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BerGenBio

Earnings Release Dec 13, 2021

3555_rns_2021-12-13_e3011d18-4be4-4fc6-becc-a9e41e6d2afd.html

Earnings Release

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BERGENBIO PRESENTS UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING

BERGENBIO PRESENTS UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING

Bergen, Norway, 13 December 2021- BerGenBio ASA (OSE:BGBIO), BerGenBio ASA (OSE:

BGBIO), a clinical-stage biopharmaceutical company developing novel, selective

AXL kinase inhibitors for severe unmet medical needs, is pleased to announce

that it is presenting updated data from the Company's Phase II study of

bemcentinib (BCBC003) in a poster presentation today at the 63rd Annual American

Society of Hematology (ASH) Meeting.

Professor Sonja Loges will provide an update from the Company's Phase II study

(BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in

older, relapsed and refractory AML patients unfit for intensive chemotherapy.

The data presented indicate that bemcentinib in combination with LDAC is well

tolerated and offers meaningful clinical benefits. Translational research has

identified immune-based activity associated with response to treatment,

demonstrating that bemcentinib elicits activation of CD8+ T cells and B

cells/plasma cells, two major adaptive immune cell populations responsible for

anti-AML immune responses. Survival data measured as median Overall Survival

(mOS) in older unfit relapsed AML patients looks encouraging compared to

historical controls all through not yet matured.

Professor Sonja Loges, Chief Investigator of the BGBC003 trial commented: "The

data on relapsed AML patients who currently have very few treatment options, is

very encouraging. These results affirm our belief that the combination of

bemcentinib and LDAC provides meaningful clinical benefits."

Details of the presentation:

Title: Bemcentinib (Oral AXL Inhibitor) in combination with Low-dose Cytarabine

Is Well Tolerated and Efficacious in Older Relapsed AML Patients. Updates from

the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results

indicating Bemcentinib elicits anti-AML immune responses.

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding

Transplantation and Cellular Immunotherapies: Poster III

Time, Location: 6.00 - 8.00 PM Eastern, Georgia World Congress Center, Hall B5

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

Consilium Strategic Communications

[email protected]

+44 20 3709 5700

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 clinical development

programme focused on combination and single agent therapy in cancer and COVID

-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is

undergoing phase I clinical testing. In parallel, BerGenBio is developing

companion diagnostic tests to potentially identify patient populations most

likely to benefit from AXL inhibition. This is expected to facilitate more

efficient registration trials supporting a precision medicine-based

commercialisation strategy.

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.

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