BerGenBio

Regulatory Filings • Apr 3, 2017

BerGenBio's first-in-class Axl inhibitor, BGB324, featured in two immuno-oncology presentations at AACR Annual Meeting

BerGenBio's first-in-class Axl inhibitor, BGB324, featured in two immuno-oncology presentations at AACR Annual Meeting

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Bergen, Norway, 3 April 2017 8am (CET): BerGenBio ASA, a clinical-stage biopharmaceutical

company developing novel, selective Axl kinase inhibitors for multiple cancer indications reported

study data on its first-in-class Axl inhibitor, BGB324 in preclinical models of lung and breast

cancer in a poster presentation at the American Association for Cancer Research (AACR) Annual

Meeting 2017 in Washington, DC. The study data confirmed Axl to be a key factor in tumor

resistance to the emerging class of cancer immunotherapies referred to as immune checkpoint

inhibitors (CPIs); these results provide further evidence supporting Axl inhibition as a mechanism

that can be targeted through combination therapy with BGB324. Furthermore, the data showed

that treatment with BGB324 led to enhanced activation of the anti-tumor immune response.

In a breast tumor model, treatment with the CPIs anti-CTLA4/PD1 increased Axl expression, which

correlated with a lack of response to these CPIs. Adding BGB324 to anti-CTLA4/PD1 led to

durable primary tumor clearance compared to treatment with CPIs. In the lung cancer model,

BGB324 in combination with anti-PD1/PDL1 CPIs significantly inhibited tumor growth compared to

treatment with anti-PD1/PDL1 alone.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"Inhibiting AXL with BGB324 potentiates the body's innate response and counteracts tumor

resistance to immune checkpoint inhibitors. This preclinical data is very encouraging and suggests

an enormous potential for BGB324's clinical utility in combination with immune checkpoint

inhibitors. We recently announced a clinical collaboration with MSD, where BerGenBio will sponsor

two Phase II trials with BGB324 in combination with KEYTRUDA, in adenocarcinoma of the lung

and triple negative breast cancer. The decision to sponsor these exciting combination clinical

trials was informed by the data presented today."

The details of the poster presentations are as follows:

BGB324, a selective small molecule inhibitor of receptor tyrosine kinase Axl, abrogates tumor

intrinsic and microenvironmental immune suppression and enhances immune checkpoint inhibitor

efficacy in lung and mammary adenocarcinoma models

- Session: PO.IM02.01 T-cell Immunity to Cancer: New Progress

- Poster presentation 626 / poster board 30

- Sunday, 2 April 2017 1:00 PM - 5:00 PM (ET), Convention Center, Halls A-C, Poster Section

26

A second poster describing a recently opened investigator-led Phase II randomized clinical study

with BGB324 in combination with dabrafenib/trametinib or pembrolizumab in melanoma patients

will be presented by the principle investigator Dr. Oddbjørn Straume, consultant oncologist at

Haukeland University Hospital and Professor at the University of Bergen Center for Cancer

Biomarkers. In parallel to this study, an extensive biomarker discovery and validation programme

will be executed.

A Phase Ib/II randomised open label study of BGB324 in combination with pembrolizumab or

dabrafenib/trametinib compared to pembrolizumab or dabrafenib/trametinib alone, in patients with

advanced non-resectable (Stage IIIc) or metastatic (Stage IV) melanoma

- Session: PO.CT02 Phase III Clinical Trials and Phase II/III Clinical Trials in Progress

- Poster presentation CT056 / poster board 6

- Monday, 3 April 2017 1:00 PM - 5:00 PM (ET), Convention Center, Halls A-C, Poster Section

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About BerGenBio

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 hematological 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 four 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., and marketed by

Roche / Genentech Corp.

-Ends-

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

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