BerGenBio Nyheter
PhD : Rolf A. Brekken
https://www.utsouthwestern.edu/labs/brekken/research/
Flink forsker som også har trua på BerGenBio…
BERGENBIO ANNOUNCES POSTER PRESENTATION AT SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) ANNUAL MEETING 2021
Bergen, Norway, 01 October 2021 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, is pleased to announce that it will deliver an e-poster presentation at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, taking place online from 10-14 November 2021.
Abstract titles have been announced online at the SITC website. Details of the presentation are below.
Title: AXL targeting with bemcentinb restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through innate immune cell mediated expansion of TCF1+ CD8 T cells
Author: Rolf A. Brekken
https://www.utsouthwestern.edu/labs/brekken/research/
Flink forsker som også har trua på BerGenBio…
BERGENBIO ANNOUNCES POSTER PRESENTATION AT SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) ANNUAL MEETING 2021
Bergen, Norway, 01 October 2021 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, is pleased to announce that it will deliver an e-poster presentation at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, taking place online from 10-14 November 2021.
Abstract titles have been announced online at the SITC website. Details of the presentation are below.
Title: AXL targeting with bemcentinb restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through innate immune cell mediated expansion of TCF1+ CD8 T cells
Author: Rolf A. Brekken
Redigert 17.01.2022 kl 08:07
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BioBull
24.02.2023 kl 06:08
10668
Ny storaksjonær i BerGenBio ?
På dagen kursnivå blir det fort meldeplikt med lommerusk.
MedWatch :
SER POTENSIAL: ILS og Milla Koistinaho sier de ser et uutnyttet potensial blant norske oppstartsbedrifter innen livsvitenskap. | Foto: Innovestor
Finsk investeringsselskap vil inn med én milliard kroner i norsk biotek
Det finske investeringsselskapet Innovestor har nylig hentet inn nær én milliard kroner for sitt Life Science-venturekapitalfond, Innovestor Life Science (ILS).
– Med denne kapitalen ser Innovestor Life Science (ILS) aktivt etter muligheter til å investere i norsk livsvitenskap, og å ta landets beste oppstartsbedrifter ut internasjonalt, heter det i en pressemelding fra Innovestor.
– Uutnyttet potensial
ILS skriver videre at de ser et uutnyttet potensial blant norske oppstartsbedrifter innen livsvitenskap, men at det vil kreve den rette typen life science-investorer med gründer-ånd og stor samarbeidsvilje for å utnytte dette.
– I Norge vil vår erfaring med å starte vitenskapsbaserte bedrifter med utgansgpunkt i akademia, og vår interesse for bioteknologi i tidlig fase og digitale helse-selskaper, komme til stor nytte, da vi ønsker å bidra til å utvikle en bransje som vi anser som en «sovende kjempe».. Og til hjelp for å nå dette målet har vi en betydelig mengde venturekapital som er klar til å bli satt til bruk, sier Milla Koistinaho.
Innovestor Life Science (ILS) har nylig fullført sin første store investering i Finland og ellers gått så vidt inn i det danske life science- og digital helse-markedet.
– Det norske markedet er «lovende»
Neste er det altså det norske markedet, som ILS omtaler som «lovende». I Norge er målet å gå inn i selskaper i tidligfase, i biofarmasi og biovitenskap.
Innovestor er et finsk investeringsselskap som fokuserer på venturekapital og eiendom. I tillegg tilbyr vi fire corporate venturing-tjenester. Firmaet forvalter for tiden fire venturekapitalfond med en totalkapital på over 200 millioner euro. De har nær 100 vekstselskaper over flere sektorer innen teknologi og life science og helse.
På dagen kursnivå blir det fort meldeplikt med lommerusk.
MedWatch :
SER POTENSIAL: ILS og Milla Koistinaho sier de ser et uutnyttet potensial blant norske oppstartsbedrifter innen livsvitenskap. | Foto: Innovestor
Finsk investeringsselskap vil inn med én milliard kroner i norsk biotek
Det finske investeringsselskapet Innovestor har nylig hentet inn nær én milliard kroner for sitt Life Science-venturekapitalfond, Innovestor Life Science (ILS).
– Med denne kapitalen ser Innovestor Life Science (ILS) aktivt etter muligheter til å investere i norsk livsvitenskap, og å ta landets beste oppstartsbedrifter ut internasjonalt, heter det i en pressemelding fra Innovestor.
– Uutnyttet potensial
ILS skriver videre at de ser et uutnyttet potensial blant norske oppstartsbedrifter innen livsvitenskap, men at det vil kreve den rette typen life science-investorer med gründer-ånd og stor samarbeidsvilje for å utnytte dette.
– I Norge vil vår erfaring med å starte vitenskapsbaserte bedrifter med utgansgpunkt i akademia, og vår interesse for bioteknologi i tidlig fase og digitale helse-selskaper, komme til stor nytte, da vi ønsker å bidra til å utvikle en bransje som vi anser som en «sovende kjempe».. Og til hjelp for å nå dette målet har vi en betydelig mengde venturekapital som er klar til å bli satt til bruk, sier Milla Koistinaho.
Innovestor Life Science (ILS) har nylig fullført sin første store investering i Finland og ellers gått så vidt inn i det danske life science- og digital helse-markedet.
– Det norske markedet er «lovende»
Neste er det altså det norske markedet, som ILS omtaler som «lovende». I Norge er målet å gå inn i selskaper i tidligfase, i biofarmasi og biovitenskap.
Innovestor er et finsk investeringsselskap som fokuserer på venturekapital og eiendom. I tillegg tilbyr vi fire corporate venturing-tjenester. Firmaet forvalter for tiden fire venturekapitalfond med en totalkapital på over 200 millioner euro. De har nær 100 vekstselskaper over flere sektorer innen teknologi og life science og helse.
Redigert 24.02.2023 kl 06:09
Du må logge inn for å svare
Move Along
25.02.2023 kl 01:13
10375
Kan jo være ja. Det eneste som nå hindrer at ny kapital renner inn i Bergenbio nå er et «closer look» - det gjelder jo flere aktørerer men bra at dette fondet er tilstede og ser masse underpriset og undervurderte medisinske kandidater i Norge. I USA hadde Bergenbio allerede hatt en børsverdi på 100-gangeren.
ctrlaltdel
25.02.2023 kl 09:19
10224
Børsverdi på 59.8 milliarder. Er du sterk i trua så kan mirakler skje!
GOV
25.02.2023 kl 09:48
10222
..hoderegning kan være utfordrende - det får holde med 0,6 miliarder pr.nå.
ctrlaltdel
25.02.2023 kl 10:12
10246
Takk. Det var et svar til MA som mener en USA notering hadde priset selskapet 100 gangeren. Trodde det var åpenbart.
omans
28.02.2023 kl 10:37
9657
Uten TMohn spørs om dette selskapet fortsatt hadde eksistert.
År ut og inn med stadig nytt behov for frisk kapital.
På tide å levere noen resultater, ikke bare lovende studier.
År ut og inn med stadig nytt behov for frisk kapital.
På tide å levere noen resultater, ikke bare lovende studier.
Seriøs
28.02.2023 kl 11:32
9574
Ting tar tid i Bio og slik er det. Det er lange studier og mye som skal godkjennes før lansering. Bgbio er litt bingo og kan gå langt ned og sinnsykt opp. Men tåler man ikke lave kurser så skal man finne en ann en aksje tenker jeg. For min del på denne kursen så er det også stor oppside
Redigert 28.02.2023 kl 11:32
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BioBull
28.02.2023 kl 15:09
9436
Stol-leken blir gøy for BGBIO aksjonærer !
Merck & Co velger nok heller å satse på BerGenBio. Det er allerede et godt og veletablert forsknings-samarbeid mellom BGBIO & Merck.
«Pfizer plukker opp tråden etter at MSD ( Merck ) trakk seg ut av deres forhandlinger med Seagen i fjor.
En avtale på flere titalls milliarder dollar nærmer seg for legemiddelgiganten Pfizer og kreft-biotek-selskapet Seagen.
Det skriver Wall Street Journal, som henviser til anonyme kilder.
Seagen har for øyeblikket en markedsverdi på 30 milliarder dollar. I fjor var MSD (Merck & Co. i USA) i samtaler om å kjøpe Seagen. Deres oppkjøp hadde kostet dem 40 milliarder dollar eller mer, ifølge avisen.
Seagen utvikler og selger antistoff-immunterapier, og omsatte for to milliarder dollar i 2022. Pfizer ønsker å legge til 25 milliarder dollar på bunnlinjen sin innen 2030, mye på grunn av 17 milliarder i kommende fallende omsetning på grunn av patenter som går ut.
I fjor kjøpet Pfizer også sigdcelle-selskapet Global Blood Therapeutics for 5 milliarder dollar og Biohaven Pharmaceutical for mer enn 10 milliarder dollar, skriver Wall Street Journal.»
Kilde :
https://medwatch.no/nyheter/legemidler_biotek/article15190466.ece?utm_campaign=MedWatch&utm_content=2023-02-28&utm_medium=email&utm_source=medwatch_no
Merck & Co velger nok heller å satse på BerGenBio. Det er allerede et godt og veletablert forsknings-samarbeid mellom BGBIO & Merck.
«Pfizer plukker opp tråden etter at MSD ( Merck ) trakk seg ut av deres forhandlinger med Seagen i fjor.
En avtale på flere titalls milliarder dollar nærmer seg for legemiddelgiganten Pfizer og kreft-biotek-selskapet Seagen.
Det skriver Wall Street Journal, som henviser til anonyme kilder.
Seagen har for øyeblikket en markedsverdi på 30 milliarder dollar. I fjor var MSD (Merck & Co. i USA) i samtaler om å kjøpe Seagen. Deres oppkjøp hadde kostet dem 40 milliarder dollar eller mer, ifølge avisen.
Seagen utvikler og selger antistoff-immunterapier, og omsatte for to milliarder dollar i 2022. Pfizer ønsker å legge til 25 milliarder dollar på bunnlinjen sin innen 2030, mye på grunn av 17 milliarder i kommende fallende omsetning på grunn av patenter som går ut.
I fjor kjøpet Pfizer også sigdcelle-selskapet Global Blood Therapeutics for 5 milliarder dollar og Biohaven Pharmaceutical for mer enn 10 milliarder dollar, skriver Wall Street Journal.»
Kilde :
https://medwatch.no/nyheter/legemidler_biotek/article15190466.ece?utm_campaign=MedWatch&utm_content=2023-02-28&utm_medium=email&utm_source=medwatch_no
Redigert 28.02.2023 kl 15:09
Du må logge inn for å svare
kongkveite
28.02.2023 kl 17:25
9282
Stopper på 6,66.
Dette går lukt til helv…foreløpig støtte på 6 ..går nok gjennom der i mars. Mer penger å hente på Bingoen i Ulan Bator 🤡
Dette går lukt til helv…foreløpig støtte på 6 ..går nok gjennom der i mars. Mer penger å hente på Bingoen i Ulan Bator 🤡
ctrlaltdel
01.03.2023 kl 11:01
8840
Slettet brukerskrevInnlegget er slettet
Takk for inf. Positiv reaksjon fra markedet har hvertfall uteblitt etter at resultatene ble presentert.
Gullit
03.03.2023 kl 12:26
8193
Hva skjer med mcap her.. det er
Kjempe spennende og ikke minst lovende data vi får servert fra Bergen bio, kursen burde vert mange gangeren
Så vet vi også att dette panelet er satt i sving:
Distinguished global experts appointed to strengthen bemcentinib development
in STK11m NSCLC -
BERGEN, Norway, February 2, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced the formation of a scientific
advisory board consisting of four world-renowned non-small cell lung cancer
(NSCLC) experts from top oncology centers around the globe to enhance the
development of bemcentinib for the treatment of NSCLC patients with STK11
mutations (STK11m).
"We are very proud and honored to have assembled a group of leading
international NSCLC experts to guide us as we investigate bemcentinib in 1st
line NSCLC STK11m in combination with today's standard of care," said Cristina
Oliva, M.D., Chief Medical Officer of BerGenBio. "Their expertise will play an
integral role in our evaluation of bemcentinib and its potential to provide
significant benefits to patients who today face a particularly poor prognosis."
Despite significant advances in immuno-oncology treatments, NSCLC is still one
of the leading causes of cancer-related deaths worldwide. Patients harboring
STK11m, which represent approximately ~20% of non-squamous NSCLC cases, almost
universally demonstrate high levels of AXL activation and show lower response
rates to current standard of care therapy of anti-PD-1/L1 combined with
chemotherapy. BerGenBio's lead compound, bemcentinib, is designed to selectively
inhibit AXL, which may potentially sensitize STK11m NSCLC patients to checkpoint
inhibitors and improve the effects of chemotherapy. The Company has initiated a
global Phase 1a/2b trial to assess bemcentinib with standard of care in 1st line
NSCLC patients with STK11m.
Members of the BerGenBio NSCLC Scientific Advisory Board:
Enriqueta Felip, M.D., Ph.D.
Dr. Enriqueta Felip is the Head of the Thoracic Cancer Unit at Vall d'Hebron
University Hospital, Spain, where she is responsible for thoracic malignancy
management and all lung cancer trials. She is President of the Spanish Society
of Medical Oncology (SEOM) 2021-23, a member of the Spanish Lung Cancer Group
(SLCG) and a Professor of Medicine at the Universitat de Vic. Previously, Dr.
Felip was on the Board of Directors of the International Association for the
Study of Lung Cancer (IASLC). She received her M.D. and Ph.D. from Autonomous
University of Barcelona.
John Heymach, M.D., Ph.D.
Dr. John Heymach is the Chair of Thoracic/Head and Neck Medical Oncology at the
MD Anderson Cancer Center, Texas, and holds the David Bruton Endowed Chair in
Cancer Research. Dr. Heymach is a co-leader of the MD Anderson Lung Cancer Moon
Shot, in addition to serving as a Principal Investigator of lung cancer programs
funded by the National Cancer Institute (NCI), LUNGevity and American
Association for Cancer Research (AACR), and earning several prestigious awards
for excellence in basic science, translational research and mentoring. He
received his M.D. and Ph.D. from Stanford University.
Tony Mok, M.D., BMSc
Dr. Tony Mok is a Professor and Chairman of the Department of Clinical Oncology
at the Chinese University of Hong Kong. Dr. Mok's research was instrumental in
establishing the use of precision medicine in advanced lung cancer. He co
-founded the Lung Cancer Research Group and served as the associate editor for
thoracic oncology for the Journal of Clinical Oncology. Dr. Mok is a Fellow of
the American Society of Clinical Oncology (ASCO), former President of IASLC and
received the ESMO Lifetime Achievement Award. He received his M.D. and BMSc from
the University of Alberta, Canada.
Solange Peters, M.D., Ph.D.
Dr. Solange Peters is a Professor and Head of Medical Oncology and Thoracic
Malignancies at the Department of Oncology at Lausanne University, Switzerland,
where she is also building a translational program in collaboration with
molecular oncology laboratories. Dr. Peters was recently the President of the
European Society for Medical Oncology (ESMO) 2020-22, and was formerly an IASLC
Board member and co-chair of the Swiss Lung Cancer Research Group. She is
Associate Editor of the Annals of Oncology and Deputy Editor of Lung Cancer. She
received her M.D. and Ph.D. from the University of Lausanne.
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
Kjempe spennende og ikke minst lovende data vi får servert fra Bergen bio, kursen burde vert mange gangeren
Så vet vi også att dette panelet er satt i sving:
Distinguished global experts appointed to strengthen bemcentinib development
in STK11m NSCLC -
BERGEN, Norway, February 2, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced the formation of a scientific
advisory board consisting of four world-renowned non-small cell lung cancer
(NSCLC) experts from top oncology centers around the globe to enhance the
development of bemcentinib for the treatment of NSCLC patients with STK11
mutations (STK11m).
"We are very proud and honored to have assembled a group of leading
international NSCLC experts to guide us as we investigate bemcentinib in 1st
line NSCLC STK11m in combination with today's standard of care," said Cristina
Oliva, M.D., Chief Medical Officer of BerGenBio. "Their expertise will play an
integral role in our evaluation of bemcentinib and its potential to provide
significant benefits to patients who today face a particularly poor prognosis."
Despite significant advances in immuno-oncology treatments, NSCLC is still one
of the leading causes of cancer-related deaths worldwide. Patients harboring
STK11m, which represent approximately ~20% of non-squamous NSCLC cases, almost
universally demonstrate high levels of AXL activation and show lower response
rates to current standard of care therapy of anti-PD-1/L1 combined with
chemotherapy. BerGenBio's lead compound, bemcentinib, is designed to selectively
inhibit AXL, which may potentially sensitize STK11m NSCLC patients to checkpoint
inhibitors and improve the effects of chemotherapy. The Company has initiated a
global Phase 1a/2b trial to assess bemcentinib with standard of care in 1st line
NSCLC patients with STK11m.
Members of the BerGenBio NSCLC Scientific Advisory Board:
Enriqueta Felip, M.D., Ph.D.
Dr. Enriqueta Felip is the Head of the Thoracic Cancer Unit at Vall d'Hebron
University Hospital, Spain, where she is responsible for thoracic malignancy
management and all lung cancer trials. She is President of the Spanish Society
of Medical Oncology (SEOM) 2021-23, a member of the Spanish Lung Cancer Group
(SLCG) and a Professor of Medicine at the Universitat de Vic. Previously, Dr.
Felip was on the Board of Directors of the International Association for the
Study of Lung Cancer (IASLC). She received her M.D. and Ph.D. from Autonomous
University of Barcelona.
John Heymach, M.D., Ph.D.
Dr. John Heymach is the Chair of Thoracic/Head and Neck Medical Oncology at the
MD Anderson Cancer Center, Texas, and holds the David Bruton Endowed Chair in
Cancer Research. Dr. Heymach is a co-leader of the MD Anderson Lung Cancer Moon
Shot, in addition to serving as a Principal Investigator of lung cancer programs
funded by the National Cancer Institute (NCI), LUNGevity and American
Association for Cancer Research (AACR), and earning several prestigious awards
for excellence in basic science, translational research and mentoring. He
received his M.D. and Ph.D. from Stanford University.
Tony Mok, M.D., BMSc
Dr. Tony Mok is a Professor and Chairman of the Department of Clinical Oncology
at the Chinese University of Hong Kong. Dr. Mok's research was instrumental in
establishing the use of precision medicine in advanced lung cancer. He co
-founded the Lung Cancer Research Group and served as the associate editor for
thoracic oncology for the Journal of Clinical Oncology. Dr. Mok is a Fellow of
the American Society of Clinical Oncology (ASCO), former President of IASLC and
received the ESMO Lifetime Achievement Award. He received his M.D. and BMSc from
the University of Alberta, Canada.
Solange Peters, M.D., Ph.D.
Dr. Solange Peters is a Professor and Head of Medical Oncology and Thoracic
Malignancies at the Department of Oncology at Lausanne University, Switzerland,
where she is also building a translational program in collaboration with
molecular oncology laboratories. Dr. Peters was recently the President of the
European Society for Medical Oncology (ESMO) 2020-22, and was formerly an IASLC
Board member and co-chair of the Swiss Lung Cancer Research Group. She is
Associate Editor of the Annals of Oncology and Deputy Editor of Lung Cancer. She
received her M.D. and Ph.D. from the University of Lausanne.
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
ctrlaltdel
03.03.2023 kl 15:45
8096
Det panelet burde vært i sving for lenge siden. Selskapet ble børsnotert i 2017. Hva er det som ha skjedd siden da. Resultater som ikke lokker beilere, presentasjoner som ikke lokker beilere og ingenting som har ført til noe som helst. Ved børsnotering ble det antydet 2 år.
Redigert 03.03.2023 kl 16:20
Du må logge inn for å svare
kongkveite
03.03.2023 kl 16:05
8139
Nok en rød uke.. blitt mange røde uker de siste 3 år.
Nærmer oss støtten på 6 👀.Bryter den gjennom der er det vel rake veien til 2 kroningen
Nærmer oss støtten på 6 👀.Bryter den gjennom der er det vel rake veien til 2 kroningen
Gullit
03.03.2023 kl 17:11
8063
Da har du ikke fått med siste top linje data:
Att det tar tid vet vi i biotek.
BGBC008 Topline Data
The open-label, multi-center, single arm, multi-cohort, international phase 2 trial conducted in collaboration with MSD (Merck and Co., Inc. Rahway, NJ, USA), enrolled 90 evaluable patients with disease progression at study entry, who had received at least one prior line of chemotherapy, immunotherapy, or the combination. Enrolled patients received the combination of bemcentiniband pembrolizumab until disease progression as assessed by investigators. Topline results from the total evaluable population:
A clinically meaningful survival benefit and evidence of disease control was demonstrated with bemcentinibin combination with pembrolizumab regardless of prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).
A significant (p-value < 0.05) and clinically meaningful improvement in mOS based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months (95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.
The observed mOS was similar regardless of patient PD-L1 status.
Treatment with bemcentinib in combination with pembrolizumab was well-tolerated.
“We are very encouraged by the topline data” said Martin Olin, Chief Executive Officer of BerGenBio. “Treatment with bemcentinib in combination with pembrolizumab demonstrated long survival benefit and sustained disease control, particularly in patients with AXL TPS > 5, substantiating the relevance of AXL as a target and bemcentinib’s selective inhibition capabilities in NSCLC. Notably, the survival benefit was observed regardless of PD-L1 status. The data support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom approximately 80% have AXL expression. This subgroup of NSCLC represents more than 30,000 patients in the US and five largest European countries, for whom there is currently no effective targeted therapy available.”
James Spicer, PhD, FRCP, Professor of Experimental Cancer Medicine at King’s College London and Principal Investigator of the BGBC008 trial, remarked, “The reported data shows that the combination of bemcentinib and pembrolizumab is well-tolerated in patients with NSCLC, and is particularly active in patients with tumour AXL expression. Other evidence suggests that current therapies are less effective in NSCLC with loss of the tumour suppressor gene STK11, and that AXL inhibition can restore susceptibility. Further investigation is warranted to confirm the role of AXL inhibition in STK11-mutated NSCLC patients, who are under-served by currently available therapeutic options.”
Att det tar tid vet vi i biotek.
BGBC008 Topline Data
The open-label, multi-center, single arm, multi-cohort, international phase 2 trial conducted in collaboration with MSD (Merck and Co., Inc. Rahway, NJ, USA), enrolled 90 evaluable patients with disease progression at study entry, who had received at least one prior line of chemotherapy, immunotherapy, or the combination. Enrolled patients received the combination of bemcentiniband pembrolizumab until disease progression as assessed by investigators. Topline results from the total evaluable population:
A clinically meaningful survival benefit and evidence of disease control was demonstrated with bemcentinibin combination with pembrolizumab regardless of prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).
A significant (p-value < 0.05) and clinically meaningful improvement in mOS based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months (95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.
The observed mOS was similar regardless of patient PD-L1 status.
Treatment with bemcentinib in combination with pembrolizumab was well-tolerated.
“We are very encouraged by the topline data” said Martin Olin, Chief Executive Officer of BerGenBio. “Treatment with bemcentinib in combination with pembrolizumab demonstrated long survival benefit and sustained disease control, particularly in patients with AXL TPS > 5, substantiating the relevance of AXL as a target and bemcentinib’s selective inhibition capabilities in NSCLC. Notably, the survival benefit was observed regardless of PD-L1 status. The data support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom approximately 80% have AXL expression. This subgroup of NSCLC represents more than 30,000 patients in the US and five largest European countries, for whom there is currently no effective targeted therapy available.”
James Spicer, PhD, FRCP, Professor of Experimental Cancer Medicine at King’s College London and Principal Investigator of the BGBC008 trial, remarked, “The reported data shows that the combination of bemcentinib and pembrolizumab is well-tolerated in patients with NSCLC, and is particularly active in patients with tumour AXL expression. Other evidence suggests that current therapies are less effective in NSCLC with loss of the tumour suppressor gene STK11, and that AXL inhibition can restore susceptibility. Further investigation is warranted to confirm the role of AXL inhibition in STK11-mutated NSCLC patients, who are under-served by currently available therapeutic options.”
kongkveite
07.03.2023 kl 11:32
7070
StockWizard skrev Blir du selv ikke lei av å skrive såååå mye B…Sh..ttt!
Ifølge DN blir det vanskelig for selskap å hente risikokapital fremover..
Tror jeg venter med ytterligere kjøp nå som vi er på god vei til 2,-..
Tror jeg venter med ytterligere kjøp nå som vi er på god vei til 2,-..
BioBull
08.03.2023 kl 13:54
6575
ctrlaltdel skrevInnlegget er slettet
Nå har BerGenBio «heisen» kommet ned til støttenivå som sist. Hopp inn og bli med opp igjen før det kommer enda flere positive nyheter…
BioKnut
08.03.2023 kl 16:17
6464
Med Trond Mohn som storaksjonær og støttespiller har vi lite å frykte. Han vil garantert sørge for nødvendig funding til BerGenBio.
BioKnut
08.03.2023 kl 16:21
6510
Det stemmer, og rent teknisk tyder alt nå på en kraftig rekyl opp. Jeg tror også det kommer positive nyheter fra selskapet før påske. Kan fort bli påskeraketten på Oslo Børs dette her👌😊
BioBull
09.03.2023 kl 15:19
6048
Da kom nyheten en dag senere enn forventet ….
Pressemelding Onsdag 9.3.23 kl 11:01
BerGenBio Announces First Patient Dosed in Phase 1b/2a Trial Evaluating Bemcentinib in 1st Line Non-Small Cell Lung Cancer with STK11 Mutations
- Global trial designed to study the safety, tolerability and efficacy of bemcentinib in combination with current standard of care –
BERGEN, Norway, March 9, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the first patient was dosed in a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, immune checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).
“Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not currently have effective treatment options,” said Martin Olin, Chief Executive Officer of BerGenBio. “One specific attribute of this group is that they almost all demonstrate high levels of AXL activation. We are elated to have dosed the first patient in our trial and to continue our evaluation of bemcentinib and its ability to inhibit AXL to revive STK11m NSCLC patients’ response to checkpoint inhibitors and chemotherapy.”
The trial’s lead investigator, Rajwanth Veluswamy, M.D., MSCR, Assistant Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai (New York, NY), commented, “Today, STK11 mutations are correlated with a very poor prognosis for patients suffering from NSCLC. These mutations are widely recognized for their ability to impede the activity of anti-PD-1/L1 therapy. My colleagues and I are driven to find a better outcome for this large patient population and are eager to assess bemcentinib’s potential in achieving this goal.”
The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
Hyggelig, men nesten utrolig at noen Påske kyllinger🐥 selger BGBO aksjen her slik at nye og eldre aksjonærer får enda større gleden av suksessen fremover . (Kan dog skyldes fond pga INDEX utgang) Partner avtaler blir nok neste nyhet ,- God Påske!!
Pressemelding Onsdag 9.3.23 kl 11:01
BerGenBio Announces First Patient Dosed in Phase 1b/2a Trial Evaluating Bemcentinib in 1st Line Non-Small Cell Lung Cancer with STK11 Mutations
- Global trial designed to study the safety, tolerability and efficacy of bemcentinib in combination with current standard of care –
BERGEN, Norway, March 9, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the first patient was dosed in a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, immune checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).
“Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not currently have effective treatment options,” said Martin Olin, Chief Executive Officer of BerGenBio. “One specific attribute of this group is that they almost all demonstrate high levels of AXL activation. We are elated to have dosed the first patient in our trial and to continue our evaluation of bemcentinib and its ability to inhibit AXL to revive STK11m NSCLC patients’ response to checkpoint inhibitors and chemotherapy.”
The trial’s lead investigator, Rajwanth Veluswamy, M.D., MSCR, Assistant Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai (New York, NY), commented, “Today, STK11 mutations are correlated with a very poor prognosis for patients suffering from NSCLC. These mutations are widely recognized for their ability to impede the activity of anti-PD-1/L1 therapy. My colleagues and I are driven to find a better outcome for this large patient population and are eager to assess bemcentinib’s potential in achieving this goal.”
The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
Hyggelig, men nesten utrolig at noen Påske kyllinger🐥 selger BGBO aksjen her slik at nye og eldre aksjonærer får enda større gleden av suksessen fremover . (Kan dog skyldes fond pga INDEX utgang) Partner avtaler blir nok neste nyhet ,- God Påske!!
Redigert 10.03.2023 kl 04:43
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kongkveite
10.03.2023 kl 12:32
5643
For å løfte kursen skal det nok mer til enn gratulasjoner på LinkedIn og melding om rekruttering av 1 ny prøvekanin..kanskje det er påskeharen vi venter på ?
Imens avslutter vi nok en BLODrød uke hvor støtten RØK.
Veien videre ? Tja - er nok mange som har SVIDD labbene på denne nå..
Imens avslutter vi nok en BLODrød uke hvor støtten RØK.
Veien videre ? Tja - er nok mange som har SVIDD labbene på denne nå..
Move Along
11.03.2023 kl 00:14
5479
Ja, det er kanksje nærliggende å tenke at enten er ikke det BGBIO driver med betydningsfult nok for at de store farma selskapene de samarbeider med skal vise særlig interesse i å erverve dette for seg selv, eller så er ledelsen alt for dårlig til å kommunisere disse resultatene i et salgs-øyemed ovenfor slike selskaper. Jeg velger heller å tro at det ventes å komme resultater (og i inneværende år) som kan massivt styrke BGBIO’s forhandlingsposisjon rundt forhandlingsbordet, være det eventuelt spørsmål om salg, partnerskap eller å gå det alene. Men at det er uansett fortsatt på alle måter i BGBIO’s interesse å vente og la resultatene fortsette å rulle inn i riktig retning, slik de har gjort og vil fortsette å gjøre. Det kan på sikt bety nesten alt i uttelling for BGBIO aksjonærer som har følgt litt med, og som har vært litt talmodig.. Og akkurat nå er det selvsagt vanskelig å tro på et slikt perspektiv, men med alle faktum tatt i hånd, er det det jeg idag velger å tro på som mest sansynlig utfall. Til syvende og sist har BGBIO siktet seg inn på områdene sine der ingen andre har et svar og har utelkkende vist bra respons uten betydningsfull sidevirkning. Og la oss ikke glemme at det tross alt er er massivt, ensomt og svært lønnsomt marked de her bevisst har peilet seg inn på. Da skal vi heller ikke glemme at « It always pays to save lives, and the facts never lie!» God fortsettelse. Courage!
Redigert 11.03.2023 kl 00:42
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omans
11.03.2023 kl 08:30
5329
Det alle vet et at selskapet må ha mer penger inn ila 2023. Det er hva som henger over denne aksjen nå. Hva blir emisjonskursen? Vil TMohn fortsette å spytte inn åndedrett? Eneste som de kan redde seg iland på er antakelig å melde om oppsiktsvekkende resultater fra tester som medfører FDA godkjenning eller liknende.
Men det overhengende nå er timeglasset som renner sakte men sikkert ut, tikk takk....
Men det overhengende nå er timeglasset som renner sakte men sikkert ut, tikk takk....
ctrlaltdel
11.03.2023 kl 10:24
5288
Finansene ser ikke helt bra ut. Cashburh på 70 mill betyr NULL på konto i Q4 23.
Q's Cash A Kurs
Q4 21 437 20,28
Q1 22 368 20,36
Q2 22 292 11,22
Q3 22 225 6,17
Q4 22 150 7,47
Q1 23 80 ?
Q2 23 110 ? Loan 100 mill
Q3 23 40 ?
Q4 23 -30 ?
Der er meldt at;
Oppdatering vedr. ut-lisensierinv av Tilvestamab skal komme i 1H 23
Fase 2 AML (BGBC003) skal komme 1H 23
Så trengs det;
En melding om partner av den sorten med tykk lommebok.
En melding om godkjent patent.
Q's Cash A Kurs
Q4 21 437 20,28
Q1 22 368 20,36
Q2 22 292 11,22
Q3 22 225 6,17
Q4 22 150 7,47
Q1 23 80 ?
Q2 23 110 ? Loan 100 mill
Q3 23 40 ?
Q4 23 -30 ?
Der er meldt at;
Oppdatering vedr. ut-lisensierinv av Tilvestamab skal komme i 1H 23
Fase 2 AML (BGBC003) skal komme 1H 23
Så trengs det;
En melding om partner av den sorten med tykk lommebok.
En melding om godkjent patent.
StockWizard
11.03.2023 kl 11:58
5399
Tilvestamab skal ikke utlisenseres!
Meldt partnerskap, se på presentasjon!
Meldt partnerskap, se på presentasjon!
kongkveite
11.03.2023 kl 12:16
5377
Q1 23 går snart inn i historiebøkene og det må komme noe substans på bordet snarest, med 2-3% nedgang pr dag er vi raskt nede på 2 kroningen..
Også topp 20 har sluttet å hive gode penger etter dårlige. Hva venter de på dersom potensialet er så enormt ?
Merkelig at det ikke er noe BP firma der ute som ser potensialet, eller?
Også topp 20 har sluttet å hive gode penger etter dårlige. Hva venter de på dersom potensialet er så enormt ?
Merkelig at det ikke er noe BP firma der ute som ser potensialet, eller?
sveipen
15.03.2023 kl 20:40
4449
Hvor mye verditap har Frank Moen på denne aksjen?
Sitter med mye aksjer.
Sitter med mye aksjer.