Regulatory Filings • Sep 8, 2019
Regulatory Filings
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BerGenBio Presents Phase II Trial Updates with Selective AXL Inhibitor Bemcentinib in Non-Small Cell Lung Cancer at 2019 World Conference on Lung Cancer
Bergen, Norway, 8 September 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, will present study updates from its Phase II
clinical development programme with bemcentinib (BGB324), a first-in-class
highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at
the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain (07 - 10
September 2019).
The two presentations will outline BerGenBio's Phase II clinical trial (BGB008,
NCT03184571) with bemcentinib and Merck's anti-PD-1 therapy pembrolizumab
(KEYTRUDA) in patients with advanced non-small cell lung cancer (NSCLC).
Data will be presented at a mini oral session entitled: Efficacy Results of
Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in
Patients with NSCLC. As announced in June 2019, the preliminary results from the
ongoing study showed promising clinical activity overall, particularly in
patients with AXL positive tumours, including those with low or no PD-L1
expression. Preliminary median overall survival has reported 12.2 months,
surpassing historical benchmarks in second-line treatment with PD-1 inhibitor
monotherapy, especially in low PD-L1 patients; and the combination treatment was
well-tolerated.
The Company will also present details of a second cohort of the Phase II trial
(BGB008, NCT03184571) at a poster session, entitled: A Phase II Study of
Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC
Refractory to Anti-PD(L)1. The trial has been expanded to include patients that
have been previously treated with a PD-(L)1 inhibitor, or a PD-(L)1 inhibitor in
combination with platinum containing chemotherapy and will further evaluate the
clinical activity and safety profile of the combination.
Full abstracts are available online at https://wclc2019.iaslc.org. Materials
presented at WCLC will be made available at www.bergenbio.com in the Investors /
Presentations section following the sessions.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "As we
continue to gather data in refractory NSCLC patients, we hope to build up a
clearer picture of the potential of bemcentinib in combination with
pembrolizumab. Our focus remains on enhancing responses to anti-PD-L1 therapies,
particularly in patients with no or limited expression of PD-L1, who may not
have benefitted from such therapies. Results to date have been encouraging, and
we look forward to providing updates as further data becomes available."
BGBC008, which began in October 2017, is being conducted under a clinical
collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a
subsidiary, and is taking place at sites in the US, UK, Norway and Spain.
Presentation details
Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab
Following Chemotherapy in Patients with NSCLC
· Enriqueta Felip et al
· #MA03.06 - Clinomics and Genomics
· Mini Oral Session
· 08 September 2019: Colorado Springs (1994), 11:05 - 11:10am CEST
A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in
Patients with NSCLC Refractory to Anti-PD(L)1
· Matthew Krebs et al
· #P1.01-83 - Advanced NSCLC
· Poster Viewing in the Exhibit Hall
· 08 September 2019: Exhibit Hall, 09:45am CEST
- 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.
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