The opportunity

BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease. With over 600 patients dosed (approx. 400 in oncology and approx. 200 in COVID-19), the Company has built a large dataset demonstrating biological and clinical activity while simultaneously defining dosing regimens to identify an appropriate balance of safety and efficacy.

The updated business strategy announced today builds on bemcentinib’s mode of action and data gathered from a broad clinical exploration to progress two distinct opportunities with the potential to significantly improve the lives of patients: NSCLC and COVID-19. Both indications show strong evidence of bemcentinib activity, with the advantage of accumulation in target organs, options for accelerated registration, compelling competitive advantages, and both represent high unmet medical needs.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "BerGenBio has been at the forefront of understanding of AXL biology and, having pioneered this area, we remain confident that selective AXL inhibition holds significant potential as a transformative treatment modality for several serious diseases. A rapidly evolving treatment landscape, with improved standards of care in areas such as oncology requires BerGenBio to be nimble and identify specific opportunities where we can address unmet needs in a competitive manner.

With this in mind we believe that by introducing a laser focus and rightsizing the organization on two key areas where we see our pipeline has the greatest impact, we are efficiently advancing BerGenBio’s potential; building on our strong scientific foundation to deliver new drugs to market resulting in better outcomes for patients and the generation of significant value for our shareholders.”

NSCLC

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. Approximately 85% of lung cancers are classified as NSCLC. BerGenBio is targeting 1st Line STK11 mutated Non-Squamous NSCLC patients, an extremely large patient population with very limited response to the standard of care treatments. STK11 is an important tumor suppressor gene reported to confer immunotherapy resistance in NSCLC and is present in up to 20% of NSCLC patients.

Pre-clinical and clinical studies have suggested a mechanism by which bemcentinib may restore response to immune checkpoint inhibitor therapy and enable the avoidance of chemoresistance in NSCLC patients harboring STK11 mutations, thus potentially offering a treatment option to those patients who respond poorly to existing therapies. Data from the subset of STK11mutated patients treated in the Company’s BGB008 study in 2nd line NSCLC also provides early indications of efficacy in this biomarker driven patient population.

The FDA has recognized that STK11 is currently a “non-actionable” mutation – one that confers poor outcome and has no specific therapeutic approaches today and have granted BerGenBio a Fast Track Designation for bemcentinib in this setting. To date, bemcentinib is to the Company’s knowledge the only selective AXL inhibitor in development for patients with STK11 mutation. BerGenBio has a strong proprietary position for treatment of this population and believes there may be a potential for an accelerated approval pathway in this patient sub-set.

COVID-19

Despite the success of vaccines, there is still a large number of hospitalized patients that remain in need of improved therapeutic options for COVID-19. Research into bemcentinib’s potential in hospitalized COVID-19 patients began in 2020, in response to the emergence of the pandemic, and based on the Company’s understanding of AXL’s role in mediating aggressive diseases.

Recently, BerGenBio announced results from the Phase II sub-protocol of the platform ACCORD2 study, which met its primary and key secondary endpoints, with demonstrable efficacy in patients on top of current standard-of-care treatments including remdesivir and corticosteroids. Further, bemcentinib has been selected to be studied under the EUSolidAct platform trial through a sub-protocol enrolling 500 patients across European sites. Given the ongoing need for new treatment options for hospitalized COVID-19 patients, the novel mechanism of action of bemcentinib (independent of the spike protein), along with potential to confirm the ACCORD2 data in the EUSolidAct trial, the Company believes that this could warrant Emergency Use Authorizations based on precedents.

The Company believes that the unique mechanism of action and properties of bemcentinib positions it well as a novel treatment modality within severe respiratory infections beyond COVID-19.



With a focused strategy and rightsized organization BerGenBio plans to unlock significant potential value related to the two indications selected and define the path to market.



An investor call will take place today at 1pm CEST (7am ET), full details below.

Web link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220504_12

Dial-in details:

PIN Code: 712491

NO: +47-21-956342

UK: +44-203-7696819

US: +1 646-787-0157

SE: +46-4-0682-0620

DK: +45 78768490

Neppe.. med mer enn en halvering av aksjekursen på ett knapt år og en kasse som går tom iløpet 12-16 mnd regner jeg med det søkes med lys og lykt etter noen med velfylte lommer som kan drive sjappen videre. Eller ?

Skjedde det noe moro på generalforsamlingen?

Ser ikke ut til at GF’en hjalp noe på oppdriften. Langt frem før det er håp om noe som helst kan materialiseres og gi inntekter Innen den tid er kassen tom- hvor skal penger til videre drift komme fra ?

Svært interessant - takk

Hvorfor publiseres ikke dette på BGBIO’s egen web side ?

https://open.spotify.com/episode/1WRLdsxfDM9ZTZ1tM8c5nr?si=ddTrEnFPS9WvJLCgy7m8kA&context=spotify%3Ashow%3A19CqqI9b5AV0t04yRcPNiq



2500 NOK pr aksje i løpet 2025 står i min almanakk…

Det er bare datamaskiner og idioter som selger BGBIO aksjer på disse nivå.

Hva skjedde på GF … gjesp ….

Anbefaler alle å lytte til podcasten Radium, episode 224, på Spotify med Martin Olin. Oppløftende informasjon og en entusiastisk CEO. Bemcentinib på markedet i løpet av 2-3 år. NSCLC STK11 data rett rundt hjørnet, nytt er en mulighet for 1.linje behandling innen NSCLC. AML og Covid fortsatt svært lovende og 3 shots on goal med store «business opportunities». Olin nevner også at studiene kan gjøres ferdig i BGBIO sin regi finansielt men at partner kan være svært aktuelt for salg og markedsføring da dette er altfor stort for et lite selskap som BGBIO. Selskapet er foreløpig på maksimal kapasitet med 3 parallelle studier men en rekke nye kommer om noen få år dersom resultatene fører til gjennombrudd for Bemcentinib. Veldig god forklaring på utviklingen av aksjekurs og liten interesse så langt. Dette er typisk for ny og banebrytende teknologi inntil bekreftende data legges fram. Dialog med big Pharma ville han ikke kommentere av naturlige årsaker. Ser vi konturene av et nytt Genmab med utspring i Bergen og Oxford?

Det var et bra intervju, og det er mye å glede seg til. Dessverre en advarsel om at data kanskje ikke modner raskt nok for stk11 slik at man rekker H1/22, men sterke data er bedre enn raske data. For meg virker det om at alle de tre satsningsområdene er best egnet for partnere fremfor at bergenbio kjører dette selv.
Martin har et 2-3 års perspektiv før man kommer i posisjon/markedet.

Dagens Radium podcast, intervju m Martin Olin. https://podcasts.apple.com/no/podcast/radium/id1483387944?i=1000558855030

Utstede aksjer til BP til 20 % overkurs = ja takk, utstede aksjer til investorer til 10-20% rabatt = nei takk

Liten interesse for aksjen siste året sier vel sitt.
Forventer at kursen gruses ytterligere og at vi ser ATL løpet av Mai.

Generalforsamling 28.04.2022

Hvilke overraskelser kan vi forvente oss.

Et tilsvarende selskap i USA som har langt svakere pipeline enn BerGenBio er ZENTALIS.

Seldkapets verdi på Nasdaq er betydelig høyere enn BerGenBio. Nå går Pfizer inn med 25 mill USD i en rettet emisjon mot selskapet på ca 20 % høyere pris enn børskurs. Dette er 60-70% lavere enn topp notering fra tidligere.

Dersom ledelsen og styret gjør det samme vil det frarøve og vanne ut eksisterende aksjonærer i BerGenBio.

Jeg håper store og små aksjonærer vet hva dette innebærer.

Ledelsen og styret i selskapet bør derfor ikke få tillatelse til å utstede nye aksjer til selskap som f.eks Merck som er en naturlig samarbeids partner. Det er bedre å innhente fremmedkapItal dersom det er behov for arbeidskapital enn å selge aksjer til spottpris.

https://ir.zentalis.com/investor-relations/

Er vel stort sett bare i Norge "folk flest" tror pandemien er over...det fortelles om rekordsmitte i Tyskland, og i Sverige forventer FMI mer enn dobling av antall dalig innlagte på sykehus framover, fra ca 25 / dag til 60.

Fler väntas läggas in på sjukhus efter ny omikronvariant
UPPDATERAD IDAG 09:22PUBLICERAD IGÅR 19:37

https://www.svt.se/nyheter/inrikes/experten-nastan-enbart-nya-varianten-ba-2-i-sverige

Dette er veldig positivt.
Korona blir ikke borte og det er alltid en reell fare for ny oppblomstring. Sannsynligvis ikke i sommer som var tilsvarende i fjor, men det kommer.

Trøkket på helsevesenet er større nå enn da den fjerde statsmakt hauset den såkalte who definerte pandemi. Nå er det krig, det er reelt.

Ja, men Kina har ikke tenkt å bekjempe pandemien med medisiner. Der er det total lockdown som gjelder. Eventuelt sure blader og løvetannjuice. Fy faen for noen Idioter.

Enig👍

Pandemien er nok ikke over enda. Det er rett før Kina stenger alt ned igjen.

Fantastisk, litt kjedelig at denne kom nå og ikke under pandemi.. Men det kan blii svært bra på litt lengre sikt.
Gratulerer 🃏

Nå har Finansavisen også tatt inn en artikkel:
" BerGenBio opplyser tirsdag at en fullstendig dataanalyse av en randomisert fase II-studie av bemcentinib i kombinasjon med standardbehandling (SoC), ACCORD2 (BGBIL019), hos innlagte covid-19-pasienter bekrefter at det primære effektendepunktet ble møtt.

På European Congress of Clinical Microbiology & Infectious møtet i juli 2021 presenterte selskapet foreløpige data fra ACCORD2-studien i kombinasjon med en covid-19-studie (BGBC020), som viste en terapeutisk fordel med meningsfulle kliniske endepunkter i totalt 177 pasienter.

I dag er det første gang komplette ACCORD2-data fra totalt 61 behandlede pasienter har blitt rapportert separat.

Totalt sett opplevde 90 prosent av pasientene behandlet med bemcentinib og SoC (26 av 29) en klinisk respons innen dag 29 (median 7 dager). Dette kan sammenlignes med 69 prosent (22 av 32 pasienter) med klinisk respons på SoC-behandling alene (median 9,5 dager), som viser statistisk signifikans."

Dette var hinsides bra resultater… spent på hvor dette tar oss, burde se en dobling av kurs idag!!

Liker denne svært godt..

"Bergen, Norway, April 26, 2022 - BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, announced today that a complete data analysis of a randomized phase II study of bemcentinib in combination with standard of care (SoC) therapy, ACCORD2 (BGBIL019), in hospitalized COVID-19

patients confirms that the primary efficacy endpoint was met. "

Siste settningen 🎯

Jeg vedder fortsatt på at BerGenBio aksjen går i 2500 før Jul - men ikke hvilken Jul…

BERGENBIO ANNOUNCES COMPLETE DATA ANALYSIS OF ACCORD2 PHASE II BEMCENTINIB STUDY IN HOSPITALIZED COVID-19 PATIENTS – PRIMARY EFFICACY ENDPOINT MET

Complete data analysis confirms that the primary endpoint of improved clinical response and key secondary endpoints were met in a subprotocol under the platform ACCORD2 study where bemcentinib was added to standard of care therapy

BerGenBio to confirm the ACCORD2 data by progressing bemcentinib into EU-SolidAct, a pan-European platform COVID-19 study enrolling up to 500 patients

Bergen, Norway, April 26, 2022 - BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, announced today that a complete data analysis of a randomized phase II study of bemcentinib in combination with standard of care (SoC) therapy, ACCORD2 (BGBIL019), in hospitalized COVID-19 patients confirms that the primary efficacy endpoint was met.

At the July 2021 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) meeting, the Company previously presented preliminary data from the ACCORD2 study in combination with a second COVID-19 study (BGBC020) showing evidence of therapeutic benefit on meaningful clinical endpoints in a total of 177 patients. Today’s announcement is the first time complete ACCORD2 data in a total of 61 treated patients has been separately reported.

Overall, 90% of patients treated with bemcentinib + SoC (26 of 29) experienced a clinical response by day 29 (median 7.0 days), as defined by either a two-point improvement in World Health Organization (WHO) category from baseline score, or discharge from hospital, whichever arose sooner. This compared to 69% (22 of 32 patients) with a clinical response to SoC treatment alone (median 9.5 days), showing statistical significance.

The data was generated under a sub-protocol of the platform ACCORD2 study (ACCORD2; EudraCT 2020-001736-95 - BGBIL019), a multi-center phase II randomized study designed to assess the efficacy and safety of candidate agents as add-on therapies to SoC for the treatment of COVID-19 in hospitalized patients.

Overall, 98% of patients received dexamethasone or an equivalent steroid in their SoC, and 18% received immunomodulatory treatment with tocilizumab. The antiviral remdesivir was used in 53% of those randomized to SoC alone, and in 21% of patients treated with bemcentinib.

In addition, key secondary endpoints saw statistically significant improvements for the bemcentinib + SoC arm compared to SoC alone, including avoidance of any deterioration by ≥1-point increase in WHO score (including death) and ventilator-free survival over 29 days. At day 29, 97% of bemcentinib + SoC treated patients were alive compared to 81% of SoC-alone.

Bemcentinib treatment was well tolerated in this patient population, with no clinically relevant safety signals in comparison to standard of care treatment.

These latest results underline bemcentinib’s potential in COVID-19 and other severe respiratory infections. As previously announced, bemcentinib will be studied in the EU-SolidAct trial in up to 500 hospitalized COVID-19 patients.

Professor Tom Wilkinson MA Cantab MBBS PhD FRCP FERS, Professor of Respiratory Medicine and Chief Investigator on the ACCORD program commented: "With COVID-19 still driving hospital admissions globally it is key that new, more effective treatments are being developed. These results from the ACCORD2 program indicate that bemcentinib has demonstrated real promise as a new therapeutic option for hospitalized patients and it now warrants testing in larger studies. These results are a testament to the great collaboration between the NHS, NIHR, the MEU and our Southampton research teams with more exciting results to follow from the platform."

Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are highly encouraged by the final data from our ACCORD2 study in hospitalized COVID-19 patients. The ability of bemcentinib to add a statistically significant benefit in clinical response over standard of care therapy is promising. We look forward to moving to the next step in the development of bemcentinib for COVID-19 through our participation in the EUSolidAct platform study, designed to enrol up to 500 hospitalized COVID-19 patients.”

Contacts:

For BerGenBio: Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700


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 clinical development programme focused on combination and single agent therapy in cancer and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing phase I clinical testing.

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

About ACCORD2 study
Under the bemcentinib sub-protocol of the ACCORD2 study, patients were enrolled within a calendar day after being admitted to hospital. Eligible patients were categorized by the WHO 9-point clinical scale and ranged from patients who did not require supplementary oxygen (grade 3) to those requiring non-invasive ventilation or high-flow nasal oxygen, but not intubated (grade 5). In the bemcentinib sub-protocol 29 patients were randomized and received bemcentinib treatment in addition to SoC.
For further details: https://clinicaltrials.gov/ct2/show/NCT04890509


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 considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Den vedder jeg imot

Sterk analyse der.
At selskapet vitenskapelig beviser at produktet deres er trygt og bedrer folks helse i løpet av en 14 dagers kur skal man ikke vektlegge spesielt.
Er sikker på at både influensa og Covid-19 blir borte av seg selv de neste ukene og aldri kommer tilbake.

Trøstesløs utvikling .. dette går bare ikke veien💸

Alle som vil får spør på GF denne uka …,

Ellers bør ikke ledelsen få BGBIO opsjoner før de leverer fase III resultater som materialiserer seg i godkjente medisiner synes jeg… utvanning grunnet ingen nytte - de må gjerne få opsjoner - men disse må forfalle verdiløse når det ikke leveres resultater innen forventet tid.

Går aksjekursen opp må det etter forfall av opsjoner settes nye innløsnings kurs…

Ledelsens tyveri av gratis opsjoner inn i evigheten fremstår som et ran på åpen gate - godkjent av idiotiske hoved aksjonærer som forvalter andre penger.

Små aksjonærer foren dere og stem mot alle opsjons ordninger på Generalforsamlingen !

Skuffende at EU ikke har kommet igang. Hvor mange år skal de bruke!

Hvor lenge har selskapet igjen her på Oslo børs? Venter oppkjøp med mine aksjer.
AXL a promising target to treat life-threatening diseases!!!!!!!

Ser meget lovende ut. Kan bli en viktig del av behandlingen mot flere varianter…

Fasten Seat Belts …. 👍


07:00 25.04.2022
BERGENBIO PRESENTS BEMCENTINIB COVID-19 CLINICAL TRIAL DATA AT ECCMID 2022

Bergen, Norway, 25 April 2022 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, announces that it is presenting data today from its Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) in a poster presentation at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), being held both online and in-person in Lisbon, Portugal, from April 23-26, 2022.

The poster presentation will share findings from the Company’s Phase IIa open label study of 115 patients evaluating bemcentinib in combination with Standard of Care (SoC) compared to a SoC control arm in the treatment of moderate to severe COVID-19 patients, immediately after hospital admission (BGBC020).

Clinical data from the study show that bemcentinib treatment (up to 14 days) confers early and sustained protection, limiting clinical deterioration in patients. Bemcentinib treated patients were discharged earlier from the hospital, required less supplementary oxygen and demonstrated a significant reduction in the need for intubation or ventilation.

Biomarker analysis demonstrates that treatment with bemcentinib reduced markers of acute inflammation and profibrotic cytokines, and increased expression of protective factors. These changes were more pronounced in patients with more serious disease, determined by high C-Reactive Protein (CRP) rates, high neutrophil to lymphocyte ratio (N/L) ratio or increased oxygen usage.

Preclinical data is also being presented from in vitro studies in lung epithelial cells on bemcentinib’s activity on variants of concern. These data suggest that bemcentinib inhibits infection of multiple SARS-CoV-2 variants, including Omicron, building on previous preclinical research from the Company.


Martin Olin, CEO of BerGenBio, commented: “The data we are presenting at ECCMID today further demonstrates the effectiveness of bemcentinib as a treatment for severe respiratory infections such as COVID-19. We have been pleased to see bemcentinib’s impact on reducing disease deterioration in patients. In addition, we’re encouraged to see that bemcentinib exerts a broad anti-inflammatory and pro-repair effect on blood biomarkers. We look forward to the initiation of the EUSolidAct platform trial which will further assess bemcentinib in hospitalised COVID-19 patients.”

Details of today’s poster presentation are as follows:

Abstract: 04778: Bemcentinib modulation of inflammatory, fibrotic and tissue repair pathways correspond with favourable clinical outcomes in hospitalised COVID-19 patients demonstrating higher severity cues: a biomarker perspective

Session Name: 12c. Clinical features, case management, outcome (incl long-term): programme no. L0383

Time, Location: Monday, 25th April 2022, 12:00pm - 13:00pm (WEST)

Viktig poeng du kommer med her i første avsnitt, Forum forum. Bemcentintinib skal tas sent i sykdomsforløp

Ja, men dette er jo en kjent behandling som allerede er beregnet i BergenBio analyse av behovet for en etterbehandling.
Denne må tas ila 3-5 dager etter smitte.

Jeg er vel så spent på Bemcentinib mot influensa. Tilbakemeldingene nå er at årets vaksine ikke gir god beskyttelse for svake og utsatte grupper.

Spennende. Undrer på hvor Bergen bio ligger i løypen?

https://finansavisen.no/nyheter/helse/2022/04/22/7853912/who-anbefaler-pfizers-coronapille?internal_source=sistenytt

Same short shit criminals - new wrapping …

ARROWSTREET CAPITAL, LIMITED PARTNERSHIP

CITADEL ADVISORS LLC

Robothandler og meglere herjer igjen....
Arrowstreet siste shortbet sørger for å holde den igjen. En får heller nyte påsken, holde på aksjene og vente på gode nyheter som vil komme.

👍 : A Predators best weapon is patience 👏👏👏