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· Advanced lung cancer (NSCLC): Additional cohort added in trial of
bemcentinib in combination with anti-PD-1 therapy KEYTRUDA®
· Anti-AXL antibody, BGB149, commenced phase I safety and pharmacokinetic
clinical trial.
Bergen, Norway, 08 May 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces its results for the first quarter 2019.
A presentation and live webcast by the Company’s management will take place
today at 10.00 am CET in Oslo, please see below for details.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
pleased to see the positive strategic and clinical momentum generated in the
last year continue into 2019. We have continued to see promising initial data
emerging from the clinical development programme with bemcentinib, particularly
in AML and NSCLC. We believe that this data provides us with sufficient evidence
to begin the initiation of late stage clinical development in these indications
during 2019. We are looking forward to providing an update on these data at the
forthcoming American Society of Clinical Oncology (ASCO) meeting in June.”
Operational Highlights
Lead candidate bemcentinib meets efficacy endpoint in combination with
cytarabine in AML patients unfit for intensive therapy
· Phase II trial evaluating bemcentinib in combination with low-intensity
chemo-therapy in AML patients unfit for intensive therapy fully recruited
· Bemcentinib in combination with Low-dose Cytarabine (LDAC) meets efficacy
endpoint: Three out of 10 evaluable LDAC patients (30%) had CR/CRi
· Combos warrant further expansion, meanwhile, company prepares for late
stage bemcentinib monotherapy trial in later line elderly AML patients unfit for
intensive chemotherapy
Phase II trial with bemcentinib and KEYTRUDA® in NSCLC made important progress
· Additional cohort (Cohort B) added under collaboration agreement with Merck
& Co extending eligibility to patients who have disease progression on prior
immune checkpoint inhibitors
Start of Phase II Investigator-Initiated Trial Evaluating Selective AXL
Inhibitor bemcentinib in high-risk MDS
· Up to 43 patients to be enrolled at leading MDS centres across Europe
Start of Phase I trial evaluating first-in-class anti-AXL antibody BGB149
· BGB149, a wholly owned asset, is the first therapeutic anti-AXL monoclonal
antibody to enter clinical development
· Phase I study will investigate safety and pharmacokinetics in healthy
volunteers
Start of phase I trial evaluating ADCT-601, a novel anti-AXL antibody drug
conjugate (ADC), in patients with advanced solid tumours
· ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed
to ADC Therapeutics for ADC development
· Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75
cancer patients
· Trial managed and sponsored by ADC Therapeutics
· First clinical milestone met and milestone payment received
Preclinical data presented at AACR reinforces bemcentinib’s potential to reverse
tumour immunosuppression and therapy resistance
· Extensive data in pre-clinical models of non-small cell lung cancer (NSCLC)
and pancreatic cancer demonstrating AXL’s role in reversing tumour-mediated
immunosuppression and therapy resistance presented at AACR
· bemcentinib shown to reverse AXL’s effects, thus acting synergistically with
immune cells and anti-cancer therapies
Key appointments to executive team and Board to prepare organisation for next
phase of development
· Key appointments to executive team and Board to prepare organisation for
next phase of development; Board of Directors strengthened. Grunde Eriksen,
Debra Barker and Pamela Trail elected as new board members.
· Dr Dominic Smethurst appointed as permanent Chief Medical Officer (CMO)
· Favourable outcome of arbitration brought by BerGenBio against Rigel
Pharmaceuticals clarifying the extent of Rigel’s entitlement to receive
compensation in the event of a sale of BerGenBio, its assets, or a license to
Bemcentinib
· R&D grant of up to NOK 11 m awarded by Research Council of Norway
Financial highlights
· Total operating expenses for the first quarter were NOK 54.5 million (Q1
2018 NOK 54.8 million)
· Research and development expenses accounted for 70% of total operating
expenses in Q1
· Comprehensive loss for the first quarter amounted to NOK 44.3 million (Q1
2018 a loss of NOK 53.8 million)
· Cash and cash equivalents amounted to NOK 306.7 million at the end of March
2019
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place today at
10:00 am CET at:
Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.
The presentation will webcast live and the link will be available
at www.bergenbio.com in the section Investors/Financial Reports. A recording
will be available shortly after the webcast has finished.
The results report and presentation will be available at www.bergenbio.com in
the section: Investors/Financial Reports from 7:00 am CET the same day.
-END-
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, 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 and
leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing
Phase I clinical testing. In parallel, BerGenBio is developing a companion
diagnostic test to identify those 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
[email protected]
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Jessica Hodgson, Chris Welsh, Nicholas Brown, Carina Jurs,
Consilium Strategic Communications
[email protected]
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
[email protected]
+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.
http://www.netfonds.no/quotes/release.php?id=20190508.OBI.20190508S21