BioCity and MSD Collaborate on Clinical Trial for BC3195-KEYTRUDA® (Pembrolizumab) Cancer Treatment
Friday, March 14, 2025
BioCity Biopharmaceutics has announced a clinical trial collaboration with MSD to assess the combination of BC3195 and KEYTRUDA® (pembrolizumab) in patients with locally advanced or metastatic solid tumours.
BC3195 is the only antibody-drug conjugate (ADC) targeting CDH3 (P-Cadherin) currently in clinical development worldwide. Preclinical studies indicate that BC3195 binds to membrane CDH3 with high affinity and is efficiently internalised.
It is designed with a clinically validated, cleavable linker and payload (vc-MMAE), enabling the destruction of targeted cancer cells and nearby cells through the bystander effect.
In animal models, BC3195 has demonstrated a favourable safety profile and strong anti-tumour activity, achieving tumour growth inhibition of 100% or more in certain cases.
The treatment is currently undergoing Phase 1 dose optimisation and dose expansion in China and the United States.
Initial clinical results show that BC3195 has a manageable safety profile, favourable pharmacokinetics, and significant anti-tumour activity, with confirmed partial responses observed across multiple tumour types.
The study will be conducted as a global Phase 1/2 clinical trial.
As part of the agreement, BioCity will oversee the trial to evaluate the safety and effectiveness of BC3195 when combined with MSD's anti-PD-1 therapy, KEYTRUDA. Both companies will retain commercial rights to their respective treatments. Recruitment for the study is expected to commence in the fourth quarter of 2025.
Early clinical data suggest that BC3195, when used alone, has demonstrated promising anti-tumour activity in certain non-small cell lung and breast cancers.
The collaboration aims to further investigate its potential when used in combination with KEYTRUDA.
Source: prnewswire.com
