BerGenBio

Legal Proceedings Report • Mar 17, 2022

BERGENBIO ANNOUNCES PUBLICATION IN CELL REPORTS MEDICINE JOURNAL INDICATING EFFICACY OF BEMCENTINIB IN STK11/LKB1 LUNG CANCER POPULATION

BERGENBIO ANNOUNCES PUBLICATION IN CELL REPORTS MEDICINE JOURNAL INDICATING EFFICACY OF BEMCENTINIB IN STK11/LKB1 LUNG CANCER POPULATION

The article identifies the key role of AXL inhibition in restoring response to

immune checkpoint blockade therapy in lung cancer with mutations in the

STK11/LKB1 gene

Bergen, Norway - 17 March 2022- BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL inhibitors for severe

unmet medical needs, today announces the publication of a peer-reviewed article

entitled "AXL targeting restores PD-1 blockade sensitivity of STK11/LKB1 mutant

NSCLC through expansion of TCF1+ CD8+ T cells" in the journalCell Reports

Medicine.

The article reports on research that identifies AXL as a critical targetable

driver of immune suppression in STK11/LKB1 mutated non-small cell lung cancer

(NSCLC). Mutations in STK11/LKB1 in NSCLC occur in approximately 20% of patients

and are associated with poor outcomes and limited response to immune checkpoint

blockade, commonly utilized treatments for lung cancer.

This article and its accompanying material are accessible here:

https://www.science.org/doi/10.1126/science.abg5827

The research was led by Professor Rolf A. Brekken, in the Hamon Center for

Therapeutic Oncology Research at the UT Southwestern Medical Center. The group

introduced a STK11/LKB1 mutation into a preclinical murine model of lung

adenocarcinoma, resulting in immune checkpoint blockade refractory tumors. The

group posits that the lack of response occurred because the STK11/LKB1 mutated

tumors lacked a specific population of immune cells (TCF1-expressing CD8+ immune

T cells). This immune cell population was also reduced in human NSCLC tumors

carrying STK11/LKB1 mutations.

Systemic inhibition of AXL by the BerGenBio molecule bemcentinib led to

increased type I interferon secretion from AXL-expressing dendritic cells,

resulting in expansion of the TCF1+ T cell population and restored therapeutic

response to immune checkpoint blockade treatment. These results were observed in

both an immunocompetent mouse model and in mice bearing human STK11/LKB1 mutant

NSCLC tumors along with a humanized immune system. The paper also summarizes

clinical data in NSCLC patients with identified STK11/LKB1 mutations receiving

bemcentinib and immune checkpoint blockage (pembrolizumab), who demonstrated

objective clinical response to combination therapy.

In November 2021 BerGenBio announced that the U.S. Food and Drug Administration

(FDA) granted Fast Track designation for bemcentinib in combination with an anti

-PD-(L)1 agent as a treatment for patients with STK11/LKB1 altered

advanced/metastatic NSCLC patients without actionable mutations.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are pleased to

receive this strong preclinical validation of the potential role of bemcentinib

to treat STK11/LKB1 mutated NSCLC patients. Data suggests that this significant

patient population is underserved by current immune checkpoint blockade

therapies, and we hope that the combination with bemcentinib can restore the

immune response in these patients. The identification of a new druggable

biomarker segment such as the STK11/LKB1 mutations may offer significant hope

for improved patient outcomes in combination with the current standard of care

therapies. We look forward to initiating a clinical trial this year to advance

bemcentinib into development for this patient population."

Contacts:

For BerGenBio: Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Consilium Strategic

Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

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 and COVID

-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is

undergoing phase I clinical testing. In parallel, BerGenBio is developing

companion diagnostic tests to potentially 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

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. Suchrisks, 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.