BERGEN, Norway, June 25, 2020 /PRNewswire/ -- 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/
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."
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.
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