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BergenBio Fundamentale Forhold (BGBIO)

BerGenBio Reports Second Quarter 2023 Financial Results

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Correction: BerGenBio ASA Seccond Quarter and half year 2023 Financial Report

Additional data on BerGenBio’s selective AXL inhibitor bemcentinib to be presented at the 2023 ESMO meeting

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New Data on BerGenBio’s Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

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BerGenBio Announces Poster Presentation at Upcoming SITC Meeting

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BerGenBio Announces Poster Presentation at Upcoming ASH Meeting

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BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

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ChatGPT gir en forklaring for ikke-forskere (som meg):
I denne meldingen forteller BerGenBio om nye funn fra en undersøkelse de gjorde på pasienter med lungekreft. De brukte et legemiddel som heter bemcentinib sammen med et annet legemiddel kalt KEYTRUDA® (pembrolizumab) for å behandle pasienter i andre linje av lungekreft. De fant ut at kombinasjonen av disse to legemidlene viser lovende resultater hos pasienter med lungekreft som har visse mutasjoner som vanligvis gir dårlig prognose.

Resultatene av undersøkelsen ble presentert på et møte om kreftimmunterapi og er tilgjengelig på BerGenBio sin nettside. Administrerende direktør, Martin Olin, sier at selv om undersøkelsen var på et begrenset antall pasienter, så tyder funnene på at bemcentinib i kombinasjon med pembrolizumab kan forbedre behandlingsresultatene for visse grupper av lungekreftpasienter som vanligvis har dårlig prognose.

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BerGenBio ASA: Invitation to third quarter 2023 results webcast

Financial calendar

BerGenBio Reports Third Quarter 2023 Financial Results

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Ovennevnte melding GPT-forenklet tekstmessig:

“We’re excited to share progress on our strategy for studying bemcentinib, a highly selective AXL inhibitor. Our focus is on first-line Non-Small Cell Lung Cancer (NSCLC) patients with mutations in the STK11 gene (STK11m). Real-world data at medical conferences underscores the urgent medical need for these patients. Our clinical data supports bemcentinib’s potential in combination with standard therapies to improve outcomes. In this quarter, we expanded clinical trial sites in the US and prepared for European sites, anticipating the Ph2a study initiation in 1L NSCLC STK11m patients in H1 2024. Operating expenses were NOK 28.1 million, down from NOK 62.4 million in Q3 2022, reflecting our focused strategy and cost containment. As of September 30, 2023, our cash position is NOK 169.3 million. We’re confident that our focused approach, along with potential funding from outstanding warrants, will allow us to generate valuable data showcasing bemcentinib’s significant potential in NSCLC,” said Martin Olin, CEO of BerGenBio.

Clinical Development - Bemcentinib

Bemcentinib, BerGenBio’s leading compound, is a promising oral inhibitor targeting the AXL receptor tyrosine kinase. AXL is activated in response to various stressors, contributing to harmful effects in cancer and severe respiratory infections. Bemcentinib selectively blocks AXL activation, hindering disease progression by modulating resistance mechanisms and the adaptive immune system.

Currently, Bemcentinib is under development for 1L STK11 mutated NSCLC and severe respiratory infections. Its unique mechanisms and lung-targeted accumulation make it suitable for addressing these challenging lung diseases.

Oncology: NSCLC

In the pursuit of our focused strategy, we are progressing with the BGBC016 trial, a global Phase 1b/2a study evaluating Bemcentinib’s safety and efficacy in combination with standard treatments for untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations. The study, already active in the US, is expanding into European sites following regulatory approvals.

The Phase 1b portion assesses the safety of Bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, irrespective of STK11 status. No significant safety concerns have been observed. The Phase 2a expansion will further evaluate Bemcentinib’s safety and efficacy in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

A substantial subgroup of 1L non-squamous NSCLC patients (up to 20%) with STK11 mutations faces challenges with standard treatments. Bemcentinib aims to address these challenges, potentially providing survival benefits. Recent data from the BGBC008 study supports Bemcentinib’s anti-tumor effects, showing promise in modulating the tumor microenvironment and enhancing the effects of immunotherapy and chemotherapy. Additional clinical data will be presented at major medical meetings throughout 2023.

Description of the 2L+ NSCLC Trial (BGBC008)

The Phase 2 BGBC008 trial, involving 90 evaluable 2L+ NSCLC patients, demonstrates that the presence of AXL expression predicts improved survival in patients treated with Bemcentinib + pembrolizumab. AXL-positive patients showed statistically significant benefits, with a median overall survival of 14.1 months compared to 6.5 months in AXL-negative patients. Analysis of subsequent therapies (3L+) suggests a higher response rate, indicating potential long-lasting immune response benefits.

Bemcentinib also appears beneficial for PD-L1 negative patients, traditionally less responsive to immune checkpoint inhibition. The combination of Bemcentinib and pembrolizumab shows promise for patients with mutations associated with poor outcomes, including STK11, KRAS, KEAP-1, and SMARCA4 mutations.

Severe Respiratory Infections (SRIs)

Bemcentinib is believed to block viral entry and replication, stimulate the innate immune system, and promote lung tissue repair, positioning it for severe respiratory infection treatment. The Phase 2b EUSolidAct trial evaluating Bemcentinib in hospitalized COVID-19 patients is paused due to limited hospitalizations, with ongoing preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS). Initial results are expected in 2023.

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BerGenBio ASA - Commencement of the first exercise period for warrants issued in connection with rights issue

BerGenBio ASA - Start av den første utøvelsesperioden for de frittstående tegningsrettene utstedt i forbindelse med fortrinnsrettsemisjonen

Bergenbios aksjonærer står i en hyggelig valgsituasjon

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BerGenBio ASA Mandatory notification of trade by primary insiders and close associates

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Noen som hiver seg på og benytter seg av kjøp på 0,13? Virker jo som en god ting, uten at jeg har tenkt for mye rundt det.

BerGenBio ASA - Information about the first exercise period for warrants issued in connection with rights issue

BerGenBio ASA - Siste dag av den første utøvelsesperioden for de frittstående tegningsrettene utstedt i forbindelse med fortrinnsrettsemisjonen

BerGenBio ASA - Last day of the first exercise period for warrants issued in connection with rights issue