BergenBio Fundamentale Forhold (BGBIO)

[TekBot]

BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL

Bergen, Norway - 02 June 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that dosing has commenced in the UK
…

Vis børsmeldingen

Government-backed Phase II clinical trial assessing bemcentinib in hospitalised
COVID-19 patients.

Bemcentinib was selected as the first candidate to be tested as part of the
ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched
by the Department of Health and Social Care (DHSC) and UK Research and
Innovation (UKRI) on 28[th] April 2020. ACCORD brings together a single, UK
-wide clinical trial platform to rapidly test potential drugs through early
stage clinical trials and feed them into the UK’s large-scale COVID-19 studies.

The first patient has been dosed with bemcentinib at the University Hospital
Southampton NHS Foundation Trust. The study is open in a further seven sites
across the UK. The Phase II study will recruit 120 subjects in total, assessing
the safety and efficacy of bemcentinib as an add-on therapy to standard of care
(SoC) in 60 hospitalised COVID-19 patients with a further 60 control group
patients receiving SoC.

BerGenBio anticipates that top line data will readout later in the summer. Data
will be open source and freely available to enable global knowledge sharing and
collaboration. If positive results are seen, bemcentinib will advance rapidly
into the large-scale Phase III trials in the UK.

The study is fully funded by the DHSC and UKRI and is being managed by clinical
research company IQVIA. Drug material and other trial resources will be provided
by BerGenBio.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
delighted that dosing has commenced with bemcentinib in the ground-breaking
ACCORD study and we hope that patients will swiftly start to see benefits.
Initiating this clinical trial in such short order is the result of tremendous
teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS,
among many others. This illustrates exactly what can be achieved when we all
work together and focus on delivering the best experimental drug candidates to
patients that so urgently need them. We look forward to providing results as
soon as is practically possible and very much hope our drug can fulfil the aims
of the study and be used to treat thousands of COVID-19 patients worldwide.”

Professor Tom Wilkinson, ACCORD clinical academic lead based at the National

Institute for Health Research (NIHR) Southampton Biomedical Research Centre,
said: “The ACCORD platform is allowing us to rapidly test potential new
treatments in response to the COVID-19 emergency. This unique national platform
for developing COVID-19 drug candidates will access the world-class expertise
and resources of the NIHR Respiratory Translational Research Collaboration and
allied centres nationwide. We believe this programme will be key to developing
effective new treatments and are delighted to see the first candidate,
bemcentinib, enter the clinic today.”

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 and
COVID-19 infections. 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, 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 companion diagnostic tests to identify those
patient populations most likely to benefit from bemcentinib or tilvestamab: this
is expected to facilitate more efficient registration trials and support 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

For more information, please contact

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, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

[email protected]

+44 7780 600290

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.

Kilde

[TekBot]

BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL

Bergen, Norway - 02 June 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that dosing has commenced in the UK
…

Vis børsmeldingen

Government-backed Phase II clinical trial assessing bemcentinib in hospitalised
COVID-19 patients.

Bemcentinib was selected as the first candidate to be tested as part of the
ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched
by the Department of Health and Social Care (DHSC) and UK Research and
Innovation (UKRI) on 28[th] April 2020. ACCORD brings together a single, UK
-wide clinical trial platform to rapidly test potential drugs through early
stage clinical trials and feed them into the UK’s large-scale COVID-19 studies.

The first patient has been dosed with bemcentinib at the University Hospital
Southampton NHS Foundation Trust. The study is open in a further seven sites
across the UK. The Phase II study will recruit 120 subjects in total, assessing
the safety and efficacy of bemcentinib as an add-on therapy to standard of care
(SoC) in 60 hospitalised COVID-19 patients with a further 60 control group
patients receiving SoC.

BerGenBio anticipates that top line data will readout later in the summer. Data
will be open source and freely available to enable global knowledge sharing and
collaboration. If positive results are seen, bemcentinib will advance rapidly
into the large-scale Phase III trials in the UK.

The study is fully funded by the DHSC and UKRI and is being managed by clinical
research company IQVIA. Drug material and other trial resources will be provided
by BerGenBio.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
delighted that dosing has commenced with bemcentinib in the ground-breaking
ACCORD study and we hope that patients will swiftly start to see benefits.
Initiating this clinical trial in such short order is the result of tremendous
teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS,
among many others. This illustrates exactly what can be achieved when we all
work together and focus on delivering the best experimental drug candidates to
patients that so urgently need them. We look forward to providing results as
soon as is practically possible and very much hope our drug can fulfil the aims
of the study and be used to treat thousands of COVID-19 patients worldwide.”

Professor Tom Wilkinson, ACCORD clinical academic lead based at the National

Institute for Health Research (NIHR) Southampton Biomedical Research Centre,
said: “The ACCORD platform is allowing us to rapidly test potential new
treatments in response to the COVID-19 emergency. This unique national platform
for developing COVID-19 drug candidates will access the world-class expertise
and resources of the NIHR Respiratory Translational Research Collaboration and
allied centres nationwide. We believe this programme will be key to developing
effective new treatments and are delighted to see the first candidate,
bemcentinib, enter the clinic today.”

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 and
COVID-19 infections. 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, 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 companion diagnostic tests to identify those
patient populations most likely to benefit from bemcentinib or tilvestamab: this
is expected to facilitate more efficient registration trials and support 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

For more information, please contact

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, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

[email protected]

+44 7780 600290

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.

Kilde

[TekBot]

BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL

Bergen, Norway - 02 June 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that dosing has commenced in the UK
…

Vis børsmeldingen

Government-backed Phase II clinical trial assessing bemcentinib in hospitalised
COVID-19 patients.

Bemcentinib was selected as the first candidate to be tested as part of the
ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched
by the Department of Health and Social Care (DHSC) and UK Research and
Innovation (UKRI) on 28[th] April 2020. ACCORD brings together a single, UK
-wide clinical trial platform to rapidly test potential drugs through early
stage clinical trials and feed them into the UK’s large-scale COVID-19 studies.

The first patient has been dosed with bemcentinib at the University Hospital
Southampton NHS Foundation Trust. The study is open in a further seven sites
across the UK. The Phase II study will recruit 120 subjects in total, assessing
the safety and efficacy of bemcentinib as an add-on therapy to standard of care
(SoC) in 60 hospitalised COVID-19 patients with a further 60 control group
patients receiving SoC.

BerGenBio anticipates that top line data will readout later in the summer. Data
will be open source and freely available to enable global knowledge sharing and
collaboration. If positive results are seen, bemcentinib will advance rapidly
into the large-scale Phase III trials in the UK.

The study is fully funded by the DHSC and UKRI and is being managed by clinical
research company IQVIA. Drug material and other trial resources will be provided
by BerGenBio.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
delighted that dosing has commenced with bemcentinib in the ground-breaking
ACCORD study and we hope that patients will swiftly start to see benefits.
Initiating this clinical trial in such short order is the result of tremendous
teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS,
among many others. This illustrates exactly what can be achieved when we all
work together and focus on delivering the best experimental drug candidates to
patients that so urgently need them. We look forward to providing results as
soon as is practically possible and very much hope our drug can fulfil the aims
of the study and be used to treat thousands of COVID-19 patients worldwide.”

Professor Tom Wilkinson, ACCORD clinical academic lead based at the National

Institute for Health Research (NIHR) Southampton Biomedical Research Centre,
said: “The ACCORD platform is allowing us to rapidly test potential new
treatments in response to the COVID-19 emergency. This unique national platform
for developing COVID-19 drug candidates will access the world-class expertise
and resources of the NIHR Respiratory Translational Research Collaboration and
allied centres nationwide. We believe this programme will be key to developing
effective new treatments and are delighted to see the first candidate,
bemcentinib, enter the clinic today.”

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 and
COVID-19 infections. 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, 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 companion diagnostic tests to identify those
patient populations most likely to benefit from bemcentinib or tilvestamab: this
is expected to facilitate more efficient registration trials and support 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

For more information, please contact

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, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

[email protected]

+44 7780 600290

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.

Kilde

[Fornybar]

Data
will be open source and freely available to enable global knowledge sharing and
collaboration.

Verden kan åpne seg raskere enn vi tror. Veldig spennende og en fantastisk gratissjanse for et norsk selskap.

[Kjell_Makrell]

Dette var en fin melding å få på en tirsdag morra

[Evilfreud]

Arctic

• BERGENBIO: FIRST PATIENT INCLUDED

1. Bemcentinib: first drug candidate to be fasttrack in UK initiative (ACCORD)
2. The phase 2 study will include 120 patients (60 on bemcentinib and 60 placebo)
3. First patient included. Result expected aug/sep, then potential fast initiation of phase 3
4. Potential approval and sales from Q4/20

[Markusf]

Når kan vi forvente oppdatert kursmål fra Arctic?

[Fornybar]

Salg i 4Q20?

[Mykle]

Går det veien vil jo det være mulig…

[one]

Two Manchester Hospitals in Drugs Trial join Desperate Search for Coronavirus...

[Flottesen]

Klart det blir salg i Q4 hvis det faktisk virker. Remdesivir fikk godkjenning på 3 måneder. Hvis man har noe som virker, så trenger man ikke å slite for å få det godkjent, myndighetene vil presse gjennom godkjenningen for deg.

[larsmkn]

Fase I studien av BGB149 er nå oppført som “complete”. De skulle komme tilbake til hvilke indikasjoner de ville prøve den i senere:

A First-time-in-human Study of BGB149 - Full Text View - ClinicalTrials.gov

[Timm]

De kunne gjerne oppdatert hjemmesiden sin ang. BGB149 …

BGB149 is a first-in-class function blocking antibody with potent pre-clinical anti-tumour activity. The fully humanised antibody is anticipated to enter the clinic towards the end of 2018.

BGB149 - BerGenBio

[larsmkn]

Siden det nå er “in clinic” så tipper jeg det blir oppdatert når de prøver det ut i en indikasjon

[Fornybar]

Har du noen formening om hva?

[larsmkn]

Vanskelig å si. De har hatt mye fokus på fibrose og NASH i det siste så tror det er sannsynlig at vi ser noe der, men også mulig at de går for noen kreftindikasjoner. BGB149 er heleid av bergenbio, men et antistoff (biological) som må gis via influsjon, så tipper de har en del strategiske hensyn rund dette. Dette er komplisert, men refusjonsordninger og patenter kan være litt mer hyggelig for et biological (sånn som jeg har forstått det), enn det er for et molekyl av typen bemcentinib.

[one]

COVID-19 Treatment: Bemcentinib, Heparin and 3 other drugs to be tested by UK...

[Magnus1]

A First-time-in-human Study of BGB149 - Full Text View - ClinicalTrials.gov

Edit: Sorry, så den var lagt ut tidligere

[one]

First patient dosed in bemcentinib COVID-19 trial

[vcp]

Det er noen ting som er svært annerledes med denne studien enn hva man kan regne som normal innen biotech. Her er de fremste spesialister involvert fra flere hold. Studien er det ikke BergenBio som faseliterer; studien er underlagt «Department of Health and Social Care and UK Research and Innovation (UKRI).
IQVIA styrer ACCORD med Astrazeneca som sektor representant.

Inn rullering er jeg ikke i det minste bekymret for. Det er fortsatt nok pasienter å ta av og samme vil etter all sannsynlighet, dessverre være tilfelle i Fase III.

Når det kommer til medisin på markedet, hvor lang tid tror du det tar om sikkerhet og effekt blir påvist i Fase II ? Det kommer til å gå fort!

Denne prosessen er allerede startet, med det mener jeg innhentet cash, tilrettelegging for eksponensiell etterspørsel og partner for distribusjon. Uttalt av Godfrey som parallell løp de jobber med.

Med alle indikasjonene som nå ligger til grunn her, med siste fra longdec i småpraten er jeg overbevist om full klaff. Det er ikke spørsmål om, men om hvor stort dette blir.