BGBIO: Høstens presentasjoner


Det vil komme flere meldinger om presentasjoner etter hvert, men vi starter tråden med at BGBIO skal presentere fase II klinisk-, preklinisk- og biomarkør-data fra programmet med bemcentinib (BGB324) på ESMO 2018-konferansen i München 19.-23. oktober.

Vi tar med den mer utfyllende meldingen på engelsk:

Merk også: Pre-clinical data on the role of AXL inhibition in Myelodysplastic Syndrome (MDS) will also be presented. Details of the presentations are below.

The posters will be made available at www.bergenbio.com in the Investors / Presentations section at the time of presentation and full abstracts will be
made available online according to ESMO's embargo schedule: https://www.esmo.org/Conferences/ESMO-2018-Congress/Abstracts

Poster presentations at ESMO:

Sunday 21 October, 11:15 - 12:15, Hall B3 - Room 21

Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective
and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical
Trials

· Robert Holt, PhD et al
· Poster Discussion session - Translational research 2
· Invited discussant: 11:15 - 11:45
· Presentation number: 63PD

Sunday 21 October, 12:45 - 13:45, Hall A3 - Poster Area

Update on the randomised Phase Ib/II study of the selective small molecule AXL
inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib
or pembrolizumab in patients with metastatic melanoma

· Cornelia Schuster, MD, PhD et al
· Poster display session - Melanoma and other skin tumours
· Presentation number: 1266P

Sunday 21 October, 16:30 - 17:45, Hall B3 - Room 21

The identification of the AXL/Gas6 signalling axis as a key player of
myelodysplastic syndrome (MDS) and the potential of the oral selective AXL
inhibitor bemcentinib in the treatment of MDS

· Hind Medyouf, PhD et al
· Poster Discussion session - Haematological malignancies
· Invited discussant: 16:30 - 16:55
· Presentation number: 1009PD

- END -

About the ESMO Congress

The ESMO Congress is the leading European meeting for medical oncology convening
over 20,000 international delegates from the field. ESMO 2018 will be held in
Munich, Germany 19- 23 October 2018.

About BerGenBio's Companion Diagnostics programme

In parallel with its phase II clinical trial programme, BerGenBio explores
predictive biomarker candidates with the aim to develop a companion diagnostic
to identify patients most likely to benefit from bemcentinib treatment.

Thus far, the company reported strong correlation with response of both plasma
soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or
MDS and advanced NSCLC, respectively.

About the BGBIL006 trial

Melanoma is the most serious type of skin cancer as it may spread to lymph nodes
and distant organs if not discovered in time. Melanoma occurs when the cells
that colour the skin, the so-called melanocytes, start to divide uncontrollably.

The BGBIL006 trial is a randomised Phase 1b/2 investigator sponsored clinical
study of bemcentinib (BGB324) in combination with either the MAPK inhibitors
MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or the immune checkpoint
inhibitor KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.

For more information please access trial NCT02872259at 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 a 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
Redigert 09.10.2018 kl 09:43 Du må logge inn for å svare
Korsar
05.11.2018 kl 10:09 3201

Lego,
ja, men det gjelder jo først og fremst de som sitter med store startposisjoner (grundere).
Legoland
05.11.2018 kl 11:06 3153

"Stor" er et relativt begrep.
Boms
05.11.2018 kl 12:08 3101

Korsar: Tror du har lest meldingen feil. Det står "options where granted" som oversatt blir "opsjoner er tildelt".

Timingen kan likevel være et tegn på at styret/ledelsen har tro på at dette skal oppover, det er jo om å gjøre å ha så lav innløsningskurs på opsjonene som mulig.
Korsar
05.11.2018 kl 12:27 3077

Boms,
før du påstår at jeg har misforstått meldingen må du først skrive korrekt engelsk. Det er f.eks. forskjell på where og were...
Og det er helt feil når du skriver at dagens melding skal forstås som "opsjoner tildelt".

Her er det korrekte (jeg har i 40 år vært del av ulike opsjonsprogrammer selv og vet utmerket hva ting betyr):
Insiderne ble TILDELT opsjonsrettighetene allerede på årsmøtet 14. mai 2018, og opsjonene kan tas ut over en 3-års periode.
Det som meldes nå er at nevnte insidere "exercised" opsjoner, dvs. AKTIVERTE fra rammen de ble tildelt i mai 2018.

Jfr. meldingsteksten:
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 277,000 share options were granted at an exercise price at NOK 28.50,
of this the following was granted to primary insiders (total holdings of share
options following this grant):

Redigert 05.11.2018 kl 12:29 Du må logge inn for å svare
Daniel
06.11.2018 kl 14:22 2876

Edit: Nå er abstractet ute! Tenkte at det kome i morgen!

Redigert 06.11.2018 kl 14:27 Du må logge inn for å svare
InVes1
06.11.2018 kl 14:25 2869


06/11-2018 14:15:10: (BGBIO) BerGenBio reports ~80% improvement in PFS of AXL-positive vs AXL-negative NSCLC patients in bemcentinib + KEYTRUDA PhII combination tria
· Late breaking abstract at SITC: Analysis of first stage of phase II trial
with selective AXL inhibitor bemcentinib + KEYTRUDA in previously treated
advanced NSCLC patients
· Median progression-free-survival (mPFS) of 5.9 months in AXL positive vs 3.3
months in AXL negative patients (~80% improvement)
· Predominantly PD-L1 negative or weak-positive patient population
Bergen, Norway, 6 November 2018 - BerGenBio ASA (OSE:BGBIO) announces that a
Late-breaking Abstract detailing median progression-free-survival (mPFS) during
the first stage of its phase II clinical trial with bemcentinib, a first-in
-class selective oral AXL inhibitor, in combination with the anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) in patients with previously treated, advanced non
-small cell lung cancer (NSCLC) has been published today and will be presented
at the annual Society for Immunotherapy in Cancer (SITC) 2018 congress in
Washington D.C. (7-10 November 2018).

24 patients have been enrolled during the first stage of the combination trial.
The median time that patients lived without progression of their disease (mPFS)
was 5.9 months in AXL positive patients (n=10) and thus greater than the mPFS of
3.3 months in patients whose tumours did not show any AXL expression as per
BerGenBio's proprietary biomarker test (n=11). mPFS is an outcome criterion that
measures the time that patients can stay on treatment in the trial without their
disease getting worse.

The full abstract is available at https://www.sitcancer.org/2018/abstracts and a
poster will be presented by the study's lead investigator at the SITC congress
in Washington DC on Friday, 9 November 2018.


https://www.netfonds.no/quotes/release.php?id=20181106.OBI.20181106S71
medico
06.11.2018 kl 14:38 2834

Aksjen faller stort på denne meldingen
"Median progression-free-survival (mPFS) of 5.9 months in AXL positive vs 3.3 months in AXL negative patients (~80% improvement)"
Biotek og børs er underlige greier
Daniel
06.11.2018 kl 14:42 2821

Det er helt snålt. 40 % får partial response og 30 % får stable disease. Dette fører til at median progression-free-survival øker med 80 %. Dette er ekstremt gode resultater. Jeg tror at Merck kommer til å kjøpe oss BerGenBio innen kort tid.

Dette er vel langt unna hva mange hadde håpet på. Ingen mirakelkur akkurat.. Blir det under 20 før nyttår?
medico
06.11.2018 kl 14:54 2793

Langt unna hva mange hadde håpet på, ja da får man jo "late breaking status" på en av verdens mest betydningsfulle konferanser på området
Redigert 06.11.2018 kl 14:55 Du må logge inn for å svare

Det finnes ingen mirakelkur for NSLC. 95% er døde innen 5 år. Dette er et betydelig fremskritt, behandlingen vil sannsynligvis ha enda større effekt for pasienter i førstelinje(som er friskere). Ikke bare har behandlingen høy effekt(relativt sett), den har også lite bivirkninger.
Dette kan endre etablert praksis for lungekreftbehandling.
Daniel
06.11.2018 kl 15:04 2161

Enig. Dette er fantastisk, og jeg tror at markedet kommer til å se det etter hvert. Det er alt for mange som ikke fatter bæret av børsmeldinger innen biotek.
InVes1
06.11.2018 kl 15:06 2154

9. november frigives hele abstractet. Kortsigtet TA siger 39,70. Så mon ikke den stiger videre, når de er færdige med at gevinstsikre.

Markedet er ikke enig. Hele poenget med BGBIO var troen på at AXL kunne være nøkkelen og at bemcentinib kunne bli en hjørnesten i kreftbehandling. Det virker mer som drømmerier nå. Resultatene så langt gjør liten forskjell og BGBIO havner i samme haugen med hundrevis av andre selskaper som håper de en dag kan kommersialisere pipeline. Dessverre sitter jeg fortsatt med aksjene mine. Angrer bittert på at jeg ikke solgte i sommer..

Selg nå naivinvest, Hvis du tror denne skal ned under 20 så er du ganske naiv hvis du blir sittende på aksjene.

Historisk så viste Keytruda som monoterapi(KEYNOTE-001) 2,9 som snitt for tilsvarende pasientgrupper, der den høyeste responsen var blant pasienter med >50% PL-L1 nivå(4,3).

5,9 er ganske mye bedre.

Fikk ny melding nå eller er den gammel?:BerGenBio reports ~80% improvement in PFS of AXL-positive vs AXL-negative NSCLC patients in bemcentinib + KEYTRUDA PhII combination trial
Late breaking abstract at SITC: Analysis of first stage of phase II trial with selective AXL inhibitor bemcentinib + KEYTRUDA in previously treated advanced NSCLC patients
Median progression-free-survival (mPFS) of 5.9 months in AXL positive vs 3.3 months in AXL negative patients (~80% improvement)
Predominantly PD-L1 negative or weak-positive patient population
Bergen, Norway, 6 November 2018 - BerGenBio ASA (OSE:BGBIO) announces that a Late-breaking Abstract detailing median progression-free-survival (mPFS) during the first stage of its phase II clinical trial with bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with previously treated, advanced non-small cell lung cancer (NSCLC) has been published today and will be presented at the annual Society for Immunotherapy in Cancer (SITC) 2018 congress in Washington D.C. (7-10 November 2018).
24 patients have been enrolled during the first stage of the combination trial. The median time that patients lived without progression of their disease (mPFS) was 5.9 months in AXL positive patients (n=10) and thus greater than the mPFS of 3.3 months in patients whose tumours did not show any AXL expression as per BerGenBio’s proprietary biomarker test (n=11). mPFS is an outcome criterion that measures the time that patients can stay on treatment in the trial without their disease getting worse.
The full abstract is available at https://www.sitcancer.org/2018/abstracts and a poster will be presented by the study’s lead investigator at the SITC congress in Washington DC on Friday, 9 November 2018.
Redigert 06.11.2018 kl 20:59 Du må logge inn for å svare
Daniel
06.11.2018 kl 21:54 1936

Den kom tidligere i dag, og har allerede vært diskutert for noen innlegg siden.
focuss
06.11.2018 kl 22:03 1931

Disse pillene er verdt 25000 usd per stk.
Korsar
07.11.2018 kl 10:01 1806

Den norske kortmeldingen i går bør vel kanskje nevnes her:

BGBIO:MPFS PÅ 5,9 MND I AXL-POSITIVE PASIENTER VS 3,9 MND I AXL-NEGATIVE
Oslo (TDN Direkt):
Bergenbio rapporterer fra første fase II-studie med bemcentinib og Keytruda i tidligere behandlede NSCLC-pasienter at median progresjonsfri overlevelse (MPFS) var 5,9 måneder i AXL-positive pasienter, mot 3,3 måneder i AXL-negative pasienter.
24 pasienter har blitt innrullert i første del av studien.

Hvis jeg skal si noe tabloid til dette, så er det at jeg gjerne vil høre mer detaljer svært så snart :-)
.
focuss
07.11.2018 kl 10:03 1800

Virker ikke som at gode resultater biter på BerBio
Daniel
07.11.2018 kl 11:02 1763

Jeg har sendt inn spørsmål rundt den siste meldingen til Radforsk, så de tar det forhåpentligvis opp i neste podcast.
focuss
07.11.2018 kl 11:16 1749

Daniel
BerBio er ikke et radforsk selskap.
Daniel
07.11.2018 kl 11:29 1738

Det vet jeg, men det betyr ikke at de ikke snakker om selskapet. De har også tidligere hatt Richard Godfrey som gjest i podcasten.
heilo888
07.11.2018 kl 17:29 1629

Daniel; Godt initiativ, men tror neppe Radforsk prioriterer å analysere Bgbio, da Einarsson trolig har nok med å kommentere deres egene selskaper.
Vi før høre i podcasten tirsdag i neste uke?
InVes1
07.11.2018 kl 18:38 1585

Bliver presentationen og frigivelse af posteren den 9. først efter børsens åbningstid?
Korsar
10.11.2018 kl 12:36 1354

Konklusjon er bl.a. disse sterke indikasjonene:

- Median PFS in AXL positive patients was 5.9 months which represents an approximately 80% improvement over
AXL negative patients (3.3 months)

- This benefit was not driven by high PD-L1 expressors. Median PFS in AXL positive and PD-L1 negative/weak
positive patients was not mature at 7.9 months and thus much better than what is expected with
pembrolizumab monotherapy, as per KEYNOTE 001 results.

Vi får se hvor mye markedet krediterer dette neste uke.
InVes1
10.11.2018 kl 12:47 1346

Og ORR er 40% for AXL positive patienter, som udgør ca 50% af patienterne.