BergenBio Fundamentale Forhold (BGBIO)

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acs.jmedchem.0c02093.pdf (5,1 MB)

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Kan SARS-CoV-2 overvinne vaksinene? - NHI.no

[TekBot]

BERGENBIO ANNOUNCES STOPPED RECRUITMENT TO THE BEMCENTINIB ARM IN UK ACCORD COVID PLATFORM TRIAL

Bergen, Norway, 30 March 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that recruitment to the bemcentinib arm of
…

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the Phase two COVID-19 trial platform ACCORD, has been stopped today following
review by the Scientific Advisory Committee.

Due to the success of the vaccine roll out and public health measures taken in
the UK, COVID-19 case incidence has fallen rapidly, and the decision has been
made to halt UK recruitment at 30 patients and a similar number of matched
controls, enabling a prompt analysis of results. No safety concerns have been
identified.

BerGenBio’s company sponsored Phase II trial (BGBC020), assessing the efficacy
and safety of bemcentinib for the treatment of COVID-19 in hospitalised patients
in South Africa and India, has completed recruitment. Data from the ACCORD study
and BerGenBio’s Phase II COVID-19 trial study will be analysed separately and in
combination in a meta-analysis to inform next steps for this potential new
treatment.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
grateful to the University of Southampton and the ACCORD clinical trial platform
for evaluating bemcentinib in hospitalised COVID-19 patients in the UK, the
cohort of 30 patients taking bemcentinib and matched controls will complement
our data sets for our similar study conducted in South Africa and India. We look
forward to closely reviewing the data generated from this trial, as well as from
our own study. We believe bemcentinib has great promise as a treatment for
COVID-19 complimentary to the ongoing global mass vaccination programs”.

-Ends-

About ACCORD

The ACcelerating COVID-19 Research & Development (ACCORD) is a clinical trial
platform sponsored by Southampton University Hospital and is being funded by the
UK Research and Innovation (UKRI) with modest financial contribution by
BerGenBio and the other drug candidate contributing companies, to test potential
drugs through early stage clinical trials and feed them for consideration into
the UK’s large-scale COVID-19 studies such as the RECOVERY trial
(https://www.nihr.ac.uk/urgent-public-health-research-studies-for-covid
-19/randomised-evaluation-of-covid-19-therapy-recovery/24513).

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
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.

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.
Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body’s immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.

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 clinical development
programme focused on combination and single agent therapy in lung cancer,
leukaemia and COVID-19. A first-in-class functional blocking anti-AXL
antibody, tilvestamab, is undergoing phase I clinical testing. In
parallel, BerGenBio is developing a companion diagnostic test to identify
patient populations most likely to benefit from AXL inhibition: 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

ir@bergenbio.com

Richard Godfrey CEO, BerGenBio ASA

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.

Kilde

[larslars]

What. Ufattelig at ACCORD bare har klart å ta inn 30 pasienter. Hva er det de driver med??

[an29o]

Det er et veldig godt spørsmål. Jeg hadde foretrukket null nyheter fra ACCORD og fullt fokus på BGBIO sine egne studier

[HeldigFyr]

Håper de har lært at UK er ikke den beste sted å ha studier på gang. Flere selskaper som sliter i UK med sånt.

[Zuba]

Accord har vært en stor skuffelse fra start. Del 1 og del 2. Jeg tror andre medisiner i Accord også blir lagt ned.
Forøvrig legger jeg merke til at de fortsatt har troa på bem mot covid og de sitter garantert på en del info fra egen studie.

We believe bemcentinib has great promise as a treatment for
COVID-19 complimentary to the ongoing global mass vaccination programs”.

[Skeptikern]

“We believe bemcentinib has great promise as a treatment for
COVID-19”

At han sier det 30.03.2021, så lenge etter at studien fra India og Sør Afrika er avsluttet, må vel bety at dataene derifra er gode (?) Eller er det mulig at han ikke har sett dataene enda?

[HeldigFyr]

Det pleier å være veldig vanntett. Tror ikke han har sett noe. Som en annen påpeker, bra at alle resultater faller mer og mer sammen.

[BillyP]

Så totalt skal det analyseres 60+60 fra BGBC020 og 30+30 fra ACCORD. Var det ikke noe info om at første armen i ACCORD var ferdig midten av mars? Det er kanskje det som BergenBio melder nå, men hvorfor melde nå? Kanskje det kommer mer før påske

[diffish]

@BillyP

men hvorfor melde nå?

Fordi aksjonærer kommer til å spørre når de oppdager det gjennom andre kilder.

[HeldigFyr]

Nei Billy, beklager men virkelig studieresulter er ikke kjent enda, ellers hadde vi fått en likt melding med resultater.

[Hayen]

@HeldigFyr

Det pleier å være veldig vanntett. Tror ikke han har sett noe

Bergenbio har fått data fra BGBC020 i minst to måneder.
De har nok veldig god oversikt over hvordan det ligger an

[BillyP]

Hva tenker du på? Vi får ikke noe mer fra ACCORD på en stund men resultater fra BGBC020 skal jo komme rundt kvartalskiftet (ser teksten min kan misforstås).

[tekdude]

Safety ok,men effekten av bem kan ikke ha vært overbevisende,ellers hadde den blitt sendt videre til recovery. Skuffende

[Hayen]

De kan jo ikke sende noe videre til Stage2 Accord eller Recovery før Accord er ferdig med å rekruttere.

[BillyP]

De kan vel ikke kjøre på med fase 3 uten å analysere resultatene? Oi, det ser ut som dette virker så rett over på neste fase.

[BillyP]

BerGenBio stanser rekruttering til Covid-19-behandling

[an29o]

Hvorfor må overskriftene og artiklene alltid ha en pseudo-negativ vinkling? For noe svada

[tekdude]

joda.håper jeg tar feil. det har blitt tidligere skrevet at ved signifikant effekt så ville medikamenter bli sendt videre til recovery. står lengre opp i denne tråden. at studiet blir stoppet igjen pga vaksinering og at bergenbio til og med har finansiert studiet med noen småkroner likevel blir stoppet taler vel for manglende effekt. håper jeg tar feil, men denne meldingen var ikke oppløftende.