BergenBio Fundamentale Forhold (BGBIO)

[Hakon]

Utelukkende positivt for meg. Det er såpass målbar effekt at de tar det videre kontra å terminerte studien slik de har gjort med de som har feilet. At bemcentinib blir en del av en cocktail er naturlig gitt omfanget av covid-19 skader. Det er alt fra hjerne til lunger til div. Da trengs det også flere legemidler med forskjellige virkeområder

[Mykle]

Godt poeng!

[Dormancy]

De har nok ikke analysert effekt enda.

Dette gjøres som Boykie sier av etiske grunner. Man holder ikke tilbake legemidler man vet fungerer for å teste noe man ikke vet om fungerer. Derfor oppdateres SoC, alle som tolker dette som noe mer baserer seg ikke på det som står i meldingen.

[Savepig]

Ble postet på shareville av en kar:

[Evilfreud]

Virker å være presentasjonen de skal ha imorgen?

[Multiple]

Det er et poeng at hvis man oppdaterer SoC så må man oppdatere bemcentinib-delen av studien.
Men, dette er neppe så enkelt som at man gir bem + remdesivir + dexamethason sammen.
Disse medikamentene bør gis på ulike stadier i sykdomsutviklingen. Bem er den som antas virke best tidlig, så har rem et smalt vindu, mens dex ikke bør gis til andre enn de aller sykeste der immunforsvaret har kommet ut av kontroll.

[Timm]

Virker å være presentasjonen de skal ha imorgen?

Den er nok fra en litt eldre pres.
På ABG seminaret 10.juni skrev de det samme og da var antall pasienter økt fra 280 til 350 …

[Evilfreud]

Ahh greit å få avklart

[arcone]

Dr. Jackson will also deliver a presentation on BerGenBio at 11:35am CEST
on 9 July.

The presentation will be made available on the Company website on 9 July:
www.bergenbio.com/investors/presentations/.

Intet nytt i dag. Forventes det intet nytt i morgen også?

Slike investor presentasjoner, gir de effekt på kursen og eventuelt når?

[Fornybar]

Ja, det gjør de. Ofte går det opp før presentasjonen og ned etterpå.

[Zuba]

Intet nytt?

[arcone]

BergenBio Småprat (BGBIO)

For øvrig ikke noe nytt fra Akil / bgbio i panel debatten. Laidback presentasjon av Bemcentinib og indikasjonene som tilsier effekt.

Ja, var slik jeg forstod det på @vcp

[Borup19]

Fra finansavisen - bgticker. Ref.: Yngling ØH

Platform Study Overview".

"The ACCORD Platform is constructed to allow simultaneous evaluation og multiple agents, compared to standard of care therapy (SOC), and is structured in two stages.

The initial stage, ramdomly allocates patients to an individual site in a one-to-one ratio, to a one of the candidate agents, or standard of care therapy.

Stage one (…) agent, will enroll 120 patients and …
compare primary endpoint of improvement along an ordinary scale, or a number of key secondary endpoints, which are specific to each agent, dependant on their machanistic properties.

The study is designed to allow seamless advancements of agents to stage two, if they show evidence of efficacy, and allows for an adaptive design based on stage one findings, in order to adequately power the compermitory(?) stage for the appropriate endpoints.

Bemcentinib is being studied in 10 NHS sites, accross the UK, in adult patients that are hospitilized due to covid disease.

At the time of the initiation of the ACCORD Platform, there were no approved agents for SARS-CoV treatment. However with the advancement of the recovery program, the study will take into account the approval of dcexamethosone and remdesivir in accordance with their recommended pausology in the UK."

• Remdesivir og dexamethosone er nå SOC.
• Det betyr at bemcentinib skal testes alene, og sammen med SOC.
• Det skal være en “seamless advancement” i ACCORD studien, basert på at medisinene som deltar viser effektivitet. Med “seamless advancement” må vi her forstå at medikamenter i studien gradvis testes bredere, på nye måter, mot flere målgrupper osv. Dr Akil Jackson forklarer også dette i presentasjonen.

Det vi vet om bemcentinib er at medikamentet ikke er en kur mot virusinfeksjoner, men studier indikerer at bemcentinib vil kunne gi pasienter et mildere sykdomsforløp. Såkalte enveloped viruses penetrerer menneskeceller ved hjelp av Gas6 / Axl.

Den samme mekanisme finnes hos Influensa A og B virus, H1N1, H5N1, H7N9 og mange flere varianter.
Disse tar mange liv hvert år, på tross av at svært mange vaksineres hvert år mot disse virusene.
Gitt at bemcentinib viser effekt mot SARS viruset, så er det svært sannsynlig av bemcentinib også vil bli brukt mot sesonginfluensa til pasienter som må legges inn pga influensa.

Dvs: BGBIO kommer til å tjene MYE på bemcentinib dersom medisinen har effekt mot SARS viruset, selv om rekruttering av pasienter tar tid.

[TekBot]

BerGenBio ASA: Registered share capital increase

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO U.S. NEWS WIRE
SERVICES, OR IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, THE HONG KONG
SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE’S REPUBLIC OF CHINA, SOUTH AFRICA OR
…

Vis børsmeldingen

JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE
UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT
THE END OF THE PRESS RELEASE

Bergen, Norway, 16 July 2020: Reference is made to the stock exchange
announcement by BerGenBio ASA (the “Company”) on 6 July 2020 regarding the final
results of the subsequent offering carried out by the Company (the “Subsequent
Offering”).

The share capital increase related to the Subsequent Offering has now been
registered with the Norwegian Register of Business Enterprises. The new share
capital of the Company is NOK 8,725,998.30 divided into 87,259,983 shares, each
with a nominal value of NOK 0.10.

Arctic Securities AS, Carnegie AS and DNB Markets, a part of DNB Bank ASA, are
acting as Joint Bookrunners and Managers for the Subsequent Offering.

Advokatfirmaet Thommessen AS is acting as the Company’s legal adviser for the
Subsequent Offering.

• END -

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

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 focused on combination and single agent therapy in lung cancer,
leukaemia and COVID19. 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 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

• IMPORTANT INFORMATION -

This document is not an offer to sell or a solicitation of offers to purchase or
subscribe for shares. Copies of this document may not be sent to jurisdictions,
or distributed in or sent from jurisdictions, in which this is barred or
prohibited by law. The information contained herein shall not constitute an
offer to sell or the solicitation of an offer to buy, in any jurisdiction in
which such offer or solicitation would be unlawful prior to registration,
exemption from registration or qualification under the securities laws of any
jurisdiction.

This communication may not be published, distributed or transmitted in or into
the United States, Canada, Australia, the Hong Kong Special Administrative
Region of the People’s Republic of China, South Africa or Japan and it does not
constitute an offer or invitation to subscribe for or purchase any securities in
such countries or in any other jurisdiction. In particular, the document and the
information contained herein should not be distributed or otherwise transmitted
into the United States of America or to U.S. persons (as defined in the U.S.
Securities Act of 1933, as amended (the “Securities Act”)) or to publications
with a general circulation in the United States of America. This document is not
an offer for sale of securities in the United States. The securities referred to
herein have not been and will not be registered under the Securities Act, or the
laws of any state, and may not be offered or sold in the United States of
America absent registration under or an exemption from registration under
Securities Act. BerGenBio does not intend to register any part of the offering
in the United States. There will be no public offering of the securities in the
United States of America.

The information contained herein does not constitute an offer of securities to
the public in the United Kingdom. No prospectus offering securities to the
public will be published in the United Kingdom. This document is only being
distributed to and is only directed at (i) persons who are outside the United
Kingdom or (ii) to investment professionals falling within article 19(5) of the
Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the
“Order”) or (iii) high net worth entities, and other persons to whom it may
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(all such persons together being referred to as “relevant persons”). The
securities are only available to, and any invitation, offer or agreement to
subscribe, purchase or otherwise acquire such securities will be engaged in only
with, relevant persons. Any person who is not a relevant person should not act
or rely on this document or any of its contents.

Any offer of securities to the public that may be deemed to be made pursuant to
this communication in any member state of the European Economic Area (each an
“EEA Member State”) that has implemented Directive 2003/71/EC (together with the
2010 PD Amending Directive 2010/73/EU, including any applicable implementing
measures in any Member State, the “Prospectus Directive”) is only addressed to
qualified investors in that Member State within the meaning of the Prospectus
Directive. This announcement is not a prospectus within the meaning of the
Prospectus Directive, as implemented in each member State of the European
Economic Area. With respect to the EEA Member States, no action has been
undertaken or will be undertaken to make an offer to the public of the
securities referred to herein requiring a publication of a prospectus in any
Member State. As a result, the securities of the Company may not and will not be
offered in any Member State except in accordance with the exemptions set forth
in Article 3 of the Prospectus Directive.

Investing in securities involves certain risks.

This publication may contain specific forward-looking statements, e.g.
statements including terms like “believe”, “assume”, “expect”, “forecast”,
“project”, “may”, “could”, “might”, “will” or similar expressions. Such forward
-looking statements are subject to known and unknown risks, uncertainties and
other factors which may result in a substantial divergence between the actual
results, financial situation, development or performance of BerGenBio and those
explicitly or implicitly presumed in these statements. Against the background of
these uncertainties, readers should not rely on forward-looking statements.
BerGenBio assumes no responsibility to update forward -looking statements or to
adapt them to future events or developments.

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

Kilde

[ezPappi]

Bortsett fra covid-19 studiene, hvilke andre kursdrivende hendelser venter vi på ?

[Savepig]

[TekBot]

BERGENBIO ANNOUNCES FIRST PATIENT DOSED IN RECURRENT GLIOBLASTOMA INVESTIGATOR SPONSORED PHASE I/II STUDY ASSESSING SELECTIVE AXL INHIBITOR BEMCENTINIB

Bergen, Norway, 20 July 2020 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that the first patient has been dosed and
…

Vis børsmeldingen

continues on therapy in a trial assessing bemcentinib in recurrent glioblastoma
(GBM). The trial is sponsored by Prof. Ichiro Nakano, MD, Professor in the
Department of Neurosurgery and co-leader of the Neuro-Oncology Program at
University of Alabama at Birmingham and funded by the National Cancer Institute
(NCI).

This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic (PK)
study of bemcentinib in patients with recurrent glioblastoma for whom a surgical
resection is medically indicated. The study will enrol up to 20 recurrent GBM
patients, at up to 15 sites in the USA. 10 patients will be treated prior to
surgery and 10 patients will have no pre-surgical treatment. However, all
patients will receive treatment with bemcentinib following surgery. The
endpoints of the study include an evaluation of bemcentinib’s ability to cross
the blood brain barrier, AXL expression, pharmacokinetics, safety and
tolerability, as well as efficacy assessments including Progression Free
Survival and Overall Survival. More information about the trial can be found at
https://clinicaltrials.gov/ct2/show/NCT03965494 (https://clinicaltrials.gov/ct2/s
how/NCT03965494)

Increased expression of the receptor tyrosine kinase AXL is significantly
correlated with poor prognosis in GBM patients and preclinical data has
suggested that bemcentinib may be a promising therapeutic agent for GBM,
particularly in post-irradiation mesenchymal-transformed GBM tumors[1]. A
comprehensive translational research programme will run in parallel with the
clinical trial, this will be conducted by Prof. Jeff Supko, Harvard Medical
School and Director of the Clinical Pharmacology Laboratory, Massachusetts
General Hospital (Boston, USA).

Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology
at University of Alabama at Birmingham (UAB) and Director of UAB’s Centre for
Clinical Translational Science’s Clinical Research Unit, commented: “GBM is
among the most lethal of adult cancers. The median survival of patients remains
less than two years despite the current available therapies, including surgery,
radiation, and chemotherapy; development of more effective therapies is urgently
needed. We welcome the opportunity to offer patients access to the
investigational AXL inhibitor bemcentinib in this pilot study and look forward
to initiating additional trial sites across the Adult Brain Tumour Consortium in
the USA later this year.”

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We
congratulate Prof. Nakano and Prof. Nabors on the start of this exciting
clinical study, which we believe will provide us with important data regarding
the ability of bemcentinib to cross the blood-brain barrier and potentially
treat GBM patients. This clinical trial is based on pioneering preclinical
research carried out by our collaborators, conducted at high profile research
hospitals in the USA and is funded by National Cancer Institute (NCI). We look
forward to reporting the potential of bemcentinib to improve patient outcomes in
this very aggressive cancer.”

• END -

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 and 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,
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. For further information, please visit:
www.bergenbio.com (http://www.bergenbio.com)

About Investigator-Sponsored Trials

Investigator-sponsored clinical trials are clinical trials proposed by front
-line patient-facing physicians who act as the regulatory sponsor and are
supported by industry in bespoke clinical development partnerships. The industry
partner does not assume the role of sponsor according to European or US
regulatory guidelines but may offer support in a variety of different ways, such
as providing investigational medicinal product at no cost.

About Glioblastoma

Glioblastoma (GBM) ranks among the deadliest of all human cancers with no
curative options available[2]. It is the most aggressive of the gliomas, a
collection of tumors arising from glia or their precursors within the central
nervous system. Gliomas are divided into four grades, grade 4 or glioblastoma
multiforme (GBM) is the most aggressive of these and is the most common in
humans. Most patients with GBMs die of their disease in less than a year[3].

For more information, please contact
Richard Godfrey
CEO, BerGenBio ASA
media@bergenbio.com
+47 917 86 304

International Media Relations

Mary-Jane Elliott, Chris Welsh, Carina Jurs,

Lucy Featherstone, Maya Bennison

Consilium Strategic Communications

bergenbio@consilium-comms.com

+44 7780 600290

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.

[1] 3. Sadahiro H, Kang KD, Gibson JT, et al. Activation of the Receptor
Tyrosine Kinase AXL Regulates the Immune Microenvironment in Glioblastoma.
Cancer Res. 2018;78(11):3002-3013.

[2,3] 3 1. Cloughesy, T., Finocchiaro, G., Belda-Iniesta, C., et al. (2016).
Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of
Onartuzumab plus Bevacizumab versus Placebo plus Bevacizumab in Patients with
Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6
-Methylguanine-DNA Methyltransferase Biomarker Analyses. J Clin Oncol,
JCO2015647685. Gilbert, M.R., Sulman, E.P., and Mehta, M.P. (2014). Bevacizumab
for newly diagnosed glioblastoma. N Engl J Med 370, 2048-2049.

Kilde

[Dilli]

BerGenBio har dosert første pasient i GBM-studie

Pasienten har blitt dosert og fortsetter terapi i studien.

FORNØYD: Richard Godfrey, adm. direktør, BergenBio, er godt fornøyd med starten på studien.

Helse

Jens Finborud

07:18 - 20. juli

BerGenBio har gjennom en studie som undersøker bemcentinib i gjentagende glioblastom (GBM) dosert den første pasienten, som fortsetter i videre terapi, melder selskapet i en børsmelding mandag.

Studien støttes av professor Ichiro Nakano ved University of Alabama at Birmingham og er finansiert av National Cancer Institute (NCI).

– Vi er stolte av professor Nakano og professor Nabors jobb i starten av denne studien og tror vi kan hente inn viktige data fremover, sier Richard Godfrey, adm. direktør, BergenBio.

Studien vil ha inntil 20 gjentagende GBM-pasienter, på opptil 15 klinikker i USA. Ti pasienter vil motta behandling før kirurgi og ti pasienter vil ikke motta noen behandling før terapi. Alle vil imidlertid motta behandling av bemcentinib etterfulgt av operasjonen, melder TDN Direkt.

BerGenBio har dosert første pasient i GBM-studie

[Evilfreud]

Bgbio fortsetter å bygge pipe på potensielle sykdommer de kan kurere. Evig nice

[Tdog]

I dag er det eneste man har mot denne forferdelige sykdommen stråling + temozolamid. Utrolig spennende å se hvor dette bærer.