CBX - China Biotech XYZ

Simcere/Zenshine/Xianxiang has submitted the IND application for the CDH6 antibody-drug conjugate (ADC) SIM0505 in China. According to the company statement, this ADC is being developed as a potential treatment for malignant tumors, such as ovarian and renal cancer. CDH6 is a type II classical cadherin, also known as K-cadherin, consisting of 790 amino acids, located in the lateral basement membrane of epithelial cells, where it mediates calcium-dependent cell-cell adhesion. CDH6 is expressed in various cancer types, including kidney, ovarian, and thyroid cancers. CDH6‐activated αIIbβ3 crosstalks with α2β1 to trigger cellular adhesion SIM0505 SIM0505 is a CDH6-targeting antibody-drug conjugate (ADC) by linking a CDH6-specific monoclonal antibody, which binds selectively to tumor cells, with camptothecin toxoid molecules. The company described the product is designed by combining the tumor targeting of antibodies with the high-efficiency killing effect of toxin molecules, while avoiding...

Duality Biologics has initiated a trial ( NCT06554795 ) of an anti-B7H3xPD-L1 BsAb ADC, DB-1419, in the United States, Australia, and China. However, Duality Bio has not yet submitted the IND application in China. In 2023, BioNTech and DualityBio entered into a partnership to globally develop, manufacture, and commercialize two assets, including an ADC (DB-1311/BNT324) targeting B7H3. Duality and BioNTech DB-1419 DB-1419 is a bispecific antibody-drug conjugate targeting B7H3 and PD-L1. It was discovered by Duality Biologics and is still in the preclinical stage according to the pipeline on the official website.  In 2022 and 2023, Duality Biologics filed patents (WO2024140846 ) covering anti-B7H3xPD-L1 BsAb ADCs. The patent includes examples of bispecific antibody-drug conjugates comprising the following components: an anti-B7H3 and PD-L1 bispecific antibody or an antigen-binding fragment thereof, a linker unit L, and TOP1 inhibitor, with a drug-to-antibody ratio (DAR) of 4, 6, or ...

 Huadong Medicine submitted the IND application for HDP-101, an anti-BCMA Antibody-Drug Conjugate, in China. In 2022, Huadong Medicine acquired Asia (excluding Japan) rights for HDP-101 and HDP-103, which is an anti-PSMA ADC, from  Heidelberg . The agreement also included an exclusive opt-in right for two additional candidates, amounting to a total of 930 million USD. HDP-101 HDP-101 is a novel ADC targeting BCMA linked to amanitin as a payload with a DAR of 2. The product is under-investigated in the phase 1/2 clinical study in patients with multiple myeloma. HDP-101 During the 2024 AACR Annual Meeting, Heidelberg presented the stage 1 results of a clinical trial. There were no dose-limiting toxicities (DLT) among the first 4 cohorts, but 3 DLTs related to thrombocytopenia occurred in cohort 5. The dose optimization for cohort 5 is still ongoing. Regarding the efficacy, 1 patient in cohort 3 archived stable disease. In cohort 5, 2 patients archived PR, and 2 have SD.  Th...

  Lepu Biopharma and Miracogen have submitted the IND application for MRG006A, an anti-GPC3 ( Glypican-3 ) ADC in China, and the IND application is also expected to be submitted to the US FDA this year. MRG006A MRG006A is a GPC3-targeting ADC composed of a novel humanized IgG1 antibody conjugated to a potent topoisomerase 1 inhibitor via a peptide-based cleavable linker, with a DAR ratio of 8. MRG006A Lepu Biopharma and  Miracogen presented the results of the preclinical study of MRG006A at the 2023 AACR Annual Meeting. Highlights demonstrated its superior binding activity to GPC3-expressing cancer cell lines, rapid internalization, and potent GPC3-dependent cytotoxic activity. In 2022, Miracogen filed a patent (WO2024061305 ) covering the GPC3 ADCs and their use in cancers, including liver cancer.  The ADCs discussed in the examples included several candidates with DAR values ranging from 2 to 4, all of which were tested in the LIV#219 liver cancer PDX model. GP...

 Biosion submitted the IND application for BSI-992, a TROP2 ADC, on April 9th, 2024 in China. The TROP2 targeting antibody, discovered by Biosion, was licensed to OBI Pharma in 2021. OBI ADC Technology  OBI Pharma (台灣浩鼎) owns the ex-China right of BSI-992/OBI-992 , with the US FDA clearing  an IND application for a Phase 1/2 Study in Jan 2024. The phase 1 trial in the US is estimated to be completed in 2025Q2. Besides OBI-992, OBI Pharma has also discovered a next-generation anti-TROP2 ADC, OBI-902, using the GlycOBI platform in various drug-antibody ratios (DAR). Furthermore, a BsADC targeting TROP2 and HER2 is currently in the preclinical stage. BSI-992/ OBI-992 OBI-992 is a TROP2-directed antibody-drug-conjugate (ADC) that carries a potent topoisomerase I inhibitor and uses a hydrophilic, enzyme-cleavable linker. Upon binding to TROP2 on the surface of cancer cells, OBI-992 is internalized into the cell and trafficked to lysosomes where the linker is cle...