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A presentation and live webcast by BerGenBio’s senior management will take place
at 10.00 am CET today, please see below for details.
Operational Highlights - third quarter of 2020 (including post-period end)
Oncology
· Primary endpoint met in BERGAMO Phase II Trial investigating bemcentinib in
patients with High Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid
Leukaemia (AML)
· The multicenter Phase II study evaluated the safety and efficacy of
bemcentinib monotherapy in 45 patients with HR-MDS or AML who had relapsed
following multiple rounds of prior treatment with hypomethylating agents (HMAs)
· The primary endpoint overall response rate (CR, Cri, PR or SD) assessed
after 4 treatment cycles was met,
· Data from this trial will be presented at ASH in December 2020.
· First patient dosed in investigator led study assessing bemcentinib in
recurrent glioblastoma (GBM)
· Increased expression of the receptor tyrosine kinase AXL is significantly
correlated with poor prognosis in GBM patients and preclinical data has
suggested that bemcentinib may be a promising therapeutic agent for GBM
· The study will enroll up to 20 recurrent GMB patients, at up to 15 sites
in the US
· First patient dosed in MiST3 trial assessing bemcentinib in relapsed
malignant pleural mesothelioma patients
· The investigator led study, sponsored by the University of Leicester, is
funded by the British Lung Foundation, and is in collaboration with MERCK; forms
part of the world’s first molecularly stratified umbrella study in mesothelioma
designed to enable the acceleration of novel, effective personalised therapy as
a basis for improving survival outcomes for patients with mesothelioma
· The study will enroll up to 26 patients at three sites in the United
Kingdom
· Pre-clinical data on humanized anti-AXL antibody tilvestamab, presented at
virtual 32[nd] EORTC NCI AACR (ENA) Symposium
· The data, presented in an ePoster at ENA in October, showed that
tilvestamab prevents AXL mediated cell signalling in cancer cell lines, reduces
cell migration and invasion and shows anti-tumor efficacy in a panel of mouse
xenograft models
· Tilvestamab is currently being evaluated in a Phase I clinical study to
evaluate safety, tolerability and pharmacokinetics
· Selected for an oral presentation at the Society for Immunotherapy of Cancer
(SITC) 35[th] Annual Meeting
· BerGenBio presented clinical translational research updates from its Phase
II bemcentinib and pembrolizumab combination study (BGBC008) in advanced non
-small cell lung cancer (NSCLC)
COVID-19
· First patient enrolled in BerGenBio-sponsored Phase II clinical trial in
South Africa and India, assessing the efficacy and safety of bemcentinib for the
treatment of hospitalised COVID-19 patients
· The first patient was enrolled in South Africa in October. The Phase II
study will recruit 120 hospitalised COVID-19 patients across five sites in South
Africa and seven sites in India
· The primary endpoint of the trial will be time to clinical improvement of
at least two points (from randomisation) on a nine-point ordinal scale, or live
discharge from the hospital, whichever comes first
· UK Research and Innovation (UKRI) has reinstated funding for the COVID-19
ACCORD clinical study in which BerGenBio’s bemcentinib is one of three drug
candidates to be evaluated
· The University Hospital Southampton NHS Trust remains the study sponsor,
and the trial will be managed by the Medicines Evaluation Unit at Manchester
University
· Several substantial administrative amendments were made, and these
required regulatory approval.
Q2 2020 Financial Highlights
(Figures in brackets = same period 2019 unless otherwise stated)
· Revenue for the third quarter of 2020 and the nine months ended 30 September
2020, respectively, amounted to NOK 0.0 million (NOK 0.0 million), and NOK 0.0
million (NOK 8.7 million).
· Total operating expenses for the third quarter and the nine months ended 30
September 2020, respectively, amounted to NOK 68.3 million (NOK 47.5 million)
and NOK 189 million (NOK 154.0 million).
· Cash and cash equivalents at the end of the third quarter amounted to NOK
777.9 million (NOK 289.5 million)
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "In this
quarter we have made solid progress with BerGenBio’s primary development
objectives to confirm clinical safety and proof of concept efficacy for
bemcentinib in lung cancer and leukaemia. While the COVID-19 crisis has
continued to delay clinical trials, including our own, we are pleased that
hospitals have opened again for clinical trials and new patients continue to be
recruited. Already enrolled patients remain on study.
“Overall, we remain well positioned. With a NOK 520 million fundraising
completed in May this year our cash position is strong. We have a promising
pipeline with two drug candidates backed by pioneering biology and a growing
bank of favourable clinical data with further important readouts anticipated in
two major cancer indications, and strong science supporting ongoing COVID-19
trials in the UK, India and South Africa. As always, I am grateful to the
patients and their families for their trust in participating in our clinical
trials, our staff and collaborators for their dedication and to our shareholders
for their continued support. I look forward to providing further updates on our
progress in the coming months.”
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place today at
10:00 am CET:
Webcast link:
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20201117_1
Dial-in numbers:
NO: +47-21-956342
SE: +46-4-0682-0620
DK: +45 78768490
UK: +44-203-7696819
US: +1 646-787-0157
Pin: 712491
The third quarter report and presentation are available on the Company’s website
in the Investors/Financial Reports section and a recording of the webcast will
be made available shortly after the webcast has finished.
-Ends-
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,
leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody,
tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is
developing companion diagnostic tests to identify 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). For more
information, visit www.bergenbio.com
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mary-Jane Elliot, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+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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