BerGenBio

Earnings Release • Jun 25, 2020

BERGENBIO ANNOUNCES POSITIVE interim CLINICAL AND TRANSlaTIONAL DATA from Phase II trial of BEMCENTINIB IN COMBINATION WITH KEYTRUDA[®] IN checkpoint inhibitor refractory NSCLC PATIENTS

BERGENBIO ANNOUNCES POSITIVE interim CLINICAL AND TRANSlaTIONAL DATA from Phase II trial of BEMCENTINIB IN COMBINATION WITH KEYTRUDA[®] IN checkpoint inhibitor refractory NSCLC PATIENTS

· 6 of 7 checkpoint inhibitor refractory cAXL-positive patients report clinical

benefit

· 12 evaluable patients for cAXL status, 7 of whom were cAXL-positive

· 2.5 fold improvement in mPFS in cAXL-positive patients

· Cohort A data-update mOS in cAXL-positive patients of 17.3 months.

· Data presented today at the virtual Next Gen Immuno-Oncology Congress

Bergen, Norway, 25 June 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, announces positive clinical and translational data

from Cohort B, stage 1 of in the phase II trial (BGBC008). This cohort of the

trial is evaluating bemcentinib in combination with MSD's Keytruda[®]

(pembrolizumab) in previously treated non-small cell lung cancer (NSCLC)

patients with confirmed progression on prior immune checkpoint therapy. The

trial is recruiting the second stage of the cohort.

The data was presented today by Professor Hani Gabra M.D. Ph.D., Chief Medical

Officer of BerGenBio ASA, at the Next Gen Immuno-Oncology Congress, a virtual

event, see: https://events.marketsandmarkets.com/3rd-annual-marketsandmarkets

-next-gen-immuno-oncology-congress/#. The presentation will be available on the

Company website in the Presentations section

www.bergenbio.com/investors/presentations/ (https://eur03.safelinks.protection.ou

tlook.com/?url=https%3A%2F%2Fpublish.ne.cision.com%2Fl%2Fxgugwcmde%2Fwww.bergenbi

o.com%2Finvestors%2Fpresentations&data=02%7C01%7Crichard.godfrey%40bergenbio.com%

7C9caa094fb45f490e09af08d810e8fb07%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C6

37277941173214848&sdata=WMouygSjk3jE%2FYKGATQDeQYTIx4Exbgp1%2BtNTFi0qHk%3D&reserv

ed=0)

BerGenBio announced on 15th January 2020 that stage 1 of this trial cohort had

met its primary end point of overall response rate and criteria were met for

expansion of this cohort to a second stage.

The Company reports that Cohort B, stage 1 included 12 evaluable patients for

cAXL, BerGenBio's proprietary composite-AXL (cAXL) immunohistochemistry

biomarker. Seven of these 12 patients were scored cAXL positive, six of these

seven patients reported clinical benefit, including1 PR and 1 PRi (unconfirmed)

and 2.5 fold improvement in mPFS. Further, an update was presented for Overall

Survival data from cohort A, where cAX-postive patients reported 12-month OS of

79% and mOS of 17.3 months (data still maturing), whereas cAXL-negative 60% and

12.4months respectively and in-line with historic controls.

The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is conducted in

three cohorts evaluating the safety and benefit of bemcentinib and Keytruda

combination in refractory NSCLC patients. Cohort A (fully recruited, patients

that are refractory to first line chemotherapy), Cohort B (enrolling second line

patients who have received single agent checkpoint inhibitor in the first line)

and Cohort C (that enrols second line patients refractory to the first line

treatment of checkpoint inhibitor in combination with chemotherapy), cohorts B2

and C are actively recruiting patients. The study is being sponsored by

BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc.,

Kenilworth, New Jersey, USA, who continue to supply Keytruda[®] for use in the

study under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: "This interim

clinical and translational data adds further confidence to the potential patient

benefit of selective AXL inhibition with bemcentinib, to reverse resistance to

immune checkpoint inhibitors in selected cAXL-positive patients who have

relapsed on immunotherapy.  This would be a highly desirable alternative to the

second-line chemotherapy standard-of-care. Top line data from expansion cohorts

B2 and cohort C should be available towards the end of 2020."

- END -

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 expression defines a very poor prognosis

subgroup in most cancers. 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,

leukaemia and COVID19. 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 identify 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). For more

information, visit www.bergenbio.com

Contacts

Richard Godfrey CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+47 995 13 891

Forward looking statements

This announcement may contain forward-looking statements, which as such are not

historical facts, but are based upon various assumptions, many of which are

based, in turn, upon further assumptions. These assumptions are inherently

subject to significant known and unknown risks, uncertainties and other

important factors. Such risks, uncertainties, contingencies and other important

factors could cause actual events to differ materially from the expectations

expressed or implied in this announcement by such forward-looking statements.

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

-12 of the Norwegian Securities Trading Act.