BergenBio Fundamentale Forhold (BGBIO)

[anon80503862]

Dette lover jo også bra for innrullering til fase3-studien.

Takk for veldig gode svar. Det gjør det lettere for sånne som meg som ikke er veldig inne i selve forskningen og hva som forsøkes bevises mot hvilket sammenligningsgrunnlag.

[anon48632287]

Veldig fine innlegg av Flottesen!

Alt som gir oversikt og dypere innsikt i BGBIO er meget interessant og verdifullt.

[Flottesen]

Det har kommet en ny presentasjon på hjemmesiden i mars som jeg ikke har sett.

Her ser det ut som det kommer et lite drypp om registreringsstudien i AML.
Vi vet at de er i diskusjoner med myndighetene og at de vil offentliggjøre studieoppsettet kanskje før sommeren en gang?

Er dette et lite glimt av studieoppsettet? Har det blitt antydet at de får en rask interimavlesning, med mulighet for AA? Richard Godfrey har jo alltid opptrådd korrekt og propert, det er vel lite sannsynlig at dette er fri fantasi.

[Triotech]

Noen som husker hva som skjedde da PCIB tok de samme ordene i sin munn? Hint, 20. Desember 2017

[drdr]

BGBio @AACR 2019!

[anon48632287]

Artikkel om Rigel, men med fokus på deres utlisensiering / partnere.

Den første som trekkes frem i så måte er Bemcentinib (BGB324) og BergenBio.

A Look At Rigel's Partnered Pipeline

[larsmkn]

BerGenBio (BGenBio)

Samarbeidspartner av BerGenBio presenterer pre-kliniske resultater på BGB149 på AACR i dag.

Presenter/Authors

Sallem Chouaib1, Stephane Terry1, Stephanie Buart1, Agnete Engelsen1, Gro Gausdal2, James Lorens3, Jean Paul Thiery1, Fathia Mami-Chouaib1. 1Gustave Roussy, Villejuif, France; 2Biobergen, Bergen, Norway; 3University of Bergen, Bergen, Norway

Disclosures

S. Chouaib: None. S. Terry: None. S. Buart: None. A. Engelsen: None. G. Gausdal: None. J. Lorens: None. J. Thiery: None. F. Mami-Chouaib: None.

Abstract

As immunotherapies are now used to treat a large proportion of NSCLC patients, defining mechanisms of immune resistance is critical. Immune resistance may arise from both genetic instability and tumor heterogeneity driven by microenvironmental stresses such as hypoxia that promotes carcinoma cell plasticity as well as extrinsic or intrinsic mechanisms of immune resistance. AXL, a member of the TAM receptor tyrosine kinase family is widely expressed human cancers and increasingly recognized for its role in cell plasticity and drug resistance. In this study, we used a model of hypoxia-induced tumor plasticity to generate multiple lung cancer clones with mesenchymal and epithelial features to address mechanisms of immune resistance. We demonstrate that AXL expression is dramatically increased in mesenchymal lung cancer clones. Moreover, expression of AXL in the cells was correlated with an increased cancer cell intrinsic resistance to both NK and CTL-mediated killing, Notably, small molecule AXL targeting potently sensitized mesenchymal lung cancer cells to cytotoxic lymphocyte-mediated killing. Mechanistically, we showed that attenuation of AXL-dependent immune resistance to immune cells involved a novel molecular network comprising NF-κB activation, increased ICAM1 expression, and upregulation of ULBP1 expression coupled with MAPK inhibition. Congruently, higher ICAM1 and ULBP1 tumor expression, correlated with improved patient survival in two NSCLC cohorts. These results reveal a novel AXL-mediated immune escape regulatory pathway, suggest AXL as a novel candidate biomarker for tumor resistance to NK and CTL immunity, and support AXL targeting to optimize immune response in NSCLC.

[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 (138 likes)

Ja, vi er snart i april og det er ikke lenge til Q1 er over for BGBIO (8. mai).

2. @Flottesen (73 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 (33 likes)

Kun 2 uker igjen i Q1 og avlesning av resultat til combo lav-dose chemo+Bemcentinib som 1.line behandling i AML! Spennende

Resten av topp 10:

4. @Boms (11 likes)

5. @vcp (9 likes)

6. @Cinvest (7 likes)

7. @anon80503862 (6 likes)

8. @Savepig (6 likes)

9. @Inkognito666 (5 likes)

10. @anon48632287 (4 likes)

Gratulerer!

[TekBot]

01/04-2019 12:01:12: (BGBIO) BerGenBio: Bemcentinib in combination with low-dose chemotherapy achieves efficacy endpoint in AML patients

Bergen, Norway, 1 April 2019 - BerGenBio ASA (OSE:BGBIO) announces that on a top-line, preliminary basis, the first efficacy endpoint has been met in a Phase II clinical trial (BGBC003, NCT02488408) evaluating bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with low-dose cytarabine (LDAC) as a potential new treatment regimen for acute myeloid leukaemia (AML) patients unable to tolerate intensive therapy. A second cohort evaluating bemcentinib in combination with decitabine is also ongoing and data is further maturing.

The pre-specified efficacy endpoint in this trial requires at least three patients out of the first 14 patients (21%) to achieve clinical responses* when treated with the novel drug combination.
…

Vis børsmeldingen

The cohort evaluating bemcentinib in combination with LDAC, summarised below, has met its primary endpoint; data is further maturing:

· In total, 15 patients were enrolled of which 10 are evaluable for response to date. Among these, 4 were newly diagnosed and 6 relapsed or refractory (R/R). 
· In newly-diagnosed patients, one complete remission (CR) and one CR with incomplete haematologic recovery(CRi) were observed (2 out of 4) and one CR among R/R patients (1 out of 6), yielding a CR/CRi rate of 30% (3 out of 10). 
· All responders were above the age of 75, at least one had secondary disease, and two had unfavourable cytogenetic profiles. Responses had an early onset (after 1 to 2 cycles), were durable and deepened over time and the combination of bemcentinib with LDAC was well tolerated causing no overlapping or new toxicities compared to each agent given alone.

An extensive translational programme continues to explore potential biomarkers for bemcentinib combination therapy. Further details will be presented at upcoming medical conferences.

Furthermore, the Company is proceeding with preparations for a late-stage bemcentinib monotherapy trial in AML. The study, expected to start in the second half of 2019, will aim to confirm previously reported monotherapy efficacy of bemcentinib in AML patients whose disease has progressed on standard of care therapy. Correlation with relevant biomarkers will be explored with the ambition to pursue an accelerated development path in a selected patient population.

Professor Dr Dr Sonja Loges, attending physician at the University Hospital Hamburg-Eppendorf and lead investigator of the BGBC003 trial, commented: “Data gathered by our group and others have established AXL as a negative prognostic factor in patients with AML and other malignancies. AXL acts both as a driver of leukaemic cell proliferation and as negative regulator of anti-tumour immunity and therefore represents a novel and promising target in AML. Bemcentinib, an oral tablet, targets AXL selectively and I am pleased to see activity in my patients receiving bemcentinib alone or in combination with standard low-intensity therapies while side effects thus far have proven to be limited and manageable. These early results warrant further investigation of bemcentinib in a larger trial addressing AML patients unfit for intensive chemotherapy.” 

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:  “Clearing the efficacy threshold for bemcentinib in combination with LDAC is very encouraging, particularly as we have seen responses in a less fit AML patient population who are considered to have unfavourable prognosis after the failure of first-line therapies, or those with high risk cytogenetics. AML patients represent a challenging patient population for clinical trials, but we are keen to pursue AML monotherapy as our first indication based on the high unmet need, strength of clinical proof-of-concept with biomarker correlation, excellent safety and potential for a fast and first route to registration. We look forward to providing more details on the trial design upon initiation and reporting further data with bemcentinib combinations in this indication as it matures.”

*defined as objective response (OR), as measured by the revised recommendations of the International Working Group (IWG) in AML

• END -

About AML and the BGBC003 trial

AML is the most common form of acute leukaemia in adults where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant. 

The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and decitabine (part B3) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities. 

For more information please access trial NCT02488408 at www.clinicaltrials.gov.

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 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 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
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=20190401.Cision.20190401:BIT:5605:0

[larsmkn]

Nice, der tikket den inn! Dette var 4 pasienter med nylig diagnostisert AML og 6 med R/R. Vi vet ikke AXL status enda. Det er lovende at 2 av 4 i den nye gruppa hadde CR. En fin ORR på 50% der. Gleder meg til å se hva AXL status blir på disse. Om noen vil ha en referanse så ble gladsdegib godkjent i nylig diagnostiserte AML pasienter kombinasjon med LDAC for pasienter som er over 75 år og ikke tåler intensiv kjemoterapi. Hva var resultatet fra deres studie? LDAC alene ga en ORR på 2,6%, mens glasdegib pluss LDAC ga en responsrate på 18,2%. Så når responsen nå er 30% uten stratifisering for sAXL, og i en pasientpopulasjon som er mye vanskligere å behandle (6 stk med R/R AML), så ser dette veldig lovende ut! Gladsegib ble forresten godkjent under priorety review med orpahn drug status. Jeg tror bemcentinib kan greie mye bedre enn gladsegib i samme pasientpopulasjon, alle fall hvis det selekteres for s-AXL-status.

Om godkjenningen av gladsegib: https://www.mdedge.com/hematology-oncology/article/190790/leukemia-myelodysplasia-transplantation/fda-approves-glasdegib-aml

[Flottesen]

Jeg setter 10 kroner på at dette ender med AA.

Det kan skje fort også, dersom de får en studiedesign med tidlig interimavlesning, slik som det er antydet i den siste selskapspresentasjonen som ligger på hjemmesiden.

[vcp]

. Om noen vil ha en referanse så ble gladsdegib godkjent i nylig diagnostiserte AML pasienter kombinasjon med LDAC for pasienter som er over 75 år og ikke tåler intensiv kjemoterapi. Hva var resultatet fra deres studie? LDAC alene ga en ORR på 2,6% , mens glasdegib pluss LDAC ga en responsrate på 18,2%. Så når responsen nå er 30% uten stratifisering for sAXL, og i en pasientpopulasjon som er mye vanskligere å behandle (6 stk med R/R

Etterfulgt av den største salgsposten i bgbio siden oktober. Undres hva det er som foregår!

[Morgo26]

I really struggle to understand the lack of love for BGBIO (goes for both forums and market). Out of my other holdings in PCIB, NANO, TRVX and PHO if I am to buy more of anything, it will be BGBIO. Might just wait till 2H 2019 as they will have to raise some cash for both NSCLC and AML going forward though…maybe…

[Flottesen]

I agree Morgo. Perhaps the case is still too complicated for many investors at least that seems to be a common argument from forum participants.
The stock exchange messages are not exactly poetry either.

Perhaps more tangible events such as start of phase3 studies will help. Especially with a favourable study design. If the company can claim the something like “the FDA will give us AA if we meet the endpoint at an interim readout”, maybe that will help as well. It worked for PCIB.

With regards to the need to raise money, i noticed that the new presentation on the company website is in “american”, all the numbers are in dollars. I will not be surprised if we get a new rights issue towards american investors.

[larsmkn]

But it’s just plain strange that the company has so little following on the forums. Ppl that follow TRVX, PCIB and NANO know those companies, and are able to digest difficult medical terms and definitions. They are able to compare with other companies and understand the importance of presentations at scientific conferences. So I think it’s strange that not more ppl who also follow those stock follows bergenbio. Last year they had the most presentations at scientific conferences with data presented at ASCO-SITC, AACR, ASCO, EHA, WCLC, ESMO, SITC and ASH. And these are the best of the best when it comes to clinical cancer conferences. They got a very coveted late-breaker status for SITC showing how impressive the NSCLC results with keytruda combos was. They got a mention in evaluate pharmas WCLC feature (https://www.evaluate.com/vantage/articles/events/conferences/world-lung-2018-alunbrig-squares-xalkori-field-getting-crowded). They have had oral presentations at ASH, and have shown promising efficacy and safety for a number of indications in NSCLC, AML and MDS. They have academic sponsors around the world who wants to run clinical trials with bemcentinib out of their own pocket! New trails are starting up left and right. And now they are on the verge of late stage trials in both NSCLC and AML. I’m not trying to rag on the other companies in Norway as they are all very different, but who of them would not have loved to see the same from their companies? I have never understood why some companies get so much more love on some of these forums, but then again, I can’t really see any correlation between activity on these forums and market cap, so why bother

However, @Investor had an interesting questionnaire on the PCIB thread where he asked who many on that thread that also had stocks in other companies and which companies. Maybe not surprising, but only 11% in the thread said they also had stock in BGBIO. Less than NANO (46%), Pho (39%), TRVX (27%).

[kanon]

Aksjen reagerer ned. Forventet markedet flere CR? Eller hva kan tolkes negativt?

[Snoeffelen]

Jeg tror kanskje det at BGBIO er ganske komplisert på flere plan gjør at mange unngår å investere.
Jeg har selv prøvd å sette meg inn i caset et par ganger, men ender opp med så mye spørsmål at jeg mister litt interessen.
Jeg har problemer med å benchmarke skikkelig.
Jeg skjønner ikke helt strategien.
Jeg har ikke klart for meg hvor mye av teknologien aksjonærene egentlig eier.
Jeg er usikker på hvor mye penger deres neste studier vil koste.
Og så har det jo litt med at jeg liker å investere i sen utvikling, så når de har klarhet i sine eventuelle pivotale studier er det straks mer aktuelt å likle på caset en gang til.

[Buffet]

Satt i denne aksjen fra September 17 til februar. Kursutviklingen i forkant av draget var like merkelig som nå husker jeg. Var et par ganger jeg var i ferd med å selge meg ut, så tenker å gjøre samme strategi med min inntreden. Sitte rolig i båten.

[larsmkn]

Ja, jeg kan skjønne at det kan bli litt komplisert. Jeg har selv gitt tilbakemdling til dem at de burde fokusere på AML mono og NSCLC kombo med keytruda, da det er litt lettere å ha fokus på dem to.

Benchmarking er alltid vanskelig så det har jeg forståelse for. I det siste så har BerGenBio vært flinkere til å vise til benchmerking ved AML og NSCLC.

Legg merke til at det som er godkjent for AML for det meste går på pasienter som er positive for spesifikke mutasjoner.

Når det kommer til hva aksjonærene eier av teknologien så er biomarkøren heleid, BGB324 er linsensiert inn fra Rigel (detaljert oversikt over milestones og royalties er lett tilgjengelig i prospekt), og BGB601 er lisensiert ut til ADC Therapeutics hvor BerGenBio motar milestones og evt. royalties.

Strategien er å bruke samarbeidspartnerene de har til å kjøre masse studier som partnerene tar på seg kostnadene å kjøre. Finne ut i hvilke indikasjoner de for de mest spennende resultatene og å kjøre på der. I tillegg så har de antistoff og et mindre molekyl som gjør at de er mer fleksible når det kommer reimbursement for de forskjellige indikasjonene.

Men du var vel inne i PCIB ganske lenge før de var i sen klinisk fase eller noe form for pivotal fase hadde tatt form?

[Flottesen]

Ser ut som det er noen som bruker dagens volum til å selge seg ned. Jaja, vi får ser hva som kommer ut av det når vi får hele datasettet i juni, korrelert mot biomarkører.