BERGENBIO ANNOUNCES UPDATE FROM INVESTIGATIONAL PHASE II TRIALS ASSESSING BEMCENTINIB IN HOSPITALISED COVID-19 PATIENTS

 

· Day 29 follow-up of last patient enrolled has now occurred in BGBC020 and
ACCORD2_002
  · Data receipt is ongoing and evaluation of efficacy data is underway
  · Exploratory analyses are looking to define subsets of patients with baseline
markers indicative of increased disease severity with the potential for greater
benefit
  · Bemcentinib was well tolerated throughout both studies, in the ACCORD2 study
there was a numerically lower number of deaths up to day 29 in the bemcentinib
arm (1 of 28 with bemcentinib + standard of care vs 5 of 32 in patients treated
with standard of care alone): in BGBC020 it was 2 vs 3 respectively
  · More detailed top line data expected to report in May

Bergen, Norway, 19[th] April 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, provides an update from the Phase II clinical study
evaluating the efficacy and safety of bemcentinib in hospitalised COVID-19
patients (BGBC020).

The BGBC020 BerGenBio-sponsored trial completed 96% of its targeted enrolment
with a total of 115 patients participating (60 in India and 55 in South Africa,
with 58 receiving bemcentinib). In addition, the Investigator sponsored study
ACCORD2-002 study stopped recruitment at 50% of the original recruitment target
due to a reduction in UK COVID-19 case incidence, and to permit a prompt
analysis. Both trials were undertaken with the same study design and clinical
endpoints. As such data from the two studies will be analysed separately and in
combination in a meta-analysis to inform next steps for this potential new COVID
-19 treatment.

Throughout both studies, bemcentinib was well tolerated by patients and no
safety signals of concern were reported. At day 29, there was a numerically
lower number of deaths reported in the bemcentinib arm of both studies: In
ACCORD2, 1 death in 28 patients treated with bemcentinib and SoC versus 5 in 32
patients treated with SoC alone, and 2 vs 3 in BGBC020.

BGBC020 is an investigational phase II study, which enrolled adult patients
within a day of admission to hospital with COVID-19, who were not intubated and
ventilated (grades 3-5 of the 9-point WHO ordinal scale for clinical
improvement[1]). Patients were randomised to receive standard of care or
bemcentinib plus standard of care. 81% of the COVID-19 patients were assessed as
grade 4 within 24 hours of admission to hospital (requiring oxygen but not
ventilatory assistance) according to the WHO ordinal scale: 75% of patients
received steroids as part of their standard of care and 50% received remdesivir,
this was evenly distributed between the two arms across both studies.

A thorough analysis of the entire patient population and subsets of the
population will be undertaken on both the primary and key secondary endpoints.
The primary endpoint of the trial is time to clinical improvement of at least
two points (from randomisation) on the 9-point WHO ordinal scale, or live
discharge from the hospital, whichever comes first. A preliminary analysis shows
the primary endpoint is numerically in bemcentinib's favour, although in this
small study, in a diverse population and demographic, it did not reach the pre
-defined statistical threshold of p<0.05. Key secondary endpoints include
avoidance of worsening of the WHO scale throughout hospitalisation up to day 29,
duration for which patients required oxygen, and changes over time in levels of
virus detected in different body fluids.

More detailed top line data expected to report in May and will be followed by
preparation for presentation at a scientific conference and publication in a
peer-review journal.

Professor Tom Wilkinson, MA Cantab MBBS PhD FRCP FERS, Professor of Respiratory
Medicine and Chief Investigator on the ACCORD programme commented: "The COVID-19
pandemic persists as the most serious global health crisis we currently face and
there is still an urgent need for safe, convenient and more effective treatment
for a broad spectrum of patients. The novel mechanism of action of bemcentinib
is independent of the SARS-CoV-2 spike protein and thus would be expected to
retain its effect with the emergence of new, potentially vaccine-resistant,
strains of the virus. The drug has a good safety profile and holds potential
promise at this vital time."Richard Godfrey, Chief Executive Officer of
BerGenBio, commented: "Our phase II studies have been completed in three
distinct geographies, with differing demographics and ethnicities and evolving
standards of care. Bemcentinib has shown to be generally safe and well-tolerated
in hospitalised COVID-19 patients. We look forward to receiving further data and
continuing our analysis of the patient populations and datasets, and
subsequently discussing these results with the market, regulators, industry and
Government partners and KOLs to determine next steps."

[1) ]WHO R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis:
available at https://www.who.int/blueprint/priority-diseases/key-action/COVID
-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf: Accessed
18 April, 2021



-Ends-

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated in infected organs with an
activation of the signalling pathway leading to suppression of the Type 1
Interferon immune response by infected cells and neighbouring cells, in their
environment. Pre-clinical research studies demonstrate that bemcentinib inhibits
SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body's immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
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.

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 clinical development
programme focused on combination and single agent therapy in cancer, leukaemia
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 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

Contacts

Richard Godfrey CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com


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.
 

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