Bergen, Norway, 22 October 2018 – BerGenBio ASA (OSE:BGBIO) announces that the company and its collaborators have presented interim clinical and biomarker data from BerGenBio’s Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, at the ESMO 2018 Congress in Munich (19 – 23 October 2018). Additionally, a pre-clinical study in myelodysplastic syndrome (MDS) was presented.

The posters are available at www.bergenbio.com in the Investors / Presentations section and a summary of results is given below.

(1)  Poster Discussion: Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials, Robert Holt et al

The poster discussed the broad biomarker programme run in parallel to the Phase II clinical trial programme with bemcentinib and detailed some of the key findings to date:

• Tumour AXL expression predicts patient benefit: 7 out of 10 second line NSCLC patients showed clinical benefit (70% CBR) including 4 responses (40% ORR) on KEYTRUDA/bemcentinib combination therapy (determined by BerGenBio’s proprietary immunohistochemistry method).
• Blood based biomarkers, including soluble AXL, have been found predictive of patient benefit in relapsed/refractory AML/MDS & NSCLC.

(2)  Poster Presentation: Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma, Cornelia Schuster et al 

The poster gave an update on the randomised trial in first line metastatic melanoma, combining bemcentinib with standard of care therapies:

• Confirmed recommended Phase II dose of bemcentinib in combination with MEKINIST/TAFINLAR and KEYTRUDA.
• All combinations continue to be well tolerated.
• Efficacy is seen across all arms with 18 out of 23 radiographically evaluated patients reporting clinical benefit including complete responses.

(3)  Poster Discussion: The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS, Hind Medyouf et al 

The poster discussed the relationship between AXL and myelodysplastic syndrome using both patient samples and animal model studies. The data show that AXL is upregulated in MDS patients and that inhibiting AXL with bemcentinib shows efficacy in pre-clinical models of the disease.

Richard Godfrey, CEO of BerGenBio, commented: The ability to predict which patients are most likely to derive benefit from treatment is an important competitive advantage as it is key to improving patient outcomes and regulatory success. The data presented at ESMO increases our confidence in the predictive nature of our proprietary biomarkers and diagnostics. What is more, 7 out of 10 AXL positive NSCLC patients showed clinical benefit in our phase II trial combining bemcentinib with KEYTRUDA, this is a remarkable observation and gives us confidence in bemcentinib’s proposed mechanism of action. Additionally, data presented at ESMO continue to show that bemcentinib is well tolerated and effective across our broad Phase II combination programme. We are looking forward to provide further updates on the development of our AXL inhibitor pipeline over the coming months.

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About the ESMO Congress

The ESMO Congress is the leading European meeting for medical oncology convening over 26,000 international delegates from the field. ESMO 2018 will be held in Munich, Germany 19- 23 October 2018. 

About BerGenBio’s Companion Diagnostics programme

In parallel with its phase II clinical trial programme, BerGenBio explores predictive biomarker candidates with the aim to develop a companion diagnostic to identify patients most likely to benefit from bemcentinib treatment.  

Thus far, the company reported strong correlation with response of both plasma soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or MDS and advanced NSCLC, respectively. 

About the BGBC008 trial

The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About the BGBIL006 trial

The BGBIL006 trial is a randomised Phase 1b/2 clinical study of bemcentinib (BGB324) in combination with either the MAPK inhibitors MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or the immune checkpoint inhibitor KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.

For more information please access trial NCT02872259at www.clinicaltrials.gov.

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for advanced and aggressive 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. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent.

In parallel, BerGenBio is developing a companion diagnostics test to identify patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials and support 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). www.bergenbio.com

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.

Contacts

Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

 Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891

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.