AWT020 / Anwita Biosci, Shanghai Junshi Bioscience - LARVOL DELTA

A Study of AWT020 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Anwita Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study of AWT020 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: Anwita Biosciences

New P1 trial • Oncology • Renal Cell Carcinoma • Solid Tumor

Preliminary results of safety and antitumor activity from a first-in-human phase 1 study of AWT020, a bifunctional anti–PD-1/IL-2 fusion protein, in patients with advanced tumors. (ASCO 2026) - P1 | "AWT020 demonstrates a manageable safety profile and promising early antitumor activity, including in patients with acquired resistance to anti-PD-(L)1 therapies and in patients with pMMR tumors which typically are unresponsive to immune monotherapy. Dose escalation is ongoing to establish MTD/RP2D."

Clinical • First-in-human • Metastases • P1 data • Adrenal Cortex Carcinoma • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immunology • Lung Cancer • Musculoskeletal Pain • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia • Thymic Carcinoma • Thymoma • Thymus Cancer • Uterine Cancer • IL2

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=864 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Melanoma • Oncology • Prostate Cancer • 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."

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

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=480 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Monotherapy • New P2 trial • Melanoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P2 | N=864 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Lung Cancer • Oncology • Solid Tumor

Preliminary results of safety and antitumor activity from a first-in-human Phase 1 study of AWT020, a bifunctional anti-PD-1/IL-2 fusion protein, in patients with advanced tumors (SITC 2025) - "Dose escalation is ongoing to establish MTD/RP2D.Acknowledgements We are grateful to the patients who have participated in this study to date.Trial Registration NCT06092580Ethics Approval This study was approved by Australia Ethics Committees: Bellberry Limited (2023-06-698-A-6) and Alfred Health (HREC/100137/Alfred-2023). All patients provided informed consent prior to enrollment."

Clinical • First-in-human • Metastases • P1 data • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Endocrine Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Mesothelioma • Non Clear Cell Renal Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Sarcoma • Small Intestinal Carcinoma • Solid Tumor • Thymic Carcinoma • Thymoma • Thymus Cancer • IL2

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

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