BergenBio Fundamentale Forhold (BGBIO)

TekBot · juli 30, 2020, 2:35pm

BerGenBio ASA: Primary Insider notification

Tekspert · august 1, 2020, 10:00am

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

@vcp (1298 likes)

@larsmkn (738 likes)

@Ekornet (414 likes)

Resten av topp 10:

@Mykle (381 likes)
@Evilfreud (372 likes)
@Flottesen (348 likes)
@Dweller (343 likes)
@ezPappi (333 likes)
@Savepig (330 likes)
@Martins (295 likes)

Gratulerer!

TekBot · august 3, 2020, 3:28pm

BerGenBio ASA: Primary Insider notification

Martins · august 3, 2020, 2:49pm

Her er det noe galt. Totalene mangler 100k. 22,53 22,53 22,68, skulle vel vært 22,53 22,63 22,68?

Thorros · august 3, 2020, 2:57pm

Neida. Meldingen fra 29.7 ble varslet dobbelt.

Timm · august 3, 2020, 3:07pm

Det var to ulike meldinger den 29 juli, en kl 12:55 om kjøp av 200.000 aksjer, og en kl. 16:36 om ytterligere 100.000 aksjer :

https://newsweb.oslobors.no/message/510419
https://newsweb.oslobors.no/message/510439

Twine · august 3, 2020, 3:23pm

Trond kjøper med begge hender. Begynner å bli søkt at han gjør det før å manipulere kursen…

Shattering84 · august 4, 2020, 7:10am

Han har da ingen insentiver for å manipulere noen kurs…
Han har gjort en investering og venter på en eventuell avkastning, det er ikke en trade…

Mannen ser mulighet til å øke beholdningen til godt under fair pris, da gjør han selvsagt det. Hadde han kjøpt særlig mer ville kursen fort gått opp. Fornuftig å akkumulere slik han gjør.

TekBot · august 4, 2020, 3:22pm

BerGenBio ASA: Primary Insider notification

Hakon · august 4, 2020, 4:15pm

Jasså @TekBot på fylla igjen?

Twine · august 4, 2020, 6:23pm

Begynner å få en sterk følelse av at BGBIO virkelig har troen på bencem. Antakelig er det meget positive resultater, men det er ikke sikkert at alt kan rapporteres fra ACCORD, det er trolig en del sensitive opplysninger.

Evilfreud · august 4, 2020, 6:53pm

Det er Accord selv som rapporterer, og de har sagt all data vil bli offentligjort når den er klar.

Twine · august 5, 2020, 8:59pm

Tipper det er mye hemmelighold i ACCORD og det kan det være gode grunner til. Tror derfor informasjonen BGBio er ganske moderat rett og slett fordi de er bundet i avtaler om informasjonsflyt med ACCORD

Evilfreud · august 5, 2020, 9:15pm

Accord styrer informasjonsflyten og all informasjon blir offentligjort når den er klar.
Er ikke så mye verre enn det.

Svessi · august 6, 2020, 4:20pm

ACCORD-studien er publisert for noen dager siden, allerede avsluttet da dette gikk i trykk så gammelt nytt men mer interessant, her ligger hele protokollen for Bemcentinib vedlagt dersom noen er interessert i å se detaljene ift denne studien (tror ikke dette er postet her før, ligger også tilsvarende for de andre medikamentene under additional files)

ACCORD-2-002_Bemcentinib_SubprotocolR0.pdf (342,6 KB)

Twine · august 6, 2020, 4:51pm

Takker! Det bekrefter blant annet at ACCORD styrer informasjonsflyt og derfor er det svært begrenset hva BERBIO kan meddele.

Forøvrig har det vært svært trivelige dager å være aksjeeiere i BB. Skulle bare ha kjøpt enda mer…

Evilfreud · august 6, 2020, 4:57pm

Det har jo aldri vært noen usikkerhet rundt hvem som styrer informasjonsflyten

Det har vært helt tydelig fra Dag1 at det er studiet som styrer.

Twine · august 8, 2020, 10:32am

Fint, men det visste ikke jeg og helt sikkert mange med med. Det er viktig å innse dette før en begynner å spekulere i betydningen av børsmeldinger, slik en har gjort i høy grad feks på HO.

TekBot · august 10, 2020, 6:04am

BerGenBio ASA: Primary Insider notification

TekBot · august 18, 2020, 5:02am

BerGenBio’s Bemcentinib Meets Efficacy Endpoint in BERGAMO Phase II Trial with High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

· Primary endpoint of overall response rate was met in the fully recruited
single arm phase II study

…

Vis børsmeldingen

Bergen, Norway,18 August 2020 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, announces that the primary endpoint of overall response rate
has been met in the BERGAMO Phase II Trial investigating BerGenBio’s selective
AXL inhibitor bemcentinib in patients with High Risk Myelodysplastic Syndromes
(HR-MDS) or Acute Myeloid Leukemia (AML), for whom treatment with
hypomethylating agents (HMAs) is ineffective.

The multicenter phase 2 BERGAMO trial (NCT03824080) evaluated the safety and
efficacy of bemcentinib monotherapy in patients with HR-MDS or AML who were
refractory to or in relapse after at least six or four cycles of the HMAs
azacitidine (AZA) or decitabine (DAC), respectively. HMAs represent the current
standard of care in both indications for patients not eligible for intensive
chemotherapy or allogeneic stem cell transplantation. The study enrolled 45
eligible patients from 10 sites across Germany, France and the Netherlands.

The primary endpoint was met and included overall response rate (CR, CRi, PR or
SD) assessed after 4 treatment cycles. All patients who achieved CR, CRi, PR or
SD after 4 cycles of bemcentinib were considered as responders and allowed to
continue treatment for a total of up to 9 cycles. Non-responding patients
stopped treatment after 4 cycles. Secondary endpoints of the trial include a
translational project evaluating the role of biomarkers and response.

The BERGAMO trial is an investigator sponsored trial co-ordinated by The
European Myelodysplastic Syndromes Cooperative Group (EMSCO). The chief
investigator is Prof. Uwe Platzbecker, MD, from Leipzig University Hospital,
Germany, and the study included 10 clinical research sites in Germany, France
and Netherlands.

Further details of results of the BERGAMO trial will be presented at appropriate
scientific medical conferences later in 2020.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: "These headline
results are in-line with previously reported efficacy data on bemcentinib in
relapsed MDS and AML patients. Despite recent improvements of first line
treatment options there remains a substantial need for novel therapeutics which
target difficult-to-treat patient groups including patients with HR-MDS and AML
who have failed front-line therapy with hypomethylating agents. This is a group
with a very poor prognosis so we are very encouraged by these data and believe
they provide further validation for our clinical development strategy in these
indications.’’

END -

About MDS and AML

Hypomethylating agents (HMAs) are the standard of care for patients with higher
-risk myelodysplastic syndrome (HR-MDS) or acute myeloid leukemia (AML), not
eligible for intensive chemotherapy or allogeneic stem cell transplantation.
However, the majority of patients do not respond to these agents or relapse,
still having a dismal outcome with very limited treatment options available.

Bemcentinib (BEM) is a selective small molecule inhibitor of AXL, a surface
membrane protein kinase receptor mediating resistance to chemotherapeutic agents
and decreased antitumor immune response. AXL is overexpressed on leukemic cells,
especially in the stem cell compartment, and represents a potential novel target
in patients with MDS and AML.

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 Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class
selective AXL inhibitor in a broad phase II clinical development programme.
Ongoing clinical trials are investigating bemcentinib in 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.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.

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, drug 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 and
leukaemia. A first-in-class functional blocking anti-AXL antibody is 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). For more
information, visit 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

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