KJ103 / Shanghai Bao Pharma, KisoJi Biotech - LARVOL DELTA

A Clinical Trial With KJ103 in Anti-GBM Disease (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Short-Term Repeat Dosing of KJ103 (Ricefidase) Enables Sustained IgG Reduction for Enhanced AAV Gene Therapy (ASGCT 2025) - "This dosing strategy will expand the therapeutic window for different types of AAV vector administration, potentially increasing patient eligibility and improving gene transduction efficiency. Theoretically, our findings support the incorporation of a repeat-dosing regimen into future protocols of AAV-based gene therapies, providing a novel insight to overcome both pre-existing and treatment-induced anti-AAV immunity."

Gene therapy • Gene Therapies

Clinical Validation of Short-Term Triple Dosing of KJ103 (Ricefidase) for Sustained IgG Reduction in AAV Gene Therapy (ASGCT 2025) - "These results establish KJ103 as a versatile tool for optimizing AAV-based gene therapy strategies, with potential implications for broader clinical applications. Disease Focus of Abstract:Autoimmune Disorders"

Clinical • Gene therapy • Gene Therapies • Immunology

KJ103: An IgG-Degrading Enzyme That Reduces Neutralizing Antibodies Against AAV2 and AAV8 to 10% with a Single Dose, with Repeat Dosing Capability Allowing Further Reductions and Potential for AAV Re-Dosing (ASGCT 2025) - "Furthermore, by effectively lowering NAbs and permitting its own repeat dosing, KJ103 may unlock viable re-dosing strategies for AAV-based therapies. Disease Focus of Abstract:Genetic Diseases"

Gene Therapies • Genetic Disorders • Infectious Disease

KJ-103: First-in-class naked anti-TROP2 HCAb with immune modulatory mechanisms and tumor regression potential in clinical trials (AACR 2025) - "This work highlights the feasibility of developing functional, payload-free anti-TROP2 antibodies for clinical use, addressing current challenges associated with ADCs and expanding therapeutic options for patients with TROP2-positive cancers. KJ-103, as the first naked anti-TROP2 HCAb is under development for clinical trials and represents a groundbreaking advancement in cancer immunotherapy."

Clinical • IO biomarker • Breast Cancer • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Safety, efficacy, and immunogenicity of a novel IgG degrading enzyme (KJ103): results from two randomised, blinded, phase 1 clinical trials. (PubMed, Gene Ther) - "These properties are ideal for the management of immune disorders, rejection responses, and immunotherapies where pre-existing antibodies can reduce efficacy. Furthermore, we tested AAV2 neutralizing antibodies to confirm the potential utility of KJ103 in enhancing gene therapy."

Journal • P1 data • Gene Therapies • Immunology

KisoJi Biotechnology Raises $41 Million to Advance Lead Program Into the Clinic and Deploy AI Tools Into Key Pipeline Indications (PRNewswire) - "KisoJi Biotechnology Inc...announces that it has raised $41 million in equity, including the conversion of previously funded convertible debentures. These funds will be used to advance its lead asset, KJ-103, the first potent naked antibody against TROP2, into the clinic to treat solid tumours. Funds will also be used to deploy its cutting-edge antibody discovery platform towards new multi-specific therapeutic antibody drugs in cardiometabolic disease, as well as immunology and inflammation."

Financing • Solid Tumor

KJ103, a novel variant of an IgG-degrading enzyme changes neutralizing antibody titers against AAV2 and AAV8, which leads to rescuing and multiple-dosing of AAV-based gene therapies (ESGCT 2024) - No abstract available

Gene therapy • Gene Therapies

Cancer Research UK and KisoJi Biotechnology Collaborate to Advance the First Naked Antibody Against TROP2 Into the Clinic (Canada Newswire) - "Cancer Research UK...and KisoJi Biotechnology Inc...have signed a landmark agreement to bring KisoJi's lead asset, KJ-103, into a first-in-human clinical trial. KJ-103 is a naked anti-TROP2 antibody that has been created by KisoJi using its proprietary antibody technology. Under the agreement, Cancer Research UK's Centre for Drug Development (CDD) will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours."

Commercial • New P1/2 trial • Oncology • Solid Tumor

A Clinical Trial with KJ103 in Anti-GBM Disease (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.

New P2 trial

A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Aug 2023

Trial completion • Trial completion date

KJ103, a novel variant of an IgG‐degrading enzyme with a lower titer of pre‐existing anti‐drug antibodies, which could improve safety, efficacy, and potential of multiple‐dosing along with AAV‐based gene therapies (ESGCT 2023) - "Among the clinical and non-clinical studies, KJ103 has the potential in becoming a pre-treatment of AAV-based gene therapy to overcome the limitation of Nabs to improve efficacy, expand the patient pool, and enable re-dosing of gene therapy. KJ103 is considered a viable solution to address the unmet medical needs of AAV-based gene therapy."

Clinical • Gene therapy • Gene Therapies • Infectious Disease

Functional characterization of KJ-103, a novel therapeutic anti-TROP2 heavy chain-only antibody (AACR 2023) - "Immunohistochemistry showed that the KJ-103 epitope was expressed across many tumor types, including breast, colon, ovarian, and head and neck among others. KJ-103 is a HCAB that has demonstrated high levels of preclinical potency and safety making it suitable for clinical development for TROP2 positive tumors."

Bladder Cancer • Breast Cancer • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Urothelial Cancer • SIRPA • TACSTD2

A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults (clinicaltrials.gov) - P1 | N=34 | Active, not recruiting | Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed