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BerGenBio

Earnings Release Jun 5, 2023

3555_rns_2023-06-05_337252a2-f52f-4726-8dcb-1224738461d0.html

Earnings Release

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BerGenBio Announces Data from Bemcentinib Trial in Mesothelioma Presented at ASCO

BerGenBio Announces Data from Bemcentinib Trial in Mesothelioma Presented at ASCO

- Investigator-led Phase IIa study met its primary endpoint of disease control

rate at 12 weeks -

BERGEN, Norway, June 5, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, announced that an oral presentation detailing the

initial results from a Phase IIa trial evaluating bemcentinib in patients with

mesothelioma was presented today at the 2023 American Society of Clinical

Oncology (ASCO) Annual Meeting in Chicago.

The abstract, Bemcentinib and pembrolizumab in patients with relapsed

mesothelioma: MiST3, a phase IIa trial with cellular and molecular correlates of

efficacy, was presented by the study lead investigator, Dr. Matthew Krebs,

Ph.D., FRCP, The University of Manchester, UK. MiST, the Mesothelioma Stratified

Therapy umbrella trial, led by Professor Dean Fennell at the University of

Leicester, UK, is a British Lung Foundation funded study dedicated to improving

survival outcomes for patients with mesothelioma. MiST3, the third arm of the

trial, was designed to assess the efficacy of AXL/PD-1 inhibition with the

combination of BerGenBio's AXL inhibitor bemcentinib and pembrolizumab.

26 patients with relapsed mesothelioma were enrolled in MiST3 and all received

at least one dose of bemcentinib and pembrolizumab. The primary endpoint of

disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI: 29.2, 63.4).

Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of

38.5% (95% CI: 20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%

CI: 4.4, 34.9). The combination of bemcentinib and pembrolizumab was generally

safe and well-tolerated.

Dr. Matt Krebs remarked, "We are encouraged by the initial results of the MiST3

trial and believe that this combination warrants further evaluation in patients

with relapsed/refractory mesothelioma. While standard PD-1 targeting

immunotherapies alone have helped some, the majority of patients are in need of

better options. Data continues to point towards AXL inhibition being synergistic

with PD-1 inhibition and that it has the potential to add significant benefit to

this population."

"We are quite pleased with the findings and thankful for all of the

collaborators in the MiST3 trial," Martin Olin, Chief Executive Officer of

BerGenBio. "These results provide additional evidence of the role of

bemcentinib's AXL inhibition in another aggressive disease such as

mesothelioma."

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

Media Relations

Jan Lilleby

[email protected]

+47 90 55 16 98

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 severe respiratory infections.

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

About the University of Leicester

The University of Leicester is led by discovery and innovation - an

international centre for excellence renowned for research, teaching and

broadening access to higher education. It is among the Top 30 universities in

the Times Higher Education (THE)'s Research Excellence Framework (REF) 2021

rankings with 89% of research assessed as world-leading or internationally

excellent, with wide-ranging impacts on society, health, culture, and the

environment. The University is home to more than 20,000 students and

approximately 4,000 staff.

About The University of Manchester

The University of Manchester is recognised globally for its pioneering research,

outstanding teaching and learning, and commitment to social responsibility. The

Russell Group institution is ranked the 6th best university in the UK and 38th

in the world (Academic Ranking of World Universities).

A truly international university, its community includes more than 44,000

students, 12,000 staff, and 500,000 alumni from 190 countries. Together, they

are tackling the world's biggest challenges - the University's social and

environmental impact is ranked in the top ten globally (Times Higher Education

Impact Rankings).

The University is a powerhouse of research and discovery; 25 Nobel laureates are

among its former staff and students; and it was ranked fifth for research power

- the quality and scale of research and impact - in the UK government's Research

Excellence Framework (REF) 2021.

The institution is the most popular in the UK for undergraduate applications

(UCAS 2021 cycle), and it is the most targeted university by the UK's leading

employers (The Graduate Market, 2023).

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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