- Favourable interim safety data reported across three phase
II clinical trials with bemcentinib in combination with KEYTRUDA®
(pembrolizumab)
- Immune response demonstrated in AML patients treated with
bemcentinib monotherapy in phase II clinical trial
- Two posters featuring four of BerGenBio's six phase II
clinical trials with selective AXL inhibitor bemcentinib presented
at the ASCO-SITC Clinical Immuno-Oncology Symposium
BERGEN, Norway, Jan. 29, 2018 /PRNewswire/ -- BerGenBio ASA (OSE:
BGBIO), a clinical-stage biopharmaceutical company focused on
developing bemcentinib as a potential cornerstone therapy for
multiple cancer indications, today announced the presentation of
data from its broad phase II clinical development programme with
its selective AXL inhibitor bemcentinib (BGB324) in two posters at
the ASCO-SITC Clinical Immuno-Oncology Symposium (January 25-27, San
Francisco, CA, USA).
One poster outlined favourable interim safety data from three
phase II clinical trials with bemcentinib in combination with
KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed by Merck
& Co., Inc., Kenilworth, N.J.,
USA (known as MSD outside the US and Canada). Furthermore, an AXL
immunohistochemistry (IHC) method developed and validated by the
Company was shown to clearly detect the presence of AXL on tumour
and immune cells in patient samples thus holding promise as a
potential future companion diagnostic.
The second poster provided translational analyses from
BerGenBio's phase II trial in acute myeloid leukaemia (AML), with
bemcentinib used as a single agent. The results showed a clear
immunomodulatory effect as a result of selective AXL inhibition, as
evidenced by increased immune activity characterised by
diversification of patients' T-cell receptor repertoire.
The data presented strengthens the Company's proposition that
its selective, first-in-class and orally bioavailable AXL inhibitor
bemcentinib may hold promise as an immunomodulatory agent, both as
backbone to current and emerging immune checkpoint inhibitor
regimens as well as a monotherapy by demonstrating the
following:
(1) Combining bemcentinib with KEYTRUDA has thus far been well
tolerated:
In a poster presentation entitled: "Combination of
bemcentinib (BGB324) – a first-in-class selective, oral AXL
inhibitor – with pembrolizumab in patients with triple negative
breast cancer and adenocarcinoma of the lung," Murray Yule (MD, PhD), Clinical Development
Officer at BerGenBio, detailed:
- A total of 34 patients across the Company's three trials
combining bemcentinib with KEYTRUDA (Trial ref. BGBC007 in
triple-negative breast cancer, trial ref. BGBC008 in non-small cell
lung cancer and trial ref. BGBIL006 in melanoma) have thus far been
evaluable for safety of the drug combination
- The spectrum of observed serious adverse events was similar to
that reported for KEYTRUDA alone.
(2) Treatment with bemcentinib has immunomodulatory effect:
In a poster presentation entitled: "The immunomodulatory
activity of bemcentinib (BGB324) – a first-in-class selective, oral
AXL inhibitor in patients with relapsed/refractory Acute Myeloid
Leukemia or Myelodysplastic Syndrome," Professor Sonja Loges (MD, PhD), attending physician at
the University Hospital in Hamburg-Eppendorf and lead investigator
of the BGBC003 trial, detailed the following:
- 35 patients with relapsed/refractory (R/R) AML or
myelodysplastic syndrome (MDS) received bemcentinib monotherapy as
part of the BGBC003 trial. Two patients achieved complete responses
with incomplete recovery of peripheral counts (CRi) and five
achieved partial responses (PR). Eight patients reported disease
stabilisation for more than four months. Three patients remain on
study at the time of data cut-off (Jan
17th 2018).
- Six out of nine patients analysed showed a diversification of
the T-cell receptor repertoire in their peripheral blood, bone
marrow or both indicative of increased immune activity as a result
of AXL inhibition.
Richard Godfrey, CEO of BerGenBio
commented: "I am pleased that the data presented at ASCO-SITC
demonstrate that our first-in-class, selective AXL inhibitor
bemcentinib is well tolerated in combination with the anti-PD-1
therapy KEYTRUDA. This is fundamental data supporting the
positioning of AXL inhibition as a future cornerstone of cancer
therapy. I am also extremely encouraged by the data reported
showing that bemcentinib can generate a positive immune response,
particularly in R/R AML and MDS patients who tend to be a severely
immunocompromised patient population. These data build on the
recently reported favourable safety data of bemcentinib in
combination with chemo- and targeted therapy as well as the first
evidence of bemcentinib's ability to reverse acquired resistance to
these treatments. I look forward to reporting continued progress
across our broad phase II development programme with bemcentinib at
medical and scientific congresses during the upcoming months."
About TNBC and the BGBC007 trial
Breast cancer is the most common cancer in women – it is
estimated that more than 250,000 new cases will be diagnosed in the
US in 2018. 20% of breast cancers lack receptors for three common
hormones (oestrogen, progesterone and HER2) and are thus called
triple-negative breast cancers (TNBC). Treatment options for TNBC
are limited to intense chemotherapy, but disease recurrence is
frequent and aggressive. Consequently, novel treatment strategies
for TNBC are urgently needed.
BGBC007 is a phase II multi-centre open label study of
bemcentinib (BGB324) in combination with KEYTRUDA in patients with
previously treated, non-resectable TNBC or triple negative
inflammatory breast cancer. Up to 56 patients will be included in
the study. For more information, please access trial NCT03184558 at
www.clinicaltrials.gov.
About NSCLC and the BGBC008 trial
It is estimated that more than 220,000 new cases of lung cancer
will be diagnosed in the US in 2018 and it is the leading cause of
cancer deaths. 65% of NSCLCs are classed as adenocarcinoma of the
lung. Although various treatments exist for NSCLC, they are often
curtailed by acquired resistance to therapy. Novel treatments
overcoming this resistance in NSCLC are urgently required.
BGBC008 is a phase II multi-centre open label study of
bemcentinib (BGB324) in combination with KEYTRUDA in patients with
previously treated advanced adenocarcinoma of the lung. Up to 48
patients will be included in the study. For more information,
please access trial NCT03184571 at www.clinicaltrials.gov.
About melanoma and the BGBIL006 trial
Melanoma is the most serious type of skin cancer and may spread
to lymph nodes and distant organs if not discovered in time.
Melanoma occurs when the pigment cells in the skin (melanocytes),
divide uncontrollably. It is estimated that in 2016, there were
almost 150,000 melanoma diagnoses in the US alone. If detected very
early, melanoma has a good prognosis; for patients with advanced
melanoma, however, the probability of surviving five or more years
is less than 20%.
BGBIL006 is an investigator initiated, randomised phase II trial
combining bemcentinib with either KEYTRUDA or dabrafenib/trametinib
in patients with advanced non-resectable or metastatic melanoma who
are naïve for systemic treatment. Up to 92 patients will be
enrolled across three arms. For more information, please access
trial NCT02872259 at www.clinicaltrials.gov.
About AML and the BGBC003 trial
AML is the most common form of acute leukaemia diagnosed in over
20,000 patients in the US annually and is rapidly lethal if left
untreated. Successful treatment typically requires intensive
therapy or bone marrow transplantation, and relapse and resistance
are common. Consequently, there is an urgent need for effective
novel therapies in R/R patients, particularly those that are
ineligible for intensive therapy.
BGBC003 is a phase Ib/II multi-centre open label study of
bemcentinib (BGB324) as a single agent in patients with AML or MDS
or in a combination with chemotherapy (cytarabine and decitabine)
in AML patients. Up to 75 patients will be enrolled at centres in
the US, Norway, Germany and Italy. For more information, please access
trial NCT02488408 at www.clinicaltrials.gov.
About the 2018 ASCO-SITC Clinical Immuno-Oncology
Symposium
The ASCO-SITC Clinical Immuno-Oncology Symposium is an
international conference focused on clinical and translational
research in immuno-oncology and the implications for clinical care.
https://immunosym.org/
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company
focused on developing a pipeline of first-in-class AXL kinase
inhibitors as a potential cornerstone of combination cancer
therapy. The Company is a world leader in understanding the
essential role of AXL kinase in mediating cancer spread, immune
evasion and drug resistance in multiple aggressive solid and
haematological cancers.
BerGenBio's lead product, bemcentinib (BGB324), is a selective,
potent and orally bio-available small molecule AXL inhibitor in
four Company sponsored Phase II clinical trials in major cancer
indications, with read-outs anticipated during 2018. It is the only
selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
- leukaemiaBGB324 with TARCEVA® (erlotinib) in advanced EGFR
mutation driven non-small cell lung cancer (NSCLC)
- BGB324 with KEYTRUDA in advanced adenocarcinoma of the lung,
and
- BGB324 with KEYTRUDA in triple-negative breast cancer
(TNBC).
- BGB324 as a single agent and combination therapy in acute
myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
The clinical trials combining BGB324 with KEYTRUDA in
adenocarcinoma of the lung and TNBC are conducted in collaboration
with Merck & Co., Inc. (Kenilworth,
NJ, USA), through a subsidiary.
In addition, a number of investigator-sponsored trials are
underway, including a trial to investigate BGB324 with either
MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in
advanced melanoma, as well as a trial combining BGB324 with
docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic
test to identify patient subpopulations most likely to benefit from
treatment with BGB324. This will facilitate more efficient
registration trials and support a precision medicine based
commercialization strategy.
The Company is also developing a diversified pre-clinical
pipeline of drug candidates, including BGB149, an anti-AXL
monoclonal antibody.
For further information, please visit:
www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc. (Kenilworth, NJ, USA). TARCEVA® is a registered
trademark of OSI Pharmaceuticals, LLC., marketed by
Roche-Genentech. TAFLINAR® is a registered trademark of
Novartis International AG and MEKINIST® is a registered trademark
of GSK plc.
Contacts
Richard
Godfrey
CEO, BerGenBio ASA
+47-917-86-304
Tom Henrik Sundby
Finance Director, BerGenBio ASA
tom.sundby@bergenbio.com
+47-477-54-415
Media Relations
David
Dible, Mark Swallow,
Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
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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