BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149

BGB149 is the first therapeutic anti-AXL monoclonal antibody to enter clinical development

BGB149 is BerGenBio's second novel clinical candidate targeting AXL

Phase I study will investigate safety and pharmacokinetics in healthy volunteers

BERGEN, Norway, Jan. 9, 2019 /PRNewswire/ -- 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, announces today that the first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL therapeutic monoclonal antibody BGB149 in healthy volunteers. 

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."

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.  

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II oncology clinical development programme focussed on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing Phase 1 clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy.

BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). 

Contacts

Richard Godfrey CEO
BerGenBio ASA
+47-917-86-304

Rune Skeie, CFO
BerGenBio ASA

+47-917-86-513

International Media Relations

David Dible
Mark Swallow
Marine Perrier
Citigate Dewe Rogerson

+44-207-638-9571

Media Relations in Norway

Jan Petter Stiff
Crux Advisers

+47-995-13-891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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