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

Adult-onset type 1 diabetes: early detection, differential diagnosis, and emerging disease-modifying therapies. (PubMed, Diabetes Res Clin Pract) - "We review adult and adolescent evidence for targeted immunomodulators, including teplizumab, abatacept, rituximab, low-dose anti-thymocyte globulin, ustekinumab, golimumab, baricitinib and alefacept, as well as β-cell-directed agents such as verapamil and imatinib, and discuss emerging HLA- and autoantibody-defined endotypes that may predict response. Collectively, current evidence supports routine autoimmune diabetes screening in adults with new-onset diabetes."

Journal • Review • Diabetes • Immunology • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

TEPLI-QUEST: A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States (clinicaltrials.gov) - P=N/A | N=550 | Recruiting | Sponsor: Sanofi

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

Immunomodulatory interventions in type 1 diabetes: a systematic review and meta-analysis revealing paradoxical dissociation between beta-cell preservation and glycemic control. (PubMed, BMC Endocr Disord) - "Immunomodulation provides modest, temporary beta-cell preservationwithout consistent glycemic improvement. The C-peptide-HbA1c disconnect likelyreflects intensive insulin management masking treatment benefits. IL-2'sparadoxical HbA1c improvement without beta-cell preservation warrants mechanistic investigation. Time-dependent benefit attenuation suggests maintenance therapy may be necessary. Safety profiles favor Treg Enhancementover WBCs Clearance approaches. Future trials should employ continuous glucosemonitoring endpoints, longer follow-up, and combination strategies to optimizedisease-modifying therapy development."

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

Redosing of anti-CD3 antibodies in NOD mice with new-onset diabetes does not alter the effect of a single treatment course. (PubMed, Diabetologia) - "These findings suggest that while a single course of anti-CD3 therapy can be effective in a subset of mice, redosing does not enhance efficacy yet is well tolerated in previously reversed mice."

IO biomarker • Journal • Preclinical • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus • CD8 • KLRG1 • PD-1

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Teizeild, intended for the treatment of type 1 diabetes (T1D). (European Medicines Agency)

CHMP • Type 1 Diabetes Mellitus

Use of Teplizumab to Modulate Stage 2 Type 1 Diabetes in Two Individuals With Autoimmune Polyendocrine Syndrome 1. (PubMed, Diabetes Care) - "Teplizumab may preserve β-cell function in APS-1-associated T1D. Larger studies are needed to define efficacy, durability, and immunologic and tissue mechanisms in this rare context."

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

Latest Updates in Prevention and Screening of Type 1 Diabetes Mellitus. (PubMed, Curr Pediatr Rep) - "Teplizumab is a humanized anti-CD3 monoclonal antibody and is the first pharmacologic agent approved by the US Food and Drug Administration (FDA) to delay progression of T1D. Additionally, there have been many trials aimed at identifying additional therapeutic targets to delay onset of clinical T1D and the need for insulin therapy."

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

Valuing Health States When Transitioning From Stage 2 to Stage 3 Type 1 Diabetes in a Sample of the General Population in the United Kingdom (ISPOR-EU 2025) - "Disease-modifying therapies (DMTs) such as Teplizumab, have shown potential to delay the progression from stage 2 (presymptomatic) to stage 3 (symptomatic) T1D... Participants rated pre-symptomatic T1D with lower HRQoL than the general population, and clinical T1D even lower. The availability of a DMT was associated with higher HRQoL compared to natural progression."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

The VIS1ON Horizon Scanning Model: Predicting the Evolution of Direct NHS Expenditure for Type 1 Diabetes in Italy up to 2028 (ISPOR-EU 2025) - "This original analysis of direct NHS expenditure for T1D in Italy offers insights for decision-makers in planning and preparing the NHS for the upcoming therapeutic and technological innovations."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Quantifying the Value of Delaying Type 1 Diabetes Progression: A New Cost-Effectiveness Model for Capturing the Value of Delayed Onset (ISPOR-EU 2025) - "OBJECTIVES: Advances in the treatment of type 1 diabetes (T1D) include early intervention with disease-modifying therapies (DMTs) like teplizumab—an anti-CD3 antibody and the first approved DMT—to delay progression from stage 2 T1D to stage 3 (clinical diabetes)... This novel T1D model captures full patient journey and provides a robust framework for evaluating DMTs by quantifying the value of delaying clinical onset. It directly translates months of delay into measurable gains in life years and QALYs, offering a practical tool for assessing the cost-effectiveness of early intervention in T1D."

Cost effectiveness • HEOR • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Reevaluating Cost-Effectiveness: A Holistic Framework for Assessing Disease-Modifying Treatments in Type 1 Diabetes (ISPOR-EU 2025) - "OBJECTIVES: Evaluating the cost-effectiveness of emerging treatments for type 1 diabetes (T1D), particularly those with disease-modifying potential such as teplizumab, requires a broader and more nuanced approach than that of traditional frameworks... Using this multidimensional approach to value assessment, decision-makers can make more informed decisions that reflect the full spectrum of benefits of new health technologies."

Cost effectiveness • HEOR • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Toward Disease-Modifying Therapies in Type 1 Diabetes: Focus on Teplizumab. (PubMed, Diabetes Care) - "With regulatory approval of this agent, clinical practice has entered a new era for treating people with type 1 diabetes, in which disease modification can become the new standard of care. Implementation of global screening for autoantibodies and dysglycemia is underway, enabling efforts to intervene during asymptomatic stages of the disease before insulin treatment is required."

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

Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes. (PubMed, Diabetologia) - P4 | "Teplizumab was safe and well tolerated in children <8 years of age with stage 2 type 1 diabetes. Adverse events were consistent with those seen in previous studies, with no new safety risks identified. Two participants progressed to stage 3 type 1 diabetes during the observation period; surveillance is ongoing."

Journal • PK/PD data • Diabetes • Hematological Disorders • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Are We Ready With Prevention for Type 1 Diabetes? (PubMed, Diabetes Metab Res Rev) - "Only teplizumab has been approved by the FDA as the first drug shown to delay the onset of Stage 3 T1D...In individuals with Stage 3 T1D, several intervention trials have led to a temporary improvement in beta-cell function, but this benefit has consistently been short-lived. Ongoing and future research will be essential to refine patient selection, identify additional therapeutic targets, and optimise the timing and durability of immunotherapy responses."

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

Generalizability of Progression Risk in the TN-10 Trial to a European Population With or Without a First-Degree Relative With Type 1 Diabetes. (PubMed, Diabetes Care) - "Time to progression to stage 3 appeared similar between the TN-10 placebo arm and the Fr1da group and between participants with and without FDRs with disease. Results suggest progression risk from the TN-10 trial may be generalizable to European populations with or without FDRs with type 1 diabetes."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Managing adults with screen-detected islet autoantibody positivity: a pragmatic framework. (PubMed, Lancet Diabetes Endocrinol) - "New disease-modifying therapies, such as teplizumab, offer opportunities to delay the clinical onset of type 1 diabetes but require islet autoantibody screening to identify individuals at increased risk of progression to diabetes...This Personal View aims to add clarity to international consensus guidelines, proposing a pragmatic framework for managing adults with islet autoantibody positivity. Although fitting within a UK National Health Service setting, we feel this framework is also relevant to other health systems."

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

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

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Assessment of Adverse Events of Teplizumab: A Real-world Pharmacovigilance Study Based on the FDA Adverse Event Reporting System. (PubMed, Clin Ther) - "This study offers an enhanced comprehension of the potential AEs that could be induced by teplizumab, thereby furnishing invaluable insights for its clinical application."

Adverse events • Journal • Real-world evidence • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Type 1 Diabetes Mellitus

Autoimmune Type 1 Diabetes in the Era of Disease-Modifying Immune Therapy. (PubMed, Diabetes Metab Res Rev) - "The approval of teplizumab, an anti-CD3 monoclonal antibody and the first disease-modifying therapy for use in individuals with preclinical T1D, has caused a major shift in the way healthcare providers can treat the T1D disease course. In this review, we discuss the chronic autoimmune nature of T1D and provide an overview of disease-modifying therapies that are under investigation to target the autoimmune mechanisms in T1D to preserve residual beta-cell function and prevent disease progression. The considerations for implementing these therapies into clinical practice are also discussed."

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

Teplizumab for stage 2 type 1 diabetes: a new era in pediatric diabetes prevention. (PubMed, Eur J Pediatr) - "Teplizumab represents a significant advance in pediatric diabetes care, enabling early immunomodulation to delay disease onset. Pediatricians play a crucial role in risk-based screening, timely referral, and supporting shared decision-making around disease-modifying therapy."

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

Neutrophil-enriched gene signature correlates with teplizumab therapy resistance in different stages of type 1 diabetes. (PubMed, J Clin Invest) - "Using an elastic-net logistic regression model, we developed a 26-gene blood-based signature predicting teplizumab response (AUC = 0.97). These findings demonstrate the predictive potential of immune gene signatures and the value of transcriptomic profiling in guiding individualized treatment strategies with teplizumab in T1D."

Gene Signature • Journal • Diabetes • Endocrine Disorders • Immunology • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • CD8

The future of type 1 diabetes therapy. (PubMed, Lancet) - "Teplizumab, the first immunotherapy treatment to delay the onset of clinical type 1 diabetes, has been approved by the US Food and Drug Administration...New-generation insulins (those that are ultrarapid, ultralong, and glucose-responsive) improve outcomes by minimising blood sugar fluctuations. Together, these breakthroughs offer renewed hope for improving long-term management and quality of life for people living with type 1 diabetes."

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

TN-10 extension study: teplizumab following stage 3 type 1 diabetes diagnosis in participants from the TN-10 trial (EASD 2025) - P2 | "Teplizumab was safe and well tolerated in participants with stage 3 T1D. No new safety signals emerged in participants who received 1 course of teplizumab in stage 2 T1D and then 1 in stage 3 T1D."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Progression from stage 2 to stage 3 type 1 diabetes in children identified by general population screening (EASD 2025) - "In this population-based screening program, family history of T1D, race/ethnicity or sex of the child did not influence the rate of progression from stage 2 to stage 3. Children positive for multiple IAbs and those younger than 8 y experienced faster progression."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Press Release: Tzield approved in China as first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes (The Manila Times) - "Approval based on the TN-10 study, demonstrating Tzield’s ability to delay the onset of stage 3 T1D in adult and pediatric patients aged eight years and older, with stage 2 T1D compared to placebo."

China approval • Type 1 Diabetes Mellitus