BergenBio Fundamentale Forhold (BGBIO)

[TekBot]

23/04-2019 07:00:05: (BGBIO) BerGenBio to present NSCLC and AML clinical data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO 2019

· Phase II data in AML combining bemcentinib with low-dose chemotherapy and
NSCLC combining with KEYTRUDA
· Accepted for presentation at ASCO in June 2019
…

Vis børsmeldingen

Bergen, Norway, 23 April 2019 - BerGenBio ASA (OSE: BGBIO) a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces that the Company and its collaborators
will present new interim clinical and biomarker data from its extensive Phase II
clinical development programme with bemcentinib, a selective, oral AXL
inhibitor, at the 2019 annual meeting of the American Society of Clinical
Oncology (ASCO) at McCormick Place in Chicago, Illinois (31 May - 4 June 2019).

Abstract titles have been announced online at https://iplanner.asco.org/am2019/
and details of the presentations are below.

The posters presented at ASCO will be made available on www.bergenbio.com in the
Investors / Presentations section at time of presentation.

Sunday 2 June, 8:00 AM - 11:00 AM Central Daylight Time

A phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL
inhibitor, with pembrolizumab in pts with advanced NSCLC: OS for stage I and
preliminary stage II efficacy.

· Enriqueta Felip et al
· Session: Lung Cancer - Non-Small Cell Metastatic
· Location: Hall A, poster board #421, abstract 9098

Monday 3 June, 8:00 AM - 11:00 AM Central Daylight Time

First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with
LDAC or decitabine exerts anti-leukaemic activity in AML pts unfit for intensive
chemotherapy: Phase II open-label study.

· Dr Sonja Loges et al
· Session: Hematologic Malignancies - Leukemia, Myelodysplastic Syndromes, and
Allotransplant
· Location: Hall A, poster board #418, abstract 7043

-END-

About BerGenBio

BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers. The
company’s proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focussed on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing
Phase I clinical testing. In parallel, BerGenBio is developing a companion
diagnostic test to identify those patient populations most likely to benefit
from bemcentinib: this is expected to facilitate more efficient registration
trials supporting 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). For more
information, visit www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Jessica Hodgson, Chris Welsh, Nicholas Brown, Carina Jurs,
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.

http://www.netfonds.no/quotes/release.php?id=20190423.OBI.20190423S4

[Morgo26]

So the one Norsk bio that has that not one, but two posters confirmed for Asco is down 2,8%…albeit on micro volume. But still…

[drdr]

[TekBot]

24/04-2019 11:30:00: (BGBIO) BerGenBio ASA: Invitation to First Quarter Presentation and Webcast

Contacts

Richard Godfrey CEO, BerGenBio ASA
…

Vis børsmeldingen

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Jessica Hodgson, Nicholas Brown, Carina Jurs, Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891

About BerGenBio

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad Phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing Phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting 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). For more information, visit www.bergenbio.com

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

http://www.netfonds.no/quotes/release.php?id=20190424.Cision.20190424:BIT:3678:0

[pdx]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @larsmkn (151 likes)

Okey, la oss kjøre i gang med tolkning av pressemeldigen som kom

2. @Flottesen (62 likes)

De første resultatene som er ventet er i leukemi(AML) og lungekreft(NSCLC). AML studien har to deler, der vi venter på resultater(respons, overlevelse kommer senere) fra den andre delen.

3. @drdr (36 likes)

Resten av topp 10:

4. @anon80503862 (14 likes)

5. @vcp (14 likes)

6. @Savepig (13 likes)

7. @Boms (11 likes)

8. @anon48632287 (7 likes)

9. @Snoeffelen (7 likes)

10. @Biotop20 (6 likes)

Gratulerer!

[TekBot]

08/05-2019 07:02:14: (BGBIO) BerGenBio ASA: Results for the First Quarter 2019

· Advanced leukaemia (AML/MDS): Phase II trial fully recruited and combination
trial with low-intensity chemotherapy meets efficacy endpoint in hard to treat
relapsed / refractory (R/R) leukaemia
…

Vis børsmeldingen

· Advanced lung cancer (NSCLC): Additional cohort added in trial of
bemcentinib in combination with anti-PD-1 therapy KEYTRUDA®
· Anti-AXL antibody, BGB149, commenced phase I safety and pharmacokinetic
clinical trial.
Bergen, Norway, 08 May 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces its results for the first quarter 2019.

A presentation and live webcast by the Company’s management will take place
today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are
pleased to see the positive strategic and clinical momentum generated in the
last year continue into 2019. We have continued to see promising initial data
emerging from the clinical development programme with bemcentinib, particularly
in AML and NSCLC. We believe that this data provides us with sufficient evidence
to begin the initiation of late stage clinical development in these indications
during 2019. We are looking forward to providing an update on these data at the
forthcoming American Society of Clinical Oncology (ASCO) meeting in June.”

Operational Highlights

Lead candidate bemcentinib meets efficacy endpoint in combination with
cytarabine in AML patients unfit for intensive therapy

· Phase II trial evaluating bemcentinib in combination with low-intensity
chemo-therapy in AML patients unfit for intensive therapy fully recruited
· Bemcentinib in combination with Low-dose Cytarabine (LDAC) meets efficacy
endpoint: Three out of 10 evaluable LDAC patients (30%) had CR/CRi
· Combos warrant further expansion, meanwhile, company prepares for late
stage bemcentinib monotherapy trial in later line elderly AML patients unfit for
intensive chemotherapy

Phase II trial with bemcentinib and KEYTRUDA® in NSCLC made important progress

· Additional cohort (Cohort B) added under collaboration agreement with Merck
& Co extending eligibility to patients who have disease progression on prior
immune checkpoint inhibitors

Start of Phase II Investigator-Initiated Trial Evaluating Selective AXL
Inhibitor bemcentinib in high-risk MDS

· Up to 43 patients to be enrolled at leading MDS centres across Europe

Start of Phase I trial evaluating first-in-class anti-AXL antibody BGB149

· BGB149, a wholly owned asset, is the first therapeutic anti-AXL monoclonal
antibody to enter clinical development
· Phase I study will investigate safety and pharmacokinetics in healthy
volunteers

Start of phase I trial evaluating ADCT-601, a novel anti-AXL antibody drug
conjugate (ADC), in patients with advanced solid tumours

· ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed
to ADC Therapeutics for ADC development
· Phase I dose escalation and expansion trial will evaluate ADCT-601 in 75
cancer patients
· Trial managed and sponsored by ADC Therapeutics
· First clinical milestone met and milestone payment received

Preclinical data presented at AACR reinforces bemcentinib’s potential to reverse
tumour immunosuppression and therapy resistance

· Extensive data in pre-clinical models of non-small cell lung cancer (NSCLC)
and pancreatic cancer demonstrating AXL’s role in reversing tumour-mediated
immunosuppression and therapy resistance presented at AACR
· bemcentinib shown to reverse AXL’s effects, thus acting synergistically with
immune cells and anti-cancer therapies

Key appointments to executive team and Board to prepare organisation for next
phase of development

· Key appointments to executive team and Board to prepare organisation for
next phase of development; Board of Directors strengthened. Grunde Eriksen,
Debra Barker and Pamela Trail elected as new board members.
· Dr Dominic Smethurst appointed as permanent Chief Medical Officer (CMO)
· Favourable outcome of arbitration brought by BerGenBio against Rigel
Pharmaceuticals clarifying the extent of Rigel’s entitlement to receive
compensation in the event of a sale of BerGenBio, its assets, or a license to
Bemcentinib
· R&D grant of up to NOK 11 m awarded by Research Council of Norway

Financial highlights

· Total operating expenses for the first quarter were NOK 54.5 million (Q1
2018 NOK 54.8 million)
· Research and development expenses accounted for 70% of total operating
expenses in Q1
· Comprehensive loss for the first quarter amounted to NOK 44.3 million (Q1
2018 a loss of NOK 53.8 million)
· Cash and cash equivalents amounted to NOK 306.7 million at the end of March
2019

Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at
10:00 am CET at:

Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.

The presentation will webcast live and the link will be available
at www.bergenbio.com in the section Investors/Financial Reports. A recording
will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in
the section: Investors/Financial Reports from 7:00 am CET the same day.

-END-

About BerGenBio

BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers. The
company’s proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing
Phase I clinical testing. In parallel, BerGenBio is developing a companion
diagnostic test to identify those patient populations most likely to benefit
from bemcentinib: this is expected to facilitate more efficient registration
trials supporting 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). For more
information, visit www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Jessica Hodgson, Chris Welsh, Nicholas Brown, Carina Jurs,
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

http://www.netfonds.no/quotes/release.php?id=20190508.OBI.20190508S21

[Flottesen]

Hyggelig å se at de har mottatt 8,7 millioner i milestone fra ADC Therapeutics i Q1. Det var vel når de doserte pasient nummer 5? Ser ut som den studien rekrutterer bra.

[drdr]

Fortsatt ikke oppdatert markedet ifm resultat av combo Decitabib/Bemcentinib for AML. Ikke rart siden det skal presenteres på ASCO, og man kan tenke at resultatet er presentabelt og fint (i hvert fall bedre enn Citarabine combo)! Gleder meg til 15. mai og lese abstrakter

[TekBot]

08/05-2019 12:15:18: (BGBIO) BerGenBio completes recruitment into second stage of Phase II trial with selective AXL inhibitor bemcentinib in combination with KEYTRUDA® in patients with advanced NSCLC

Bergen, Norway, 08 May 2019 - BerGenBio ASA (OSE: BGBIO) announces that it has completed enrolment into the second stage of its Phase II trial (BGBC008, Cohort A NCT03184571) evaluating the Company’s selective AXL inhibitor bemcentinib in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing on or after prior systemic chemotherapy.

The trial has previously met the efficacy endpoint in the first stage and reported preliminary efficacy including a 40% ORR and 5.9 months Progression-free survival (PFS) in AXL positive patients (n=10). The second stage of the trial enrolling a further 24 patients for a total of 48 is designed to confirm the safety, clinical efficacy and biomarker correlation of the combination.
…

Vis børsmeldingen

Comprehensive exploratory studies will continue to evaluate biomarkers in tumour and blood indicative of AXL expression and immune modulation. Results from the trial are expected during 2019.

The trial, which began in October 2017, is being conducted under a clinical collaboration with Merck & Co., Inc., Kenilworth, N.J., USA, through a subsidiary, and is taking place at sites in the US, UK, Norway and Spain.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “A majority of NSCLC patients now receive anti-PD(L)-1 therapies like KEYTRUDA as a first- or second-line treatment for their advanced disease. Enhancing responses to these novel agents, particularly in patients with no or limited expression of PD-L1, the established biomarker for these drugs, is a significant unmet need. I am encouraged by the efficacy signals seen during stage 1 of the trial, particularly in AXL positive, and often PD-L1 negative or low, patients and look forward providing data from an extended dataset during the coming months together with further details on our late stage strategy in this indication.”

• End -

About NSCLC

It is estimated that more than 230,000 new cases of lung cancer have been diagnosed in the US in 2018 and it is the leading cause of cancer deaths. 65% of NSCLCs are of adenocarcinoma pathology. Although various treatments exist for NSCLC, they are often curtailed by acquired resistance to therapy and immune evasion. Novel treatments overcoming these mechanisms in NSCLC are urgently required.

About the BGBC008 trial

The BGBC008 trial is a Phase II open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated patients with advanced adenocarcinoma of the lung run at centres in the US, UK, Spain and Norway. The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

Patients eligible for participation in Cohort A must have progressed on or after prior therapy excluding immunotherapy whereas patients in Cohort B will be actively progressing on a therapy regimen containing an anti-PD(L)-1 therapy.

Both cohorts follow a two-stage design, Cohort A has previously successfully progressed into the second stage after meeting its first efficacy endpoint. Cohort B will evaluate advancement into stage 2 after 13 patients have been assessed for response.

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.

About BerGenBio ASA  

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II oncology clinical development programme focussed on combination and single agent therapy in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing Phase 1 clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting 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

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

http://www.netfonds.no/quotes/release.php?id=20190508.Cision.20190508:BIT:5075:0

[larsmkn]

Hvis BerGenBio sin Q1 var en flott middag så var pressemeldingen som kom etterpå en fantastisk dessert!

Dette har generelt vært en veldig fin dag for norsk biotech med fine vacc data presentert på PCIB sin Q1, som også var veldig bra, og melding om ferdig rekruttert studie for TRVX før det var forventet. Markedet er fortsatt så som så, men nå tjener vi snart penger på alle fronter (NANO, PCIB og BGBIO) folkens, og PHO ser virkelig ut til å befeste sin posisjon på markedet. Om markedet fortsatt skal være surt, så tror jeg ikke det kan vare mer enn et år til, for når kapitalen kommer så skjønner også olje og fiskefolka hva som skjer, og da er det greit å allerede ha sin plass ved bordet

Legger ved link til Q1 og analyse fra Trinity Delta, som er et fint utgangspunkt, for dem som nå vurderer å ta plass i nok et selskap som er klar for late-stage fasen i biotek. Jeg tror, og håper, at vi nå står foran en helt syk og eksepsjonell periode i norsk biotech! La oss håpe på suksess på alle fronter

Lykke til!
https://webtv.hegnar.no/presentation.php?webcastId=97815287

BerGenBio-Outlook-140219.pdf

[drdr]

Nedtelling til ASCO abstrakt release 15. mai kl 17 ES; kl 23 norsk tid

[Boms]

Her er et intervju som kan gi litt info for dere som ikke fulgte forrige ukes presentasjon.

[larsmkn]

Så nettopp at det kom ut en artikkel i April som tar for seg hvordan hemming av AXL signalering kan motvirke en kritisk mekanisme for spredning i bukspytt(pancreas)kreft. Forfatterene, Rolf A. Brekken sin forskningsgruppe, er viktige samarbeidspartnere av BerGenBio, og de holder til på UT Southwestern.
Da gir det også mening hvorfor UT Southwestern har en investigator sponsered studie innen pancreaskreft hvor de kombinerer med BerGenBio sin BGB324.

https://insight.jci.org/articles/view/126117#SEC5

Chemotherapy With Nab-paclitaxel/Germcitabine/Cisplatin +/- BGB324 With...

[Flottesen]

Dette er et spennede studie og det er artig at det er randomisert med 2 armer, chemo som monterapi og chemo+bemcentinib.

[Flottesen]

Abstract-release i morgen kveld!

[busk1]

Håper dette forventningsrallyet stopper snart.

[larsmkn]

I følge Brad Lonecar så blir abstract frigjort kl 5 pm ET, som blir kl 22 i kveld norsk tid. Da vil BerGenBio sine to abstracts bli frigjort

Edit:
Jeg kan ikke klokka, men nå har @busk1 og @anon21766851 lært meg hvilken tidssone Norge faktisk har, så da sier vi klokka 23 i stede

[busk1]

Er ikke 5pm EST kl 23 Norsk tid?

[larsmkn]

Hmm, da har jeg i så fall bommet. Jeg stolte blindt på google

[busk1]

Klassisk tabbe. Oslo er på CEST nå på sommeren. En time foran CET.