BerGenBio

Earnings Release • Feb 15, 2023

BerGenBio Announces Positive Data From Phase 2 Trial of Bemcentinib in Combination with Pembrolizumab in 2L+ NSCLC Patients

BerGenBio Announces Positive Data From Phase 2 Trial of Bemcentinib in Combination with Pembrolizumab in 2L+ NSCLC Patients

- The Company will discuss the topline results during its Q4 2022 results

presentation on Thursday, February 16, 2023, at 10:00 AM CET -

BERGEN, Norway, February 15, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced topline data from BGBC008, a phase 2

trial evaluating its lead compound bemcentinib in combination with MSD's anti-PD

-1 therapy pembrolizumab in 2L+ Non-Small Cell Lung Cancer (NSCLC) patients.

BGBC008 Topline Data

The open-label, multi-center, single arm, multi-cohort, international phase 2

trial conducted in collaboration with MSD (Merck and Co., Inc. Rahway, NJ, USA),

enrolled 90 evaluable patients with disease progression at study entry, who had

received at least one prior line of chemotherapy, immunotherapy, or the

combination. Enrolled patients received the combination of bemcentinib and

pembrolizumab until disease progression as assessed by investigators. Topline

results from the total evaluable population:

· A clinically meaningful survival benefit and evidence of disease control was

demonstrated with bemcentinib in combination with pembrolizumab regardless of

prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI:

10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6,

9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall

response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).

· A significant (p-value < 0.05) and clinically meaningful improvement in mOS

based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS >

5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6)

compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI:

6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months

(95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with

AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.

· The observed mOS was similar regardless of patient PD-L1 status.

· Treatment with bemcentinib in combination with pembrolizumab was well

-tolerated.

"We are very encouraged by the topline data" said Martin Olin, Chief Executive

Officer of BerGenBio. "Treatment with bemcentinib in combination with

pembrolizumab demonstrated long survival benefit and sustained disease control,

particularly in patients with AXL TPS > 5, substantiating the relevance of AXL

as a target and bemcentinib's selective inhibition capabilities in NSCLC.

Notably, the survival benefit was observed regardless of PD-L1 status. The data

support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom

approximately 80% have AXL expression. This subgroup of NSCLC represents more

than 30,000 patients in the US and five largest European countries, for whom

there is currently no effective targeted therapy available."

James Spicer, PhD, FRCP, Professor of Experimental Cancer Medicine at King's

College London and Principal Investigator of the BGBC008 trial, remarked, "The

reported data shows that the combination of bemcentinib and pembrolizumab is

well-tolerated in patients with NSCLC, and is particularly active in patients

with tumour AXL expression. Other evidence suggests that current therapies are

less effective in NSCLC with loss of the tumour suppressor gene STK11, and that

AXL inhibition can restore susceptibility. Further investigation is warranted to

confirm the role of AXL inhibition in STK11-mutated NSCLC patients, who are

under-served by currently available therapeutic options."

The Company plans to present further details of the BCBG008 trial at an upcoming

medical conference.

First-Line STK11m NSCLC Trial (BGBC016)

BerGenBio is studying bemcentinib in a global, open-label, phase 1b/2a trial

evaluating bemcentinib in combination with the current standard of care of

pembrolizumab and platinum doublet chemotherapy, for the treatment of 1L NSCLC

patients with mutations in the STK11 gene. More than 30,000 NSCLC patients (US

and EU5) harbor STK11 mutations which are associated with poor prognosis with

currently available therapies. The Company believes that STK11 mutations create

a severely immunosuppressed tumor microenvironment associated with AXL

expression and activation, resulting in the development of drug resistance,

immune evasion, and metastases.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / International Media Relations

Graham Morrell

graham.morrell@bergenbio.com

Media Relations Norway

Jan Lilleby

jl@lillebyfrisch.no

+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. The Company is focused on advancing its lead candidate,

bemcentinib, a potentially first-in-class, oral, selective AXL inhibitor in

STK11 mutated NSCLC and severe respiratory infections including 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, visit?www.bergenbio.com

About Bemcentinib

BerGenBio's lead compound, bemcentinib, is a potentially first-in-class, oral,

selective inhibitor of the receptor tyrosine kinase AXL, which is expressed and

activated in response to oxidative stress, inflammation, hypoxia, and drug

treatment, resulting in a number of deleterious effects in cancer and severe

respiratory infections.  Bemcentinib selectively inhibits AXL activation to

prevent the progression of serious diseases through the modulation of resistance

mechanisms and the adaptive immune system.

Bemcentinib is currently being developed in STK11 mutated NSCLC and severe

respiratory infections including COVID-19. Its novel mechanisms of action and

primary accumulation in the lungs uniquely position it to address these severe

lung diseases.

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 considered to be inside information pursuant to the EU

Market Abuse Regulation and subject to the disclosure requirements pursuant to

section 5-12 of the Norwegian Securities Trading Act.