BERGEN, Norway, Jan. 21, 2019 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), announces that the first patient has been
dosed in a phase I clinical trial evaluating the safety,
tolerability, pharmacokinetics and anti-tumour efficacy of
ADCT-601, an AXL-targeting antibody drug conjugate (ADC), in
patients with advanced solid tumours.
ADCT-601 is composed of a humanised monoclonal antibody against
human AXL (BGB601) discovered by BerGenBio, conjugated to a
pyrrolobenzodiazepine (PBD) dimer toxin. BGB601 was out-licensed
for ADC development to ADC Therapeutics SA (ADCT). In preclinical
studies, ADCT-601 has demonstrated potent and specific anti-tumour
activity in multiple in vivo models and was stable
and well tolerated, as reported by ADCT at the American Association
of Cancer Research (AACR) annual congress in 2018.
The open-label, multi-centre, single arm phase I trial will
enrol approximately 75 patients with selected tumour types and will
be managed and sponsored by license partner ADC Therapeutics. For
more information
see https://clinicaltrials.gov (accessing trial
identifier NCT03700294).
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "We congratulate ADC
Therapeutics on reaching this important milestone. We are pleased
to now see three of our AXL-targeting modalities in clinical
development with the potential to address large patient
populations. Our focus remains on completing our ongoing oncology
phase II programme with bemcentinib, a first-in-class highly
selective oral AXL inhibitor, and start randomised, potentially
pivotal trials later this year. In the meantime, we look forward to
providing updates on the development of BGB149, a therapeutic AXL
antibody, and ADCT-601, an anti-AXL
ADC, as they progress through phase I testing."
About ADCT-601
BerGenBio out-licensed two novel and proprietary anti-AXL
monoclonal antibodies invented by the Company to ADC Therapeutics
SA (ADCT) for the development of an antibody drug conjugate
(ADC).
ADCT-601 is composed of BGB601, a humanised monoclonal antibody
that binds to human AXL, conjugated using GlycoConnect™ technology
to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once
bound to an AXL-expressing cell, ADCT-601 is internalised into the
cell where enzymes release the PBD-based warhead. The PBD-based
warhead has the ability to form highly cytotoxic DNA interstrand
cross-links, blocking cell division and ultimately killing the
cancer cell. ADCT-601 is currently undergoing Phase I clinical
testing (NCT03700294).
Under the license, a series of development, regulatory and
sales-based milestones are due to BerGenBio from ADCT upon the
achievement of certain specified events. The first milestone
payment is triggered during the phase I clinical study.
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
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 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 focussed on combination and
single agent therapy in lung cancer and leukaemia. A
first-in-class functional blocking AXL antibody (BGB149) and an
AXL-ADC (ADCT-601) are 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). 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
Mark Swallow/David Dible, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
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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