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BergenBio Fundamentale Forhold (BGBIO)

AML/MDS - mono
n=35
5% CR
14% PR
22% SD
41% DCR

NSCL - kombo m/docetaxel
n=11
29% PR
29% SD
58% DCR

Har jeg regnet riktig?
Det ser jo absoulutt lovende ut.
Spesielt lovende at det er verifisert aktivitet som mono, slik at man ikke går på en IDO-smell.

2 Likes

Ja, er disse to jeg har hatt mest tro på, sammen med NSCLC med EGFR inhibitor.

Syns dette ser lovende ut, men jeg savner TNBC data :thinking:

De meldte første del (23 pasienter) ferdig innrullert i februar. Skulle tro de hadde noe responsdata nå.

https://www.bergenbio.com/bergenbio-completes-recruitment-into-first-stage-of-phase-ii-breast-cancer-trial-with-selective-axl-inhibitor-bemcentinib-combined-with-keytruda/

Ja, det er lite data for keytruda kombo-forsøkene generelt.

NSCL - kombo m/keytruda
n=4
25% PR
25% SD
50% DCR

Metastatisk Melanom - kombo m/ketruda
n=19
efficacy ikke rapportert ved cutoff

TNBC - kombo m/keytruda
?

Cutoff var jo i februar

Håper de har mer oppdatert data på ASCO, om de ikke sparer det til senere. De skal vel på både SABCS, ESMO, ASH og World Lung senere i år så nok av andre konferanser vi kan se mer data på.

Som jeg nevnt sist er det AML som var forventet å ha beste response :wink:

Som en som driver med kreft pasienter daglig er jeg veldig veldig imponert for AML gruppen: 33 pasienter med R/R AML, dvs ingen håp!!
´2 pts achieved complete responses with incomplete recovery of peripheral counts (CRi) and 5 achieved partial responses (PR). 8 pts reported disease stabilisation for more than 4 months… Conclusions: Bemcentinib is well tolerated in MDS and AML pts and exhibits anti-leukemic activity through multiple mechanisms including immune modulation. Pt benefit (CRi/PR/SD > 4 mths) is predictable by measurement of plasma markers soluble AXL and angiogenin. `

Vanligvis bare 50% av AML pasienter har AXL expressjon, dvs forvented respons på medikament: man skulle ikke forvente klinisk respons hos mere enn 16 pasienter! Nå 2+5+8=15 responder! Det også er nevnt i conclusion veldig tydelig at Bemcentinib HAR (ikke Can, May eller annen tvilsom ord) anti leukemic activity! Hvis man er kjent med fagspråk og artikler har disse små ord, stor betydning ved tolkning av resultat!
Ordbruket i Bergenbio har åpenbar endret fra can, may, potensial osv Til veldig bestemte setninger.
Ikke glem at R/R gruppen er en gruppe som vanligvis dør! Hele AML pasienter har 5 year survival bare 27%.

5 Likes

Det er fredag og jeg kunne ikke dy meg.

BerGenBio to present interim clinical and biomarker data with selective AXL inhibitor bemcentinib in AML and MDS at EHA

Bergen, Norway, 18 May 2018 - BerGenBio ASA (OSE:BGBIO) announces that the company and its collaborators will present interim clinical data from its Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, in acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS) at the 23rd Congress of the European Hematology Association (EHA) in Stockholm (14-17 June 2018). Abstracts are now available online at https://ehaweb.org and details of the presentations are below. The posters presented at EHA will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.

Presentations at EHA

Saturday 16 June, 5:30 - 7:00 PM CEST

 Ph II trial with selective oral AXL inhibitor bemcentinib (BGB324) in relapsed/refractory AML and MDS: Identification of predictive and pharmacodynamic biomarker candidates associated with pt benefit 

· Sonja Loges, MD, PhD et al
· Session: Acute myeloid leukemia - Clinical 
· Abstract code: PS981

Single cell signaling pharmacodynamics and clonal evolution in a phase I/II clinical trial of selective AXL inhibitor bemcentinib (BGB324) in R/R acute myeloid leukemia and myelodysplastic syndrome

· Monica Hellesøy, PhD et al
· Session: Acute myeloid leukemia - Biology & Translational Research 
· Abstract code: PS965

 -End-

 About BerGenBio ASA 

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. The Company is a world leader in understanding the essential role of AXL kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive solid and haematological cancers.
BerGenBio’s lead product, bemcentinib (BGB324), is a selective, potent and orally bio-available small molecule AXL inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:

· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
· Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)

 The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.

 In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.

 BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization strategy.

 The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com 

 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.

 Contacts 

Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

 Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

 Media Relations in Norway
Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

 International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
[email protected]
+44 207 638 9571

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

Ekstern link: http://news.cision.com/bergenbio-asa/r/bergenbio-to-present-interim-clinical-and-biomarker-data-with-selective-axl-inhibitor-bemcentinib-in,c2524214

Nyheten er levert av Cision.

http://www.netfonds.no/quotes/release.php?id=20180518.Cision.20180518:BIT:9714:0

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BerGenBio to present interim clinical and biomarker data with selective AXL inhibitor bemcentinib in AML and MDS at EHA

Bergen, Norway, 18 May 2018 - BerGenBio ASA (OSE:BGBIO) announces that the
company and its collaborators will present interim clinical data from its Phase
II clinical development programme with bemcentinib, a selective, oral AXL
inhibitor, in acute myeloid leukaemia (AML) and myeloid dysplastic syndrome
(MDS) at the 23rd Congress of the European Hematology Association (EHA) in
Stockholm (14-17 June 2018).

Abstracts are now available online at https://ehaweb.org and details of the
presentations are below. The posters presented at EHA will be made available on
www.bergenbio.com in the Investors / Presentations section following the
sessions.
Presentations at EHA

Saturday 16 June, 5:30 - 7:00 PM CEST

Ph II trial with selective oral AXL inhibitor bemcentinib (BGB324) in
relapsed/refractory AML and MDS: Identification of predictive and
pharmacodynamic biomarker candidates associated with pt benefit

· Sonja Loges, MD, PhD et al
· Session: Acute myeloid leukemia - Clinical
· Abstract code: PS981

Single cell signaling pharmacodynamics and clonal evolution in a phase I/II
clinical trial of selective AXL inhibitor bemcentinib (BGB324) in R/R acute
myeloid leukemia and myelodysplastic syndrome

· Monica Hellesøy, PhD et al
· Session: Acute myeloid leukemia - Biology & Translational Research
· Abstract code: PS965

-End-

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on
developing a pipeline of first-in-class AXL kinase inhibitors as a potential
cornerstone of combination cancer therapy. The Company is a world leader in
understanding the essential role of AXL kinase in mediating cancer spread,
immune evasion and drug resistance in multiple aggressive solid and
haematological cancers.
BerGenBio’s lead product, bemcentinib (BGB324), is a selective, potent and
orally bio-available small molecule AXL inhibitor in four Company sponsored
Phase II clinical trials in major cancer indications, with read-outs anticipated
during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:

· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non
-small cell lung cancer (NSCLC)
· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
· Bemcentinib as a single agent and combination therapy in acute myeloid
leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of
the lung and TNBC are conducted in collaboration with Merck & Co., Inc.
(Kenilworth, NJ, USA), through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including
a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus
TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial
combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify
patient subpopulations most likely to benefit from treatment with bemcentinib.
This will facilitate more efficient registration trials and support a precision
medicine based commercialization strategy.

The Company is also developing a diversified pre-clinical pipeline of drug
candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of
OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a
registered trademark of Novartis International AG and MEKINIST® is a registered
trademark of GSK plc.

Contacts

Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

Media Relations in Norway
Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
[email protected]
+44 207 638 9571

This information is subject to the disclosure requirements pursuant to section
5-12 of the Norw

Ekstern link: http://www.newsweb.no/index.jsp?messageId=451748

Nyheten er levert av OBI.

http://www.netfonds.no/quotes/release.php?id=20180518.OBI.20180518S18

BerGenBio ASA: Share options to primary insiders

Bergen, Norway, 23 May 2018 - The board of directors in BerGenBio ASA (the
“Company”) (OSE:BGBIO) has granted options to primary insiders.

The annual general meeting in the Company at 14 May 2018 approved the share
options program. Options granted under the option program is vested over a
three-year period and each option, when exercised, will give the right to
acquire one share in the Company.

A total of 385,027 share options were granted at an exercise price at 46.70, of
this the following was granted to primary insiders (total holdings of share
options following this grant):

Richard Godfrey - CEO: 122,484 (1,067,484)

Rune Skeie - CFO: 24,090 (24,090)

James B. Lorens - CSO: 10,707 (710,707)

Murray Yule - CDO: 40,797 (190,797)

Anthony Brown - Director of research: 26,499 (176,499)

Endre Kjærland - Associate Director of IP and Contracts: 15,225 (85,225)

Julia Schoelermann - Associate Director of Business development: 15,418 (80,418)

David R. Micklem - Director of Diagnostics & Biomarkers: 11,949 (236,949)

-End-

Contacts

Richard Godfrey

CEO, BerGenBio ASA

[email protected]

+47 917 86 304

Rune Skeie

CFO, BerGenBio ASA

[email protected]

+47 917 86 513

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.

Ekstern link: http://www.newsweb.no/index.jsp?messageId=452023

Nyheten er levert av OBI.

http://www.netfonds.no/quotes/release.php?id=20180523.OBI.20180523S118

Jævla digg å være utafor :sweat_smile:

Det er mulig jeg er på kollisjonskurs med andre når det gjelder opsjoner men jeg ser på det som noe positivt med tanke på den langsiktige utviklingen i selskapet.

I dette tilfellet var heller ikke prisen satt veldig lavt slik jeg har sett i andre selskaper.

Jeg tolker meldingen positivt.

Jeg er usikker på om du er ironisk @Hakon

1 Like

Helt korrekt. Det er ironi

1 Like

Må ikke skremme meg slik @Hakon :grin:
Så bare melding ifarten når jeg var ute.
Var redd det var noe jeg ikke hadde fått med meg frem til jeg hadde lest den skikkelig.

1 Like

Vi nærmer oss mot slutten av H1 og 6 interim data/read outs! Spennende dager!
Så langt som en helsepersonell og aktiv i kreftbehandling er jeg MEGET imponert over AML resultater og har stor tro på tidlig FDA godkjenning og oppkjøp i nær fremtid $ Som sagt AML pasienter, spesielt R/R gruppe, har veldig dårlig prognose og har ikke tid for phase III osv! En god phase II fører til fast track og tidlig kommersialisering $
Som regel aldri er dumt å ta gevinst, men jeg tillater meg å kalle øretrilling og gevinst sikring i dagene fremover `amatøraktig´ og dumt! Så good luck for alle pasienter og ikke minst smarte investorer i BGBIO :wink:

3 Likes

Er der ikke 5 uger tilbage af H1?

2 Likes

Sant :stuck_out_tongue_winking_eye:

1 Like
1 Like

BerGenBio - Invitation to conference call: interim update on Ph II clinical programme with selective AXL inhibitor bemcentinib being presented at ASCO

Bergen, Norway, 29 May 2018 - BerGenBio ASA (OSE:BGBIO) will host a conference call on Monday, 4 June at 8:30 AM CEST to present updated interim clinical and biomarker results from its ongoing Phase II development programme with selective AXL inhibitor bemcentinib. The data will be presented at the Annual American Society of Clinical Oncology (ASCO) meeting and at a reception hosted by BerGenBio (details below). 

Conference call details:

The call will be hosted by BerGenBio senior management and take place on:

Monday, 4 June 2018 at 8:30 AM CEST. 

To take part, please dial in 5-10 minutes prior to the scheduled start using below phone number and confirmation code 1068189:

Norway                      +47 2100 2608

United Kingdom       +44 (0) 330 336 9106

United States            +1 323 794 2594

A slide deck presentation to accompany the call will be made available at www.bergenbio.com in the Investors / Presentations section from 8:00 AM CEST on 4 June 2018.

Presentations to be made during the annual ASCO meeting:

Saturday 2 June, 6:00 - 8:00 PM CDT, Chicago School of the Art Institute, Chicago, IL

· BerGenBio reception
· New interim Phase II clinical trial data with bemcentinib and selected pre-clinical data to be discussed by BerGenBio principal investigators and invited key opinion leaders
· For further details and to receive an invitation, please email to [email protected]

Monday 4 June, 8:00 AM - 11:30 AM CDT, ASCO Annual Meeting, McCormick Center, Chicago, IL

· Interim clinical data from clinical trial ref. BGBC008 - Poster Board: #292, Abstract 3078 
· Interim clinical data from clinical trial ref. BGBC003 - Poster Board: #80, Abstract 7020
· To be discussed at the Poster Discussion Session. 11:30 AM - 12:45 PM CDT
· Biomarker study -  Poster Board: #385, Abstract 2559

Monday 4 June, 1:15 PM - 4:45 PM CDT, ASCO Annual Meeting, McCormick Center, Chicago, IL

· Interim clinical data from clinical trial ref. BGBIL006 - Poster Board: #375, Abstract 9548

The posters presented at ASCO will be made available www.bergenbio.comin the Investors / Presentations section at the time of presentation.

-End-

About BerGenBio ASA 

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. The Company is a world leader in understanding the essential role of AXL kinase in mediating aggressive disease, including immune evasive, drug resistant, metastatic solid and haematological cancers.

BerGenBio’s lead product, bemcentinib (BGB324), is a selective, potent and orally bio-available small molecule AXL inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated during 2018. It is the only selective AXL inhibitor in clinical development.

The Company sponsored clinical trials are:

· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
· Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization strategy.

The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.

For further information, please visit: www.bergenbio.com 

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.

Contacts  

Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

International Media Relations

David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
[email protected]
+44 207 638 9571

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.

Ekstern link: http://news.cision.com/bergenbio-asa/r/bergenbio—invitation-to-conference-call–interim-update-on-ph-ii-clinical-programme-with-selective,c2533435

Nyheten er levert av Cision.

http://www.netfonds.no/quotes/release.php?id=20180529.Cision.20180528:BIT:9035:0

2 Likes