On January 9, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class drug candidates targeting AXL kinase to treat aggressive diseases including immune-evasive and therapy resistant cancers, reported that the first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL therapeutic monoclonal antibody BGB149 in healthy volunteers (Press release, BerGenBio, JAN 9, 2019, View Source [SID1234532614]).
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BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter clinical development and is BerGenBio’s second clinical stage drug development programme targeting AXL.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to initiate this Phase I study as planned. BGB149 has cleared all required regulatory pre-clinical evaluations. This AXL functional blocking antibody is BerGenBio’s second drug candidate to enter clinical trials: An important milestone in expanding our pipeline of first-in-class AXL targeting drug candidates positioned to treat aggressive diseases with severe unmet medical need. We are expecting results from this Phase I trial in 2019 and are looking forward to announcing BGB149’s further clinical development strategy in the coming months."
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About BGB149 and the Phase I Healthy Volunteer Trial
BGB149 is a fully humanised anti-AXL functional blocking monoclonal antibody, developed and fully-owned by BerGenBio. A robust, high yielding manufacturing process has been established and preclinical studies have confirmed its mechanism of action as well as efficacy.
The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following single dose administration.The study is being sponsored by BerGenBio.
For more information, see ClinicalTrials.gov: NCT03795142
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that Axl mediates other aggressive diseases