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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriBioteknik
BerGenBio är ett norskt onkologibolag. Idag bedriver bolaget forskning och utveckling av hämmande läkemedel för behandling av aggressiva cancertyper. Bolaget har utvecklat ett flertal produkter vars sammansättning ämnar blockera proteinet AXL, ett protein positivt relaterat med spridning av cancercellerna. Bolaget grundades under 2007 och har sitt huvudkontor i Bergen, Norge.
2020-06-25 19:05:22
· 6 of 7 checkpoint inhibitor refractory cAXL-positive patients report clinical
benefit
  · 12 evaluable patients for cAXL status, 7 of whom were cAXL-positive
  · 2.5 fold improvement in mPFS in cAXL-positive patients
  · Cohort A data-update mOS in cAXL-positive patients of 17.3 months.
  · Data presented today at the virtual Next Gen Immuno-Oncology Congress

Bergen, Norway, 25 June 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces positive clinical and translational data
from Cohort B, stage 1 of in the phase II trial (BGBC008). This cohort of the
trial is evaluating bemcentinib in combination with MSD's Keytruda[®]
(pembrolizumab) in previously treated non-small cell lung cancer (NSCLC)
patients with confirmed progression on prior immune checkpoint therapy. The
trial is recruiting the second stage of the cohort.

The data was presented today by Professor Hani Gabra M.D. Ph.D., Chief Medical
Officer of BerGenBio ASA, at the Next Gen Immuno-Oncology Congress, a virtual
event, see: https://events.marketsandmarkets.com/3rd-annual-marketsandmarkets
-next-gen-immuno-oncology-congress/#. The presentation will be available on the
Company website in the Presentations section
www.bergenbio.com/investors/presentations/ (https://eur03.safelinks.protection.o
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tlook.com/?url=https%3A%2F%2Fpublish.ne.cision.com%2Fl%2Fxgugwcmde%2Fwww.bergenb
i
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ed=0)

BerGenBio announced on 15th January 2020 that stage 1 of this trial cohort had
met its primary end point of overall response rate and criteria were met for
expansion of this cohort to a second stage.

The Company reports that Cohort B, stage 1 included 12 evaluable patients for
cAXL, BerGenBio's proprietary composite-AXL (cAXL) immunohistochemistry
biomarker. Seven of these 12 patients were scored cAXL positive, six of these
seven patients reported clinical benefit, including1 PR and 1 PRi (unconfirmed)
and 2.5 fold improvement in mPFS. Further, an update was presented for Overall
Survival data from cohort A, where cAX-postive patients reported 12-month OS of
79% and mOS of 17.3 months (data still maturing), whereas cAXL-negative 60% and
12.4months respectively and in-line with historic controls.

The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is conducted in
three cohorts evaluating the safety and benefit of bemcentinib and Keytruda
combination in refractory NSCLC patients. Cohort A (fully recruited, patients
that are refractory to first line chemotherapy), Cohort B (enrolling second line
patients who have received single agent checkpoint inhibitor in the first line)
and Cohort C (that enrols second line patients refractory to the first line
treatment of checkpoint inhibitor in combination with chemotherapy), cohorts B2
and C are actively recruiting patients. The study is being sponsored by
BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc.,
Kenilworth, New Jersey, USA, who continue to supply Keytruda[®] for use in the
study under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: "This interim
clinical and translational data adds further confidence to the potential patient
benefit of selective AXL inhibition with bemcentinib, to reverse resistance to
immune checkpoint inhibitors in selected cAXL-positive patients who have
relapsed on immunotherapy.  This would be a highly desirable alternative to the
second-line chemotherapy standard-of-care. Top line data from expansion cohorts
B2 and cohort C should be available towards the end of 2020."

- 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 expression defines a very poor prognosis
subgroup in most cancers. 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,
leukaemia and COVID19. 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 Elliott, 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.