News Bergen Bio

Slettet bruker
BGBIO 27.09.2019 kl 12:19 5007

BerGenBio Presents Phase II Trial Updates with Selective AXL Inhibitor Bemcentinib at the European Society for Medical Oncology (ESMO) 2019 Congress
Bergen, Norway, 27 September 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, is to provide study updates in two poster
presentations from its Phase II clinical development programme with bemcentinib
(BGB324), a first-in-class highly selective oral AXL inhibitor, at the European
Society for Medical Oncology (ESMO) 2019 Congress, in Barcelona (27 September -
01 October 2019).

The first poster outlines data from BerGenBio's Phase II clinical trial (BGB008)
with bemcentinib and Merck's anti-PD-1 therapy pembrolizumab (KEYTRUDA) in
patients with advanced non-small cell lung cancer (NSCLC). Data shows that the
combination is well tolerated and showed promising efficacy in previously
treated NSCLC patients, particularly in those with AXL expression in tumour,
immune and stromal cells, including PDL-1 low/negative patients. The poster also
highlights the identification of a new novel predictive plasma protein
biomarker.

The second poster provides a trial update on a randomized Phase Ib/II study of
bemcentinib in combination with either dabrafenib/trametinib (D/T) or
pembrolizumab in patients with metastatic melanoma. Data from the trial shows
that bemcentinib is well tolerated in combination with both D/T and
pembrolizumab, with adverse effect profiles consistent with those reported for
either therapeutic approach alone.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "AXL mediates
aggressive traits when expressed on tumour, immune and stromal cells in cancers.
Bemcentinib inhibits this, and we see encouraging and very durable clinical
benefit in patients who otherwise would not be expected to respond to PD-1
inhibitors. Our comprehensive translational research program is yielding novel
biomarkers and validation of the mode of action of bemcentinib. We look forward
to providing updates as data from our ongoing investigations becomes available."

Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 12:22 4998

RIEF-Bergenbio Presents Phase II Trial Updates With Selective AXL Inhibitor Bemcentinib
Innkommet 27.09.2019 12:14

Sept 27 (Reuters) - Bergenbio ASA :
* BERGENBIO PRESENTS PHASE II TRIAL UPDATES WITH SELECTIVE
AXL
INHIBITOR BEMCENTINIB AT THE EUROPEAN SOCIETY FOR MEDICAL
ONCOLOGY (ESMO) 2019 CONGRESS
* SECOND POSTER PROVIDES A TRIAL UPDATE ON A RANDOMIZED
PHASE
IB/II STUDY OF BEMCENTINIB IN COMBINATION WITH EITHER
DABRAFENIB/TRAMETINIB (D/T) OR PEMBROLIZUMAB IN PATIENTS WITH
METASTATIC MELANOMA
* DATA FROM TRIAL SHOWS BEMCENTINIB IS WELL TOLERATED IN
COMBINATION WITH BOTH D/T AND PEMBROLIZUMAB, WITH ADVERSE EFFECT
PROFILES CONSISTENT WITH THOSE REPORTED FOR EITHER THERAPEUTIC
APPROACH ALONE
* BERGENBIO - ON FIRST POSTER: DATA SHOWS THAT COMBINATION
IS WELL
TOLERATED AND SHOWED PROMISING EFFICACY IN PREVIOUSLY TREATED
NSCLC PATIENTS
* BERGENBIO - 1ST POSTER OUTLINES DATA FROM BERGENBIO'S
PHASE II
CLINICAL TRIAL (BGB008) WITH BEMCENTINIB AND MERCK'S ANTI-PD-1
THERAPY PEMBROLIZUMAB (KEYTRUDA) IN PATIENTS WITH ADVANCED
NON-SMALL CELL LUNG CANCER (NSCLC)

Source text for Eikon:
Further company coverage:

(Gdynia Newsroom)
((gdynia.newsroom@thomsonreuters.com; +48 58 772 0920;))
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 12:24 4974

Nå går vi rett til 20kr
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Jens1
27.09.2019 kl 12:28 4959

Veldig bull
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 12:31 4942

DNB har kursmål 44 så her er det mye å gå på.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 12:39 4921

Herlig. Dette er spennende, og ikke minst lovende!
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 12:40 4903

BGBIO:VIL PRESENTERE STATUS PÅ TO STUDIER PÅ ESMO-KONGRESS
Oslo (TDN Direkt): BerGenBio skal presentere foreløpig status fra sine to kliniske studier med bemcentinib (BGB324) på European Society for Medical Oncology-kongressen i Barcelona 28.september og 30.september, ifølge en melding fredag.

I den ene presentasjonen skal det gis en oppdatering fra kliniske fase II-studien (BGB008) der man tester ut bemcentinib og Mercks anti PD-1 terapi pembrolizumab (KEYTRUDA) på pasienter med avansert ikke-småcellet lungekreft.

I den andre presentasjonen skal det gis en oppdatering fra en randomisert fase 1b/II- studie der man benytter bemcentinib i kombinasjon med enten dabrafenib/trametinib (D/T) eller pembrolizumab hos pasienter med metastatisk melanom.

SSN finans@tdn.no

TDN Direkt, +47 21 95 60 70
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Martin10
27.09.2019 kl 12:41 4893

Er det tid for optimisme i aksjen. Kommer når det er minst ventet. God utvikling på dagens melding.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 13:03 4827

Bare å lese seg opp i helga... for de som har tid...

https://www.bergenbio.com/
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
27.09.2019 kl 13:06 4809

Her gjelder det å holde på aksjene det er mange som vil inn før close i dag.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Salbei
27.09.2019 kl 13:09 4800

Kjøpte litt nå her..virker spennende :)
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Salbei
27.09.2019 kl 13:12 4787

bare å komme seg inn før børsen lukker i ettermiddag :O
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Saldo@
27.09.2019 kl 13:16 4773

Positive resultater her så ser vi 50-100 kr pr aksje
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Jens1
27.09.2019 kl 13:34 4726

Mye mer enn det... Se på Genmab i dannmark.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Saldo@
27.09.2019 kl 14:24 4657

Stiger fort opp på 20 tallet neste uke da det blir rift om aksjene.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Saldo@
27.09.2019 kl 15:19 4562

Det ligger vel litt i kortene at de kommer med bra resultater.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
28.09.2019 kl 08:24 4353

Ser topp 10 eier 59,8% av aksjene. Kan bli spennende hvis det blir kamp om aksjene til uken
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Seriøs
28.09.2019 kl 09:33 4295

Har ligget lenge i ro denne aksjen nå. Vi får se hva presentasjonen kl 12 i dag viser. Er den oppløftende kan vi få et byks til uken
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
YNWA250505
28.09.2019 kl 09:38 4285

NANO la frem sykt bra tall og steg rett opp, en uke etterpå er aksjen rett ned igjen. Så vi får se, håper den stiger til himmels og blir der
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Seriøs
28.09.2019 kl 09:41 4276

Hva er potensiell høyde for aksjen. Mange spådommer men?
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
28.09.2019 kl 10:05 4249

Men angående nano så frykter vel investorer emisjon der
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Saldo@
28.09.2019 kl 10:46 4208

Kommer børsmelding om resultatene mandag eller tirsdag?
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Seriøs
28.09.2019 kl 10:50 4198

Spennende
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
naivinvest
07.12.2019 kl 02:03 3457

Lovende resultater presenteres i ASH mandag!


Results

A total of 16 pts were enrolled. Median age was 76 years (range 66-83). Of the 13 pts with available cytogenetic results, 5 pts (38%) had a poor risk cytogenetic profile, 7 (54%) were intermediate, 1 (8%) favorable. Bone marrow results showed a median of 35% myeloblasts at screen (range 3-96%).

As of July 2019, 15 pts were evaluable for response by BM aspirate on or after C2D1. Six of the evaluable pts had objective responses (ORR 40%, 4 CR/CRis + 2 PRs). Five of the responses (4 CR/CRi + 1 PR) were durable, ranging from 3.4 to 11.7 mos, all still ongoing. All 5 pts with durable responses were >75 years old (range: 76-83). Survival of these 5 pts ranged from 8.8-12.4 months at cut-off, with no relapse or significant events yet reported. Of these 5 pts, 1 had relapsed disease, 3 had secondary AML, and 2 had unfavorable cytogenetics.

Additionally, 3 pts (aged 71-78 years old) had durable stable disease lasting approximately 4 mos, with 1 remaining on study. Of the 3 pts, 1 had newly-diagnosed and 2 refractory AML, and at least 1 had secondary AML.

The RFS and OS data is not yet mature and will be reported at a later stage.

The combination was generally well tolerated with expected and manageable AE profile, with pts continuing the combination up to >19 cycles at cut-off. All pts experienced at least one AE regardless of relation to study treatment, the most common being diarrhea (7/16, 44%) and anaemia (6/16, 38%). The most common treatment-related AEs (TRAEs) were diarrhea (4/16, 25%), electrocardiogram QTc prolongation (3/16, 19%) and decreased platelet count (3/16, 19%). Of these TRAEs, 1 drug interruption and 1 withdrawal were reported; none of these events were reported as SAEs. SAEs occurring in >1 patient were febrile neutropenia (4/16, 25%; 1 related to study drug), and pyrexia (2/16, 12.5%; not related to study drug). These SAEs are typically observed in AML.

Conclusions

The combination of bemcentinib + LDAC induced a response rate of 40% in pts with newly-diagnosed and relapsed AML. CRs were durable, lasting more than 11 mos in some pts. Durable responses were seen in elderly AML pts including those with adverse disease features. AEs reported were as expected in this population. The DOR of the combination has the potential to improve the OS in this population. Further biomarker exploration will be reported at the conference.

Encouraging results in this elderly pt population will lead to further clinical development with this treatment combination.


Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
007 James Bond
07.12.2019 kl 13:52 3239

Flott med gode resultater. Det som ikke blir flott, er kanskje kursutviklingen framover. Skal det testes nye bunner? Høyst sannsynlig.
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
Slettet bruker
07.12.2019 kl 17:16 3145

Godfrey er en glimrende taler . Overgår selv bergenserne . Og veldig tillitvekkende.
Tror han vil gjøre et godt inntrykk også på ASH
'Happy wife. Happy life'
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
naivinvest
09.12.2019 kl 02:49 2807

Presentasjonen er natt til tirsdag, men jeg tror vi vil se positiv utvikling i morgen også. Aksjen er underpriset delux. Det er også superspennede hvordan AXL påvirker en rekke sykdommer, ikke bare kreftceller. Når Godfrey sier BGBIO er verdensledende i å forstå aggressive kreftceller må man nesten klype seg i armen. Tror vi vil se mange ulike samarbeid her fremover. Spennende tider!
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
007 James Bond
09.12.2019 kl 07:06 2731

"The bemcentinib-LDAC combination was safe and well tolerated in elderly AML patients and showed promising efficacy among both newly diagnosed and relapsed/refractory AML patients. The overall response rate and duration surpass historical benchmarks and compare favorably to other LDAC combinations. Pretreatment sAXL holds as a predictive biomarker in AML patients treated with the combination, and a new novel blood based predictive biomarker is identified and associated with clinical benefit in AML and Lung cancer patients receiving bemcentinib."

Skal tro om det blir en liten opptur før nedturen, eller om det bærer rett ned?
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
focuss
09.12.2019 kl 07:53 2642

Hvorfor i all verden skal det bli nedtur av dette.Selvsagt bare tull
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare
StockWizard
09.12.2019 kl 09:57 2459

Good morning ‘00 CLOWN’!
Redigert 20.01.2021 kl 22:01 Du må logge inn for å svare