BergenBio Fundamentale Forhold (BGBIO)

[Longtrader]

Fart i dag da , oppover

[larsmkn]

Over 25% ORR i hele cohorten er veldig positivt.

Den har ligget på rundt 29% så dette kom kanskje ikke som en bombe, men nå er alle pasienter inkludert og det er fint å se at responsraten fortsatt holder seg over 25%.

Noe av det nærmeste vi kommer en sammenlikning er keytruda etter kjemoterapi og studien under som viser 18 % ORR (vs. BGBIO sin som er over 25 %):

NB!: merk at alle pasienter i bilde over har PD-L1 uttrykk, mens BGBIO sin studie inkluderte flere som var negative, noe som taler i BGBIO sin fordel.

Mer om Keytruda sin effekt etter kjemo, før kjemo eller sammen med kjemo kan leses her:
https://www.keytruda.com/non-small-cell-lung-cancer/keytruda-clinical-trials-previously-treated/

[Snoeffelen]

Noen som vet hvor mange pasienter det er i kohorten?

[larsmkn]

Fra SITC abstract:

"Enrolment for both stages is complete. As of July 2019, 50 patients have been dosed with the combination.

To date, 43 patients were radiologically evaluable, with 10 PRs observed (ORR 23%). 17 AXL-positive patients were radiologically evaluable, with 6 responses observed (35%), as opposed to 2 (15%) in the 13 radiologically evaluable AXL-negative patients. Of the 10 responders, 4 had a TPS <1% (2 AXL positive, 2 negative), 3 TPS 1-49% (2 AXL-positive, 1 unknown), 1 TPS >50% (1 AXL-positive); 2 did not have a PD-L1 status available (1 AXL-positive, 1 unknown).

In Stage 1, mPFS was 4.0 months overall (95% CI 1.9 –NR) and 5.9 months in AXL-positive pts (n=10; 3.0 - NR). mPFS for the entire cohort continues to mature and will be reported at the meeting."

Tydligvis så må man ha fått respons på flere pasienter etter dette abstractet var skrevet. Det kan noen ganger ta litt tid før man ser effekt av immunterapi, men det blir spennende på SITC å se om de inkluderer alle 50 stk i den RR eller bare 43.

[Sjakk]

mulig jeg ser litt enkelt på det. Differanse 7% (25-18) AXLp er røft 50%, om alt er som forventet skal bemcentinib få respons over 33% om du selekterer for AXLp. Da smaker det fugl (og det står vel strengt tatt i abstractet. 35%. Det går litt i surr, klarer ikke holde tunge rett i munnen i BG)

[drdr]

Bare 2 timer til abstract release ASH-19

https://www.hematology.org/Annual-Meeting/Abstracts/

[larsmkn]

Spennende poster på Multiple Myeloma fra en forskergruppe fra Belgia:
https://ash.confex.com/ash/2019/webprogram/Paper126834.html

Konklusjon: We observed that AXL is highly expressed in dormant MM cells and environmental myeloid cells. Despite its association with a good prognosis in MM, AXL serves as an interesting target to eradicate dormant myeloma cells as AXL inhibitors affect viability and induce apoptosis of myeloma cells, especially in combination with melphalan. Therefore, AXL can be considered as a new therapeutic strategy, to target both the immunosuppressive myeloid cells and the residual cancer cells in MM patients.

Forskerene brukte Bemcentinib for studere effekten av hemming av AXL.

[larsmkn]

Konklusjon fra Bemcentinib + LDAC i 1/2L AML pasienter:
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.

Mulighet for biomarkør data ser det ut til. Hvis sAXL er spot-on her for å velge ut riktige pasienter så vil ORR kunne øke fra 40 % til høyere i nye studier.

https://ash.confex.com/ash/2019/webprogram/Paper128683.html

[TekBot]

BERGENBIO ASA: Invitation to third quarter 2019 results presentation and webcast

Bergen, Norway, 7 November 2019 - BerGenBio ASA (OSE:BGBIO), will announce its
results for the third quarter on Tuesday 19 November 2019. A presentation by
BerGenBio’s senior management team will take place at 10am CET at:
…

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Arctic Securities
Haakon VIIs gate 5
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.

-Ends-

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Lucy Featherstone, Carina Jurs,
Consilium Strategic Communications
[email protected]
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+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

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

Kilde

[TekBot]

BerGenBio to present clinical data from Phase II combination trial of bemcentinib and LDAC trial in elderly AML patients at ASH 2019

Bergen, Norway, 7 November 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, is pleased to announce it has been accepted for a
…

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poster presentation at the 61st Annual American Society of Hematology (ASH)
Meeting, which takes place from 7-10 December 2019 in Orlando, Florida.

The poster will provide an update on its phase II study of bemcentinib (BGB324)
in combination with Low-dose Cytarabine in elderly AML patients.

Abstract titles have been announced
online (https://ash.confex.com/ash/2019/webprogram/Paper128683.html). Details of
the presentation are below.

Title: Durable responses observed in elderly AML patients unfit for intensive
chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in
combination with LDAC: Phase II open-label study

Date: Monday 9th December 2019

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Poster III

Time, Location: 6:00 PM - 8:00 PM, Orange County Convention Center, Hall B

• END -

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases. In cancer, AXL
suppresses the body’s immune response to tumours and drives cancer treatment
failure across many indications. AXL inhibitors, therefore, have potential high
value at the centre of cancer combination therapy, addressing significant unmet
medical needs and multiple high-value market opportunities. Research has also
shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.

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 focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL
-ADC (ADCT-601) are 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). www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic
Communications

[email protected]

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

Kilde

[TekBot]

BerGenBio presents updated phase 2 NSCLC clinical and translational data for bemcentinib in combination with KEYTRUDA®

· BerGenBio’s proprietary Composite AXL Tumor-Immune Score predicts patients
that have significantly prolonged clinical benefit
· Primary endpoint of ORR in cohort A met, in predominantly PD-L1 low/negative
…

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patients
· Combination is 5-fold more active in composite AXL positive patients (33%
ORR) vs AXL negative patients (7% ORR)
· Secondary endpoint, median Progression Free Survival of 8.4 months in
composite AXL score positive patients, exceeds expectations, 3-fold longer than
for composite AXL negative patients.

Bergen, Norway, 8 November 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, today presents comprehensive clinical and
translational data from Cohort A of its Phase II clinical trial (BGBC008)
evaluating bemcentinib, its first in class selective AXL inhibitor, in
combination with MSD’s, (a tradename of Merck & Co., Inc., Kenilworth, NJ., USA)
anti-PD-1 therapy KEYTRUDA® (pembrolizumab), as a potential new treatment
regimen for previously treated advanced non-small cell lung cancer (NSCLC) at an
oral presentation at the prestigious High Impact Clinical Trial session at the
Society for Immunotherapy of Cancer (6-10 November 2019) conference in
Washington DC.

In cohort A, 44 patients were evaluable for response; of IHC evaluable patients:
50% were composite AXL positive, 52% were PD-L1 negative (<1%TPS), and 38%
patients were PD-L1 low positive (1-49% TPS). The primary endpoint of Overall
Response Rate (ORR) was met, with 33% ORR in AXL positive patients; five times
the response rate of AXL negative patients (7%).

A secondary endpoint of median Progression Free Survival (mPFS) reported
significant 3-fold improvement in AXL positive vs negative patients - 8.4 months
in composite AXL positive patients significantly surpassing what has been shown
historically in second line treatment with PD-1 inhibitor monotherapy.

Dr. Matthew Krebs, MD, PhD, the lead investigator who will give the presentation
at SITC said: “The clinical benefit seen with the drug combination in AXL
positive patients is impressive and provides a potential new treatment approach
for patients with low or negative PD-L1 status. The mPFS observed for the AXL
positive patients is far higher than that seen with pembrolizumab monotherapy
results from earlier clinical trials for patients with PD-L1<50%. Furthermore,
the combination is well tolerated by patients.”

RNA sequence analysis of pretreatment patient biopsies revealed that clinical
benefit from the combination therapy correlates with total tumor AXL expression.
A proprietary predictive signature for response to bemcentinib and pembrolizumab
combination derived from the transcriptional analysis is enriched for genes
associated with epithelial-to-mesenchymal transition (EMT) and myeloid cell
activation. “This is exactly where we know AXL is important.” added Professor
James Lorens PhD, Chief Scientific Officer of BerGenBio.

The gene expression measured in responding patients correlates with gene
signatures known to be associated with poor prognosis and lack of response to
immunotherapy. This indicates that previously treated patients are particularly
benefiting despite exhibiting these adverse traits. Professor Hani Gabra MD PhD,
Chief Medical Officer of BerGenBio said: “This indicates that bemcentinib is
conditioning the tumor microenvironment in AXL positive patients and optimizing
pembrolizumab response in these previously treated patients.”

Multispectral immunofluorescence analysis detected tumor infiltrating AXL
-expressing macrophages closely adjacent to T cells in the tumors of patients
who responded to the combination therapy. “Seeing the AXL expressing macrophages
interacting with T regulatory cells in the tumor of a patient who responded to
the treatment really underscores the potential.” added Dr. Krebs.

Prof. Lorens added: “Previously we only considered AXL expression in the tumor
cells, ignoring the immune cell compartment of the tumor. Our deeper biomarker
analysis clearly shows that our earlier tumor cell-only score did not fully
capture the population of patients who benefit from the combination.” A
proprietary composite AXL tumor-immune score has now been developed, derived
from gene expression and immunohistochemistry analysis that selects patients
likely to benefit from bemcentinib.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: “Our improved
ability to select and predict patients with durable clinical benefit with a
refined AXL composite biomarker is an important development for our AXL
targeting clinical programs. Importantly for patients is the prolonged duration
of benefit or mPFS and improved Overall Survival (mOS), which is still maturing,
these are also critical regulatory end points. I look forward to reporting mOS
and data from additional cohorts in the coming months.”

Presentation details

A phase II study of bemcentinib (BGB324), a first-in-class selective AXL
inhibitor, in combination with pembrolizumab in patients with advanced NSCLC:
Updated analysis

· Matthew G. Krebs, MD, PhD -The University of Manchester
· Concurrent Session 206: High Impact Clinical Trials
· Oral Session
· 08 November 2019: Prince George’s Exhibition Hall C
· 5:10 - 5:25 p.m. EST (Session runs from 4:50 - 6:15 p.m.)

Presentation will be available at www.bergenbio.com in the section:
Investors/Presentations when the presentation starts.

• END -

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases. In cancer, AXL
suppresses the body’s immune response to tumours and drives cancer treatment
failure across many indications. Tumour AXL expression is associated with poor
prognosis in NSCLC and most other cancer types. AXL inhibitors, therefore, have
potential high value at the centre of cancer combination therapy, addressing
significant unmet medical needs and multiple high-value market opportunities.
Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.

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 focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL
-ADC (ADCT-601) are 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). www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Lucy Featherstone

Consilium Strategic Communications

[email protected]

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+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.

Kilde

[Morgo26]

Thoughts? Improved biomarker analysis is definitely a good thing.

[larsmkn]

Need to have a closer look at the data when the presentation is out, but isn’t the mPFS high than it was before?

[ufo]

8% økning på en slik melding???
Undres hva som styrer denne børsen vår?
80% økning kunne jeg forstått.

[Mykle]

En close over 20 hadde vært nais, men ender vel i minus. Herregud for et fjøs!

[Sjakk]

jeg lar pengene fly, kjøpt mer nå på 19.2x

[Sjakk]

Hvis jeg klarer å holde tunga rett i munnen med alle studiene og datasettene så var mPFS rapportert til 5,5mnd. (og med 8,4 nå så tilsvarer det nesten keytruda+chemo på 9.0)

Adverse events er vel og bare 1/2del av SoC

[Flottesen]

Sjakk, keytruda+chemo er vel 1.linje, bem+keytruda er 2.linje så de kan vel ikke sammenliknes?

[Mykle]

Og der var vi i minus!

[Sjakk]

Bare imponerende at 2linje er i nærheten