AWT020 / Anwita Biosci, Shanghai Junshi Biosci - LARVOL DELTA

Phase 1 Study of AWT020 in Advanced Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Anwita Biosciences | N=30 ➔ 60 | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Feb 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Hepatocellular Cancer • Oncology

First-in-human study of AWT020, a bifunctional anti-PD-1/IL-2 fusion protein, in patients with advanced cancer. (ASCO 2025) - P1 | "The initial data from this FIH study indicates that AWT020 has a manageable safety profile and is clinically active in cancers with primary or secondary resistance to anti-PD-1 therapies. The study is ongoing to optimize the dosing regimen and to establish MTD and RP2D."

Clinical • Metastases • P1 data • Back Pain • Dental Disorders • Diabetes • Dysphonia • Endocrine Disorders • Fatigue • Immunology • Inflammatory Arthritis • Metabolic Disorders • Musculoskeletal Pain • Oncology • Pain • Pulmonary Disease • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Stomatitis • Thymic Carcinoma • Thymoma • Thymus Cancer • IL2

AWT020-001-I: A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=214 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Synergistic enhancement of immunogenic cell death: Combining AWT020 with antibody-drug conjugates for superior anti-tumor activity (AACR 2025) - "Compared to B7H3-Exa monotherapy or the combination of B7H3-Exa and anti-mPD-1, mAWT020 treated groups significantly increased CD3+ T cell infiltration within the tumor, as well as tumor-specific T cells, as detected by ELISpot assay.These preclinical findings demonstrate that ADC-induced ICD is amplified by AWT020, but not by anti-mPD-1, resulting in greater tumor regression and enhanced immunological memory. These results support the continued clinical development of AWT020 and to explore its potential in combination with ADCs, aiming to improve long-term survival and complete response rates in cancer patients."

Immunogenic cell death • IO biomarker • Oncology • CALR • CD276 • HER-2 • IL2

A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=214 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P1 trial • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

AWT020: a novel fusion protein harnessing PD-1 blockade and selective IL-2 Cis-activation for enhanced anti-tumor immunity and diminished toxicity. (PubMed, Front Immunol) - "Notably, this selective tumoral T-cell stimulation enables potent tumor-specific T-cell responses, underscoring the molecule's enhanced efficacy and safety. The AWT020 fusion protein offers a promising novel immunotherapeutic strategy by integrating PD-1 blockade and IL-2 signaling, conferring enhanced anti-tumor activity with reduced toxicity."

Journal • Oncology • CD8 • IL2

Junshi Biosciences: AWT020 sterile powder for injection clinical trial application approved [Google translation] (Eastmoney.com) - "Beijing News Shell Junshi Biosciences announced on February 5 that it recently received the 'Notice of Approval for Drug Clinical Trial' issued by the National Medical Products Administration, and the clinical trial application for AWT020 sterile powder for injection (project code 'JS213') was approved. JS213 is a bifunctional antibody fusion protein of PD-1 and interleukin-2, mainly used for the treatment of advanced malignant tumors."

New trial • Oncology

The PD-1/IL-2 fusion protein introduced by Junshi Biosciences has been submitted for clinical trials [Google translation] (vbdata.cn) - "Junshi Biosciences introduced the PD-1/IL-2 fusion protein AWT020 and applied for clinical trials. The protein has the potential to drive targeted and anti-tumor immune responses, and is also conducting Phase 1 clinical trials in Australia."

Trial status • Oncology

Phase 1 Study of AWT020 in Advanced Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Anwita Biosciences | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Oncology

Phase 1 Study of AWT020 in Advanced Cancer (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Anwita Biosciences

Metastases • New P1/2 trial • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Oncology

A safe and highly potent PD-1-IL-2 fusion (AWT020) that decouples the efficacy and toxicity of IL-2 therapy (SITC 2022) - "Ethics Approval The protocol of animal studies has been reviewed and approved by IACUC. Download figure Open in new tab Download powerpoint Abstract 1104 Figure 1 MOA of AWT020AWT020 is highly specific to tumor infiltrated T cells"

Clinical • IO biomarker • Breast Cancer • Colon Cancer • Colorectal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD3D • CD8 • CXCR3 • CXCR6 • IL2RA • PD-1 • STAT5 • STAT5AWqe • ZAP70