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

Beigene has submitted the IND application for the PRMT5 (Protein arginine methyltransferase 5) inhibitor BGB-58067 in China. This aligns with the plan to enter the clinic in Q4 2024. BGB-58067 BGB-58067 is a second-generation MTA-cooperative PRMT5 inhibitor with brain-penetrating and good intracranial efficacy. MTAP-deletion lung cancer and GI cancers are the target diseases for the PRMT5 inhibitor. 2nd generation PRMT5 inhibitor BG PRMT5i In 2019 and 2023, Beigene filed patents for PRMT5 inhibitors, providing several examples. Patents [Update]  In September 2024, Beigene registered a phase 1 trial ( NCT06589596 ) of BGB-58067 monotherapy in solid tumors patients. The potential of combining PRMT5 inhibitor with IO therapy (anti-PD-1, etc.) may be explored. PRMT5 Inhibitors in China Currently, no PRMT5 inhibitors are under investigation in the clinical stage. SIM0272 , discovered by Simcere, was terminated from the phase 1 trial as an R&D strategy adjustment.  GTA182 GTA182 is

 Simcere and its subsidiary Xianxiang have initiated the phase 1 study ( NCT06375044 ) of SIM0500, an anti-GPRC5D×BCMA×CD3 tri-specific antibody  in China. The first-in-human trial is estimated to enroll 130 patients  to evaluate the safety, tolerability, efficacy, and pharmacokinetics of SIM0500. SIM0500 The US FDA has recently approved several anti- GPRC5D ×CD3 and anti-BCMA×CD3 bispecific antibodies for patients with multiple myeloma (MM). Up to now, no tri-specific antibody has been approved for MM.  Previously, we reported the submission of the IND application for the phase 1 trial of SIM0500. The preclinical study showed the binding and efficacy data compared to teclistamab ( 特立妥单抗,  JNJ 7957) and  talquetamab (塔奎妥单抗,  JNJ 7564). Preclinical results of SIM0500 The phase 1 study for SIM0500 is focused on patients with refractory or relapsed multiple myeloma (rrMM) who have not responded to conventional standard-of-care treatments. Since no anti- GPRC5D ×CD3 and anti-BCMA×CD3 bispe