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BerGenBio

Regulatory Filings May 11, 2021

3555_rns_2021-05-11_5838f6ab-e361-458d-9886-729cb85d53b4.html

Regulatory Filings

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BEMCENTINIB PRE-CLINICAL COVID-19 DATA PRESENTED AT VIRTUAL IMMUNOLOGY 2021

BEMCENTINIB PRE-CLINICAL COVID-19 DATA PRESENTED AT VIRTUAL IMMUNOLOGY 2021

Bergen, Norway, 11 May 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 COVID-19

data has been presented at Virtual Immunology 2021, which is taking place from

10-15 May 2021.

The poster presentation illustrates findings from a pre-clinical study conducted

by BerGenBio's scientific collaborator Professor Wendy Maury, Professor of

Microbiology and Immunology at the University of Iowa. Data from the

study provides evidence that SARS-CoV-2 utilizes phosphatidylserine (PS)

receptors (TIM1 and AXL) as a key pathway for virus entry and that inhibition of

AXL signalling by BerGenBio's selective inhibitor bemcentinib reduces infection.

Reduced viral infection was also observed in a complementary data set following

AXL knockout in epithelial cells, further providing evidence of the important

role AXL plays in SARS-CoV-2 viral entry. As expected, bemcentinib´s anti-viral

efficacy ceased following AXL knockout, indicating its target specificity. In

conclusion, PS receptors enhance SARS-CoV-2 infection and inhibition of AXL is a

potentially promising therapeutic target for COVID-19.

Full poster presentation details are below. The author, Dana Bohan, will receive

a 2021 AAI Late Breaking Poster Award for the abstract, which was deemed to be

exceptional by the Virtual Immunology 2021 reviewers.

Title: Phosphatidylserine Receptors Enhancement of SARS-CoV-2 Entry: AXL as a

Therapeutic Target for COVID-19

Date: Monday, 10 May 2021

Time: 6:30-8:00pm ET

The poster 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: acting as a co

-receptor to ACE2 and promoting viral entry into the host cell. Further, AXL

upregulation and activation leads to suppression of the Type 1 Interferon immune

response by host cells and in their environment. Research data confirms that

bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the 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 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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