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first half of 2020.
A presentation and live webcast by BerGenBio’s senior management will take place
at 10.00 am CET today, please see below for details.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Set against
the unprecedented backdrop of a global pandemic, this has been an eventful
period for BerGenBio. During this time we have continued our focus on
progressing clinical trials of our lead candidate bemcentinib in non-small cell
lung cancer (NSCLC) and Acute Myeloid Leukaemia (AML) and more recently COVID
-19, while ensuring that the safety and wellbeing of our staff and the patients
participating in our clinical trials has been and remains our top priority.
"The COVID-19 crisis has and will likely continue to delay clinical trials
throughout the sector and as anticipated has impacted patient recruitment into
BerGenBio clinical studies and extended previously anticipated timelines. The
impact of the pandemic on our clinical trials has continued through the second
quarter, but we are pleased that new patients continue to be recruited into our
clinical studies with bemcentinib, and already enrolled patients have been able
to continue their treatment throughout the restrictions.
"We continue to make progress, with a latest milestone in NSCLC trial presented
at the Next Gen Immuno-Oncology Congress conference where 6 of the 7 identified
AXL positive patients reported clinical benefit and data showed a 2.5-fold
improvement in median Progression-free Survival.
“The Company remains in a strong cash position, with two drug candidates backed
by pioneering biology, continued favourable clinical results and important data
readouts on the horizon in two major cancer indications, as well as a potential
COVID-19 treatment. This is an exciting time for us.”
Operational Highlights - second quarter and the first half of 2020 (including
post-period end)
· Positive interim clinical and translational phase II data with bemcentinib
in combination with KEYTRUDA® in checkpoint inhibitor refractory NSCLC patients
· In June, BerGenBio presented positive data from its Cohort B, stage 1, in
the phase II trial evaluating bemcentinib in combination with KEYTRUDA® in
patients with advanced non-small cell lung cancer (NSCLC) and with confirmed
progression on prior immune checkpoint therapy.
· The trial included 12 evaluable patients for cAXL, BerGenBio’s proprietary
composite-AXL (cAXL) immunohistochemistry biomarker. 7 of these 12 patients were
cAXL-positive whereby 6 of these 7 patients reported clinical benefit and 2.5
-fold improvement in mPFS.
· BerGenBio also reported an update on Overall Survival data from Cohort A,
where cAXL-positive patients reported 12-month Overall Survival of 79% and
median Overall Survival of 17.3 months, whereas cAXL-negative reported 60% and
12.4 months respectively.
· Data was presented at the NextGen Immuno-Oncology Congress, 25 June
· First patient dosed in bemcentinib COVID-19 study in June 2020
· In April, BerGenBio announced the selection of bemcentinib as the first
candidate in a UK Government-backed national ACCORD study.
· The study was a multicentre, seamless, Phase II adaptive randomisation
platform trial to assess the efficacy and safety of multiple candidate agents
for the treatment of COVID-19 in hospitalised UK NHS patients, and the first
patient was dosed in June.
· At the end of July, the incidence of COVID-19 in the UK had drastically
reduced and the UK Research and Innovation’s (UKRI) decided to cease grant
funding. Subsequently, the University Hospital Southampton NHS Trust notified
all sites in the ACCORD programme to cease the recruitment of new patients into
the trial for all candidate agents. Patients already recruited, including those
dosed with bemcentinib, will continue on treatment as per the protocol.
· The decision to halt the study reflected the significant decrease in the
incidence of COVID-19 in the UK and difficulty recruiting a sufficient number of
patients and in no way reflected any interpretation of the efficacy or safety of
any of the candidate agents.
· BerGenBio is now in the late stage set-up phase to sponsor a similar
study to ACCORD in a country of high COVID-19 incidence.
· First patient dosed in bemcentinib Glioblastoma study in July 2020 (post
-period)
· In July, BerGenBio announced the first patient was dosed in an
investigator-initiated trial (IIT) assessing bemcentinib in recurrent
glioblastoma (GBM). The study will enrol up to 20 recurrent GBM patients, at up
to 15 sites in the USA.
· 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,
particularly in post-irradiation mesenchymal-transformed GBM tumors.
· A comprehensive translational research programme will run in parallel with
the clinical trial.
Q2 2020 Financial Highlights
(Figures in brackets = same period 2019 unless otherwise stated)
· Revenue for the second quarter amounted to NOK 0.0 million (NOK 0.0 million)
and for the six months ended 30 June NOK 0.0 million (NOK 8.7 million). The
revenue in 2019 reflects clinical milestone payments from ADCT.
· Total operating expenses for the second quarter amounted to NOK 64.7 million
(NOK 52.0 million) and for the six months ended 30 June NOK 121.0 million (NOK
106.5 million). NOK 7.5 million (NOK - 2.5 million) of operating expenses was
non cash accruals for option cost.
· The operating loss for the quarter came to NOK 64.7 million
(NOK 52.0 million) and for the six months ended 30 June NOK 121.0 million (NOK
97.8 million), reflecting the level of activity related to the clinical trials
BerGenBio are conducting.
· Cash and cash equivalents increased to NOK 828.4 million by 30 June (NOK
419.4 by 31 March 2020).
· Private placement completed in May 2020, with gross proceeds NOK 520 million
(including NOK 20 million from repair issue in July). Net proceeds to be used to
take full advantage of clinical development opportunities stemming from the
Company’s technology and to progress readiness for early commercialisation
possibilities and general corporate purposes.
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/webcast/hegnarmedia/20200818_6/
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 second quarter report and presentation is 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
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 and 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 those patient populations most
likely to benefit from bemcentinib or tilvestamab: this is expected to
facilitate more efficient registration trials and support 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 further information, please 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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