Developing first-in-class drugs to treat aggressive cancer - Norne Securities - Vestlandsbørsen Rune Skeie - CFO - BerGenBio
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Developing first-in-class drugs
to treat aggressive cancer
4th June 2018
Norne Securities – Vestlandsbørsen
Rune Skeie - CFO
1
Disclaimer
Certain statements contained in this presentation constitute forward-looking statements. Forward-looking statements are statements that
are not historical facts and they can be identified by the use of forward-looking terminology, including the words "anticipate", "believe",
"intend", "estimate", "expect", "will", "may", "should" and words of similar meaning. By their nature, forward-looking statements involve a
number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or
implied by the forward-looking statements. Accordingly, no assurance is given that such forward-looking statements will prove to have
been correct. They speak only as at the date of the presentation and no representation or warranty, expressed or implied, is made by
BerGenBio ASA or its affiliates ("BerGenBio"), or by any of their respective members, directors, officers or employees that any of these
forward-looking statements or forecasts will come to pass or that any forecast result will be achieved and you are cautioned not to place
any undue influence on any forward-looking statement. BerGenBio is making no representation or warranty, expressed or implied, as to
the accuracy, reliability or completeness of this presentation, and neither BerGenBio nor any of its directors, officers or employees will
have any liability to you or any other person resulting from the use of this presentation.
Copyright of all published material, including photographs, drawings and images in this presentation remain with BerGenBio and relevant
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written permission, and only with appropriate acknowledgements.
2
3
Where does Biotech fit into the food chain?
A Patients
Specialty
Pharma u
t
h Payers
Academia Big o
Biotech r
Pharma
i Hospitals
Hospitals
t
CROs i
Generics e Retail
s
KTLs
4
The drug development value chain
Launch &
Pre-clinical Submission
Discovery Phase I Phase II Phase III Post market
development & approval
surveillance
• Long-term
• Target • Safety and • First in man • Small scale • Large scale • Market
safety
identification & toxicity safety studies patient studies pivotal approval
• Marketing
validation • Initial • Healthy • Efficacy & patients
• Life cycle
• Compound formulation volunteers activity in • Efficacy & side
management
design and • PK/PD • PK/PD disease effects
screening setting • Benefit/risk
• Lead • Optimal ratio
optimization dosage
5
Global cancer burden
• In 2018, cancer accounts for about one in seven deaths worldwide and by 20301
• the American Cancer Society expects the global cancer burden to grow to 22 million new cases
per year with 13 million cancer deaths due to growth and aging of the population1
• The global oncology market reached USD 121 billion in 2017 and is expected to grow with a
compound aggregate growth rate (“CAGR”) of 7.4% to reach USD 173 billion by 20221
• Immunotherapy is one of the fastest growing areas within oncology R&D2
1. QuintilesIMS 2. Citi Research
6Immuno-oncology market development
“ The cost of oncology drugs will exceed $150 billion by
2020 (…) especially immunotherapies – will drive
much of this growth
- IMS Institute, Global Oncology Trend Report
”
Sales within the CPI drug category alone are forecasted to
increase significantly over the ten-year period from 2014 to 2024
(aggregated figures for the seven major markets US, France,
Germany, Italy, Spain, the UK and Japan):
7Combination treatments are driving clinical benefit &
commercial opportunity
Multiple examples of potentially high value partnerships; Expected new combination regimen launches
trend particularly prominent within immune-oncology
"Combination treatments are becoming the treatment of
choice"
40 Expected combination regimen
launches in oncology 34
30
19
20
15
13
10 8 7 7
4
0
2014 2015 2016 2017 2018 2019 2020 2021+
“After 2018, combos targeting solid
“Breast and haematology combos will predominate tumours, especially lung cancer and
in the early years” melanoma, will increase
dramatically”
üGrowth expected in indications targeted by BerGenBio
8 Source: IMS Institute – Developments in Cancer Treatments, Market Dynamics, Patient Access and Value; Business Insights - The Cancer Market Outlook to 2016,
Pfizer, AstraZeneca, ChemistryWorld, BioPharma-ReporterCorporate Snapshot
Background Bemcentinib (BGB324) Pipeline
Leaders in developing selective AXL First-in-class highly selective oral Bemcentinib (BGB324)
inhibitors: innovative drugs for AXL inhibitor AXL antibody
aggressive diseases, including immune Broad phase II clinical programme in
evasive, drug resistant and metastatic AXL ADC (partnered)
NSCLC, TNBC, AML/MDS, melanoma
cancers Immunomodulatory small molecules
Diversified pipeline, lead drug is
tested in several indications of high
unmet medical need and large market
potential OSE:BGBIO Corporate
Cash runway through to 2020 35 staff
Promising efficacy with sustained
treatment benefit and confirmed Included in the OSEBX index from 1st Headquarters and research
favourable safety June 2018 in Bergen, Norway; Clinical Trial
+138% year to date share price Management in Oxford, UK
Companion diagnostic increase (30 May)
9Key events in BerGenBio history
2008 - 2010 2011 2012 2013 2014 2015 2016 2017 2018
• UiB Spin- out • NOK 54m • Grant NOK • Phase I • Phase Ib • Grant NOK • Phase II • IPO NOK400m • BGB324 named
equity issue 12m 13m bemcentinib
• Seed funding • NOK 37m • NOK 165m • NOK 212m • Merck
• In license • Preclinical equity issue equity issue • UK office capital raise collaboration • PIPE NOK 187,5m
• Patents filed
BGB324 Oxford
• Wellcome • Grants • Grant NOK • IFU Grant • Included in OSEBX
Trust NOK24m 15m NOK 24m
• Interim data
investment
• Out-License announced at
ADC ASCO
program
• Orphan
designation
Key Partners
Meteva
rev.15.12.2011
Prosjektregnskapsrapport
Rapporter i henhold til Veiledning til prosjektregnskapsrapport, se www.forskningsradet.no/rapportering
AS
Fyll inn tekstfeltene på denne siden. M D Anderson
Denne periode 01.06.2012 - 31.12.2012
Prosjektnummer 219701/O30
Prosjekttittel Targeting Cancer Stem Cells with Axl inhibitors to Treat Advanced Metastatic Cancer
Prosjektansvarlig (institusjon/bedrift) BerGenBio AS
Adresse Jonas Lies vei 91
Postnr og poststed 5009 Bergen Telefon 4791786304
Prosjektansvarlig bankkonto 3624.25.01289
Prosjektleder David Micklem Betaling merkes: BIA 219701
E-post david.micklem@bergenbio.com
Legg inn tall i Kostnadsspesifikasjonen
1. Faktiske kostnader Denne periode
1.1. Personal- og indirekte kostnader kr 3 721 174
1.2. Innkjøp FoU-tjenester (fra norske U&H, institutter) kr 21 812 (Konto 8920)
10 Motpost FoU-tjenester (kun til Forskningsrådets bruk)
1.3. Utstyr kr 47 658
(Konto 8921)
1.4. Andre driftskostnader kr 2 072 412
Totalsum faktiske kostnader 100 % kr 5 863 056AXL and bemcentinib Overview and clinical development 11
AXL’s role in cancer
Gas6
90% of cancer deaths result from tumors spreading,
becoming immune evasive and drug resistant
AXL is a key mediator of these traits in most cancers
AXL
The AXL receptor has an important role in:
• Cancer cell survival
• Drug resistance
• Immune suppression / evasion
• Metastasis
Interest in AXL as a key target for aggressive disease is
increasing rapidly
12Bemcentinib, first in class highly selective AXL inhibitor
Most advanced
selective, orally
bioavailable, small
molecule AXL kinase
inhibitor in phase II
clinical development
Once daily dosing
Well tolerated
Safely combined with chemo,
targeted and IO drugs
13Pipeline of innovative AXL inhibitors
Preclinical Phase I Phase II Phase III
Bemcentinib – AXL kinase inhibitor
Patients:
>350
(1)
2nd line Ph II KEYTRUDA combo previously treated advanced adenocarcinoma of the lung
NSCLC 1st & 2nd line Ph II TARCEVA combo advanced NSCLC with activating mutations of EGFR
Later line Ph I/II docetaxel combo previously treated advanced NSCLC
2nd line (1)
TNBC Ph II KEYTRUDA combo metastatic or locally advanced triple negative breast cancer
metastatic
Sites in Europe
Melanoma 1st & 2nd line
Ph II randomised combo with
KEYTRUDA or TAFINLAR/MEKINIST
newly diagnosed unresectable melanoma and North
Ph II monotherapy and combo with
America:
AML / MDS unfit patients with AML or previously treated MDS
50
1st & 2nd line
low dose chemo
Antibody programmes
BGB149 oncology Anti-Axl mAb
(2)
BGB601 metastatic cancer ADC
Key read-outs:
2018
Discovery Pipeline – small molecule inhibitors
BGB002/
oncology Small molecule
BGB003
Companion Diagnostics Pipeline Biomarker Discovery Biomarker Verification Validation
tissue & blood
BerGenBio sponsored study
(1): Clinical trial collaboration, no preferential rights (2): out licensed Investigator sponsored study
14Clinical Development Strategy
2014 2016 2018 2020 2022
Phase I
Phase II Pivotal studies
Bemcentinib Confirm safety & PK
• 2nd line setting • 1st line setting
Selective oral AXL • Monotherapy Launch
inhibitor
• Multiple indications • Select indication(s)
• Combination
• Multiple combos • Biomarker enriched
Early efficacy
Phase II
BGB149 Phase I
• 2nd line setting
AXL antibody safety & PK
• Multiple indications
Companion Clinical utility Clinical validation
Preclinical
Diagnostics • Clinical PoC • Pt stratification Launch
discovery
Liquid & solid • Analytical validation • Label considerations
15Bemcentinib: Most advanced selective AXL inhibitor
AXL selective –
small molecule
AXL selective –
BGB149
other
Non-selective
IND / Phase I Phase II Phase III Approved
16Partnership with Merck Sharp & Dohme B.V. (MSD):
Clinical trial collaboration bemcentinib + KEYTRUDA
The 24th of November 2016, BerGenBio and MSD entered a collaboration
with BerGenBio as sponsor of two Phase II clinical trials for a combination of
bemcentinib with MSD 's antibody pembrolizumab (Keytruda TM):
• In patients with previously treated advanced adenocarcinoma of the lung
(NSCLC)
• In patients with previously treated, locally advanced and unresectable or
metastatic TNBC or Triple Negative Inflammatory Breast Cancer
Each party has access to all data generated and after study completion
either party can propose a Phase III registration study (or other subsequent
study) for the combination.
Merck has no preferential rights to bemcentinib
17Bemcentinib – Set to become a highly attractive and valuable
asset
Late stage, first-in-class assets will be highly sought after BerGenBio retains full strategic flexibility
Broad clinical
application –
alone and in
combination
AXL inhibition:
Compelling a game- Progress bemcentinib clinical trials
Phase II data changing
mechanism
bemcentinib Clear
Clear Phase III commercial-
strategy Clear go to market opportunities
(2018) isation strategy
First-in-class
Companion
molecule diagnostic First-in-class selective drug with broad
AA/BT/PRIME AXL+ tumours clinical application potentially triggering
status
Convenient interest from bigger pharma
administration,
straight-forward
manufacturing
18 AA: Accelerated approval; BT: Breakthrough designation; PRIME: Priority Medicine status in EUSuccessful IPO, PIPE and broadened shareholder base
Listing on OSE Share facts
Currency NOK
• IPO completed 7 April 2017, (OSE:BGBIO) Market Oslo (NOK)
• Raised NOK 400 million in gross proceeds ISIN code NO0010650013
Ticker code BGBIO
• Private placement completed 13 April 2018
Industry Biotechnology
• Raised NOK 187,5 million in gross proceeds Market Capitalization NOK 2.7 bn
• Adding institutional investors in US specialising in the Number of Shares 54,711,446
biotechnology industry Number of shareholders 2,779
• Included in the OSEBX index from 1 June 2018
• Share price increase 138% YTD (30 May)
19Significant milestones expected in 2018 & 2019
2017 2018 2019
H1 H2 H1 H2
Significant
KEYTRUDA Final
milestones expected
combo NSCLC Phase II Phase II Readout
over the next 12
Initiation pivotal programme
KEYTRUDA
combo TNBC Phase II Phase II
Final
Readout
months:
combo Final
bemcentinib
MELANOMA Phase II Phase II Readout
Bemcentinib
erlotinib
Combo NSCLC Phase II Phase II Phase II
Final
Readout
• Interim clinical data from
6 phase II trials at ASCO
Docetaxel
NSCLC Phase II Phase II Phase II
Final
Readout
• Final readout from 4
phase 2 trials in H2
AML Final
Phase II Phase II Readout
BGB149
BGB149
Phase I
Phase I
complete • Initiation of AXL
antibody BGB149 clinical
Conferences World World
ASCO
AACR
World
Lung
ASH /
SABCS
ASCO
AACR
Lung /
ESMO
ASH
/SABCS
ASCO
AACR
Lung /
ESMO
ASH
/SABCS
trials in H2
Initiation Interim data Clinical data Conference
20 NB: Progression of ongoing and start-up of new clinical trials are subject to customary regulatory reviews and approvalsASCO 2018 - HIGHLIGHTS
AS AS AS
C
C
Jun O po Jun O po C
Jun O po
e4 s
e4 s
8 A ter # 8 A ter # e4 s
8 A ter #
M C 385 M C 292 M C 80,
T ,
T T
Biomarker programme Bemcentinib + KEYTRUDA: NSCLC Bemcentinib monotherapy: AML/MDS
ü AXL IHC: AXL expression shows ü 8 of 15 pts radiographically evaluated to ü chosen for poster discussion: Monday
promising early correlation with patient date had tumour shrinkage, including June 4 11:30 AM
benefit in KEYTRUDA combo study 3PRs
ü Plasma soluble AXL found predictive of
ü Liquid biopsy: Soluble AXL is predictive of ü Correlation with AXL expression: 5 of 6 patient benefit
patient benefit in AML/MDS pts found to be AXL positive, 4 of those
had clinical benefit
AS
C
Jun O po
e4 s
1:1 ter #
5P 3
M C 75,
T
Bemcentinib + EGFR inhibition: NSCLC Bemcentinib + KEYTRUDA & TAF/MEK: Bemcentinib + docetaxel: NSCLC
Melanoma
ü 5 of 6 pts receiving bemcentinib + TARCEVA ü 3 of 7 pts radiographically evaluated to
first line and radiographically evaluated to ü 15 of 19 pts radiographically evaluated to date date showed PRs in a disease setting that
date showed tumour shrinkage incl 1 PR showed tumour shrinkage incl. CRs, 8 PRs normally sees response rates < 10%
and 6 SDs
ü Durable responses and meaningful clinical ü Soluble predictive biomarker candidates
benefit observed in second line both as ü All combos well tolerated identified
monotherapy and in combo with TARCEVA
21Thank you.
For further information please visit www.bergenbio.com
Developing first-in-class drugs to treat
aggressive cancer
22Glossary AA Accelerated approval FDA US Food and Drug Administration ADC Antibody drug conjugate GLP Good Laboratory Practice ALK Alkaline phosphatase IHC Immunohistochemistry AML Acute myeloid leukemia mAb Monoclonal antibody BLA Biologic license application MDS Myeloid dysplastic syndrome BT Breakthrough therapy NDA New drug application CAB Clinical advisory board NSCLC Non-small cell lung cancer CBR Clinical benefit rate pAxl Phosphorylated Axl (activated Axl) CDx Companion diagnostic PD Progressive disease CLIA Clinical Laboratory Improvement Amendments PR Partial response CLL Chronic lymphocytic leukemia RCC Renal carcinoma CPI Checkpoint inhibitor RP2D Recommended Phase II Dose CR Complete response RTK Receptor tyrosine kinase CTL Cytotoxic T-lymphocytes TAM Tyro, Axl, Mer (family of kinases) ECG Electrocardiogram TNBC Triple negative breast cancer EGFR Epidermal growth factor receptor sAxl Soluble Axl ELISA Enzyme-linked immunosorbent assay SD Stable disease EMT Epithelial-to-mesenchymal transition SoC Standard of Care EU5 France, Germany, Italy, Spain, United Kingdom QTcF QT inverval, a measure of time in the heart’s electrical cycle 23
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