Pfizer Submits IND Application in China for PF-06730512, a First-in-Class ROBO2 Ligand Trap for Proteinuric Glomerular Kidney Diseases

Today, the CDE official website announced that Pfizer has submitted a clinical trial application in China for its Class 1 new drug, PF-06730512 Injection. Public information indicates that this product is a potential "first-in-class" project developed by Pfizer, containing a ROBO2 ligand (SLIT) trap.Public information shows that this product is a potential "first-in-class" project developed by Pfizer, containing a ROBO2 ligand (SLIT) trap. Currently, the product is in Phase 2 clinical research globally and is being developed for the treatment of a rare progressive kidney disease.

Screenshot source: CDE official website

ROB0 is a family of transmembrane receptors related to development, including four members: ROB01, ROB02, ROB03, and ROB04. Among them, ROB02 is mainly expressed in the nervous system and plays a crucial regulatory role in axon guidance and neuronal migration. R0B02 is a cell adhesion molecule immunoglobulin and serves as the receptor for SLIT1 and SLIT2. The SLIT-ROB0 signaling pathway achieves its diverse biological functions through various downstream signaling pathways, not only guiding axonal growth and neuronal migration but also playing a significant regulatory role in the migration of non-neuronal cells such as leukocytes, muscle cells, vascular endothelial cells, and vascular smooth muscle cells.

According to publicly available information from Pfizer, PF-06730512 is an innovative biologic developed by the company that contains a ROBO2 ligand trap. This product has the potential to alter the course of disease. A ligand trap is a recombinant molecule that includes relevant ligand-binding domains and can bind to its corresponding cytokines with high specificity and affinity. PF-06730512 can improve the function of renal podocytes, and therefore holds promise for the development of treatments for various proteinuric glomerular diseases associated with podocytes.

Previously, PF-06730512 has achieved positive results in a Phase 2a clinical trial for the treatment of focal segmental glomerulosclerosis (FSGS). FSGS is a rare progressive kidney disease, with approximately 60% of patients developing end-stage renal disease within 5 to 10 years. The interim analysis showed that PF-06730512 significantly reduced the urine protein-to-creatinine ratio (UPCR) in patients with drug-resistant FSGS. Additionally, the treatment, administered once every two weeks, was well-tolerated with no significant safety signals observed.