BerGenBio’s selective first-in-class Axl inhibitor, BGB324, Featured in a Poster Presentation at ASCO Annual Meeting 2017

06.06.2017

Bergen, Norway, June 6 2017 – BerGenBio ASA, a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications, reported encouraging clinical and in vitro data with its lead, first-in-class Axl inhibitor, BGB324 in patients with high-risk Myeloid Dysplastic Syndrome (MDS) in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in Chicago, IL.

The clinical data presented at ASCO showed that BGB324 could be a promising novel treatment for patients with MDS. One patient treated with BGB324 experienced a partial response and remained on treatment for more than 18 months. BGB324 was well-tolerated and at the time of data cut off for the poster the maximum tolerated dose had not yet been reached. The majority of adverse events reported with BGB324 in this patient population were Grade 1 and 2, including diarrhea and fatigue. The clinical data are from the on-going Phase 1b/2 study in patients with AML and high-risk MDS (NCT02488408).

The ASCO poster also includes compelling in vitro data which showed that BGB324 inhibited cell proliferation in both primary bone marrow mononucleated cells (BMMNC) and mesenchymal stroma cells (MSC) isolated from low- and high-risk MDS patients while the BMMNC and MSC from healthy donors were resistant to BGB324 suggesting a significant therapeutic index.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “These clinical and in vitro data are very encouraging and suggest that BGB324 could become an important new treatment for patients with MDS, a disease where there is a pressing need for improved therapies as there have been no new licensed therapies for more than a decade. These data also support our belief that inhibiting Axl kinase in combination with standard-of-care treatment or novel immunotherapies can provide better treatment outcomes across a broad range of cancers.”

The details of the poster presentation are as follows:

Blockade of Axl with the small molecule inhibitor BGB324 shows activity in vitro and in patients with high-risk MDS.

◦ Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
◦ Abstract number: 7059
◦ Monday Jun 5, 2017 8:00 AM – 11:30 AM (CT)

Further details can be found at http://abstracts.asco.org/.

About MDS
MDS refers to a range of conditions that can occur when the blood-forming cells in the bone marrow are damaged, interfering with the making of new blood cells. In about one-third of patients, MDS can progress into AML. Treatment typically consists of supportive therapy and may include bone marrow stimulation, hypomethylating agents and bone marrow transplantation. Existing therapies are particularly inadequate in patients with high risk MDS, who have a median survival of only five months following hypomethylating treatment.

About BerGenBio ASA
BerGenBio (Bergen, Norway) is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the central role of Axl kinase in promoting cancer spread, immune evasion and drug resistance in multiple aggressive haematological and solid cancers.

BerGenBio’s lead product, BGB324, is a selective, potent and orally bio-available small molecule Axl inhibitor in Phase II clinical development in three major cancer indications. It is the only selective Axl inhibitor in clinical development. BGB324 is being developed by BerGenBio as a single agent therapy in acute myeloid leukaemia (AML)/myeloid dysplastic syndrome (MDS) and in combination with TARCEVA® (erlotinib) in advanced non-small-cell lung cancer (NSCLC); and in combination with KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple negative breast cancer (TNBC) in collaboration with Merck & Co. Inc. (MSD).

The Company is also developing a diversified pre-clinical pipeline of selective Axl inhibitors including BGB149, 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. TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech.

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Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304

David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedr.co.uk

+44 207 638 9571

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