BerGenBio

Regulatory Filings • Oct 7, 2020

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

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

tumour phenotype and clinical outcome of patients with malignant pleural

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.