BerGenBio’s lead candidate BGB324 is a first in class, highly selective, potent and orally available small molecule Axl kinase inhibitor in clinical development in a variety of cancer indications. The Axl tyrosine kinase is a key driver of cancer spread, immune evasion and drug resistance – the cause of the majority of cancer-related deaths.
Increased understanding of the role of Axl in suppressing innate immunity supports the rationale for evaluating BGB324 in combination with Keytruda.
Under the terms of the collaboration with MSD, BerGenBio will conduct two international Phase II studies to evaluate the potential clinical synergy of combining BGB324 with MSD’s anti-PD-1 therapy, Keytruda. Details of the studies are as follows:
BGBC007 – A Phase II multi-centre study of BGB324 in combination with Keytruda in patients with previously treated, locally advanced or unresectable TNBC.
BGBC008 – A Phase II multi-centre study of BGB324 in combination with Keytruda in patients with previously treated unresectable adenocarcinoma of the lung.
Biomarker studies will be conducted in parallel to the above studies with the goal of developing companion diagnostics to identify patients who would be most suitable for treatment with the BGB324/Keytruda combination.
The clinical trials will be sponsored by BerGenBio while MSD will provide the trial with Keytruda. The rights to the study results will be shared. No further details are disclosed.
BerGenBio is investigating BGB324 in multiple cancer indications based on preclinical and early clinical findings. Phase II studies with BGB324 as a single agent in relapsed acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS); and in combination with erlotinib (TARCEVA) in advanced EGFR-positive NSCLC are in progress.
BerGenBio CEO Richard Godfrey said: “We are delighted to enter this collaboration with MSD, a leader in developing novel cancer therapies. This new agreement gives us the opportunity to evaluate the clinical potential of BGB324 in combination with Keytruda in advanced lung and breast cancer; two of the areas of significant unmet medical need.
“We believe that BGB324 is a unique drug candidate that addresses a critical cancer mechanism responsible for promoting immune evasion. We believe the clinical utility of BGB324 in combination with immunotherapies has enormous potential.
“BerGenBio is excited to advance BGB324 in combination with Keytruda into Phase II trials and we anticipate results in mid-2018.”