BERGENBIO ANNOUNCES FIRST PATIENT DOSED WITH BEMCENTINIB IN RELAPSED MALIGNANT PLEURAL MESOTHELIOMA INVESTIGATOR SPONSORED PHASE IIA STUDY

 

Bergen, Norway, 7 October 2020 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that the first patient has been dosed and
continues on therapy in a trial assessing bemcentinib in relapsed malignant
mesothelioma patients, sponsored by the University of Leicester.

With the support of the British Lung Foundation, which has provided £2.5 million
in funding, the University of Leicester is leading the development of the
world's first molecularly stratified umbrella study in mesothelioma named
Mesothelioma Stratified Therapy (MiST). The goal of MiST is to enable the
acceleration of novel, effective personalised therapy as a basis for improving
survival outcomes for patients with mesothelioma. The current study assessing
bemcentinib, MiST3, is a part of this umbrella study and is an all-comers arm,
with no requirement for molecular markers for eligibility.

MiST3 is a two-stage, single-arm Phase IIa clinical trial of bemcentinib and
pembrolizumab for the treatment of relapsed malignant pleural mesothelioma
patients. The study will enroll up to 26 patients at three sites in the United
Kingdom. The primary endpoint of this trial is disease control rate at 12 weeks,
with an analysis of complete or partial responses in patients. Other endpoints
include safety and toxicity, objective response rate, and disease control rate
at 24 weeks for bemcentinib in combination with pembrolizumab.

More information about the trial can be found
here (https://clinicaltrials.gov/ct2/show/NCT03654833).

AXL is over-expressed in many solid tumours, including malignant pleural
mesothelioma (MPM). Within mesothelioma, AXL expression has been shown in 74% of
tissue samples analysed[1]. AXL has also been implicated in epithelial-to
-mesenchymal transition (EMT), which promotes metastasis and the ability of
cells to migrate through extracellular matrix and intravasate into blood
vessels[2]. A strong association between EMT status and an inflammatory tumour
micro-environment with an elevation of multiple targetable immune checkpoint
molecules has been previously shown[3]. Bemcentinib has been shown to enhance
the efficacy of checkpoint inhibitors, such as pembrolizumab, in preclinical
cancer models and in patients with lung cancer (SITC 2019). Key effects of
bemcentinib in this setting include activation of innate immunity in the tumour
microenvironment, leading to activation of adaptive anti tumour T cell
responses.

Professor Gavin Murphy, Director of the Leicester Clinical Trials Unit,
commented:

"Leicester Clinical Trials Unit are delighted to announce the opening and
recruitment of the first participant to this important Phase IIa study. The
collaboration includes the British Lung Foundation, BerGenBio, University of
Leicester Professors Anne Thomas and Professor Dean Fennell and Dr. Matthew
Krebs from The Christie, Manchester, and represents the culmination of three
years' work. The ultimate output of this study will be the potential to provide
benefit to the MPM population."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We congratulate Professor Anne Thomas, Dr. Matthew Krebs and Professor Dean
Fennel on the start of this novel clinical study. We believe this trial can
provide an opportunity to potentially prolong the duration of response with a
combination of bemcentinib and pembrolizumab to patients who currently have no
standard option of care. With the UK having the highest global incidence of MPM,
several patients are likely to benefit from this trial recruiting in Manchester,
Leicester, and Newcastle. Data obtained from this trial will not only benefit
the UK population but also benefit the MPM population globally as a result of
the continued use of asbestos in the developing world."

- END -

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 and therapy resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focused on combination and single agent therapy in lung cancer,
leukaemia 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 identify those patient populations most
likely to benefit from bemcentinib or tilvestamab: this is expected to
facilitate more efficient registration trials and support a precision medicine
-based commercialisation strategy. For further information, please visit:
www.bergenbio.com (http://www.bergenbio.com)

About Investigator-Sponsored Trials

Investigator-sponsored clinical trials are clinical trials proposed by front
-line patient-facing physicians who act as the regulatory sponsor and are
supported by industry in bespoke clinical development partnerships. The industry
partner does not assume the role of sponsor according to European or US
regulatory guidelines but may offer support in a variety of different ways, such
as providing investigational medicinal product at no cost and providing
additional financial support as required.

About Malignant Pleural Mesothelioma

Malignant pleural mesothelioma (MPM) is a cancer that develops in the lungs.
The cause of pleural
mesothelioma (https://www.asbestos.com/mesothelioma/causes/) is exposure to
asbestos fibres (https://www.asbestos.com/exposure/), which are inhaled into the
lungs. It usually takes from 20 to 50 years for mesothelioma to develop after a
person's first exposure to asbestos. Because of this latency period, the disease
usually affects people older than 75. (www.asbestos.com) In the UK, 65,000
people are expected to die by 2050 (after 2001), making mesothelioma one of the
few predicted cancer epidemics. The average life expectancy for pleural
mesothelioma (https://www.asbestos.com/mesothelioma/life-expectancy/) is often
less than 18 months.

For more information, please contact
Richard Godfrey
CEO, BerGenBio ASA
media@bergenbio.com
+47 917 86 304


International Media Relations

Mary-Jane Elliott, Chris Welsh, Carina Jurs,

Lucy Featherstone, Maya Bennison

Consilium Strategic Communications

bergenbio@consilium-comms.com

+44 7780 600290

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.

 1. D. J. Pinato, F. A. Mauri, T. Lloyd, V. Vaira, C. Casadio, R. L. Boldorini,
and R. Sharma, "The expression of Axl receptor tyrosine kinase influences the
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mesothelioma.," Br. J. Cancer, vol. 108, no. 3, pp. 621-628, Feb. 2013.

 2. G. Mudduluru, P. Vajkoczy, and H. Allgayer, "Myeloid zinc finger 1 induces
migration, invasion, and in vivo metastasis through Axl gene expression in solid
cancer.," Mol. Cancer Res., vol. 8, no. 2, pp. 159-169, Feb. 2010

 3. Y. Lou, L. Diao, E. R. P. Cuentas, W. L. Denning, L. Chen, Y. H. Fan, L. A.
Byers, J. Wang, V. A. Papadimitrakopoulou, C. Behrens, J. C. Rodriguez, P. Hwu,
I. I. Wistuba, J. V Heymach, and D. L. Gibbons, "Epithelial-Mesenchymal
Transition Is Associated with a Distinct Tumor Microenvironment Including
Elevation of Inflammatory Signals and Multiple Immune Checkpoints in Lung
Adenocarcinoma.," Clin. Cancer Res., vol. 22, no. 14, pp. 3630-3642, Jul. 2016.
 

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