XTMAB-16 / Xentria, Nanjing King-Friend Bio, Meitheal Pharmaceuticals - LARVOL DELTA

REmission in pulmonary Sarcoidosis using Early Treatment with TNF-alpha inhibitors (RESET-TNF study) (ERS 2026) - "Methotrexate (MTX) was found non-inferior to prednisone as first-line treatment in pulmonary sarcoidosis with regard to forced vital capacity (FVC) at week 24, but with different side effects...Methods RESET-TNF is an investigator-initiated, open-label randomized controlled trial designed to evaluate whether the TNF-α inhibitor XTMAB-16 is superior to MTX in pulmonary sarcoidosis...Furthermore, we will investigate mechanistic impact through baseline blood biomarkers and in-vitro granuloma formation after treatment. Discussion The RESET-TNF study will be the first study to assess if first-line treatment with anti-TNF-α is superior to conventional treatment in pulmonary sarcoidosis, and provide novel insights into the potential for immune system resetting."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Sarcoidosis

An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations (clinicaltrials.gov) - P2 | N=182 | Not yet recruiting | Sponsor: Xentria, Inc. | Phase classification: P1/2 ➔ P2

Phase classification • Immunology • Sarcoidosis

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=31 | Active, not recruiting | Sponsor: Xentria, Inc. | Enrolling by invitation ➔ Active, not recruiting | N=94 ➔ 31

Enrollment change • Enrollment closed • Immunology • Sarcoidosis

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=94 | Enrolling by invitation | Sponsor: Xentria, Inc. | Trial completion date: Jan 2029 ➔ Nov 2026 | Trial primary completion date: Jan 2029 ➔ Nov 2026

Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

Steroid-Sparing and Pulmonary Stability Across XTMAB-16 Dose Regimens in Pulmonary Sarcoidosis: Cohort-Level Findings from XTMAB-16-201 Part A (WASOG 2026) - No abstract available

Immunology • Sarcoidosis

A Seamless, Adaptive Multiple-Ascending-Dose and Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations (clinicaltrials.gov) - P1/2 | N=182 | Not yet recruiting | Sponsor: Xentria, Inc.

New P1/2 trial • Immunology • Sarcoidosis

A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Xentria, Inc. | Trial primary completion date: Apr 2026 ➔ May 2029 | Trial completion date: Apr 2026 ➔ May 2029

Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

Targeting Tnf-α to Preserve Lung Function in Pulmonary Sarcoidosis: Results From a Phase 1b/2a Multiple-ascending-dose Trial of Xtmab-16 (ATS 2026) - No abstract available

Late-breaking abstract • P1/2 data • Immunology • Sarcoidosis • TNFA

Characterization of Anti‑Drug Antibody Responses in Healthy Volunteers Following XTMAB‑16 Administration & Implications for Clinical Development in Pulmonary Sarcoidosis (WASOG-AASOG 2025) - P1 | "Given the known risk of anti-drug antibody (ADA) formation with chimeric mAbs often driven by murine sequences and influenced by sex, dose, and immunosuppressant use (Bensalem and Ternant, 2020; Herskovitz et al, 2017), Xentria prioritized ADA surveillance early in XTMAB-16 development to support participant safety and robust immunogenicity and dosing profiling.Methods ADA and neutralizing antibodies (nAbs) were measured using validated electrochemiluminescence ligand binding assays (ECL-LBA and ECL-competitive LBA) developed by Xentria for use in therapeutic clinical trials...For clinical studies, ADA assessments will be strategically timed relative to drug concentrations and assessed in the context of concurrent methotrexate and corticosteroids...Physicochemical Characterization and Phase I Study of Cmab008, an Infliximab Biosimilar Produced by a Different Expression System...2017; 19(2):447-455. doi:10.1208/s12248-016-0026-8"

Clinical • Chronic Cough • Cough • Immunology • Respiratory Diseases • Sarcoidosis

XTMAB16 Study: A Phase 2, Randomized, Double-blind Clinical Trial Investigating the Safety and Efficacy of Intravenous XTMAB-16 Versus Placebo in Patients With Pulmonary Sarcoidosis (ATS 2025) - P1, P1/2, P2 | "Conclusion There is an urgent unmet need to develop beneficial therapies for sarcoidosis. The XTMAB16 Study remains ongoing globally."

Clinical • P2 data • Immunology • Oncology • Rare Diseases • Sarcoidosis

Xentria Advances XTMAB16 Study in Pulmonary Sarcoidosis with Completed Enrollment and Key Conference Selections (PRNewswire) - "Xentria...announced the successful completion of enrollment in the therapeutic dose-ranging phase of its global XTMAB16 Study in pulmonary sarcoidosis, an immune-mediated inflammatory disorder with few available treatment options. The dose-ranging study successfully enrolled 39 patients across 17 centers in 4 countries, surpassing initial enrollment targets—a testament to both the strong interest in advancing pulmonary sarcoidosis research and the momentum behind XTMAB16's clinical development....This critical milestone will inform the next phase of investigation, with screening anticipated to begin in Fall 2025....In recognition of its scientific impact, the XTMAB16 Study has been selected for a thematic poster session at the 2025 American Thoracic Society (ATS) Conference....Xentria will share progress in its XTMAB-16 program at the ATS Respiratory Innovation Summit, including novel translational efforts that integrate totality of evidence in drug development."

Enrollment closed • Sarcoidosis

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=94 | Enrolling by invitation | Sponsor: Xentria, Inc. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Immunology • Sarcoidosis

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P2 | N=94 | Not yet recruiting | Sponsor: Xentria, Inc. | Phase classification: P3 ➔ P2

Phase classification • Immunology • Sarcoidosis

An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P3 | N=94 | Not yet recruiting | Sponsor: Xentria, Inc.

New P3 trial • Immunology • Sarcoidosis

A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Xentria, Inc.

Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Xentria, Inc. | Phase classification: P1b/2 ➔ P1/2

Phase classification • Immunology • Sarcoidosis

Xentria’s XTMAB-16 Receives Orphan Drug Designation From European Medicines Agency as First Patient is Enrolled in Study (Businesswire) - "Xentria, Inc...announced that its lead candidate, XTMAB-16, has been granted Orphan Drug Designation by the European Medicines Agency (EMA). The company is also announcing that the first US patient has been enrolled in its global study to evaluate XTMAB-16 as treatment for the rare disease sarcoidosis."

European regulatory • Orphan drug • Trial status • Immunology • Sarcoidosis

A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis (clinicaltrials.gov) - P1b/2 | N=94 | Recruiting | Sponsor: Xentria, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Sarcoidosis

XTMAB-16 Clinical Trial in Sarcoidosis: an anti-TNF investigational new drug & its biosimulation model Robert Baughman (USA), E (WASOG 2023) - "Sponsored by Xentria (Gold Sponsor)"

Clinical • IND • Immunology • Sarcoidosis

Leveraging in vitro and pharmacokinetic models to support bench to bedside investigation of XTMAB-16 as a novel pulmonary sarcoidosis treatment. (PubMed, Front Pharmacol) - P1 | "Interstitial lung concentrations on average, following 2 or 4 mg/kg administered Q2W or Q4W, are anticipated to exceed the in vitro IC concentrations. The data presented in this report provide a rationale for dose selection and support the continued clinical development of XTMAB-16 for patients with pulmonary sarcoidosis."

Journal • PK/PD data • Preclinical • Immunology • Oncology • Sarcoidosis • IL1B

XTMAB-16 Attenuates Granuloma Formation in a Human In Vitro Sarcoidosis Model (ATS 2022) - "The effect of XTMAB-16 at the higher doses was comparable to that of prednisone (1-10 µM) pretreatment. Findings are supportive of our hypothesis that XTMAB-16 suppresses the inflammatory pathways promoting sarcoidosis granuloma formation, supporting further evaluation of this potential therapy in patients with sarcoidosis.Figure 1. Area Fraction: XTMAB-16 Pre-treatment"

Preclinical • Immunology • Infectious Disease • Oncology • Sarcoidosis

Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Xentria, Inc. | Recruiting ➔ Completed

Trial completion

Xentria to Present Initial Findings from Preclinical Study of XTMAB-16 at ATS 2022 International Conference (Businesswire) - "Xentria partnered with Dr. Elliott Crouser, MD...to explore the potential of XTMAB-16 to reduce granuloma formation in an in vitro human model representing the complex immune responses during sarcoidosis granuloma formation."

Preclinical • Idiopathic Pulmonary Fibrosis • Sarcoidosis

Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Xentria, Inc. | Trial completion date: Nov 2021 ➔ Mar 2022 | Trial primary completion date: Nov 2021 ➔ Mar 2022

Trial completion date • Trial primary completion date