BerGenBio

Regulatory Filings • Nov 9, 2021

BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR BEMCENTINIB IN STK11-MUTATED ADVANCED/METASTATIC NON-SMALL LUNG CANCER (NSCLC)

BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR BEMCENTINIB IN STK11-MUTATED ADVANCED/METASTATIC NON-SMALL LUNG CANCER (NSCLC)

Bergen, Norway, 9 November 2021?-BerGenBioASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL inhibitors for severe

unmet medical needs, today announces that the U.S. Food and Drug Administration

(FDA) has granted Fast Track designation for bemcentinib in combination with an

anti-PD-(L)1 agent as treatment for patients with STK11 altered

advanced/metastatic NSCLC patients without actionable mutations.

Fast Track designation is intended to facilitate the development and review of

drugs used to treat serious conditions and to fill an unmet medical need. It

will enable BerGenBio to have more frequent interactions with the FDA throughout

the drug development process so that an approved product can potentially reach

the market faster.

In a separate release today 9 November 2021, BerGenBio announced that in pre

-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1

blockade was evaluated in the absence and presence of bemcentinib. Systemic

inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated

T cells and restored therapeutic response to anti-PD-1 check point inhibition.

Further, data from BerGenBio's Phase II bemcentinib and pembrolizumab

combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable

patients with identified STK11/LKB1 mutations demonstrated objective clinical

response / clinical benefit to the combination of AXL inhibitor bemcentinib and

pembrolizumab.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are very

pleased to receive Fast Track designation from the FDA for the second time this

year and look forward to continuing to explore bemcentinib's potential as a

treatment option for NSCLC patients. It has been reported that patients

habouring STK11 mutations represents up to 20% of the total NSCLC patient

population, representing a large, identifiable subgroup of patients who may

benefit from treatment with an AXL inhibitor such as bemcentinib."

-Ends-

AboutBerGenBioASA

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 a

potential companion diagnostic test to 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.

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

About FDA Fast Track

Fast Track designation is intended to facilitate the development and review of

drugs used to treat serious conditions and to fill an unmet medical need. The

designation provides Eligibility forAccelerated Approval, enabling approval

based on a surrogate clinical endpoint;Priority Review, which allows New Drug

Application (NDA) review in six months instead of 10,and eligibility for Rolling

Review, whereby the Company will be able to submit completed sections of its NDA

for review by the FDA before the complete application is submitted.

Contacts

Martin Olin, CEO,BerGenBioASA

ir@bergenbio.com

RuneSkeie, CFO,BerGenBioASA

rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

ConsiliumStrategic Communications

bergenbio@consilium-comms.com

+44 20 3709 5700

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 considered to be inside information pursuant to the EU

Market Abuse Regulation and is subject to the disclosure requirements pursuant

to section 5-12 of the Norwegian Securities Trading Act.