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BerGenBio

Regulatory Filings Jul 21, 2021

3555_rns_2021-07-21_f80ffb27-4149-45f4-adfd-50504668feb5.html

Regulatory Filings

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BERGENBIO COVID-19 DATA PRESENTED AT THE ANNUAL AMERICAN SOCIETY FOR VIROLOGY

BERGENBIO COVID-19 DATA PRESENTED AT THE ANNUAL AMERICAN SOCIETY FOR VIROLOGY

Bergen, Norway, 21 July 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, is pleased to announce that pre-clinical data

evaluating bemcentinib, BerGenBio's first-in-class, potent and highly selective

AXL inhibitor, for the treatment of SARS-CoV-2 infection has been presented at

the 40[th] Annual American Society for Virology (ASV).

The presentation was given by BerGenBio's collaborator, Mr. Dana Bohan, a PhD

candidate from the University of Iowa, who outlined previously announced

findings from preclinical studies conducted in the Lab of Professor Wendy Maury,

Professor of Microbiology and Immunology at the University of Iowa. The studies

aimed to evaluate AXL as a therapeutic target for COVID-19 infection and the

potential effect of BerGenBio's selective AXL inhibitor bemcentinib to prevent

infection by SARS-CoV-2. The investigators concluded that phosphatidylserine

receptors, such as AXL, enhance SARS-CoV-2 infection and that inhibition of AXL

is a potentially promising therapeutic target for COVID-19.

New data investigating bemcentinib against SARS-CoV-2 mutations was also

presented. These data show that bemcentinib is also efficacious in preventing

SARS-CoV-2 infection by carrying circulating mutations. Details on the

presentation can be found below.

Presenter: Mr. Dana Bohan, PhD candidate, University of Iowa

Title: Phosphatidylserine Receptors Enhance SARS-CoV-2 Infection: AXL as a

Therapeutic Target for COVID-19

Workshop: W16: Receptors, Attachment and Entry

Presentation Time: July 20, 2021 at 2:45 PM to 3:00 PM Eastern Time

The presentation will be made available at BerGenBio's website,

www.bergenbio.com.

-Ends-

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the

biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor

to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters

the host cell, and AXL expression is upregulated in infected organs with an

activation of the signalling pathway leading to suppression of the Type 1

Interferon immune response by infected cells and neighbouring cells, in their

environment. Pre-clinical research studies demonstrate that bemcentinib inhibits

SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug

resistance and immune escape by tumour cells, leading to aggressive metastatic

cancers. AXL suppresses the body's immune response to tumours and drives

treatment failure across many cancers. High AXL expression defines a very poor

prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,

therefore, have potential high value as monotherapy and as the cornerstone of

cancer combination therapy, addressing significant unmet medical needs and

multiple high-value market opportunities. Research has also shown that AXL

mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent

and highly selective AXL inhibitor, currently in a broad phase II clinical

development programme. It is administered as an oral capsule and taken once per

day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and

multiple solid and haematological tumours, in combination with current and

emerging therapies (including immunotherapies, targeted therapies and

chemotherapy), and as a single agent. Bemcentinib targets and binds to the

intracellular catalytic kinase domain of AXL receptor tyrosine kinase and

inhibits its activity.

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, leukaemia

and COVID-19. A first-in-class functional blocking anti-AXL antibody,

tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is

developing a companion diagnostic test to identify patient populations most

likely to benefit from AXL inhibition: this is expected to facilitate more

efficient registration trials supporting a precision medicine -based

commercialisation strategy.

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

Contacts

[email protected]

Richard Godfrey CEO, BerGenBio ASA

Rune Skeie, CFO, BerGenBio ASA

[email protected]

+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

[email protected]

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

[email protected]

+47 995 13 891

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 subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.

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