Risk reward of buying bio stocks on the Oslo børs before the announcement of new data is non existent. If its bad news you are of course crushed, if it is good news it doesnt seem to matter anyway.
I really need to stop doing it…
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Bergenbio @SITC 2018
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Noen som har litt conformation bias til låns 
Edit. Vi er jo i blått !
Føler det må en siste shakeout under 30 tallet før neste rally. Skal vi si 27.50… #bgbio
BergenBio og Nordic Nanovector nevnt som nordiske oppkjøpskandidater av ABG. Takk til @SkogensKonge.
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BerGenBio enters second stage of phase II trial with selective AXL inhibitor bemcentinib in combination with KEYTRUDA® in patients with advanced NSCLC
Bergen, Norway, 5 October 2018- BerGenBio ASA (OSE: BGBIO) announces that the first patient has been dosed in the second stage of the phase II trial (BGBC008) evaluating the Company’s selective AXL inhibitor bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing.
The trial was advanced into the second stage on the basis that the first stage met its clinical efficacy endpoint (as announced on 26 June 2018). Updated results from the first stage (n=24) were presented at the 19th Annual World Conference on Lung Cancer (WCLC; 25 September 2018)*. The Company reported an overall response rate (ORR) of 40% in patients who tested positive for AXL expression (4 out of 10 pts). Efficacy was also seen in PD-L1 negative patients (ORR of 27%, 3 out of 11 pts) for whom KEYTRUDA monotherapy is currently not indicated. Treatment with the bemcentinib/KEYTRUDA combination was well tolerated.
The second stage will enrol a further 24 patients at sites in Norway, Spain, UK and the US, and aims to confirm the safety and clinical efficacy of the combination. Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Preliminary results from the trial are expected during 2019.
The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey, USA, will continue to supply KEYTRUDA for use in the study under a collaboration agreement signed in March 2017.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We recently reported positive data from this phase II clinical trial at WCLC. Patients that were AXL positive reported a clinical response rate of 40%. Most notably, this included PD-L1 negative patients who do not benefit from KEYTRUDA monotherapy. These data strengthen our confidence in bemcentinib’s mode of action, as well as the value of AXL inhibition to enhance patient outcomes to KEYTRUDA immunotherapy. Additional combination data in NSCLC, including bemcentinib with targeted and chemotherapy, also presented at WCLC provide further proof supporting the concept that AXL is a key player in mediating resistance to therapy and immune evasion, and that bemcentinib has the potential to become a cornerstone therapy in this challenging indication. We look forward to reporting outcome and biomarker data at upcoming leading medical congresses.”
* James Lorens et al. Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC (abstract P2.04-27)
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
END
About NSCLC
It is estimated that more than 230,000 new cases of lung cancer will be diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.
About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).
For more information please access trial NCT03184571 at www.clinicaltrials.gov.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for advanced and aggressive 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. 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.
In parallel, BerGenBio is developing companion diagnostics test to identify patient populations most likely to benefit from bemcentinib; 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). www.bergenbio.com
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.
Contacts
Richard Godfrey, CEO, BerGenBio ASA
+47 917 86 304Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Nyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20181005.Cision.20181004:BIT:2256:0
1 Like
BerGenBio enters second stage of phase II trial with selective AXL inhibitor bemcentinib in combination with KEYTRUDA® in patients with advanced NSCL
Bergen, Norway, 5 October 2018- BerGenBio ASA (OSE: BGBIO) announces that the
first patient has been dosed in the second stage of the phase II trial (BGBC008)
evaluating the Company’s selective AXL inhibitor bemcentinib in combination with
MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with previously
treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC)
whose disease is progressing.
The trial was advanced into the second stage on the basis that the first stage
met its clinical efficacy endpoint (as announced on 26 June 2018). Updated
results from the first stage (n=24) were presented at the 19th Annual World
Conference on Lung Cancer (WCLC; 25 September 2018)*. The Company reported an
overall response rate (ORR) of 40% in patients who tested positive for AXL
expression (4 out of 10 pts). Efficacy was also seen in PD-L1 negative patients
(ORR of 27%, 3 out of 11 pts) for whom KEYTRUDA monotherapy is currently not
indicated. Treatment with the bemcentinib/KEYTRUDA combination was well
tolerated.The second stage will enrol a further 24 patients at sites in Norway, Spain, UK
and the US, and aims to confirm the safety and clinical efficacy of the
combination. Comprehensive exploratory studies will continue to evaluate
biomarkers in tumour and blood indicative of AXL expression and immune
modulation. Preliminary results from the trial are expected during 2019.The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being
sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New
Jersey, USA, will continue to supply KEYTRUDA for use in the study under a
collaboration agreement signed in March 2017.Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We recently
reported positive data from this phase II clinical trial at WCLC. Patients that
were AXL positive reported a clinical response rate of 40%. Most notably, this
included PD-L1 negative patients who do not benefit from KEYTRUDA monotherapy.
These data strengthen our confidence in bemcentinib’s mode of action, as well as
the value of AXL inhibition to enhance patient outcomes to KEYTRUDA
immunotherapy. Additional combination data in NSCLC, including bemcentinib with
targeted and chemotherapy, also presented at WCLC provide further proof
supporting the concept that AXL is a key player in mediating resistance to
therapy and immune evasion, and that bemcentinib has the potential to become a
cornerstone therapy in this challenging indication. We look forward to reporting
outcome and biomarker data at upcoming leading medical congresses.”
- James Lorens et al. Ph II Study of Oral Selective AXL Inhibitor Bemcentinib
(BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC
(abstract P2.04-27)KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA.END
About NSCLC
It is estimated that more than 230,000 new cases of lung cancer will be
diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of
NSCLCs are of adenocarcinoma pathology. Although various treatments exist for
NSCLC, they are often curtailed by acquired resistance to therapy and immune
evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently
required.About the BGBC008 trial
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in
combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy
naïve, patients with advanced adenocarcinoma of the lung, the most common form
of non-small cell lung cancer (NSCLC). The objective of the trial is to
determine the anti-tumour activity of this novel drug combination and responses
will be correlated with biomarker status (including AXL kinase and PD-L1
expression).For more information please access trial NCT03184571 at www.clinicaltrials.gov.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
advanced and aggressive 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. 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.In parallel, BerGenBio is developing companion diagnostics test to identify
patient populations most likely to benefit from bemcentinib; 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). www.bergenbio.comAbout AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms that drive aggressive and life-threatening diseases. In
cancer, AXL drives tumour survival, treatment resistance and spread, as well as
suppressing the body’s immune response to tumours. AXL expression has been
established as a negative prognostic factor in many cancers. AXL inhibitors,
therefore, have potential value at the centre of cancer combination therapy,
addressing significant unmet medical needs and multiple high-value market
opportunities.Contacts
Richard Godfrey, CEO, BerGenBio ASA
+47 917 86 304Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities TrEkstern link: http://www.newsweb.no/index.jsp?messageId=460761
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20181005.OBI.20181005S14
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Nice! Her går det fort!
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Was just about to say the same thing. BGBIO certainly keeps things ticking along
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Første del av studien rekrutterte raskere enn forventet, andre del starter bra! Første pasient inn i studien kun et par uker etter at venteperioden mellom første og andre del er over.
1 Like
Interessant å se at aksjen faller på tross av fin mld og nevnt som nordisk oppkjøpskandidat. Det er mildt sagt merkelig. noen større som vil ut?
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Not sure why one of the bigger owners would be on the way out based on the results at WCLC. Pullback from 40 is very odd if you ask me, but what do i know. And then down again today, while announcing the dosing of the first patient of second stage (in a pretty quick turnaround from releasing results of the first stage). Its all very odd. Makes me want to buy more…
1 Like
I dont’ get it either…
I know it sounds stupid, but the last runs BerGenBio had was when analysts updated their price target for BerGenBio. Maybe som new price targets will do the trick?
I think the new target should be revised up based on the data combined with results from the biomarker.
The loss of TNBC will be a minus, but the soon-to-be addition of BGB149 and new trials in mesothelioma and pancreas should more then make up for that loss.
3 Likes
Lever litt sitt eget liv dette aksjemarkedet. Det skal i alle fall ikke være lett
Det jeg tenker er at når først kjøpsinteressen kommer, så kommer det til å gå fort oppover. Kanskje skjer det nå, kanskje må det komme noe mer med BGB149 eller ADCT601, eller andre nyheter først? Ikke godt å vite. Har uansett en svært god feeling for Bergen Bio fremover, og krysser fingrene for at det å øke antall aksjer på disse nivåene vil vise seg å være en god avgjørelse
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Ja, da vet vi at vi kan sende en stor kaktus til JPMorgan og Clearstream Banking!
BerGenBio ASA (OSE:BGBIO): 5 October 2018 - Responsibility Statement for First Half 2018 report
Reference is made to our stock exchange notice 21 August 2018 and release of our
Second Quarter and First Half results 2018 report, we are pleased to release the
attached Responsibility Statement. This is also available at our web site
https://www.bergenbio.com/investors/reports/.Contact
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513This 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=460794
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20181005.OBI.20181005S47
Jeg har tidligere skrevet om forholdet mellom Euroclear Bank og Morgan Stanley med å dempe kursnivåer gjennom å veksle aksjer med hverandre!
Se på top 20 listen i uke 20 og 21: uke 20 på 10.plass Morgan Stanley med 1085000 aksjer og 14.plass Euroclear bank med 905720 aksjer. Uke 21 Euroclear bank på 4. Plass med 1990000 aksjer og Morgan S. helt ute ( exact 1990720 aksjer)!!!
Dessverre driver de samme spillet hver eneste uke på hele biotech. på OB!
Jeg har skrevet litt om resultatene BerGenBio la frem ved WCLC for noen uker siden: http://blogg.nordnet.no/bergenbio-legger-frem-resultater-fra-lungekreftstudier/
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Shareholder disclosure
The mutual funds managed by Nordea Funds Ltd have on October 8th, 2018
pur-chased 19.000 shares in Bergenbio ASA (ISIN: NO0010650013).After this transaction, the mutual funds managed by Nordea Funds Ltd own
2.742.813 shares equivalent to 5,01323% of the total outstanding number of
shares.The voting rights are equivalent to 5,01323% of the total votes.
Ekstern link: http://www.newsweb.no/index.jsp?messageId=460843
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20181008.OBI.20181008S42
2 Likes
Hoho, det ble i dag tidlig omtalt på Tekinvestor Insider Biotech at det foregikk skikkelig kjøping i bgbio.
1 Like