BerGenBio - US Clinical Trial Update

 

Bergen, Norway, 15 March 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective Axl kinase inhibitors for
multiple cancer indications, provides an update on BGBC004, an ongoing, company
sponsored USA only phase Ib/II clinical trial evaluating bemcentinib in
combination with TARCEVA® (erlotinib) in first and second line patients with non
-small cell lung cancer (NSCLC).
In November 2017, BerGenBio informed that the Company was in voluntary
discussions with the Regional Ethics Committee (REK) in Bergen and the Norwegian
Board of Health about gaining retrospective approval for the study: the Company
can confirm that it has now received a notice of non-acceptance from the
Norwegian National Ethics Committee (NEM) for the retrospective approval for the
conduct of this clinical trial outside Norway.

In accordance with international good clinical practice BerGenBio secured all
necessary approvals from the US Food & Drug Administration (FDA) and from the
ethics committees at the participating USA hospitals prior to initiating the
study in 2014.

To date 33 NSCLC patients have been enrolled in the trial and ten patients have
reported clinical benefit (four partial responses and six stable disease) from
taking the combination of bemcentinib and erlotinib. In some cases, the patient
benefit is observed for more than two years. This preliminary outcome is viewed
as very promising at this stage in the clinical development of bemcentinib.

The clinical trial remains ongoing in the USA, BerGenBio maintains the view that
the study qualifies for retrospective approval and will formally ask NEM to
reconsider their decision. There is currently uncertainty what implications the
decision may have for the study (if the decision is upheld), as no research
activities are carried out in Norway and all necessary foreign approvals have
been acquired. BerGenBio will attempt to secure a meeting with the authorities
to determine the future next steps.

BerGenBio has relevant approvals for all of the other Phase II clinical trials
with bemcentinib that are currently ongoing in multiple cancer indications,
alone and in combination with other cancer therapies.

Richard Godfrey, BerGenBio CEO: commented: "We are disappointed and perplexed
that NEM has not provided us with a clear explanation for its decision not to
provide retrospective approval for the bemcentinib-erlotinib combination study.
This trial has all the necessary approvals in the USA where it is being
conducted and is generating promising clinical results in patients with advanced
lung cancer. We are strongly committed to working towards a solution with the
relevant authorities in Norway, and in the meantime the clinical trial remains
ongoing in the USA, with an interim readout expected in mid-2018."

- Ends -

About the BGBC004 trial

The BGBC004 trial is a Phase I/II multi-centre open-label study of bemcentinib
in combination with erlotinib in patients with EGFR mutation driven Stage IIIb
or Stage IV NSCLC. The trial is designed to evaluate reversal of resistance to
EGFR targeted therapy in later line patients who are negative for the T790M
mutation as well as prevention of resistance in patients receiving the EGFR
inhibitor erlotinib first line. Patients are currently being enrolled at centres
across in the US. For more information please access trial NCT02424617
at www.clinicaltrials.gov.

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on
developing a pipeline of first-in-class AXL kinase inhibitors as a potential
cornerstone of combination cancer therapy. The Company is a world leader in
understanding the essential role of AXL kinase in mediating cancer spread,
immune evasion and drug resistance in multiple aggressive solid and
haematological cancers.

BerGenBio's lead product, bemcentinib (BGB324), is a selective, potent and
orally bio- available small molecule AXL inhibitor in four Company sponsored
Phase II clinical trials in major cancer indications, with read-outs anticipated
during 2018. It is the only selective AXL inhibitor in clinical development.

The Company sponsored clinical trials are:

  ·
Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-
small cell lung cancer (NSCLC)

  ·
Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and

  ·
Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).

  · Bemcentinib as a single agent and combination therapy in acute myeloid
leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the
lung and TNBC are conducted in collaboration with Merck & Co., Inc., Kenilworth,
NJ, USA, through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a
trial to investigate bemcentinib with either MEKINIST® (trametinib) plus
TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial
combining bemcentinib with docetaxel in advanced NSCLC.

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BerGenBio is simultaneously developing a companion diagnostic test to identify
patient subpopulations most likely to benefit from treatment with bemcentinib.
This will facilitate more efficient registration trials and support a precision
medicine based commercialization strategy.

The Company is also developing a diversified pre-clinical pipeline of drug
candidates, including BGB149, an anti-AXL monoclonal antibody.

For further information, please visit: www.bergenbio.com

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of
OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a
registered trademark of Novartis International AG and MEKINIST® is a registered
trademark of GSK plc.

Contact

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

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

Media Relations

Jan Petter Stiff, Crux Advisors
stiff@crux.no
+47 995 13 891

David Dible, Mark Swallow, Marine Perrier: Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securitie 

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