Har kommet veldig mye biotek på kort tid, blir nok smurt litt tynt utover om man ikke får økt tilflytning til sektoren
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Noen som har tilgang til denne?
Vill gjerne lese den jag og!
Fin artikkel i BT, om kreftforskning i Bergen, CCBIO, biomarkers og BGBIO.
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Bergen, Norway, July 26 2017 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company focussed on developing novel, selective AXL kinase
inhibitors for multiple cancer indications, is pleased to announce that Murray
Yule, MD, PhD, Clinical Development Officer at BerGenBio, will present an
outline of the phase II clinical development programme of BerGenBio’s lead
product, BGB324, in non-small cell lung cancer (NSCLC) at the Precision: Lung
Cancer conference in Boston, July 25-26, 2017.
The presentation will take place on Wednesday 26, 3pm EST and will cover recent
evidence of the benefits of selective AXL inhibition in order to overcome
therapy resistance and immune escape as well as boost anti-tumour immunity. Dr
Yule will discuss in detail the scientific and clinical rationale underpinning
BerGenBio’s phase II clinical trial portfolio with BGB324 in NSCLC in
combination with chemo-, targeted and immunotherapy. The aim of these clinical
studies is to deliver proof-of-concept of BGB324’s potential to counteract AXL
driven immune evasion and acquired resistance to therapy thereby uniquely
synergising with and enhancing current and emerging therapies.
About NSCLC
It is estimated that more than 220,000 new cases of lung cancer will be
diagnosed in the US in 2017 and it is the leading cause of cancer death. 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 BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on
developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple
cancer indications. The Company is a world leader in understanding the essential
role of AXL kinase in mediating cancer spread, immune evasion and drug
resistance in multiple aggressive haematological and solid cancers.
BerGenBio’s lead product, BGB324, is a selective, potent and orally bio
-available small molecule AXL inhibitor in six Phase II clinical trials in major
cancer indications with read-outs expected in the second half of 2018. It is the
only selective AXL inhibitor in clinical development.
The clinical trials are:
· BGB324 as a single agent therapy in acute myeloid leukaemia (AML)/myeloid
dysplastic syndrome (MDS)
· BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small
cell lung cancer (NSCLC)
· BGB324 with KEYTRUDA® (pembrolizumab) in advanced NSCLC (adenocarcinoma of
the lung), and
· BGB324 with KEYTRUDA® in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA® in NSCLC and TBNC are
conducted in collaboration with Merck & Co. Inc. (MSD).
In addition, a number of investigator-led trials are underway, including a trial
to investigate BGB324 with either MEKINIST® (trametinib) and TAFINLAR®
(dabrafenib) or KEYTRUDA® in advanced melanoma as well as a trial exploring
TAXOTERE® (docetaxel) in advanced non-small-cell lung cancer (NSCLC).
BerGenBio is simultaneously developing a companion diagnostic test that will be
able to identify patient subpopulations most likely to benefit from the
treatment. This will facilitate more efficient registration trials and support a
precision medicine approach in reimbursement and commercialisation strategy.
The Company is also developing a diversified pre-clinical pipeline of drug
candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc. TARCEVA® is a registered trademark of OSI Pharmaceuticals,
LLC., marketed by Roche-Genentech.
-Ends-
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
Flere selskaper i artikkelen:
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Noen tanker om hvor langt denne skal ned før det snur oppover?
Den har hatt noen dager med løft nå, men jeg har ikke vurdert inngang på dagens kurs riktig enda. Gikk litt ned igjen i dag, så håpet er å få en inngang under 20. Da er den ned 5 fra IPO, og 20% ned må være bra! Fikk ikke ut fingeren da den var på 19,5 sist, men er klar nå…
Laber interesse her til nå, men vil tro at når de første meldingene kommer - og dersom de er positive - vil kursen begynne å gå…
Tanker om fornuftig inngang?
Tenker likt som deg. Hadde denne på raderen etter IPO og så gikk den litt i glemmeboken. Laber interesse (omsatt under 100k i dag) men ekstremt spennende selskap. Legger inn kjøp nå under 20 blank 
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Triggere i nærmeste fremtid i Bergenbio? Ser kursen ligger på 20 blank nå, falt fra 25kr siden den kom på børs.
Valgte til slutt å gå for PHO her i stedet, men følger med videre da BGBIO er svært spennende. Den ligger egentlig der som jeg ønsket å kjøpe nå, men ikke mer ledig kapital… så måtte gjøre en tøff prioritering…
Ønsker å komme inn her på et tidspunkt, men det blir nok til høyere pris. 
Så får jeg se om det var riktig vurdert litt frem i gaten… 
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28/09-2017 08:00:14: (BGBIO) BGB324, BerGenBio’s Selective First-in-Class AXL Inhibitor, Featured in Three Clinical Presentations at the 18th World Conference on Lung Cancer
Bergen, Norway, Sep 28 2017 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective Axl kinase
inhibitors (http://www.bergenbio.com) for multiple cancer indications, is
pleased to announce that the Company will present three ongoing lung cancer
clinical trials with BGB324 at the 18th World Conference on Lung Cancer in
Yokohama, Japan, October 15 - 18, 2017.
The three presentations will show clinical results to date and discuss the
rationale of the clinical studies undertaken with BGB324, BerGenBio’s lead
candidate, a first-in-class and highly selective small molecule Axl kinase
inhibitor which is being developed to target tumour immune evasion and drug
resistance.
Don L. Gibbons (MD, PhD) from the MD Anderson Cancer Center, Houston (US) will
give an oral presentation entitled: A Ph I/II Study of BGB324, a Selective AXL
Inhibitor as Monotherapy and in Combination with Erlotinib in Advanced NSCLC.
The presentation will focus on the tolerability and efficacy combining BGB324
and erlotinib (TARCEVA®) in patients with advanced NSCLC driven by an EGFR
mutation.
· Abstract 10388 - Monday, October 16, 2017, Oral and Mini Oral Abstract
Sessions: 11:00-12:30 (JST)
· ClinicalTrials.gov identifier: NCT02424617
Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, will present a
poster entitled: A Phase II Study of BGB324 in Combination with Pembrolizumab in
Patients with Previously Treated Advanced Lung Adenocarcinoma. The trial-in
-progress poster introduces the scientific rationale of combining BGB324 with
pembrolizumab (KEYTRUDA®) in non-small cell lung cancer patients.
· Abstract 10315 - Tuesday, October 17, 2017, P2.07 Poster Session: 9:30 -
16:00 (JST)
· ClinicalTrials.gov identifier: NCT03184571
David E. Gerber (MD, PhD) from the Harold C. Simmons Comprehensive Cancer
Center, University of Texas Southwestern Medical Center (US) will present a
poster entitled: A Phase 1 trial of dose escalated BGB324 in combination with
docetaxel for previously treated advanced NSCLC. The trial-in-progress poster
introduces the scientific rationale of combining BGB324 with chemotherapeutic
agents and will present available clinical data from the ongoing investigator
initiated trial combining BGB324 with docetaxel.
· Abstract 10230 - Tuesday, October 17, 2017, P2.07 Poster Session: 9:00 -
16:00 (JST)
· ClinicalTrials.gov identifier: NCT02424617
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
pleased to have the opportunity to share our results and research at the 18th
World Conference on Lung Cancer this year. The studies highlight our broad
clinical development strategy, which is designed to demonstrate the potential of
BGB324, a highly selective Axl inhibitor, to significantly improve the treatment
of lung cancer.
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Jeg trodde ikke at abstraktene ble tilgjengelige før konferansen, men de ligger visst på nettsiden til konferansen allerede. Siden studien som omtales i det første abstraktet her ikke er fullført er det litt uklart om de snakker om bivirkninger fra kun 8 pasienter eller hele gruppen, uansett virker det som det er milde bivirkninger. Dette er snakk om veldig få pasienter, men det er i hvert fall lovende!
Edit: Når jeg leser abstraktet på nytt så er det tydlig at det kun er snakk om 8 pasienter her. I følge clinicaltrials.gov er det fulle studiet på 66 pasienter, så det blir spennende å se når hele studien er fullført.
Abstract 10388
Background:
BGB324 is an orally available selective inhibitor of the receptor tyrosine kinase AXL (Biochemical IC50 0.4nM). In animal models of NSCLC exposure, BGB324 restricts cellular plasticity and prevents the development of resistance to Epithelial Growth Factor Receptor (EGFR) inhibitors through mesenchymal transformation.
Method:
BGB324 was administered at an oral loading dose (600 mg) on days one and two followed by a daily maintenance dose (200 mg) to eight patients with previously treated NSCLC (EGFR mutant or wildtype). The tolerability of two different loading doses BGB324 (600 mg on days one and two or 400 mg on days one two and three) were then explored in combination with erlotinib at a dose of 150 mg daily in patients with EGFR mutated NSCLC.
Result:
Two of eight patients treated with BGB324 monotherapy achieved at least six months of stable disease. Both dose levels of BGB324 were tolerated in combination with erlotinib although most patients experienced a transient worsening in gastrointestinal toxicity during the loading dose prior to returning to baseline. A three day loading dose was preferred. Treatment with BGB324 was accompanied by increases in patient serum levels of soluble AXL receptorconsistent with receptor inhibition. One patient who previously experienced progression during treatment with another EGFR inhibitor remains on treatment with erlotinib plus BGB324 for more than eighteen months with a best response of stable disease. The most common treatment related adverse events were increased serum creatinine, diarrhea, nausea and dysguesia.
Conclusion:
Conclusion BGB324 can be safely administered to patients with advanced NSCLC for prolonged periods at doses that abrogate AXL signalling either as monotherapy or in combination with erlotinib. A proportion of patients achieve durable disease stabilisation following treatment with BGB324 alone further exploration of the efficacy of the combination is ongoing.
Abstract 10230
Background:
AXL is a member of the TAM family of receptor tyrosine kinases that regulate multiple cellular responses including cell survival, proliferation, and migration. AXL expression is associated with a variety of human cancers including NSCLC, and is predictive of poor patient overall survival. AXL is associated with epithelial-to-mesenchymal transition (EMT) and is required to maintain invasiveness and metastasis. Importantly, AXL confers resistance to both chemotherapeutic agents as well as EGFR tyrosine kinase inhibitors. BGB324 is a selective clinical-stage small molecule AXL kinase inhibitor. We found in a colony formation assay with NCI-H1299 cells (AXL[+], EGFR wt) that BGB324 displayed anti-proliferative activity as single agent (IC50 348nM). In a 3D organotypic assay, BGB324 prevented 3D-growth, and formation of aggregates and migration. In a mouse xenograft NCI-H1299 model non-responsive to docetaxel, BGB324 treatment significantly enhanced the antitumor activity of docetaxel. This suggested that BGB324 could overcome acquired resistance in in vivo models of NSCLC and provided a translational rationale for combining AXL targeted therapy with docetaxel in NSCLC to enhance anti-cancer response
Method:
This is a multi-centre, open-label phase Ib study of BGB324 in combination with docetaxel in advanced NSCLC. The study consists of a dose escalation and expansion phase. BGB324 is administered as monotherapy for 1week after which BGB324 and Docetaxel are co-administered as a continuous treatment with 21‑day treatment cycles. It is anticipated that a maximum of two BGB324 dose levels will be evaluated, with up to 12 patients enrolled in the dose-escalation phase. BGB324 is administered orally with a loading dose/maintenance dose regimen with the first three doses (200mg or 400mg) in Cycle 1 serving as the ‘loading’ dose and a maintenance dose of either 100mg or 200mg daily thereafter. Docetaxel 75 mg/m[2 ]is administered as a one-hour IV infusion every 21 days. The BGB324 dose will be escalated in a standard 3+3 fashion until a MTD or RP2D is reached. DLT will be assessed using the NCI CTCAE version 4.03 during the first cycle of treatment (7-day lead-in plus 21 days of combination therapy). Efficacy endpoints include the response rate, progression-free survival and overall survival. Blood and archival tumor tissue samples are taken to assess the pharmacokinetic profile of BGB324 and docetaxel, and for the investigation of pharmacodynamic effects of BGB324, including tissue epithelial markers, mesenchymal markers, and AXL expression; circulating Gas6 (AXL ligand), and systemic immune response. Enrollment began in December 2016
Result:
Section not applicable
Conclusion:
Section not applicable
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Hegnar: God rekruttering av pasienter
http://www.hegnar.no/Nyheter/Boers-finans/2017/10/God-rekruttering-av-pasienter
BerGenBio announces strong recruitment and encouraging safety profile for AXL Inhibitor BGB324 in a melanoma study at 9th World Congress of Melanoma
http://www.newsweb.no/newsweb/search.do?messageId=436579
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BerGenBio forventer nye resultater i 2018
http://www.hegnar.no/Nyheter/Boers-finans/2017/10/BerGenBio-forventer-nye-resultater-i-2018
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BerGenBio Announces Start of PhII Trial Assessing Selective AXL Inhibitor BGB324 in Combination with KEYTRUDA for Patients with Advanced Breast Cancer
Bergen, Norge, 19 oktober 2017 – BerGenBio ASA (OSE: BGBIO), er et bioteknologiselskap i klinisk fase som utvikler nye, selektive Axl kinase hemmere til bruk i flere kreftindikasjoner. Selskapet kunngjør at den første pasienten har blitt dosert i fase 2 studiet, som evaluerer selskapets mest avanserte legemiddelkandidat mot kreft, BGB324, i kombinasjon med KEYTRUDA® (pembrolizumab) i pasienter med lokalt fremskredet non-resectable eller metastatisk trippel negativ brystkreft (TNBC) eller trippel negativ inflammatorisk brystkreft (TNIBC). BerGenBio sponser studien, der MSD (Merck&Co., Inc., Kenilworth, N.J., USA) leverer KEYTRUDA, en anti-PD-1 terapi, til bruk i studien ifølge en samarbeidsavtale mellom selskapene som ble inngått i mars 2017. I følge planene vil studiet registrere opp til 56 pasienter i sykehus i Norge, Spania, Storbritannia og USA (ClinicalTrials.gov identifier: NCT03184558).
Den kliniske studien vil primært evaluere anti-kreft aktivitet, objective response rate og hvor godt pasientene tåler kombinasjonen av de to medikamentene. I tillegg vil studiet vurdere den farmakokinetiske profilen av BGB324 når den blir gitt i kombinasjon med KEYTRUDA. Omfattende utforskende studier vil evaluere biomarkører i svulsten og blod som indikerer immun modulasjon og Axl signaler, inkludert uttrykksnivåer for PD-L1 og Axl. Studien er forventet å levere preliminære resultater mot slutten av 2018.
Richard Godfrey, Chief Executive Officer i BerGenBio, kommenterer: “At Axl er en drivende mekanisme som gjør at kreft celler blir etterhvert mindre mottagelig for kreftbehandling og angrep fra immunsystemet er godt dokumentert. Prekliniske og tidlige kliniske data viser at BGB324 motvirker kreftens aggressivitet og motstand mot legemidler i en rekke kreftindikasjoner og støtter rasjonalen for å teste BGB324 i kombinasjon med andre kreft behandlinger. KEYTRUDA og anti-PD-1 behandlinger har vekket begeistring på grunn av høye respons rater og varige fordeler for pasientene. Dessverre utvikler en rekke pasienter resistens mot anti-PD-1 behandlinger og kreftlegene søker derfor etter nye kombinasjonsmuligheter med medikamenter som forbedrer utfallet for pasientene. BerGenBio mener at det å kombinere BGB324 med KEYTRUDA har potensiale til å forbedre overlevelsesraten hos kreftpasienter. Denne studien vil evaluere kombinasjonen hos TNBC pasienter og vi planlegger å starte enda ett fase 2 studie hos pasienter med fremskredet lungekreft i løpet av de kommende uker.”
Om TNBC
Brystkreft er den mest vanlige krefttypen hos kvinner. Det er estimert at mer enn 250.000 nye tilfeller vil bli diagnostisert i USA i 2017. 20% av brystkreft tilfellene mangler reseptorer for tre vanlige hormoner (østrogen, progesteron og HER2) og er således kalt trippel negativ brystkreft (TNBC). Behandlingsalternativer mot TNBC er begrenset til intens kjemoterapi, men tilbakefall er hyppige og aggressive. Følgelig trengs det å utvikle nye behandlingsstrategier mot TNBC.
BergenBio twitrer jevnt og trutt:
Hadde ønsket meg samme iveren fra Nordic Nanovector
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Abstrakt fra ASH:
The Orally Available Selective Axl Inhibitor BGB324 Induces Diversification of the Immune Repertoire and Specific Changes in Plasma Biomarker Profiles
Introduction:The RTK Axl represents a novel therapeutic target in AML promoting proliferation and therapy resistance. In addition, Axl suppresses immune responses by decreasing antigen presentation and inhibiting NK cells. BGB324 is a first-in-class, orally available, selective Axl kinase inhibitor which is being explored as a therapy for solid tumours and myeloid malignancies. Selective blockade of Axl by BGB324 in AML is currently being explored in the Phase 1/2 trial BGBC003 (NCT02488408). Until now, n=25 patients have been treated in a classical 3+3 dose escalation design and treatment was generally well-tolerated (n=22 with AML and n=3 with MDS). Steady-state levels of BGB324 were achieved between three and six days after initiation of treatment. One AML patient achieved a CRi of five months, a second achieved a PR and another achieved clearance of circulating blasts accompanied by peripheral blood count recovery > three months (ORR 10%). Four additional AML patients (25%) experienced disease stabilisation for more than four months. Two MDS patients experienced a PR.
Here, we report the spectrum of plasma proteins modulated by BGB324 in patients with AML/MDS and their relationship to treatment outcome and compound exposure. Furthermore, we analysed the B- and T- cell repertoire in order to assess potential effects of BGB324 on the immune response in AML patients.
Methods: We used the DiscoveryMap panel (Myriad RBM) to measure plasma protein biomarker levels in a selection of patients pre-dose and at C2D1 and performed a cross-comparison with samples from an ongoing NSCLC study with BGB324 (BGBC004, NCT02424617) to identify candidates specifically modulated in AML. The TCRß repertoire was quantified by Next Generation Sequencing of DNA isolated from peripheral blood MNCs using an Illumina MiSeq sequencer. TCRß gene containing the entire Vß, Dß and Jß segments were amplified with BIOMED2-TCRß-A and –B primer pools. The IGH repertoire was analysed using BIOMED2-FR1/-FR3 primer pools. Using genomic DNA as template, the amplicons were tagged with Illumina adapters and indices in two consecutive PCR reactions. Demultiplexing and FastQ formated data output was generated by the MiSeq reporter. Analysis of TCRß and IGH data was performed on a Microsoft Cloud using our in-house analysis pipeline Pippa, which relies on MiXCR analysis tools.
Results: Treatment with BGB324 significantly modulated Gas6, soluble Axl (sAxl), Angpt2, CXCL1 (GROalpha), SCGB1A1 (uteroglobin, club cell 10kDa protein) and PLAU (uPAR) levels in patient plasma. Of these, Gas6 was modulated after treatment with BGB324 in AML but not in lung cancer patients while CXCL1 and SCGB1A1 were only influenced in lung cancer patients. sAxl levels correlated with BGB324 exposure indicating that the shed Axl receptor represents a novel biomarker of Axl kinase inhibition.
Furthermore, we studied the effects of BGB324 on the T- and B- cell receptor repertoire in n=5 available matched PB samples. We could demonstrate diversification of the TCR repertoire in PB by higher abundance of small T-cell clones at C2D1 with BGB324 compared to pre-treatment levels in three out of five analysed patients.
The analyses of the IGH repertoire in the PB indicates higher diversity at C2D1 in two out of five available patients.
Thus, treatment with BGB324 can increase the diversity of the IGH and TCRb repertoire in the PB of AML patients.
Conclusion: BGB324 is well tolerated in AML patients, exhibits anti-leukemic activity and induces exposure-related modulation of biomarker candidates. Furthermore, BGB324 can induce a diversification of the TCR repertoire in AML patients and might hold potential as an immune-activating drug.
Stiger litt på lavt volum i dag. I følge mine notater har jeg ingen studieavlesninger i BGBIO før andre halvdel 2018. Får se på Q3 om det er flere triggere å legge til.
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Jeg antar at de da vil gjøre som de har gjort i lungestudien og kjøre en monoterapi og en kombinasjonsterapi i fase II når de har funnet optimal dose? Det er flere immunterapier i AML/MDS nå, men ser at de kun har listet opp Cytarabine og Decitabine. Blir spennende å høre hva de sier rundt dette på ASH.
BerGenBio Investorpresentasjon 21. november 2017
I denne presentasjonen ser du Richard Godfrey, CEO i BerGenBio, gi en oppdatering på selskapets pågående studier, samarbeidsavtaler og andre viktige hendelser.
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