BioCity Biopharmaceuticals and MSD have signed a clinical trial partnership agreement to assess BC3195 in conjunction with the latter’s Keytruda (pembrolizumab) in a global Phase I/II trial for individuals with locally advanced or metastatic solid tumours.
As per the agreement terms, the trial is set to be conducted by BioCity to investigate the efficacy and safety of the combination.
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Both companies will retain commercial rights to their compounds, with the trial’s recruitment anticipated in the fourth quarter of this year.
BioCity Biopharmaceuticals executive president and co-founder Ivy Wang said: “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.”
According to BioCity, BC3195 claims to be the sole antibody-drug conjugate (ADC) targeting cadherin 3 (CDH3) in clinical development worldwide.
Preclinical studies have shown that the ADC attaches to CDH3 with a ‘strong’ affinity and is internalised.
Its design includes a ‘clinically validated’, cleavable linker, as well as a vc-MMAE payload, which enables it to destroy targeted cancer cells and adjacent ones through the bystander effect.
The ADC is currently being assessed in Phase I dose optimisation and dose expansion trials in the US and China.
BioCity, founded in 2017, is a clinical-stage biopharmaceutical company focused on developing therapeutics for cancer and autoimmune conditions, including chronic kidney conditions.
It has a diverse pipeline of over ten drug candidates, ranging from small molecules to monoclonal and bispecific antibodies, as well as ADCs.
