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
Or LinkedIn BioCity Biopharma
Contact:
BD@biocitypharma.com
IR@biocitypharma.com
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SOURCE BioCity Biopharma
