroon. (PubMed, Wiad Lek) - " The majority of children and adolescents with T1DM in the northern regions of Cameroon had poor glycemic control, with only 19% achieving the current unified target of HbA1c ≤7.0% (≤53 mmol/mol). Belonging to the Adamaoua region, intensive insulin therapy (>2 injections/day), proximity to the care center (<20 km), fewer severe hypoglycemic episodes, shorter disease duration (<2 years), and regular therapeutic education were identified as factors associated with good glycemic control. Although global innovations such as hybrid closed-loop insulin delivery systems and teplizumab represent transformative advances in T1D management, these technologies remain inaccessible in the study setting. Intensification of therapeutic education, creation of satellite CDiC centers, and progressive adoption of affordable monitoring technologies are urgently needed."

Journal • Diabetes • Endocrine Disorders • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial. (PubMed, Diabetologia) - P3 | "Teplizumab treatment per protocol led to greater beta cell function preservation, greater TIR and lower exogenous insulin use compared with placebo. Beta cell function preservation was maintained irrespective of HLA subtype or the presence of type 1 diabetes autoantibodies."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

TN40A: Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not yet recruiting ➔ Recruiting

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

Teplizumab for Type-1 DM (ESPE 2026) - No abstract available

Diabetes • Metabolic Disorders

Teplizumab for Type-1 DM (ESPE 2026) - No abstract available

Diabetes • Diabetic Nephropathy • Metabolic Disorders

Fireside chat: Preparing for teplizumab infusion in practice (EASD 2026) - "Sponsored by Sanofi"

Metabolic Disorders

Teplizumab in treatment of T1D: Why Stage 2 autoimmune T1D management is changing (EASD 2026) - "Sponsored by Sanofi"

Metabolic Disorders

A new era in autoimmune T1D: Navigating the realities of teplizumab treatment (EASD 2026) - "Sponsored by Sanofi"

Metabolic Disorders

Defining the opportunity: The rationale for teplizumab in Stage 2 autoimmune T1D (EASD 2026) - "Sponsored by Sanofi"

Metabolic Disorders

A new era in autoimmune T1D: Translating emerging potential into clinical reality with teplizumab (EASD 2026) - "Sponsored by Sanofi"

Clinical • Metabolic Disorders

Integrating early immune signature changes to predict immunotherapy outcomes in type 1 diabetes (EASD 2026) - "Materials and We analyzed data from three randomized controlled trials (RCTs) involving T1D patients receiving adaptive immune-targeted therapies: Teplizumab (AbATE study), Abatacept (TN-09 study), and Rituximab (TN-05 study), as well as placebo groups... Our findings underscore the high predictive value of early immune signatures (3-6 months post-treatment) in T1D immunotherapy. By integrating shared immune features across diverse therapies, this model provides a robust framework for early response prediction, and supports early intervention strategies in T1D management. Future research should validate these predictive biomarkers in larger cohorts and explore their clinical application in personalized treatment regimens."

IO biomarker • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Teplizumab in stage 2 type 1 diabetes: first real-world experience across children and adults in the UK (EASD 2026) - "These first UK cases demonstrate the feasibility and tolerability of teplizumab delivery in Stage 2 T1D outside clinical trials, across children and adults. Treatment was successfully completed in all individuals, even in the presence of cytokine release syndrome, and our early experience highlights the importance of anticipatory monitoring and supportive management, including close glycaemic monitoring during infusions. Follow-up is ongoing to assess longer-term outcomes."

Clinical • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Compassionate use of Teplizumab in children and adolescents with stage 2 type 1 diabetes: short-term safety and efficacy in an Italian case series (EASD 2026) - "In this pediatric cohort with stage 2 T1D,teplizumab showed a favorable short-term safety profile and was feasible in routine clinical practice.Early follow-up showed no metabolic deterioration,supporting longitudinal evaluation."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Tepli-real: a real-world retrospective study characterising individuals with type 1 diabetes treated with teplizumab and their metabolic outcomes (EASD 2026) - P | "This RW study shows high TPZ infusion completion in those ≥8 years and provides insights into treatment from different diagnostic pathways."

Real-world • Real-world evidence • Retrospective data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Evaluation of CD8 Treg prevalence and MTX-101-mediated activation of peripheral blood mononuculear cells from newly-diagnosed pediatric and adult type 1 diabetes patients (EASD 2026) - "In type 1 diabetes (T1D) patients that respond to immunotherapies, including teplizumab and alefacept, CD8 Treg prevalence is increased after therapy and correlates with improved outcomes. Collectively, our data support the development of MTX-101 as a therapeutic to restore CD8 Treg functions and preserve C peptide in patients with newly-diagnosed Stage 3 T1D"

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

Anti-CD3 antibody modulates gamma-aminobutyric acid (GABA) signalling in immune cells from healthy and type 1 diabetes individuals (EASD 2026) - "Teplizumab, a humanized monoclonal antibody targeting CD3 on T cells, has been approved to delay the onset of stage 3 T1D in adults... Anti-CD3 stimulation of human PBMCs and T cells induces GAD67 expression and leads to endogenous release of GABA, which acts through autocrine and paracrine signaling to modulate cytokine release in both healthy and T1D donors. These findings reveal a previously unrecognized mechanism by which anti-CD3-based immunotherapies may exert their immunomodulatory effects through GABAergic signaling."

Clinical • Immune cell • IO biomarker • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8 • IFNG

Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) (clinicaltrials.gov) - P2/3 | N=188 | Active, not recruiting | Sponsor: Provention Bio, a Sanofi Company | Phase classification: P ➔ P2/3

Phase classification • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Teplizumab in stage 2 type 1 diabetes- pediatric considerations, realistic expectations, and the evolving technological landscape. (PubMed, Ther Adv Endocrinol Metab) - No abstract available

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

From genes to environment: A life-course approach to prevent pediatric autoimmune diseases. (PubMed, World J Clin Pediatr) - "The review details a multi-tiered prevention strategy: Primordial prevention focuses on optimizing maternal and early-life health to establish immune tolerance in the first 1000 days; primary prevention targets at-risk children with personalized nutritional and lifestyle interventions; secondary prevention uses early screening and surveillance to identify preclinical autoimmunity, allowing for targeted immunomodulatory therapies that can delay or prevent disease onset; and tertiary prevention employs early aggressive therapy to limit long-term complications in children with established disease. By synthesizing epidemiological data, mechanistic understanding, and a comprehensive prevention framework, this article aims to inform clinical practice, guide research priorities, and support public health policies to combat the increasing incidence of pediatric autoimmunity."

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

Gene-edited hypoimmune islets as a cure for type 1 diabetes: a review of the immunological challenges. (PubMed, Expert Opin Biol Ther) - "Durable graft survival will likely require multimodal approaches combining gene-edited islets with adjunct immunomodulation (e.g. teplizumab, low-dose ATG, tegoprubart) and metabolic support. If these long-term challenges can be overcome, gene-edited hypoimmune islets could transform T1DM treatment paradigms."

First-in-human • Journal • Review • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Transplant Rejection • Transplantation • Type 1 Diabetes Mellitus

Baseline Serum Metabolites as Predictors of Teplizumab Response in Individuals With Type 1 Diabetes. (PubMed, Diabetes) - "Fifteen metabolites were identified as significantly different. Our findings suggest that baseline serum metabolomic signatures could be used to predict which newly diagnosed type 1 diabetes patients will respond to teplizumab, enabling more personalized treatment decisions."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Reducing Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: The Impact of Screening Programs and Early Disease-Modifying Treatment. (PubMed, J Clin Med) - "Teplizumab delayed progression from stage 2 to stage 3 T1D by a median of approximately 24 months in the original TN-10 trial, with extended follow-up demonstrating a median delay of 32.5 months... Reducing DKA at T1D onset requires integrated, sustained strategies combining public awareness, systematic autoantibody screening, structured follow-up, and access to emerging immunotherapies. Coordinated care across primary providers, pediatric endocrinologists, and research networks is essential to advance a proactive, prevention-oriented model of pediatric T1D care."

IO biomarker • Journal • Review • Diabetes • Immune Modulation • Immunology • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Fulminant Secondary HLH Following EBV Reactivation in an Adult With Trisomy 21 After Teplizumab Treatment for Stage 2 Type 1 Diabetes. (PubMed, Diabetes Care) - "This case documents EBV reactivation-associated secondary HLH after teplizumab treatment in a patient with trisomy 21. Causality cannot be established, and the absence of pretreatment EBV PCR limits assessment of whether preexisting EBV DNAemia at treatment initiation contributed to the poor outcome. The observation raises a plausible but unproven host-virus-drug interaction and supports early EBV PCR and HLH evaluation after severe inflammatory deterioration after teplizumab."

Journal • Diabetes • Epstein-Barr Virus Infections • Hemophagocytic lymphohistiocytosis • Immunology • Metabolic Disorders • Rare Diseases • Renal Disease • Type 1 Diabetes Mellitus