Godfrey:
No, tenemos que analizar todos los pasos estén en un mes más. sea paciente.
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BEMCENTINIB PRE-CLINICAL COVID-19 DATA PRESENTED AT VIRTUAL IMMUNOLOGY 2021
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Er en pre klinisk studie, men signalene om hva som kan/vil komme fra SA/India/Uk studien er vel ikke helt usannsynlig?
Skjønner ikke alt dette på den Posteren til BB, men det ser jo lovende ut når man leser:
“To investigate the effect of AXL inhibition in permissive, disease-relevant lung epithelial cell lines
(HCC2302 and H1650), we treated cells with bemcentinib and challenged with SARS-CoV-2.
Bemcentinib dramatically reduced viral loads in all both cell lines (G, H) and dramatically reduced
infectious titers 48 hpi in HCC2302 cells (I)”
“In H1650 cells bemcentinib is most effective when present at the
earliest stages of infection, supporting our hypothesis that AXL enhances viral entry”
“Translating these observations to a mouse model of MHV (a related β CoV),
treatment with bemcentinib by oral gavage significantly reduced infectious titers in liver at 5 dpi (O). Viral loads
were similarly reduced in these experiments (not shown)”
Ut fra min begrensede kunnskap kan vel ikke dette tolkes annet en svært positivt for Bemc?
Det blir spennende når BB slipper mer data, forhåpentligvis i løpet av mai, og hva vi får data på vedrørende VIRUS LOAD.
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BERGENBIO TO PRESENT UPDATED CLINICAL DATA AT EUROPEAN HEMATOLOGY ASSOCIATION (EHA) 2021 VIRTUAL MEETING
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Abstract: EP463
Type: E-Poster Presentation
Session title: Acute myeloid leukemia - Clinical
Background
Low-dose cytarabine (LDAC) in elderly relapsed (REL) & refractory (REF) (r/r) AML patients (pts) unfit for intensive therapy shows limited response (CR rate up to 17%) and survival benefit (mOS 4-6mos). This population has significant unmet need for new treatments. Bemcentinib (BEM) is an oral selective small molecule inhibitor of AXL, a RTK mediating poor prognosis, resistance to chemotherapeutics and decreased antitumor immune response. AXL is overexpressed on leukemic cells, especially in the stem cell compartment, and represents an important novel target in pts with AML.
Aims
The ongoing BGBC003 PhII trial cohorts receiving BEM+LDAC (B+L) include newly diagnosed (ND) and r/r AML pts unfit for intensive therapy. Based on observed activity, r/r AML pts were selected in an expansion cohort, to explore safety and efficacy and to undertake translational biomarker analysis. Here, we report on preliminary efficacy in r/r pts, with a safety overview for all pts treated with the combination.
Methods
Pts received BEM at the RP2D (200mg PO/d)+LDAC SoC schedule. Efficacy endpoints included objective response (OR) and clinical benefit (OR+SD [unchanged disease for at least 3 BEM cycles]). Secondary objectives include overall survival (OS) and exploratory biomarker analyses. Single cell RNA sequencing and T-cell repertoire analysis are being conducted to unravel the immunotherapeutic MOA of B+L.
Results
As of 06 Jan 21, the B+L cohorts (n=31) comprised 7 ND and 24 r/r (17 REL, 7 REF) AML pts; here, we focus on r/r pts. Median prior lines of therapy: 1 [1-8] in REL, 3 [1-4] in REF. Median age: 75yrs [66-86] for REL, 75 [71-81] for REF. Adverse cytogenetic risk profile: 5/17 (29%) in REL, 2/7 (29%) in REF. Median bone marrow (BM) myeloblast count at screening: 32% [6-94] for REL, 40% [3-54] for REF.
12 REL pts were evaluable for efficacy (BM assessment at C2D1). 5/12 (42%) achieved remission (4 CR/CRi, 1PR). Notably, first CR/CRi’s were reported between wk13(C5)–wk19(C7). These later onset responses may reflect the importance of AXL-related immunological mechanisms for relatively chemo-resistant relapsed pts and contribute to a longer time-on-treatment (ToT).
An additional 3 had SD; with clinical benefit rate 67%.
Median ToT was 28.0wks for CR/CRi pts. mDOR was 13.1wks [2.1-43.1+] in all responders and 14.0wks [10.0-43.1+] in CR/CRi pts. 7 pts remain on treatment. Survival outcomes continue to mature.
In contrast, no REF pts showed response (0/7), with 2/7 (28%) reporting clinical benefit; median ToT was 8.0wks. No pts remain on treatment.
Previously-reported results of preliminary scRNAseq analysis of these pts indicated differences in the T- and NK cell compartment associated with treatment response, pointing to BEM-mediated immune MOA in context of synergy of B+L. Further analyses of scRNAseq and CITE-seq data are ongoing.
Overall, the safety of B+L (compared with previously published BEM monotherapy) was in keeping with the known safety profile of LDAC. TRAEs of ≥G3 observed in ≥10% of pts were anemia (29% B+L; 0% BEM), platelet count decr. (29% B+L; 0% BEM), thrombocytopenia (19% B+L; 8% BEM), neutrophil count decr. (13% B+L; 0% BEM), white blood cell count decr. (13%B+L; 0% BEM) and ECG QT prolonged (10% B+L; 6% BEM). No G5 TRAEs reported.
Conclusion
These data show that B+L is efficacious and well tolerated in the elderly/unfit REL AML population. An in-depth translational research program aiming to identify predictive molecular and biological factors associated with response is ongoing. B+L should be considered for evaluation in a randomized pivotal trial in this population.
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BERGENBIO KUNNGJØR TOPPLINJEDATA FRA FASE-II UTPRØVINGSSTUDIE AV BEMCENTINIB I SYKEHUSINNLAGTE COVID-19 PASIENTER
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Dette bør det vel være brukbar betalingsvilje for?
Sett opp mot bivirkninger og enkelheten med administrering er det vel god grunn til å teppebombe India og U-land som står i fare for å komme i samme situasjon med Bem piller
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Ikke mye å rope hurra for den meldingen der. Tenker at det ikke blir tatt videre
Utdyp er du snill?
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Her fikk vi en trolig årsak til at Kvinnsland takket for seg i Koronakommisjonen:
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Hadde akkurat tenk til å poste denne, men dere kom meg i forkjøpet 
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Noen som har funnet link til presentasjon?
Kvinnsland skal på banen 
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BGBIO: BEKREFTELSESSTUDIE EN SANNSYNLIG VEI VIDERE -GODFREY
Oslo (TDN Direkt): Bergenbio mener det er usannsynlig at regulatoriske myndigheter vil oppfordre selskapet til å søke om godkjenning for nødbruk av bemcentinib på covid-19-pasienter på bakgrunn av dataen fra denne undersøkelsen, men tidlige samtaler indikerer at det kan være aktuelt med en bekreftelsesstudie.
Det sier administrerende direktør Richard Godfrey i Bergenbio under dagens presentasjon av topplinjedata fra BGBC020-studien.
På spørsmål om hva som er en mulig tidslinje for en bekreftende fase 3-studie, svarer Godfrey at han tror de er nødt til å først bli enige om en vei videre med regulatoriske myndigheter og andre parter, men at de vil absolutt gjøre noe så snart de kan.
-Det er vanskelig å sette en fast tidsramme på det, men av erfaring så klarte vi å mobilisere og sette i gang fase 2-studiene innen rundt 15 uker, sier han, og legger til at det fortsatt er litt arbeid som gjenstår, og at det er mulig å kunne annonsere en slags vei videre i løpet av sommeren.
Martin Brennmoen martin.brennmoen@tdndirekt.com
BERGENBIO PRESENTING AT SACHS 7[th] ANNUAL IMMUNO-ONCOLOGY INNOVATION FORUM
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BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2021
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BERGENBIO TO PRESENT DATA FROM PHASE I/II BEMCENTINIB/ERLOTINIB COMBINATION TRIAL IN NSCLC AT ASCO MEETING
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