BGBIO / Bemcentinib => Game-Changer

BioBull
BGBIO 03.05.2022 kl 06:23 1925

BGBIO’s Bemcentinib vil bli en medisinsk «Game-Changer» tror jeg.

Det er stadig flere tegn som tyder på at mRNA vaksinene som er utviklet langt i fra er den beste måten å beskytte jordens befolkning mot pandemier.

A Moratorium on mRNA 'Vaccines' is Needed
Re-Visiting the Biodistribution of Lipid Nanoparticles

Dr. Byram W. Bridle
Apr 2022.

(Note: this is a long but thorough article to make important scientific information accessible to the general public.)

https://viralimmunologist.substack.com/p/a-moratorium-on-mrna-vaccines-is





Bill Gates utelukker ikke nye pandemier i fremtiden

«Bill Gates: It’s not likely, but 'the worst’ of Covid could still be ahead..» Bill Gates

“We’re still at risk of this pandemic generating a variant that would be even more transmissive and even more fatal,” the billionaire Microsoft co-founder and public health advocate told the Financial Times on Sunday. “It’s not likely, I don’t want to be a voice of doom and gloom, but it’s way above a 5% risk that this pandemic, we haven’t even seen the worst of it.”

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Redigert 03.05.2022 kl 06:24 Du må logge inn for å svare
BioBull
04.05.2022 kl 07:29 1545

Viktigste BerGenBio melding ever:

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

mimer
04.05.2022 kl 14:38 1215

Ja, hva øker du kursmålet til? 10000?
Predator
04.05.2022 kl 14:47 1188

………..translating BerGenBio’s strong scientific foundation into significant value generation ………

Det er dette vi vil høre!
Ps. Significant = betydelig.