China-based CStone Pharmaceuticals (HKG: 2616) has announced the clinical filing for its CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. This first-in-human study is registered and published on Clinicaltrials.gov with the NCT number: NCT06741644.
Innovative Design and Mechanism of CS2009
CS2009 boasts an innovative molecular design that simultaneously targets PD-1, VEGFA, and CTLA-4 while maintaining balanced affinity for PD-1 and CTLA-4. This unique feature allows the drug to preferentially target and block PD-1 and CTLA-4 on double positive tumor infiltrating lymphocytes (TILs) without affecting CTLA-4 on single positive cells, reducing potential systemic toxicity while ensuring therapeutic efficacy. Furthermore, CS2009 induces high and rapid internalization, leading to the down-regulation of PD-1 and CTLA-4 expression on the TIL cell membrane.
Pre-Clinical Synergistic Effects and Upcoming Clinical Trials
In pre-clinical studies, CS2009 has demonstrated significant synergistic effects in terms of anti-VEGF function and immune checkpoint inhibition function, significantly enhancing anti-PD-1 and anti-CTLA-4 activities. A multi-regional, first-in-human clinical trial for CS2009 is planned to commence in Australia in early 2025, with subsequent expansion into China and the United States.-Fineline Info & Tech