9MW3811 / Mabwell (Shanghai) Biosci, Calico Life Sciences - LARVOL DELTA

Dual Blockade of TSLP and IL11 with a bispecific antibody: A Promising Strategy for the Treatment of Asthma and Other Airway Disorders (EAACI 2026) - "In the TSLP inhibition assay, HX16118 inhibited TSLP signaling with a sub-nanomolar IC₅₀, outperforming Tezepelumab...Importantly, in hyper-IL11 trans-signaling assays, HX16118 (IC₅₀ ~1.04 nM) displayed markedly enhanced potency compared to both HB0056 and 9MW3811 (~18.60 nM)...Accordingly, HX16118 holds strong potential for the treatment of asthma and other inflammatory airway diseases. Preclinical development of HX16118 is currently underway."

Bispecific • Dermatitis • Immunology • Inflammation • CRLF2 • STAT3 • STAT5 • TSLP

Design and Preclinical Development of a Bispecific Antibody Targeting IL11 and TL1A (EAACI 2026) - "Results HX15105 demonstrated markedly enhanced potency against IL11 compared with the benchmark antibody 9MW3811, effectively inhibiting both IL11 classical signaling and hyper–IL11–mediated trans-signaling. For TL1A, HX15105 bound recombinant TL1A with sub-nanomolar affinity and exhibited robust functional blocking activity in both TF-1 apoptosis assays and DR3–NF-κB reporter assays, with efficacy comparable to its parental antibody TLA0238-45 and the clinical benchmark RVT-3101...Conclusion HX15105 is a bispecific antibody that simultaneously neutralizes IL11 and TL1A while preserving the functional potency of each parental binding arm. Its strong dual-target inhibitory activity in vitro supports its potential to more effectively suppress inflammation-driven fibrotic processes, offering a promising therapeutic strategy for the treatment of fibrotic and autoimmune diseases across multiple clinical settings."

Bispecific • Preclinical • Fibrosis • Immunology • Inflammation

A Phase II Study of 9MW3811 in Patients With Pathological Scar (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2 trial

Disrupting IL-11/IL-11R signaling by an efficacious anti-IL-11 antibody 9MW3811 enhances T cell tumor infiltration and synergizes with anti-PD-1 therapies in vivo (AACR 2024) - "Our results demonstrated profound antitumor activity of 9MW3811 in different tumor models. 9MW3811 is currently in phase I clinical trials in AU, CN and US."

IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IL1R1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting ➔ Completed

First-in-human • Trial completion • Immunology • Pulmonary Disease • Respiratory Diseases

Mabwell…announced that its novel anti‑IL‑11 monoclonal antibody 9MW3811 has received approval from the China National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for pathological scarring. (The Manila Times) - "The Phase II clinical trial of 9MW3811 for pathological scarring is planned to start at the end of 2025."

New P2 trial • Immunology

IL-11/IL-11R signal inhibition by 9MW3811 remodels immune tumor microenvironment and enhances anti-tumor efficacy of PD-1 blockade. (PubMed, NPJ Precis Oncol) - "Furthermore, 9MW3811 counteracts PD-1-induced T cell exhaustion, with anti-PD-1 antibodies effectively mitigating PD-1 upregulation post-9MW3811 treatment. These compelling findings support ongoing clinical trials of 9MW3811, aiming to translate these preclinical insights into therapeutic benefits for cancer patients."

Biomarker • Journal • Oncology • CD8

IL-11/IL-11R signal inhibition by 9MW3811 remodels immune tumor microenvironment and enhances anti-tumor efficacy of PD-1 blockade (Nature) - "By disrupting the IL-11/IL-11Rα/gp130 complex, 9MW3811 inhibits JAK/STAT3 signaling, significantly reducing tumor growth in diverse mouse models. More importantly, 9MW3811 synergizes with anti-PD-1 therapy, even in PD-1 non-responsive models like CT26. Single-cell RNA-seq analysis reveals that 9MW3811 remodels the tumor microenvironment by enhancing CD8+ T cell infiltration and reversing T cell exhaustion via upregulated XCL1 and downregulated CCL7, boosting anti-tumor cytotoxicity. Furthermore, 9MW3811 counteracts PD-1-induced T cell exhaustion, with anti-PD-1 antibodies effectively mitigating PD-1 upregulation post-9MW3811 treatment."

Preclinical • Oncology

Mabwell Releases Preclinical Study Results of Multiple Innovative Drugs Released at the 2024 AACR Annual Meeting (PRNewswire) - "Studies have shown that high expression of IL-11 is associated with the prognosis of various tumors such as lung cancer, hepatic cancer, and colorectal cancer. IL-11 not only promotes the growth of tumor cells through the STAT3 pathway but also has a significant impact on immune cells in the tumor microenvironment. 9MW3811 effectively blocks the formation of the IL-11/IL-11Ra/gp130 ternary complex by binding to IL-11, thereby inhibiting the activation of downstream signaling pathways. 9MW3811 has shown good anti-tumor therapeutic effects in multiple preclinical pharmacodynamic models, especially when used in combination with anti-PD-1 antibodies, it significantly promotes lymphocytic infiltration of CD8+ T cells, improves the T cell exhaustion caused by anti-PD-1 antibodies, upregulates the secretion of cytotoxic cytokines, thus exhibiting better combined anti-tumor effects."

Preclinical • Oncology • Solid Tumor

Mabwell to Present Pre-clinical Results at the 2024 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire-Asia) - "Mabwell...announced that it will present results of three preclinical studies as poster presentation at the AACR Annual Meeting to be held in San Diego, USA, from April 5-10, 2024."

Preclinical • Oncology

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Mabwell Announces the U.S. FDA approval of 9MW3811 for IND (PRNewswire) - "Mabwell...announced the clinical trial application of its self-developed 9MW3811 injection for idiopathic pulmonary fibrosis has been approved by the United States Food and Drug Administration (FDA). As China's First anti-IL-11 monoclonal antibody approved to clinical study, 9MW3811 has received IND clearance in three countries (AUS, CN & USA)."

IND • Fibrosis • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Oncology

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases

"#Mabwell Announces the TGA Approval of #9MW3811 for #InvestigationalNewDrug application https://t.co/yG2OWj4TpL" (,@1stOncology)

IND

First in Class, Mabwell Announces the TGA Approval of 9MW3811 for IND (PRNewswire) - "Mabwell...announced that its IND application of its self-developed 9MW3811 injection for tumor and pulmonary fibrosis has been approved by the Therapeutic Goods Administration (TGA) in Australia. 9MW3811 is the first IL-11 targeting monoclonal antibody approved to clinical study at present....9MW3811 is first IL-11-targeting monoclonal antibody and first non recombinant protein drug candidate targeting IL-11 approved to clinical study as well."

Non-US regulatory • Oncology

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases