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BerGenBio

Regulatory Filings Oct 23, 2023

3555_rns_2023-10-23_bf55c00d-ea51-4cee-b3b8-ef975a1ce431.html

Regulatory Filings

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

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

BERGEN, Norway, October 23, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced that the full results of its Phase 2

BGBC008 study of bemcentinib and pembrolizumab in second line Non-Small Cell

Lung Cancer (NSCLC) were presented during the European Society of Clinical

Oncologists (ESMO) Annual Meeting 2023.

The poster presentation is now available on BerGenBio's website under

?Pipeline?Scientific Publications.

In addition, on October 21st, Dr.  Oddbjorn Straume, M.D., Ph.D., Assistant

Professor, Clinical Science at the Haukeland University Hospital in Bergen,

Norway presented results of the Investigator Led Study LBA52 of bemcentinib in

addition to pembrolizumab or the targeted therapies dabrafenib/trametinib in 1L

and 2L metastatic melanoma patients.

Cristina Oliva, Chief Medical Officer of BerGenBio, commented: "The full data

analysis of the BGBC008 second line NSCLC study of bemcentinib in combination

with the immune checkpoint inhibitor pembrolizumab showed promising long-term

clinical benefits in patients regardless of their prior therapies, or PD-L1

status.  In addition, the combination of bemcentinib with pembrolizumab was well

tolerated with no new safety signals identified.  These data provide a strong

foundation for further clinical investigations of bemcentinib in NSCLC patients

with high unmet needs, including those with STK11 mutations."

Dr. Oliva continued, "During the meeting, our collaborator, Dr. Oddbjorn

Straume, also presented data on the combination of bemcentinib with standard of

care therapies in first line and second line melanoma patients. While this small

study failed to show the benefit of adding a selective AXL inhibitor to the

treatment for melanoma patients, the results are consistent with the current

limited understanding of the function of AXL in melanoma.In totality, these new

data substantiate BerGenBio's focused strategy on the treatment of first line

NSCLC patients with STK11m patients in our on-going BGBC016 study."

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

Investor Relations / Media Relations

Jan Lilleby

[email protected]

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 cancer and severe respiratory infections. The

Company is focused on its proprietary lead candidate, bemcentinib, a potentially

first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC

and COVID-19.

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, visitwww.bergenbio.com

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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