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IndustriBioteknik
BerGenBio är ett norskt onkologibolag. Idag bedriver bolaget forskning och utveckling av hämmande läkemedel för behandling av aggressiva cancertyper. Bolaget har utvecklat ett flertal produkter vars sammansättning ämnar blockera proteinet AXL, ett protein positivt relaterat med spridning av cancercellerna. Bolaget grundades under 2007 och har sitt huvudkontor i Bergen, Norge.
2022-03-17 08:15:15
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.cell.com/cell-reports-medicine/fulltext/S2666-3791(22)00060
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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.