BergenBio Fundamentale Forhold (BGBIO)

vcp · oktober 23, 2021, 9:13am

Takk begge for gode svar, blingset på estimert completion.
Har du tilsvarende for AML studien @larosaleda ?

En alle bullers mor melding på AML hadde smakt av fugl !
Papirtapet pt. er trasig lesning, trøsten er at det over natten kan snu til et par hundre 100% i pluss

larosaleda · oktober 23, 2021, 9:48am

https://clinicaltrials.gov/ct2/history/NCT02488408?A=5&B=6&C=merged#StudyPageTop

Har ikke fått tid til å gå igjennom så oppsummer gjerne.

vcp · oktober 23, 2021, 9:55am

Utvidet fra 75-90 deltakere og Italia er tatt inn i tillegg til Norge og Tyskland.
Enrollment: endret fra 75 [Anticipated] til 121 Actual

Estimert completion om 2 mnd, des.2021

InfoLeecher · oktober 23, 2021, 10:44am

Endret til «active not recrutring»…. Ferdig rekrutert

Borup19 · oktober 23, 2021, 12:29pm

Burde det ikke afføde en børsmelding?

larosaleda · oktober 23, 2021, 4:30pm

Jo;
https://newsweb.oslobors.no/message/541816

larosaleda · oktober 29, 2021, 12:50pm

Pancreatic den gangen her.
https://clinicaltrials.gov/ct2/history/NCT03649321?A=5&B=6&C=merged#StudyPageTop

Her var det en del nytt fra forrige versjon. 1 arm mindre,

Fra 74 til 44 pasienter.

Fra randomisert til ikke randomisert.

Fra CR til ORR som primær.

laplagam · oktober 31, 2021, 5:23pm

Ser ut til at safety armen er tatt bort og kontroll armen som du sier er nå lagt på bemcentinib. Hovedforskjellen på de to bemcentinib armene som går videre nå er at det er en med og en uten cisplatin.

Veldig spennende.

Tekspert · november 1, 2021, 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:

@anon28800809 (279 likes)

@Roc (146 likes)

@vcp (102 likes)

Resten av topp 10:

@Hayen (78 likes)
@alfred_e_neuman (41 likes)
@HeldigFyr (40 likes)
@tverilytt (38 likes)
@Direkte (37 likes)
@Multiple (36 likes)
@larosaleda (33 likes)

Gratulerer!

TekBot · november 4, 2021, 2:13pm

BERGENBIO TO PRESENT UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING

Bergen, Norway, 4 November 2021 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
significant unmet medical needs, is pleased to announce a poster presentation at
…

Vis børsmeldingen

the 63[rd] Annual American Society of Hematology (ASH) Meeting, taking place 11
-14[th] December 2021 in Atlanta, GA.

Prof Sonja Loges will provide an update from the Company’s Phase II study
(BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in
older, relapsed and refractory AML patients unfit for intensive chemotherapy.

The data to be presented suggest that bemcentinib in combination with LDAC is
well tolerated and offers promising survival benefit to relapsed AML patients.
Translational research has further identified immune-based activity associated
with response to treatment, suggesting that bemcentinib elicits activation of
the two major adaptive immune cell populations responsible for anti-AML immune
effect.

Abstracts have been announced online and details of the presentation are below.

Title: Bemcentinib (Oral AXL Inhibitor) in combination with Low-dose Cytarabine
Is Well Tolerated and Efficacious in Older Relapsed AML Patients. Updates from
the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results
indicating Bemcentinib elicits anti-AML immune responses.

Date: Monday, December 13, 2021

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster III

Time, Location: 6.00 - 8.00 PM Eastern, Georgia World Congress Center, Hall B5

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

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 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 potential 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

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 · november 9, 2021, 1:00pm

BERGENBIO PRESENTS PRE-CLINICAL AND CLINICAL DATA ON BEMCENTINIB IN STK11-POSITIVE NSCLC AT SITC ANNUAL MEETING 2021

Bergen, Norway, 9 November 2021- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, is pleased to announce that it will deliver an e-poster
…

Vis børsmeldingen

presentation at the Society for Immunotherapy of Cancer (SITC) 36th Annual
Meeting, taking place online from 10th-14th November 2021.

The e-poster presentation provides pre-clinical and clinical data suggesting
that bemcentinib restored response to anti-PD-1 treatments in non-small cell
lung cancer (NSCLC) patients harboring STK11 mutations. STK11 is an important
tumor suppressor gene reported in some studies to confer immunotherapy
resistance in NSCLC. STK11 mutations are present in about 10-20% of NSCLC
patients.

In pre-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD
-1 blockade was evaluated in the absence and presence of bemcentinib. Systemic
inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated
T cells and restored therapeutic response to anti-PD-1 check point inhibition.

In parallel, data from BerGenBio’s Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable
patients with identified STK11 mutations demonstrated objective clinical
response / clinical benefit to the combination of bemcentinib and pembrolizumab.

Martin Olin, Chief Executive Officer at BerGenBio, commented: “While the data
are limited, they suggest a mechanism by which treatment with bemcentinib could
restore sensitivity to anti-PD-1 treatment in NSCLC patients harboring STK11
mutations. Up to 20% of the NSCLC patient population has been reported to harbor
STK11 mutations representing a large subgroup of NSCLC.”

Mutations in the tumor suppressor STK11/LKB1 have in some studies been reported
as associated with negative predictive and prognostic impact in NSCLC patients
receiving anti-PD-1/PD-L1 treatments. STK11 mutant tumors are characterized by a
suppressive tumor micro-environment devoid of cytotoxic T cells. The study
hypothesized that targeting the receptor tyrosine kinase AXL, a known driver of
an innate immune suppressive microenvironment, would restore sensitivity to PD-1
blockade in pre-clinical models as well as in patients harboring STK11 mutated
NSCLC.

Full abstracts are available on the SITC website here:
Home - SITC 2021

Full details of the presentation are below.

Title: AXL targetingwithbemcentinibrestores PD-1 blockade sensitivity
ofSTK11/LKB1mutant NSCLC throughinnate immune cellmediatedexpansion of TCF1+CD8T
cells

Author: Rolf A. Brekken et al.

Session/Abstract ID: 602

The presentation will be made available on BerGenBio’s website, under
‘Presentations (Presentations - BerGenBio)’.

-Ends-

Contacts

Martin Olin
Chief Executive Officer, BerGenBio ASA
ir@bergenbio.com

Rune Skeie
Chief FinancialOfficer, BerGenBio ASA
rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

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 cancer 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 potentially 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

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. Suchrisks, 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 · november 9, 2021, 1:06pm

BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR BEMCENTINIB IN STK11-MUTATED ADVANCED/METASTATIC NON-SMALL LUNG CANCER (NSCLC)

Bergen, Norway, 9 November 2021?-BerGenBioASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, today announces that the U.S. Food and Drug Administration
…

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(FDA) has granted Fast Track designation for bemcentinib in combination with an
anti-PD-(L)1 agent as treatment for patients with STK11 altered
advanced/metastatic NSCLC patients without actionable mutations.

Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. It
will enable BerGenBio to have more frequent interactions with the FDA throughout
the drug development process so that an approved product can potentially reach
the market faster.

In a separate release today 9 November 2021, BerGenBio announced that in pre
-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1
blockade was evaluated in the absence and presence of bemcentinib. Systemic
inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated
T cells and restored therapeutic response to anti-PD-1 check point inhibition.

Further, data from BerGenBio’s Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable
patients with identified STK11/LKB1 mutations demonstrated objective clinical
response / clinical benefit to the combination of AXL inhibitor bemcentinib and
pembrolizumab.

Martin Olin, Chief Executive Officer of BerGenBio, commented: “We are very
pleased to receive Fast Track designation from the FDA for the second time this
year and look forward to continuing to explore bemcentinib’s potential as a
treatment option for NSCLC patients. It has been reported that patients
habouring STK11 mutations represents up to 20% of the total NSCLC patient
population, representing a large, identifiable subgroup of patients who may
benefit from treatment with an AXL inhibitor such as bemcentinib.”

-Ends-

AboutBerGenBioASA

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 cancer 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
potential 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

About FDA Fast Track

Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. The
designation provides Eligibility forAccelerated Approval, enabling approval
based on a surrogate clinical endpoint;Priority Review, which allows New Drug
Application (NDA) review in six months instead of 10,and eligibility for Rolling
Review, whereby the Company will be able to submit completed sections of its NDA
for review by the FDA before the complete application is submitted.

Contacts

Martin Olin, CEO,BerGenBioASA
ir@bergenbio.com

RuneSkeie, CFO,BerGenBioASA
rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

ConsiliumStrategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.

Kilde

CanonBoy · november 9, 2021, 1:59pm

Abstract SITC 2021

Conclusion / Summary
Lack of TCF1-expressing CD8 T cells prevents ICB efficacy in KPL tumors. Systemic inhibition of
AXL increased type I interferon secretion from dendritic cells that expanded tumor-associated
TCF1+ PD-1+ CD8 T cells and restored anti-PD-1 efficacy in STK11/LKB1 mutant tumors.
Anecdotally, NSCLC patients with identified STK11/LKB1 mutations receiving bemcentinib and
pembrolizumab demonstrated objective clinical response to combination therapy. These results
show that AXL is a critical targetable driver of immune suppression in STK11/LKB1 mutant NSCLC

TekBot · november 9, 2021, 3:31pm

BerGenBio ASA: Increase of share capital, exercise of share options

Bergen, Norway, 9 November 2021

The Board of Directors in BerGenBio ASA (the"Company") (OSE: BGBIO) have, to
…

Vis børsmeldingen

fulfil the Company’s obligations under the share option agreements and in
accordance with the authorization granted by the general meeting on 19 March
2021, resolved to increase the Company’s share capital by NOK 7,000 by issuance
of 70,000 new shares. The new shares are subscribed for by option owners who
wishes and are entitled to exercise options in accordance with the Company’s
option scheme. Each option gives a right to receive one share in the Company.
The subscription price is in accordance with the prevailing options price
pursuant to the Company´s option scheme, in average NOK 15.00 per share.

The capital increase is expected to be registered within 7 days, and following
the issuance of the new shares, the issued share capital of BerGenBio ASA will
be NOK 8,845,525.50 consisting of 88,455,255 shares, each with a par value of
NOK 0.10.

-End-

Contacts

Martin Olin

CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie

CFO, BerGenBio ASA

rune.skeie@bergenbio.com

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

vcp · november 13, 2021, 10:45pm

Du jobber utrettelig💪 Håper Merck kjenner på sulten! En fase 3 partneravtale hadde smakt av fugl.

Fast track i både NSCLC og AML!
Må kunne sies å være en fantastisk validering av bemcentinib.

Så har vi alle de andre studiene i tillegg.

Verdsettelsen av selskapet derimot, synest å reflektere noe helt annet.

Ser fram til q3 presentasjon mandag!

larosaleda · november 16, 2021, 6:23am

https://newsweb.oslobors.no/message/546936

AML confirmayory trial H2 2022
NSCLC 1b i H1 2022. 1L ( STK11)
COVID multinational collaboration H1.

TekBot · november 17, 2021, 4:51pm

BerGenBio ASA: Share capital increase

Bergen, Norway, 17 November 2021 - Reference is made to the stock exchange
notice published by BerGenBio ASA (the “Company”) (OSE: BGBIO) on 9 November
2021 where the Company announced that the board of directors of the Company had
…

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resolved to increase the Company’s share capital in connection with the exercise
of options pursuant to the Company’s share option program. A total of 70,000
options were exercised and 70,000 new shares were issued at an average
subscription price of NOK 15.00 per share.

The share capital increase has been duly registered in the Norwegian Register of
Business Enterprises. Following such registration, the Company’s share capital
is NOK 8,845,525.50 divided into 88,455,255 shares, each with a nominal value of
NOK 0.10.

-End-

Contacts

Martin Olin

CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie

CFO, BerGenBio ASA

Rune.skeie@bergenbio.com

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

tverilytt · november 27, 2021, 5:06pm

https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20211116_4

Tekspert · desember 1, 2021, 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:

@anon28800809 (680 likes)

@Roc (308 likes)

@Hayen (120 likes)

Resten av topp 10:

@vcp (107 likes)
@Multiple (67 likes)
@Scrivener (64 likes)
@Ekornet (63 likes)
@larosaleda (51 likes)
@Fornybar (47 likes)
@Matadoren (44 likes)

Gratulerer!

TekBot · desember 13, 2021, 2:00pm

BERGENBIO PRESENTS UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING

Bergen, Norway, 13 December 2021- BerGenBio ASA (OSE:BGBIO), BerGenBio ASA (OSE:
BGBIO), a clinical-stage biopharmaceutical company developing novel, selective
AXL kinase inhibitors for severe unmet medical needs, is pleased to announce
…

Vis børsmeldingen

that it is presenting updated data from the Company’s Phase II study of
bemcentinib (BCBC003) in a poster presentation today at the 63rd Annual American
Society of Hematology (ASH) Meeting.

Professor Sonja Loges will provide an update from the Company’s Phase II study
(BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in
older, relapsed and refractory AML patients unfit for intensive chemotherapy.

The data presented indicate that bemcentinib in combination with LDAC is well
tolerated and offers meaningful clinical benefits. Translational research has
identified immune-based activity associated with response to treatment,
demonstrating that bemcentinib elicits activation of CD8+ T cells and B
cells/plasma cells, two major adaptive immune cell populations responsible for
anti-AML immune responses. Survival data measured as median Overall Survival
(mOS) in older unfit relapsed AML patients looks encouraging compared to
historical controls all through not yet matured.

Professor Sonja Loges, Chief Investigator of the BGBC003 trial commented: “The
data on relapsed AML patients who currently have very few treatment options, is
very encouraging. These results affirm our belief that the combination of
bemcentinib and LDAC provides meaningful clinical benefits.”

Details of the presentation:

Title: Bemcentinib (Oral AXL Inhibitor) in combination with Low-dose Cytarabine
Is Well Tolerated and Efficacious in Older Relapsed AML Patients. Updates from
the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results
indicating Bemcentinib elicits anti-AML immune responses.

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster III

Time, Location: 6.00 - 8.00 PM Eastern, Georgia World Congress Center, Hall B5

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

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 cancer 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 potentially 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.

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

Kilde