Regulatory Filings • Sep 27, 2019
Regulatory Filings
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BerGenBio Presents Phase II Trial Updates with Selective AXL Inhibitor Bemcentinib at the European Society for Medical Oncology (ESMO) 2019 Congress
Bergen, Norway, 27 September 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, is to provide study updates in two poster
presentations from its Phase II clinical development programme with bemcentinib
(BGB324), a first-in-class highly selective oral AXL inhibitor, at the European
Society for Medical Oncology (ESMO) 2019 Congress, in Barcelona (27 September -
01 October 2019).
The first poster outlines data from BerGenBio's Phase II clinical trial (BGB008)
with bemcentinib and Merck's anti-PD-1 therapy pembrolizumab (KEYTRUDA) in
patients with advanced non-small cell lung cancer (NSCLC). Data shows that the
combination is well tolerated and showed promising efficacy in previously
treated NSCLC patients, particularly in those with AXL expression in tumour,
immune and stromal cells, including PDL-1 low/negative patients. The poster also
highlights the identification of a new novel predictive plasma protein
biomarker.
The second poster provides a trial update on a randomized Phase Ib/II study of
bemcentinib in combination with either dabrafenib/trametinib (D/T) or
pembrolizumab in patients with metastatic melanoma. Data from the trial shows
that bemcentinib is well tolerated in combination with both D/T and
pembrolizumab, with adverse effect profiles consistent with those reported for
either therapeutic approach alone.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "AXL mediates
aggressive traits when expressed on tumour, immune and stromal cells in cancers.
Bemcentinib inhibits this, and we see encouraging and very durable clinical
benefit in patients who otherwise would not be expected to respond to PD-1
inhibitors. Our comprehensive translational research program is yielding novel
biomarkers and validation of the mode of action of bemcentinib. We look forward
to providing updates as data from our ongoing investigations becomes available."
Presentation details
Full abstracts are available online at https://www.esmo.org/Conferences/ESMO
-Congress-2019/Abstracts and details of the presentations are below. The posters
presented at ESMO will be made available at www.bergenbio.com in the Investors /
Presentations section following the sessions.
Preliminary efficacy results of selective AXL inhibitor bemcentinib with
pembrolizumab following chemo in patients with NSCLC (ID 2041)
· Jose M. Trigo Perez et al
· 1576P - Poster Display session 1
· 28 September 2019: Poster Area (Hall 4), 12:00 - 13:00
Trial update: A randomized Phase Ib/II study of the selective small molecule Axl
inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib
(D/T) or pembrolizumab in patients with metastatic melanoma (ID 2131)
· Oddbjørn Straume et al
· 1336P - Poster Display session 3
· 30 September 2019: Poster Area (Hall 4), 12:00 - 13:00
- END -
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 bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class
selective AXL inhibitor in a broad phase II clinical development programme.
Ongoing clinical trials are investigating bemcentinib in multiple solid and
haematological tumours, in combination with current and emerging therapies
(including immunotherapies, targeted therapies and chemotherapy), and as a
single agent. Bemcentinib targets and binds to the intracellular catalytic
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.
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 focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL
-ADC (ADCT-601) are undergoing phase I 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). www.bergenbio.com
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic
Communications
+44 20 3709 5700
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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