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· ADCT-601 is BerGenBio’s third clinical candidate targeting AXL
Bergen, Norway, January 21 2019 - 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 GlycoConnectT 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 Secur
http://www.netfonds.no/quotes/release.php?id=20190121.OBI.20190121S4
De har tydeligvis fortsatt tilgode å fullføre hvordan oppsettet av studiet skal se ut. Det kom også frem når det kommer til kostnader. Det har kommet signaler om at det kan komme en emisjon i løpet av 2019. Den kommer garantert ikke før de er ferdig med å planlegge studiet, for per nå så vet de ikke hvor mye de to studiene vil koste.