SHANGHAI, March 13, 2025 /PRNewswire/ — BioCity Biopharmaceutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate the combination of BioCity’s BC3195 and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors.
Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025.
“We are encouraged by the clinical data we have seen thus far for BC3195 as monotherapy, which have demonstrated improved anti-tumour activity in patients with certain non-small cell lung and breast cancers. We now look forward to exploring the potential of BC3195 in combination with KEYTRUDA through this collaboration, as we continue to advance our clinical program and seek to further validate our differentiated drug discovery and development approach.” Said by Ivy Wang, Co-founder and Executive President of BioCity.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About BC3195
BC3195 is currently the only ADC targeting CDH3 (P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers.
BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and in US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types.
About BioCity
Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC).
Currently, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. In addition, BioCity’s SC0062, a highly selective ETA antagonist, is in phase 3 clinical development for IgA nephropathy and a global phase 3 registration trial is being planned.
For more information, please visit www.biocitypharma.com
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