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BerGenBio

Regulatory Filings Nov 7, 2019

3555_rns_2019-11-07_408ab5cb-4401-4565-a80e-8c2c295fa2ec.pdf

Regulatory Filings

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BerGenBio to present clinical data from Phase II combination trial of bemcentinib and LDAC trial in elderly AML patients at ASH 2019

Bergen, Norway, 7 November 2019 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is pleased to announce it has been accepted for a poster presentation at the 61st Annual American Society of Hematology (ASH) Meeting, which takes place from 7-10 December 2019 in Orlando, Florida.

The poster will provide an update on its phase II study of bemcentinib (BGB324) in combination with Low-dose Cytarabine in elderly AML patients.

Abstract titles have been announced online. Details of the presentation are below.

Title: Durable responses observed in elderly AML patients unfit for intensive chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC: Phase II open-label study

Date: Monday 9th December 2019

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Time, Location: 6:00 PM - 8:00 PM, Orange County Convention Center, Hall B

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About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body's immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

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, 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 and leukaemia. A first-in-class functional blocking AXL antibody (BGB149) and an AXL-ADC (ADCT-601) are undergoing phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify those patient populations

most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting 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

Contacts

Richard Godfrey CEO, BerGenBio ASA +47 917 86 304

Rune Skeie, CFO, BerGenBio ASA [email protected] +47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Carina Jurs, Consilium Strategic Communications [email protected] +44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers [email protected] +47 995 13 891

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