KJ103 / Shanghai Bao Pharma, KisoJi Biotech - LARVOL DELTA

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