BerGenBio Provides Interim Update on Phase II Clinical Programme With Selective Oral AXL Inhibitor Bemcentinib

CHICAGO, June 3, 2018 /PRNewswire/ -- BerGenBio ASA (OSE:BGBIO) announces that interim data from its Phase II clinical development programme with bemcentinib, a selective AXL inhibitor, was presented at a reception hosted yesterday by the company in Chicago, IL, USA. The reception, which coincides with the annual American Society of Clinical Oncology (ASCO) meeting, provided stakeholders, including clinicians, investors, analysts and media, with interim data from the ongoing clinical trials of bemcentinib alone and in combination with standard of care drugs in multiple cancer indications. Presentations were made by key opinion leaders, clinical trial principle investigators and members of the BerGenBio team.

All materials presented at the reception are available on the BerGenBio website in the Investors / Presentations section. A conference call to discuss the presentations and updates will be held on Monday 4thJune at 8:30 AM CEST (details below).

Key Findings

Note that all Phase II trials are ongoing and results presented are preliminary and subject to change as the trials progress to completion. Updated data will be presented throughout 2018.

• Bemcentinib plus KEYTRUDA® (pembrolizumab) shows early promise in advanced lung cancer (NSCLC) patients who failed previous treatment (study BGBC008):
• Tumour shrinkage was reported in 8 of 15 evaluable patients to date, including three Partial Responses (PR) and one mixed response,
• Response assessment according to biomarker expression analysis available thus far:
• 6 of 7 PD-L1 negative patients reported clinical benefit, including 2 PRs and 2 patients with evidence of tumour shrinkage.
• 5 of 6 patients thus far tested for AXL expression with BerGenBio's proprietary immunohistochemistry assay, were AXL positive.
• 4 of 5 AXL positive patients reported clinical benefit including 1 PR and 2 patients with evidence of tumour shrinkage.
• All 4 AXL positive patients reporting clinical benefit were found to be PD-L1 negative. 
• An acceptable safety profile of the combination was reported with only a minority of patients experiencing fully reversible adverse events. 
• Analysis of metastatic triple-negative breast cancer (TNBC) patients who had failed previous treatment and who were enrolled to receive bemcentinib plus KEYTRUDA (study BGBC007) showed low prevalence of AXL and PD-L1:
• 14 of 18 patients tested for AXL expression were AXL negative and reported no benefit. 
• 12 of 15 patients tested for PD-L1 expression were PD-L1 negative; 6 were evaluable for efficacy with 1 reporting tumour shrinkage.
• Superior response rates to bemcentinib monotherapy in relapsed/refractory (R/R) acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) could be predicted by soluble AXL (plasma sAXL) levels as determined by liquid biopsy (study BGBC003):
• 20 R/R AML and MDS patients who were evaluable for response were analysed for pre-treatment plasma sAXL 
• 12 of 13 patients reporting sAXL levels below pre-defined thresholds at pre-treatment experienced clinical benefit, including 3 Complete Remissions, 3 Partial Remissions. 
• 6 of 7 patients with sAXL above the threshold experienced a best response of progressive disease.
• Bemcentinib in combination with established first-line therapies (KEYTRUDA or MEKINIST (dabrafenib) plus TAFINLAR (trametinib) in unresectable melanoma was well tolerated and showed encouraging tumour responses:
• 15 of 19 evaluable patients showed evidence of tumour shrinkage and to date there were 2 CRs, 8 PRs and a further 6 patients with a best overall response of stable disease.
• Blood-based biomarker candidates were identified.
• Bemcentinib in combination with targeted therapy TARCEVA® (erlotinib) or docetaxel chemotherapy (trials BGBC004 and BGBIL005, respectively) continue to show promising activity in heavily pre-treated patients:
• Part C of the BGBC004 trial of bemcentinib in combination with EGFR targeted therapy introduces bemcentinib in a first-line setting in patients who have achieved their optimum benefit from TARCEVA monotherapy. 5 of 6 evaluable patients showed evidence of tumour shrinkage including 1 PR and 1 mixed response. In parts A and B, patients who achieved an objective response continue on treatment. 
• 3 of 7 (43%) evaluable patients in a trial combining bemcentinib and docetaxel (BGBIL005) achieved durable PRs in a disease setting where the response rate to docetaxel monotherapy is expected to be 10-20%.
• BerGenBio continues to develop a Bemcentinib companion diagnostic
• A standardised AXL immunohistochemistry (IHC) assay, has reported strong correlation with tumour response to bemcentinib treatment.
• Blood-based biomarkers continue to report correlation with tumour response to bemcentinib treatment with particularly encouraging results in R/R AML and MDS.

Richard Godfrey, BerGenBio CEO, commented: "We are excited to present these very encouraging interim results from our broad Phase II clinical development programme in a variety of tumour types with a significant unmet medical need. These results continue to support our view that bemcentinib could become a cornerstone of future cancer therapy. This data provides further evidence of bemcentinib's activity in patients whose cancer progression is mediated by AXL. In addition, we are making good progress with our studies to identify predictive biomarkers that we anticipate may be developed as companion diagnostics for personalized therapy. We look forward to advancing these studies to completion and defining the future development strategy of bemcentinib with the greatest value for patients."

Abstracts to be presented at ASCO

Monday 4 June, 8:00 AM - 11:30 AM Central Daylight Time

• Interim data from BGBC008 – Poster Board: #292, Abstract 3078 
• Interim data from BGBC003 – Poster Board: #80, Abstract 7020
• To be discussed at the Poster Discussion Session. 11:30 AM - 12:45 PM
• Biomarker study –  Poster Board: #385, Abstract 2559

Monday 4 June, 1:15 PM – 4:45 PM CDT

• Interim data from BGBIL006 – Poster Board: #375, Abstract 9548

The posters presented at ASCO will be made available www.bergenbio.com in the Investors / Presentations section following the sessions.

Conference call

A conference call to discuss the presentations from the reception and those to be presented at ASCO will take place on Monday 4 June 2018 at 08:30 AM CEST. Details of the call are available in the Investors section of the BerGenBio website (www.bergenbio.com). A recording of the call will be available shortly after the event at the same place. A presentation will be available at www.bergenbio.com in the section: Investors/Reports and presentations from 8:00 am CEST the same day.

 About BerGenBio ASA 

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. The Company is a world leader in understanding the essential role of AXL kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive solid and haematological cancers.

BerGenBio's lead product, bemcentinib (BGB324), is a selective, potent and orally bio-available small molecule AXL inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated during 2018. It is the only selective AXL inhibitor in clinical development.

The Company sponsored clinical trials are:

• Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
• Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
• Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
• Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization strategy.

The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.

For further information, please visit: www.bergenbio.com 

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.

Contacts 

Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

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

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

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

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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