BerGenBio

Regulatory Filings • Mar 12, 2021

BERGENBIO COMPLETES ENROLMENT INTO LATEST COHORT OF PHASE II BEMCENTINIB COMBINATION STUDY IN REFRACTORY NSCLC

BERGENBIO COMPLETES ENROLMENT INTO LATEST COHORT OF PHASE II BEMCENTINIB COMBINATION STUDY IN REFRACTORY NSCLC

Bergen, Norway, 12 March 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 it has completed

enrolment into Cohort C1 of its Phase II study (BGBC008) of bemcentinib in

combination with anti-PD-1 therapy Keytruda[®] (pembrolizumab) in refractory non

-small cell lung cancer (NSCLC) patients.

The BGBC008 trial ClinicalTrials.gov Identifier: NCT03184571 is being conducted

in three cohorts evaluating the safety and benefit of bemcentinib and

pembrolizumab combination in refractory NSCLC patients. Cohort C is assessing

second line patients refractory to first line treatment with checkpoint

inhibitors in combination with chemotherapy. A total of 13 patients have been

enrolled in Cohort C1 and the first efficacy data is expected within 24 weeks.

If successful the trial will expand to Cohort C2, assessing a further 29

patients.

The study is being sponsored by BerGenBio in collaboration with MSD, a tradename

of Merck & Co., Inc., Kenilworth, New Jersey, USA, who continue to supply

Keytruda[®] (pembrolizumab) for use in the study, under a collaboration

agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

pleased to have completed enrolment into the first stage of the third cohort

planned for this study. We are excited by the potential patient benefit of

selective AXL inhibition with bemcentinib, to reverse acquired resistance to

immune checkpoint inhibitors in cAXL-positive patients who have relapsed on

immunotherapy and chemotherapy. There are currently limited treatment options

for patients for whom first line therapies in NSCLC have been ineffective. If

successful, this combination treatment could provide an important alternative to

second line chemotherapy standard-of-care. I look forward to providing an update

on the data from this cohort in due course."

-End-

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 that leads to suppression of

the Type 1 Interferon immune response by host cells and in their environment.

Research data confirms 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 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

ir@bergenbio.com

Richard Godfrey CEO, BerGenBio ASA

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

International Media Relations

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

Consilium Strategic Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+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.