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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JanH
21.03.2023 kl 18:32
10001
Litt overraskede dårlig utvikling i dag. Hvem hadde trodd det liksom. Hva tenker du om dette Biobull ?
omans
21.03.2023 kl 18:42
9980
Denne må over 6-7 kroner før det ser bedre ut, inntil en slik bekreftelse er det vel kun bear rallies i aksjen.
JanH
22.03.2023 kl 08:06
9705
Jeg tror den på sikt kan komme opp i disse kursene du snakker om her. I all fall 6 kr bør være et langsiktig mål. Og da er vi helt der oppe igjen; og alle er happy!
omans
22.03.2023 kl 08:22
9706
Tror det bør skje på mer kortere sikt, ellers må en begynne å spekulere i hva emisjonskursen blir. Bio selskaper kan dobles over natten med den riktige nyheter, men dette selskapet har ikke innfridd så langt. En må melde om at et fremforsket produkt virker så bra at det vil bli tatt ibruk innen legemiddel sektoren. Hvis ikke blir det bare tåkemeldinger rundt noen tester som viser tegn til positive resultater.
Timespa
22.03.2023 kl 09:38
9666
Ikke helt dødt ennå Covid 19 studiene for Bemcentinib👍 Hadde vært positivt om en kunne fått onboardet nok pasienter til å få en rapport ila de neste kvartalene. Potensielt viktig forskning for å forstå verdien av Bemcentinib ved covid lignende sykdommer og influensa.
Publisert under newsletters i dag: https://eu-response.eu/wp-content/uploads/2023/03/Newsletter8.pdf
First of all we would like to thank all sites for their continued support to the trial despite changing
epidemiology and declining number of eligible patients. Due to slow inclusions in AXL SolidAct, a
substantial amendment to the protocol will now allow for inclusion of nosocomial COVID
pneumonia. We will use the next couple of months to assess how this will impact inclusion rates.
We continue to work with sites to get them up and running in the AXL-SolidAct trial. There are
now 22 centres with bemcentinib on site.
Publisert under newsletters i dag: https://eu-response.eu/wp-content/uploads/2023/03/Newsletter8.pdf
First of all we would like to thank all sites for their continued support to the trial despite changing
epidemiology and declining number of eligible patients. Due to slow inclusions in AXL SolidAct, a
substantial amendment to the protocol will now allow for inclusion of nosocomial COVID
pneumonia. We will use the next couple of months to assess how this will impact inclusion rates.
We continue to work with sites to get them up and running in the AXL-SolidAct trial. There are
now 22 centres with bemcentinib on site.
Redigert 22.03.2023 kl 09:46
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Seriøs
22.03.2023 kl 11:33
9596
BGBIO står seg greit i dag på en rød dag ellers. Min personlige antagelse er at denne kan plutselig ta helt av og derfor er jeg inne i denne. Nedsiden kan være like stor og det ser ut til at den er i en fallende trend teknisk, men her i en bio aksje så har teknisk lite å si da den er så uforutsigbar begge veier..Når det gjelder studier så er det selvsakt tidkrevende og mange forventer hyppigere meldinger leser jeg men slik er et ikke i denne verden. Økonomisk så vil jeg ikke tro det kommer mer penger inn eller garantier før rett før de er tomme for cash da de har penger ut 2023.. Mulig vi ser noe i Q4 om det temaet hvis ikke annen info har kommet før det.. Har ingen tro på at de største eierne vil konke BGBIO på noen måte. Emisjon har jeg heller ikke tro på men heller et nytt lån/garantier fra METEVA, eller om det kommer partnere inn med kapital. .
Redigert 22.03.2023 kl 11:34
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JanH
23.03.2023 kl 00:03
9491
Ja. Det ble en utrolig fin dag for BergenBio. Jeg tror heller ikke at det blir emisjon i selskapet. Dere an fint løses på andre måter. Samarbeid er stikkordet. Jeg tror også at selskapet blir kjøpt opp snart. Da kan dere selv regne ut hvor mye dere tjener! Men da kommer den til å stige mange prosent !
Seriøs
23.03.2023 kl 08:56
9285
Nå er det ikke noen overhengende fare for oppkjøp hvis ikke oppkjøper vet mer enn vi vanlige folk da.. Tviler på at noen finansiell løsning vil komme før sent i Q4. Ikke noe poeng å flagge det ennå da de har finansielle muskler ut 2023. Imens vil kursen gå dit den vil og ikke noe hast med mindre du vil selge da?
JanH
24.03.2023 kl 20:31
8867
Det var jo en sterk dag for BergenBio da! Er det flere som er positivt overrasket over kursen i dag?
StockWizard
24.03.2023 kl 21:59
8847
@JanH: Enig!
Det var blodbad på OB i dag! Jeg hadde forventet rund 10 % fall på BGB! Veldig overrasket på 0,57% fall, og tok en lodd på 10k aksjer 😎
Det var blodbad på OB i dag! Jeg hadde forventet rund 10 % fall på BGB! Veldig overrasket på 0,57% fall, og tok en lodd på 10k aksjer 😎
JanH
25.03.2023 kl 10:07
8626
Ja; nettopp! Slike blodbad som vi hadde i går kunne fort ført en aksje som BergenBio ned nær 10 prosent. Sik for eksempel Qec opplevde.
Ellers leste jeg at noen kommentere meg at oppkjøp ikke vil være aktuelt, da man sitter med alt for lite informasjon. Det er jo bare tull. Jeg bygger selv opp et par selskaper, og har blitt kontaktet av flere som muligens kunne tenke seg å kjøpe meg opp. De får da selvsagt alt de ber om av opplysninger, for å vurdere dette videre. Om en aktør tar kontant med Bergenbiofordi han vurderer oppkjøp, så får han selvsagt alt han ber om. Jeg tror både oppkjøp og gå av børs er aktuelt.
Ellers leste jeg at noen kommentere meg at oppkjøp ikke vil være aktuelt, da man sitter med alt for lite informasjon. Det er jo bare tull. Jeg bygger selv opp et par selskaper, og har blitt kontaktet av flere som muligens kunne tenke seg å kjøpe meg opp. De får da selvsagt alt de ber om av opplysninger, for å vurdere dette videre. Om en aktør tar kontant med Bergenbiofordi han vurderer oppkjøp, så får han selvsagt alt han ber om. Jeg tror både oppkjøp og gå av børs er aktuelt.
StockWizard
25.03.2023 kl 13:05
8521
@JanH: enig!
De som skal ta over BGB har DEFINITIVT mere info. og detaljer!
Også har lest at Martin Olin har nylig blitt nevnt som styreleder i et dansk biotek selskap. Kan det være tegn på at oppkjøpsprosesset på BGB er mot slutten og han forbereder seg til sin neste prosjekt?! 🤓
Bla. på interview med Medtech hadde han sagt at han ikke hadde tid før (mens han var styremedlem), men han har nå mere tid å fungere som styreleder ! Hva kan dette bety? Oppkjøpet skal snart offentliggjøres?! 🤓
De som skal ta over BGB har DEFINITIVT mere info. og detaljer!
Også har lest at Martin Olin har nylig blitt nevnt som styreleder i et dansk biotek selskap. Kan det være tegn på at oppkjøpsprosesset på BGB er mot slutten og han forbereder seg til sin neste prosjekt?! 🤓
Bla. på interview med Medtech hadde han sagt at han ikke hadde tid før (mens han var styremedlem), men han har nå mere tid å fungere som styreleder ! Hva kan dette bety? Oppkjøpet skal snart offentliggjøres?! 🤓
Redigert 25.03.2023 kl 13:13
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BioBull
28.03.2023 kl 08:10
7787
Nyheter i dag kl 08:00.
BerGenBio to Present at Upcoming Scientific Conferences
– Data on AXL as a therapeutic target in lung cancers to be highlighted at AACR –
– Ph1a/2b 1L STK11m NSCLC trial design to be outlined at ELCC –
BERGEN, Norway, March 28,2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that the Company will be presenting three posters at two upcoming scientific conferences: ESMO’s European Lung Cancer Congress (ELCC) 2023 and the American Association for Cancer Research (AACR) Annual Meeting 2023.
European Lung Cancer Conference 2023
March 29 – April 1, 2023
Bella Center – Copenhagen, Denmark
Poster Title: Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous NSCLC with/without STK11 mutations
Session Title: Poster Display session (ID 51)
Session Date & Time: Friday March 31, 2023, 12:00 PM – 12:45 PM
Location: Exhibition and Poster area
Presentation Number: 78TiP
American Association for Cancer Research Annual Meeting 2023
April 14 – 19, 2023
Orlando County Convention Center – Orlando, Florida
Poster Title: AXL as a Therapeutic Target in STK11 mutant NSCLC
Session Title: Combination Immunotherapies 1
Session Date and Time: Monday Apr 17, 2023, 1:30 PM - 5:00 PM
Location: Section 39
Poster Board Number: 18
Abstract Presentation Number: 3245
Poster Title: Combined inhibition of AXL and ATR enhances replication stress, cell death and immune response in small cell lung cancer
Session Title: DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM
Location: Section 18
Poster Board Number: 8
Abstract Presentation Number: 6206
The posters from both conferences will be available on the Company’s website in the Scientific Presentations portion of the Investors section following their presentations.
BerGenBio to Present at Upcoming Scientific Conferences
– Data on AXL as a therapeutic target in lung cancers to be highlighted at AACR –
– Ph1a/2b 1L STK11m NSCLC trial design to be outlined at ELCC –
BERGEN, Norway, March 28,2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that the Company will be presenting three posters at two upcoming scientific conferences: ESMO’s European Lung Cancer Congress (ELCC) 2023 and the American Association for Cancer Research (AACR) Annual Meeting 2023.
European Lung Cancer Conference 2023
March 29 – April 1, 2023
Bella Center – Copenhagen, Denmark
Poster Title: Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous NSCLC with/without STK11 mutations
Session Title: Poster Display session (ID 51)
Session Date & Time: Friday March 31, 2023, 12:00 PM – 12:45 PM
Location: Exhibition and Poster area
Presentation Number: 78TiP
American Association for Cancer Research Annual Meeting 2023
April 14 – 19, 2023
Orlando County Convention Center – Orlando, Florida
Poster Title: AXL as a Therapeutic Target in STK11 mutant NSCLC
Session Title: Combination Immunotherapies 1
Session Date and Time: Monday Apr 17, 2023, 1:30 PM - 5:00 PM
Location: Section 39
Poster Board Number: 18
Abstract Presentation Number: 3245
Poster Title: Combined inhibition of AXL and ATR enhances replication stress, cell death and immune response in small cell lung cancer
Session Title: DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM
Location: Section 18
Poster Board Number: 8
Abstract Presentation Number: 6206
The posters from both conferences will be available on the Company’s website in the Scientific Presentations portion of the Investors section following their presentations.
Timespa
28.03.2023 kl 09:06
7798
Bemcentinib sammen med Pemrolizunab viser lovende resultater. Verdt å vise til Merck sine rapporter om salget av Pemrolizumab - helt hinsidig vekst og resultater:
"Keytruda is not only Merck & Co.'s top product but also one of the best-selling drugs worldwide, generating nearly 21 billion U.S. dollars in revenue during 2022. The cancer drug with the generic name pembrolizumab increased its revenues for some 3.7 billion U.S. dollars compared to 2021."
"Keytruda is not only Merck & Co.'s top product but also one of the best-selling drugs worldwide, generating nearly 21 billion U.S. dollars in revenue during 2022. The cancer drug with the generic name pembrolizumab increased its revenues for some 3.7 billion U.S. dollars compared to 2021."
JanH
29.03.2023 kl 08:49
7605
Hva betyr 6,04 nå? Det må være en feil. Skal nok væte 5,04. Blir uansett en spennende dag dette !
BioBull
03.04.2023 kl 08:01
7215
Hektisk bytte og økning i beholdning av aksjer blant de 20 største aksjonærene i BGBIO sist uke . Større endringer enn handels volumet på Oslo Børs.
Påske nøtter og Påske nyheter på gang mon tro…
30-03-2023 88,660,532 51,551,881
29-03-2023 88,660,532 51,268,472
28-03-2023 88,660,532 51,273,669
27-03-2023 88,660,532 51,509,506
24-03-2023 88,660,532 51,486,906
23-03-2023 88,660,532 51,487,383
22-03-2023 88,660,532 51,488,712
https://www.bergenbio.com/investors/our-shareholders/
Påske nøtter og Påske nyheter på gang mon tro…
30-03-2023 88,660,532 51,551,881
29-03-2023 88,660,532 51,268,472
28-03-2023 88,660,532 51,273,669
27-03-2023 88,660,532 51,509,506
24-03-2023 88,660,532 51,486,906
23-03-2023 88,660,532 51,487,383
22-03-2023 88,660,532 51,488,712
https://www.bergenbio.com/investors/our-shareholders/
Redigert 03.04.2023 kl 08:02
Du må logge inn for å svare
BioBull
03.04.2023 kl 08:09
7285
Stoltenberg’s FHI «roper fortsatt i skogen»
Ny og sannsynligvis større COVID pandemi kommer - «den enes død er den andres brød»…. Når og hvor den kommer er fortsatt uvisst….
Uansett spennende for BGBIO ?
https://www.tv2.no/nyheter/innenriks/advarer-mot-ny-pandemi-kan-bli-mye-verre/15633445/
Ny og sannsynligvis større COVID pandemi kommer - «den enes død er den andres brød»…. Når og hvor den kommer er fortsatt uvisst….
Uansett spennende for BGBIO ?
https://www.tv2.no/nyheter/innenriks/advarer-mot-ny-pandemi-kan-bli-mye-verre/15633445/
kongkveite
03.04.2023 kl 08:15
7317
E24 i dag: Det kommer til å bli brutalt for biotek aksjer fremover … Vel, hva annet er nytt ? - Bingoselskapet har rast i over 2 år nå
Seriøs
03.04.2023 kl 08:39
7261
Alt avhenger av hva BGbio kommer med. Kan dra på skikkelig eller gruses. Slik er det i bio
BioBull
03.04.2023 kl 09:05
7251
Mange som synes dette er interessant :
Ref børs melding 28.03.23
https://cslide.ctimeetingtech.com/elcc23hybrid/attendee/confcal_1
78TiP - Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous NSCLC with/without STK11 mutations.
Presentation Number
78TiP
Speakers
R. Veluswamy (New York, United States of America)
Authors
R. Veluswamy (New York, United States of America) S. Bhalla (Dallas, United States of America) R. Mehra (Baltimore, United States of America) O. Gligich (Miami, United States of America) M. C. Garassino (Chicago, United States of America) C. Oliva (Oxford, United Kingdom) C. Gorcea-Carson (Oxford, United Kingdom) N. McCracken (Oxford, United Kingdom)
Presentation Topic
Advanced NSCLC
Abstract
Background
The combination of platinum chemotherapy, pemetrexed and pembrolizumab (CIT) has become a standard of care as first-line (1L) treatment in patients with non-squamous NSCLC. Despite improvements in response rates and survival, the emergence of primary or acquired resistance limits its efficacy. Serine/threonine kinase 11 mutations (STK11m) are common (˜20%) in NSCLC and promote immune suppression by activation of AXL signalling. Bemcentinib (BEM), a selective AXL inhibitor, has been shown in preclinical studies to sensitize STK11m NSCLC to pembrolizumab. Therefore, the addition of BEM to CIT has the potential to improve the 1L treatment outcomes of NSCLC, particularly in tumors harboring STK11m.
Trial design
This is an open-label, multi-center, phase Ib/IIa clinical study to assess the safety, tolerability, and preliminary anti-tumor activity of BEM in combination with CIT as 1L treatment in patients with advanced (stage IIIb/IIIc) or metastatic (stage IV) non-squamous NSCLC without actionable mutations. In the phase IIa, patients with a STK11 mutation will be enrolled. All patients will receive BEM orally on Day 1 of each 21-day CIT treatment cycle. After the completion of 4 cycles of CIT + BEM, patients will receive maintenance with BEM + pemetrexed + pembrolizumab. Phase Ib follows a 3+3 design. Patients will receive BEM + CIT at one of 3 daily BEM dose levels: Cohort 1 = 75 mg; Cohort 2 = 100 mg; or Cohort 3 = 150 mg. An independent data safety monitoring board will review the safety data from each cohort at the end of the dose-limiting toxicity assessment period (the first 21 days of cycle 1 for each patient of each cohort) and will recommend the BEM dose for the phase IIa expansion. The study consists of a screening period (up to 28 days), a treatment period (up to 24 months) and overall survival follow up for each subject for at least 2 years. Up to 24 and 40 patients will be enrolled in the phase Ib and IIa, respectively. The trial is currently enrolling patients in the phase Ib in the US; patients’ recruitment for the phase IIa is planned to open in Q2 2023 in Europe, UK, and US.
Clinical trial identification
EudraCT 2019‐003806‐28/NA/124645.
Legal entity responsible for the study
BerGenBio Ltd, UK.
Funding
BerGenBio.
Disclosure
R. Veluswamy: Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb, AstraZeneca, Merck, Boehringer Ingelheim, BerGenBio, Merus, Novocure, G1 Therapeutics, Regeneron; Financial Interests, Personal, Other, Steering Committee: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Other, consulting honorarium: BeiGene; Non-Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb, Onconova,, AstraZeneca, Boehringer Ingelheim, Lung Cancer Research Foundation, Stand Up 2 Cancer. S. Bhalla: Financial Interests, Personal, Advisory Board: Takeda. R. Mehra: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Personal, Advisory Board: Rakuten Medical, Coherus, Janssen. M.C. Garassino: Financial Interests, Personal, Advisory Board: AstraZeneca, MDS International GmBH, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron, Merck, Ose Immuno Therapeutics, Blueprint, Janssen, Sanofi; Financial Interests, Institutional, Invited Speaker: Eli Lilly, MDS, Pfizer, AstraZeneca, MDS International GmBH, BMS, Boehringer Ingelheim Italia S.p.A., Celgene, Eli Lilly, Ignyta, Incyte, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals; Other, Institutional, Other: AIRC, AIFA, Italian MoH, TRANSCAN, research fundings, Horizon 2020. C. Oliva: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. C. Gorcea-Carson: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. N. McCracken: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. All other authors have declared no conflicts of interest.
Ref børs melding 28.03.23
https://cslide.ctimeetingtech.com/elcc23hybrid/attendee/confcal_1
78TiP - Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous NSCLC with/without STK11 mutations.
Presentation Number
78TiP
Speakers
R. Veluswamy (New York, United States of America)
Authors
R. Veluswamy (New York, United States of America) S. Bhalla (Dallas, United States of America) R. Mehra (Baltimore, United States of America) O. Gligich (Miami, United States of America) M. C. Garassino (Chicago, United States of America) C. Oliva (Oxford, United Kingdom) C. Gorcea-Carson (Oxford, United Kingdom) N. McCracken (Oxford, United Kingdom)
Presentation Topic
Advanced NSCLC
Abstract
Background
The combination of platinum chemotherapy, pemetrexed and pembrolizumab (CIT) has become a standard of care as first-line (1L) treatment in patients with non-squamous NSCLC. Despite improvements in response rates and survival, the emergence of primary or acquired resistance limits its efficacy. Serine/threonine kinase 11 mutations (STK11m) are common (˜20%) in NSCLC and promote immune suppression by activation of AXL signalling. Bemcentinib (BEM), a selective AXL inhibitor, has been shown in preclinical studies to sensitize STK11m NSCLC to pembrolizumab. Therefore, the addition of BEM to CIT has the potential to improve the 1L treatment outcomes of NSCLC, particularly in tumors harboring STK11m.
Trial design
This is an open-label, multi-center, phase Ib/IIa clinical study to assess the safety, tolerability, and preliminary anti-tumor activity of BEM in combination with CIT as 1L treatment in patients with advanced (stage IIIb/IIIc) or metastatic (stage IV) non-squamous NSCLC without actionable mutations. In the phase IIa, patients with a STK11 mutation will be enrolled. All patients will receive BEM orally on Day 1 of each 21-day CIT treatment cycle. After the completion of 4 cycles of CIT + BEM, patients will receive maintenance with BEM + pemetrexed + pembrolizumab. Phase Ib follows a 3+3 design. Patients will receive BEM + CIT at one of 3 daily BEM dose levels: Cohort 1 = 75 mg; Cohort 2 = 100 mg; or Cohort 3 = 150 mg. An independent data safety monitoring board will review the safety data from each cohort at the end of the dose-limiting toxicity assessment period (the first 21 days of cycle 1 for each patient of each cohort) and will recommend the BEM dose for the phase IIa expansion. The study consists of a screening period (up to 28 days), a treatment period (up to 24 months) and overall survival follow up for each subject for at least 2 years. Up to 24 and 40 patients will be enrolled in the phase Ib and IIa, respectively. The trial is currently enrolling patients in the phase Ib in the US; patients’ recruitment for the phase IIa is planned to open in Q2 2023 in Europe, UK, and US.
Clinical trial identification
EudraCT 2019‐003806‐28/NA/124645.
Legal entity responsible for the study
BerGenBio Ltd, UK.
Funding
BerGenBio.
Disclosure
R. Veluswamy: Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb, AstraZeneca, Merck, Boehringer Ingelheim, BerGenBio, Merus, Novocure, G1 Therapeutics, Regeneron; Financial Interests, Personal, Other, Steering Committee: Novartis; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Other, consulting honorarium: BeiGene; Non-Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb, Onconova,, AstraZeneca, Boehringer Ingelheim, Lung Cancer Research Foundation, Stand Up 2 Cancer. S. Bhalla: Financial Interests, Personal, Advisory Board: Takeda. R. Mehra: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Personal, Advisory Board: Rakuten Medical, Coherus, Janssen. M.C. Garassino: Financial Interests, Personal, Advisory Board: AstraZeneca, MDS International GmBH, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron, Merck, Ose Immuno Therapeutics, Blueprint, Janssen, Sanofi; Financial Interests, Institutional, Invited Speaker: Eli Lilly, MDS, Pfizer, AstraZeneca, MDS International GmBH, BMS, Boehringer Ingelheim Italia S.p.A., Celgene, Eli Lilly, Ignyta, Incyte, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine, GSK, Spectrum Pharmaceuticals; Other, Institutional, Other: AIRC, AIFA, Italian MoH, TRANSCAN, research fundings, Horizon 2020. C. Oliva: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. C. Gorcea-Carson: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. N. McCracken: Financial Interests, Institutional, Full or part-time Employment: BerGenBio. All other authors have declared no conflicts of interest.
JanH
03.04.2023 kl 12:22
7098
Dette er bra! Og det er en ekstremt hyggelig inngang å kjøpe i dag! Det er mange som har fått med at kursen nå er på bunnen. Dermed vil den også gå rett opp!
JanH
03.04.2023 kl 17:34
6959
Det ble en fin avslutning på dagen
Da fant vi ut hvor bunnen er! Utrolig viktig det
Da fant vi ut hvor bunnen er! Utrolig viktig det
JanH
05.04.2023 kl 13:37
6474
Da går vi inn i påskeuken etter en fantastisk uke😀. Blir spennende etter påske !
StockWizard
05.04.2023 kl 15:06
6433
Snart er det slutt påskesalget og sannsynlig fall-trenden!
Vi per definisjon er nærmere til H1 avslutning og godmeldinger bla. utlisensering og finansiering!
Vi per definisjon er nærmere til H1 avslutning og godmeldinger bla. utlisensering og finansiering!
Move Along
12.04.2023 kl 00:38
5572
Det jeg liker mest med denne aksjen nå er at den har blitt så totalt fille-ristet at ingenting betyr noe lenger. Vi kan bare sitte i den, finne oss en lun og fin plass i askebegeret å legge oss i, så våkner vi sikkert til igje og når og dersom det er nyhetsverdige bevegelser igjen. Med andre ord er min satsning i denne aksjen totalt avskrevet forlengst, med navnelappen «dårligste investering ever», men jeg velger å ikke selge fordi jeg faktisk (fortsatt) har (veldig) troen på det dette selskapet holder på med! Så da sitter vi bare her da, som nyttige idioter, alt tapt, men med troen i beholld. Funker greit for meg, når vi likevel har komt hittil. Svaret kommer til sist.
StockWizard
12.04.2023 kl 16:19
5299
Plutselig store poster på kjøpersiden siden kl 16!
Vet noen noe?
Vet noen noe?
Redigert 12.04.2023 kl 16:21
Du må logge inn for å svare
Seriøs
12.04.2023 kl 19:56
5119
Kan virke slik. Blir spennende fremover nå. Cash har de ut året men må ha påfyll i Q4 vil jeg tro. Får de et gjennombrudd så går det av seg selv. Hvis ikke spøker der litt mer. Sitter og venter og var litt i pluss i dag noe som føltes helt ok👍
kongkveite
14.04.2023 kl 09:36
4684
StockWizard skrev Plutselig store poster på kjøpersiden siden kl 16! Vet noen noe?
Og der var gutta 1 aksje klubben atter aktiv på slagsiden..Djeeze for et opplegg
Småland
14.04.2023 kl 11:50
4571
Tipper vi har en langt høyere kurs på BgBio neste fredag etter Orlandopresentasjonene :) Selskapet er nå verdsatt til ca 40 mill. dollar og lommerusk for BP. Strong buy!
April 14 – 19, 2023
Orlando County Convention Center – Orlando, Florida
Poster Title: AXL as a Therapeutic Target in STK11 mutant NSCLC
Session Title: Combination Immunotherapies 1
Session Date and Time: Monday Apr 17, 2023, 1:30 PM - 5:00 PM
Location: Section 39
Poster Board Number: 18
Abstract Presentation Number: 3245
Poster Title: Combined inhibition of AXL and ATR enhances replication stress, cell death and immune response in small cell lung cancer
Session Title: DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM
Location: Section 18
Poster Board Number: 8
Abstract Presentation Number: 6206
April 14 – 19, 2023
Orlando County Convention Center – Orlando, Florida
Poster Title: AXL as a Therapeutic Target in STK11 mutant NSCLC
Session Title: Combination Immunotherapies 1
Session Date and Time: Monday Apr 17, 2023, 1:30 PM - 5:00 PM
Location: Section 39
Poster Board Number: 18
Abstract Presentation Number: 3245
Poster Title: Combined inhibition of AXL and ATR enhances replication stress, cell death and immune response in small cell lung cancer
Session Title: DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM
Location: Section 18
Poster Board Number: 8
Abstract Presentation Number: 6206
Småland
16.04.2023 kl 21:50
4145
Pr. 29.03.23 hadde DNB BANK ASA MEGLERKONTO INNLAND 362,275 aksjer i BGB. 13.04.23 står den samme kontoen med 614,214 aksjer. De 20 største aksjonærene har i samme periode økt fra 51,268,472 aksjer til 51,569,967 stk. Småttingene selger mens de store forholder seg rolig, eller kjøper. Blir uansett spennende de neste to ukene, da med tanke på hva som skjer i forhold til US raidet :)
Mulla3
16.04.2023 kl 22:24
4081
Småland.
Du kan virkelig klare oppgaven med å koke suppe på en spiker.
Du kan virkelig klare oppgaven med å koke suppe på en spiker.
Småland
16.04.2023 kl 22:38
4059
Takker så mye for det Mulla3 :) Har kokt suppe før i et selskap som het Algeta, suppa ble god den...^_^
BioBull
18.04.2023 kl 08:14
3513
Jeg antar at mange potensielle partnere står i kø for å få tak i BerGenBio’s rettigheter før FDA godkjenning,- etter disse revolusjonerende og banebrytende resultater med Bemcentinib :
Fra: BerGenBio ASA
Dato: 18. april 2023 kl. 07:00:50 CEST
BerGenBio Presents Data on STK11 Loss of Function and AXL Activation at AACR
- In addition to STK11 mutations, KEAP1m identified as being associated with STK11 loss of function -
- STK11 loss of function correlated to AXL activation and poorer outcomes in NSCLC -
BERGEN, Norway, April 18, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that it presented data linking AXL activation to STK11 loss of function in Non-Small Cell Lung Cancer (NSCLC) in an abstract titled, AXL as a Therapeutic Target in STK11 mutant NSCLC, at the American Association for Cancer Research (AACR) Annual Meeting 2023.
An analysis of tumors lacking STK11 function from BerGenBio’s 2nd line NSCLC trial (BGBC008) and publicly available datasets suggest that STK11 and KEAP1 mutations are transcriptionally similar and share a common signature for STK11 loss of function. Loss of function leading to inactivation of STK11 is found in approximately 30% of lung adenocarcinomas as a result of both mutational and non-mutational mechanisms. These tumors with inactivated STK11 are likely to promote AXL activation due to high levels of energetic and metabolic stress, resulting in a poorer prognosis in NSCLC.
AXL, a member of the TAM family of receptor tyrosine kinases, is expressed in over 80% of NSCLC tumors that demonstrate loss of STK11 function. AXL is activated in response to inflammation, hypoxia, cellular stress or drug treatment. AXL is expressed in both tumor cells, where it enhances survival and drug resistance, and in innate immune cells, such as dendritic cells and macrophages, where AXL drives immune suppression. BerGenBio’s selective AXL inhibitor bemcentinib targets key survival and resistance mechanisms within the tumor and restores the anti-tumor characteristics of innate immune cells within the tumor microenvironment.
“There is accumulating evidence substantiating the importance of targeting AXL within the tumor and innate immune cells of the tumor microenvironment,” said Nigel McCracken,Ph.D., Chief Scientific Officer of BerGenBio. “A loss of STK11 function due to STK11 or KEAP1 mutations is associated with a poorer prognosis, irrespective of treatment modality and represents a large subgroup of NSCLC patients with high unmet need. Our preclinical data and the clinical data from our Phase 2 trial evaluating bemcentinib in combination with pembrolizumab support targeting AXL in both STK11 and KEAP1 mutated NSCLC patients.”
The abstract will be available on the Company’s website in the Scientific Presentations portion of the Investors section.
https://www.bergenbio.com/wp-content/uploads/2023/04/Poster_AACR_2023_print_20030331.pdf
Fra: BerGenBio ASA
Dato: 18. april 2023 kl. 07:00:50 CEST
BerGenBio Presents Data on STK11 Loss of Function and AXL Activation at AACR
- In addition to STK11 mutations, KEAP1m identified as being associated with STK11 loss of function -
- STK11 loss of function correlated to AXL activation and poorer outcomes in NSCLC -
BERGEN, Norway, April 18, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that it presented data linking AXL activation to STK11 loss of function in Non-Small Cell Lung Cancer (NSCLC) in an abstract titled, AXL as a Therapeutic Target in STK11 mutant NSCLC, at the American Association for Cancer Research (AACR) Annual Meeting 2023.
An analysis of tumors lacking STK11 function from BerGenBio’s 2nd line NSCLC trial (BGBC008) and publicly available datasets suggest that STK11 and KEAP1 mutations are transcriptionally similar and share a common signature for STK11 loss of function. Loss of function leading to inactivation of STK11 is found in approximately 30% of lung adenocarcinomas as a result of both mutational and non-mutational mechanisms. These tumors with inactivated STK11 are likely to promote AXL activation due to high levels of energetic and metabolic stress, resulting in a poorer prognosis in NSCLC.
AXL, a member of the TAM family of receptor tyrosine kinases, is expressed in over 80% of NSCLC tumors that demonstrate loss of STK11 function. AXL is activated in response to inflammation, hypoxia, cellular stress or drug treatment. AXL is expressed in both tumor cells, where it enhances survival and drug resistance, and in innate immune cells, such as dendritic cells and macrophages, where AXL drives immune suppression. BerGenBio’s selective AXL inhibitor bemcentinib targets key survival and resistance mechanisms within the tumor and restores the anti-tumor characteristics of innate immune cells within the tumor microenvironment.
“There is accumulating evidence substantiating the importance of targeting AXL within the tumor and innate immune cells of the tumor microenvironment,” said Nigel McCracken,Ph.D., Chief Scientific Officer of BerGenBio. “A loss of STK11 function due to STK11 or KEAP1 mutations is associated with a poorer prognosis, irrespective of treatment modality and represents a large subgroup of NSCLC patients with high unmet need. Our preclinical data and the clinical data from our Phase 2 trial evaluating bemcentinib in combination with pembrolizumab support targeting AXL in both STK11 and KEAP1 mutated NSCLC patients.”
The abstract will be available on the Company’s website in the Scientific Presentations portion of the Investors section.
https://www.bergenbio.com/wp-content/uploads/2023/04/Poster_AACR_2023_print_20030331.pdf
Redigert 18.04.2023 kl 08:16
Du må logge inn for å svare
habbiten
18.04.2023 kl 08:27
3462
Oppfatter meldingen som kryptisk. Får se om noen står i kø for emisjonen 😅😅
StockWizard
18.04.2023 kl 08:39
3411
Seriøs skrev Hadde vært morro om Bayer tok opp shoppingen igjen.
De i hverdall har en tjukk lommebok pga covid Vaccine ;)
Småland
18.04.2023 kl 08:39
3414
Folk skjønner visst ikke hvor stor samling av forskere og investorer dette er Link: https://www.google.com/search?client=firefox-b-d&q=American+Association+for+Cancer+Research+%28AACR%29+Annual+Meeting+2023
keane
18.04.2023 kl 08:42
3408
For dere som følger med....! Er denne et kjøp nå, ser den har falt mye meg jeg har fulgt selskapet med et øye og vet ikke helt hvordan pipeline etc ser ut framover.....
Gullit
18.04.2023 kl 08:50
3387
Absolutt, i dag blir det trangt, dette var nok vendepunktet for BB sin kursutvikling, kan gå høyt idag