landscape of innovation - clearvie€¦ · within the nucleic acid therapy space, ex vivo therapies...
TRANSCRIPT
Landscape of Innovation
Drivers of Value for Innovators
June 3, 2019
2 Introduction
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5
Key Questions for Discussion – Trends in Innovation
VC Pipeline Trends
Which innovative therapeutic classes and modalities
attracted VC funding in 2018? 1
What therapeutic classes stand out as notable areas for
discussion? 2
6
Our analysis looked at the portfolio strategies across 30 companies with the
largest venture raises in 2018 to assess the landscape of innovation.
Source: ClearView Analysis.
VC Pipeline Trends
Top Venture Raises of 2018
Top 15 U.S. Venture Raises Top 15 Ex-U.S. Venture Raises
Pipeline analyses were conducted for the companies above to identify promising, innovative
therapeutic classes that have attracted venture capital funding over the last year
7
The top VC-funded company pipeline is relatively similar in distribution to
the industry pipeline, though a disproportionate focus on oncology exists.
Source: Global Data; ClearView Analysis. 1 Reported as a proportion of total drugs being explored in the Top 10; includes programs designated as discovery, preclinical, P1, P2, P3, and Pre-registration (N=27,661); does not
account for drugs being explored in multiple therapeutic areas.
VC Pipeline Trends
56%
7% 7% 5% 4% 4% 4% 3% 2% 2%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
VC Pipeline Industry Pipeline
Top TAs in VC Development Pipeline Top TAs in Industry Drug Development1
32%
16% 16%
8% 8% 6% 5% 4% 3% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
The pipeline for top VC-funded
companies is concentrated
heavily in oncology
Outside of oncology, both the VC-
funded and broad industry
pipelines focus in on infectious
diseases and CNS indications
% o
f P
rog
ram
s
% o
f P
rog
ram
s
8
Venture capital funding in the past year reflects an increasing trend of large
raises directed towards the development of platform technologies.
Source: Global Data; ClearView Analysis. 1 Top 30 VC companies classified based on where majority of pipeline lies (e.g., in small molecules, antibody technologies); 2 Includes assets with undisclosed mechanisms of action.
VC Pipeline Trends
Therapeutic Classes in the VC Development Pipeline
Therapeutic Class % of Pipeline Assets
Recombinant & Fusion Proteins ~4%
Polysaccharides ~2%
Other Therapeutic Classes2 ~16%
Antibody Technology ~24%
Nucleic Acid Technologies (Including Cell and Gene Therapy)
~34%
Small Molecules ~20%
% of Companies1
~30%
~18%
~34%
~3%
~3%
~12%
9
$400 $260
$100
$125
$610
$102
$321
$117 $133
$675
$740
$242
$150
$100
$500
$437
$494
$434
$0
$200
$400
$600
$800
$1,000
$1,200
$1,400
$1,600
$1,800
$2,000
Series A Series B Series C Series D Series E Series F Series G
This focus on disruptive technologies is reflected by the significant growth
in early investments in nascent technologies.
Source: Global Data; ClearView Analysis. 1 Denotes latest development stage in global, U.S., or EU trials.
VC Pipeline Trends
To
tal S
eri
es
Fu
nd
ing
Le
ve
l ($
B)
Funding Rounds by Companies’ Latest Development Stage1
Investment from the top 30
VC raises of 2018 has been
concentrated in early funding
rounds, increasingly so with
large Series A rounds
Discovery Preclinical P1 P2 P3
10
To create value, innovators must differentiate their technologies across
diverse applications while ensuring operational focus and fiscal discipline.
Source: ClearView Analysis.
VC Pipeline Trends
For innovator companies, how do you balance pursuit of a
breadth of potential applications against focused advancement
of a single lead program?
How does the path to value creation differ for innovator
companies focused on a platform technology versus a clearly
defined lead asset?
For investors, what are the greatest value-driving activities that
innovator companies can pursue? What value inflection points
do you consider critical to providing funding?
How have current markets affected your collective approaches
to (seeking) investment? How does the flow of global capital,
and the rise of global innovators, affect your approach?
11
Trends by Therapeutic Class
Nucleic Acid Technology
What have been the key trends in pharmaceutical
development and innovation in 2018? 1
What therapeutic classes stand out as notable areas for
discussion? 2
12
Companies with significant venture capital funding in the past year possess
pipelines that focus heavily on nucleic acid technology and novel antibodies.
Source: Global Data; ClearView Analysis. ADC: Antibody Drug Conjugate.
VC Pipeline Trends
Nucleic Acid Technologies (Including Cell and Gene Therapy)
Antibody Technologies
Small
Molecules Nucleic Acid
Technology
Antibody
Tech
Fusion
Proteins Other
VC Development Pipeline Therapeutic Classes of Interest
Various nucleic acid
modalities are being
explored to address
indications spanning a
broad array of TAs
Bispecific antibodies
comprise ~10% of the
broader antibody
technology pipeline
Ex vivo
In vivo
Non-DNA
Monoclonal Ab
ADC
Bispecific
Poly.
13
Trends by Therapeutic Class – Nucleic Acid Technology
Nucleic Acid Technology
What have been the key trends in pharmaceutical
development and innovation in 2018? 1
What therapeutic classes stand out as notable areas for
discussion? 2
Nucleic Acid
Technologies
Novel Antibody
Technologies
14
Nucleic acid technologies encompass a variety of therapeutic modalities,
spanning ex vivo and in vivo gene therapies, as well as non-DNA therapies.
Source: ClearView Analysis. ASO: Antisense Oligonucleotide. CAR-NK: Chimeric Antigen Receptor – Natural Killer Cell; CAR-T: Chimeric Antigen Receptor – T cell.
Nucleic Acid Technology
Nucleic Acid Technologies
Example Agents Example Agents Example Agents
• Ex vivo therapies are
produced by transfecting
host cells in vitro and re-
introducing modified cells
• Novel editing techniques
(e.g., ZFN, CRISPR) are
increasingly being used in
addition to viral vectors
• In vivo approaches include
extra-chromosomal
therapies employing viral
vectors (e.g., AAV) and
therapies that perform
genome editing within the
body
• RNA-based therapies are
used to modify translation
in various ways
• ASOs / RNAi inhibit gene
expression, while mRNA
therapy uses translation of
delivered mRNA to confer
therapeutic benefit
Ex Vivo Gene Therapies 1 In Vivo Gene Therapies 2 Non-DNA Nucleotide
Therapies 3
Extra-chromosomal
Gene Therapy
In Vivo Genome
Editing
Antisense
Oligonucleotides (ASO)
mRNA Therapy
Adoptive Cell
Therapy
Ex vivo Stem Cell
Therapy
RNAi
15
Within the nucleic acid therapy space, ex vivo therapies are relatively more
mature as a class, with a greater proportion of clinical stage programs.
Source: Global Data; ClearView Analysis. 1 Distribution of industry-wide pipeline by development phase. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
0
10
20
30
40
50
60
70
80
90
100
10%
Preclinical Discovery Phase 3 Phase 1
29%
Phase 2
13%
20%
57%
36%
15%
54%
26%
45%
11%
26%
16%
8%
14%
2% 2%
7%
0%
7%
Nucleic Acid Therapy Pipeline Distribution by Development Phase
Pro
po
rtio
n o
f C
las
s P
ipe
lin
e (
%)
Agents in each nucleic acid
therapeutic class have
successfully been approved in
the past few years (e.g., Kymriah,
Luxturna, Spinraza)
The non-DNA nucleic acid therapy pipeline
(e.g., antisense, RNAi) is relatively more
nascent, and primarily concentrated in
discovery and preclinical stages
Ex Vivo In Vivo Non-DNA Industry (Index)1
16
The ex vivo gene therapy pipeline is concentrated heavily in oncology, where
approved CAR-Ts have validated the therapeutic class.
Source: Global Data; ClearView Analysis. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
Top 10 TAs in the Ex Vivo Gene Therapy Pipeline
Nu
mb
er
of
Tri
als
Discovery Preclinical P1 P2 P3
0
100
200
300
400
500
600
700
800
900
1,000
1,100
Infect. Oncology Genetic
30
Hem. Derm. Immun. CNS Metabolic Musc. Cardio
1,017
42 40 18 13 10 9 8
31
Ex vivo gene therapies continue to
focus primarily in oncology, given the
precedent set by approved CAR-Ts
(e.g., Kymriah, Yescarta)
Interest in genetic and hematological
disorders has waned, potentially due to
technological innovations that have facilitated in
vivo gene therapy interventions
17
Late-stage ex vivo therapy programs are being pursued by public companies
of all sizes, while early programs are driven by small, private biotechs.
Source: Global Data; Evaluate Pharma; ClearView Analysis. 1 Juno and Kite have been acquired by larger biopharmaceutical companies (Celgene and Gilead, respectively). Note: Includes non-global programs captured by
Global Data (e.g., development solely in China).
Nucleic Acid Technology
Kite
Juno
Novartis
Shanghai
GeneChem
25
Bellicum
PersonGen
Takara
Innovative
Cellular 9
Autolus
Mustang
18
17
13
13
10
9
9
9
P1
P2
P3
Key Players
(P1 – 3 Programs, 2019)
Top Players in the Ex Vivo Gene Therapy Pipeline
70% 64% 69% 71%
25%
14% 14%
10% 10%
21%
3% 4%
5% 2%
9% 10% 6%
21%
2%
8%
5% 7% 10% 12% 25%
P3 Discovery
PC P1
5%
P2
Distribution of Ex Vivo R&D Projects
by Market Cap (2019)
>$10 B $1 – 5 B <$0.5 B
$5 – 10 B $0.5 – 1 B Private
128 443 316 320 24
18
$0
$20
$40
$60
$80
$100
$120
$140
$160
$180
$200
Jul-14 Jan-15 Jul-15 Jan-16 Jul-16 Jan-17 Jul-17 Jan-18
Companies like Kite Pharma have driven tremendous value by advancing
their platform and demonstrating differentiated clinical benefit.
Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. NHL: Non-Hodgkin’s Lymphoma; R/R: Relapsed/Refractory.
Nucleic Acid Technology
Ex Vivo Gene Therapy Development Case Study
Sh
are
Pri
ce
($ p
er
sh
are
)
Company:
1 1/1/15
P1/2 trial in NHL
patients initiated
(ZUMA-1)
2 11/9/15
P2 trial initiated in R/R
Mantle Cell Lymphoma
(ZUMA-2)
3 2/28/17
Positive data from
primary analysis of
ZUMA-1 announced
4 8/28/17
Gilead announces
acquisition of Kite for
$11.9 B
Gilead acquisition completed on 10/3/17, with
Yescarta approved by the FDA on 10/18/17
Agent: Indication: R/R Large B-cell Lymphoma
19
The in vivo pipeline focus is spread more evenly across TAs compared to the
ex vivo pipeline, with heavy investment in CNS and ophthalmology.
Source: Global Data; ClearView Analysis. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
Top 10 TAs in the In Vivo Gene Therapy Pipeline
Nu
mb
er
of
Tri
als
Discovery Preclinical P1 P2 P3
0
50
100
150
200
250
300
350
CNS Oncology
53
Ophth. Musc. Hem. Metabolic Cardio. Infect. Resp. Immun.
305
157
126
17
112
52 47
26 25
Most recently, the FDA approved Zolgensma
(Novartis/Avexis) for spinal muscular atrophy
in May 2019
By definition, the vast majority of
indications included in the listed
therapeutic areas possess a
genetic basis to disease
20
Early research is dominated by private biotechs while larger pharma
companies typically become involved in later stages of development.
Source: Global Data; Evaluate Pharma; ClearView Analysis. PC: Preclinical. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
DNAtrix
RegenxBio
ViroMed
Vyriad
Sarepta
Candel
MeiraGTx
7
Targovax
Sangamo
Oncosec
9
9
8
6
5
5
5
5
5
P1
P2
P3
Key Players
(P1 – 3 Programs, 2019)
Top Players in the In Vivo Gene Therapy Pipeline
61% 66% 72%
43% 30%
16% 14%
10%
23%
26%
9% 7% 3%
6% 15%
11% 8%
18% 22%
1% 1% 2% 3%
3% 8% 7% 7%
Discovery
PC P1 P2
4%
P3
4%
Distribution of In Vivo R&D Projects
by Market Cap (2019)
>$10 B $1 – 5 B <$0.5 B
$5 – 10 B $0.5 – 1 B Private
122 557 107 159 27
21
$0
$5
$10
$15
$20
$25
$30
Jan-17 Jul-17 Jan-18 Jul-18 Jan-19
Sangamo generated meaningful value in part through partnerships that
validated its strategy, though mixed trial results have impacted that value.
Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. MPS: Mucopolysaccharidosis.
Nucleic Acid Technology
In Vivo Gene Therapy Development Case Study
Sh
are
Pri
ce
($ p
er
sh
are
)
Company: Key Agent(s):
1 5/10/17
Collaboration with
Pfizer on Hem. A
gene therapy
2 11/15/17
First ever patient
dosed with in vivo
genome editing
therapy (SB-913)
3 1/3/18
Pfizer collaboration
expanded to CNS
disorders
4 9/5/18
Stock drops due to
mixed reactions to
early results from
SB-913 trial
5 4/3/19
Sangamo and
Pfizer release
positive data from
ALTA study
SB-525 (Hemophilia A); SB-318 (MPS I); SB-913 (MPS II)
Though partnerships with Pfizer
helped drive valuation, mixed trial
results have dampened
Sangamo’s trajectory
$1.1 B
Market Cap
22
Top 10 TAs in the Non-DNA Nucleic Acid Therapy Pipeline
The pipeline focus of non-DNA therapies is relatively similar to that of the
industry pipeline, though greater emphasis is placed on genetic disorders.
Source: Global Data; Evaluate Pharma; ClearView Analysis. CNS: Central Nervous System; GI: Gastrointestinal. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
0
50
100
150
200
250
Oncology Infectious CNS Cardio Ophth.
29
Immun.
244
86
49 43
Genetic
Disorders
122
37
Metabolic
29
Resp.
20
GI
29
Discovery Preclinical P1 P2 P3
Nu
mb
er
of
Tri
als
Genetically-defined disorders span many of
the therapeutic areas listed, with particular
concentration in CNS (e.g., Huntington’s
disease, spinal muscular atrophy)
23
Key players in the late-stage pipeline are comprised of large biotechs that
have recently started to commercialize assets (e.g., Ionis, Alnylam, Sarepta).
Source: Global Data; Evaluate Pharma; ClearView Analysis. PC: Preclinical. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Nucleic Acid Technology
Ionis
Moderna
AstraZeneca
BioNTech
Akcea
Curevac
Alnylam
ProQR
Sanofi
Sarepta
16
11
5
5
5
4
4
3
3
3
P1
P2
P3
Key Players
(P1 – 3 Programs, 2019)
67% 61%
36% 25%
14%
12% 20%
13%
15% 31%
10% 2%
4%
7%
14%
6% 4%
5% 10%
7%
4%
22%
8%
21%
1% 8% 20%
36%
14%
Discovery
PC P2 P1 P3
4%
Distribution of Non-DNA R&D Projects
by Market Cap (2019)
>$10 B $1 – 5 B <$0.5 B
$5 – 10 B $0.5 – 1 B Private
Top Players in the Non-DNA Nucleic Acid Therapy Pipeline
222 411 55 61 17
24
$0
$20
$40
$60
$80
$100
$120
$140
$160
$180
Jan-12 Jan-13 Jan-14 Jan-15 Jan-16 Jan-17 Jan-18 Jan-19
Alnylam has driven its value through a collaboration model for its lead
program, with a diverse pipeline of therapies in tow.
Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. ATTR: Transthyretin-mediated Amyloidosis.
Nucleic Acid Technology
Non-DNA Nucleic Acid Development Case Study
Sh
are
Pri
ce
($ p
er
sh
are
)
Company: Agent: Indication: Polyneuropathy of hereditary ATTR
1 7/6/12
Positive P1 Trial
Results
2 10/22/12
Enters into alliance
with Genzyme to
develop Onpattro
3 11/10/13
Positive P2 trial
results
4 9/20/17
Positive topline
results from P3
APOLLO study
5 8/10/18
Onpattro approved
by FDA as first
RNAi therapeutic
Revusiran
discontinued due
to safety concerns
(Oct. 2016)
Stock drops following release
of Q2 2015 earnings report
showing missed revenues
$7.24 B
Market Cap
25
Trends by Therapeutic Class – Bispecific Antibodies
Bispecific Antibodies
What have been the key trends in pharmaceutical
development and innovation in 2018? 1
What therapeutic classes stand out as notable areas for
discussion? 2
Nucleic Acid
Technologies
Novel Antibody
Technologies
26
While mAbs have historically been used and studied widely, bispecific
antibodies represent a relatively newer class of antibodies.
Source: ClearView Analysis. ADC: Antibody Drug Conjugate; TA: Therapeutic Area.
Bispecific Antibodies
Key Antibody Technologies in Development
Example Agents Example Agents Example Agents
Key: Today’s Focus
• Traditional mAbs have been
used widely across various
therapeutic areas
• Concentration within both
marketed and pipeline
agents is heaviest in
oncology and immunology
• ADCs have been developed
to increase potency of
antibodies by linking them
to cytotoxic agents
– The ADC class is still
emergent, with few
approved agents
• Bispecific antibodies are
increasingly being explored
as novel interventions
• Within the oncology space,
bispecific antibodies have
been deployed to recruit T
cells to tumor cells
Traditional Monoclonal
Antibodies 1
Antibody Drug
Conjugates (ADC) 2
Bispecific
Antibodies 3
Cytotoxic
Agent Linker
Binds Distinct
Epitopes
27
• Bispecific antibodies in oncology have
focused heavily on liquid tumors, aiming to
target T cells (e.g., CD3) and cell surface
markers (e.g., CD19) on B cells
• Though only two bispecifics are approved in
the U.S., pipeline activity continues to grow
• Bispecific antibodies were prominent at ASH
2018, while early-stage activity has emerged
in the immunology space (e.g., RA)
Bispecific Antibody Overview
Bispecific antibodies have been approved in oncology and hematology
indications, though pipeline activity is primarily concentrated in oncology.
Source: ClearView Analysis. ALL: Acute Lymphocytic Leukemia; RA: Rheumatoid Arthritis. 1 Blincyto was also granted accelerated approval to treat B-cell precursor ALL patients who are in remission, bust still have minimal
residual disease (MRD).
Bispecific Antibodies
Approved Agents Description of the Technology
Manufacturer
Target
Indication1
CD19 x CD3
Amgen
Refractory B-cell precursor ALL
Manufacturer
Target
Indication
Roche
Factor IXa x Factor X
Hemophilia A
Possess two
antigen-binding
sites
28
The bispecific antibody pipeline is relatively nascent compared to the
industry pipeline, with few programs in late-stage trials.
Source: Global Data; ClearView Analysis. DME: Diabetic Macular Edema; nAMD: Neovascular (wet) Age-related Macular Degeneration. Note: Includes non-global programs captured by Global Data (e.g., development solely in
China).
Bispecific Antibodies
7%
Phase 3
Phase 1
Phase 2
7%
Preclinical 43%
Discovery
1%
14%
21%
15%
45%
29%
20%
Pipeline Distribution by Phase
Bispecific Distribution Industry Distribution
Maturity of the Bispecific Antibody Pipeline
The vast majority of
bispecific development
programs have yet to
enter human trials
P3 trials include faricimab
(Roche) in DME and nAMD, as
well as additional Blincyto trials
29
Bispecific antibody development across all stages is highly concentrated in
oncology, with an overwhelming focus on liquid tumors in late-phase trials.
Source: Global Data; ClearView Analysis. CNS: Central Nervous System; GI: Gastrointestinal. Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Bispecific Antibodies
0
50
100
150
200
250
300
350
400
450
Oncology Immun. Infect. Metabolic GI Cardio Ophth. CNS Heme. Derm.
30
429
24 11 10 7 5 4 4 3
Discovery Preclinical P1 P2 P3
Though Hemlibra was approved
in Hemophilia A, development
in hematological disorders is
currently sparse
Nu
mb
er
of
Tri
als
Top 10 TAs in the Bispecific Antibody Pipeline
Late-stage development is highly
concentrated in oncology as multiple
companies aim to improve upon
Blincyto’s dosing frequency and safety
profile
Clinical stage development in
immunology includes indications
such as rheumatoid arthritis and
systemic lupus erythematosus
30
Key Players in the Bispecific Antibody Pipeline
Larger cap companies (>$10 B) dominate the late-stage pipeline, while
private companies make up a significant portion of early-stage R&D activity.
Source: Global Data; ClearView Analysis. PC: Preclinical Note: Includes non-global programs captured by Global Data (e.g., development solely in China).
Bispecific Antibodies
73%
52%
23% 24%
100%
8%
17%
10%
24%
2%
4%
5%
8%
9%
10%
13%
3%
8% 14%
50% 43%
Discovery
P1 PC P2 P3
Distribution of Bispecific R&D Projects
by Market Cap (2019)
>$10 B $1 – 5 B <$0.5 B
$5 – 10 B $0.5 – 1 B Private
MacroGenics
Roche
Alphamab
Merus
Amgen
J&J
Regeneron
Xencor
Eli Lilly
AstraZeneca
Zymeworks
9
19
Affimed
19
9
8
7
6
4
4
4
3
3
Key Players
(P1 – 3 Programs, 2019)
P1
P2
P3
156 230 111 37 6
31
$0
$10
$20
$30
$40
$50
$60
Jan-14 Jul-14 Jan-15 Jul-15 Jan-16 Jul-16 Jan-17 Jul-17 Jan-18 Jul-18 Jan-19
Xencor has seen a rise in its valuation through parallel development of
multiple programs and partnerships.
Source: Global Data; Evaluate Pharma; Yahoo Finance; ClearView Analysis. AML: Acute Myeloid Leukemia; R/R: Relapsed / Refractory. 1 The collaboration with Novartis was recently terminated, citing strategic pipeline
reprioritization by Novartis; 2 XmAb14045 trial also includes other CD123-expressing hematologic malignancies.
Bispecific Antibodies
Sh
are
Pri
ce
($ p
er
sh
are
)
Company: Therapeutic Area(s): Immuno-oncology, autoimmune diseases
1 12/18/14
Enters discovery
collaboration with
Novo Nordisk
2 6/28/16
Enters Novartis
collaboration for
XmAb14045 and
XmAb136761
3 8/1/16
XmAb14045
initiates P1 trial in
R/R AML2
4 7/5/18
First patient dosed
in P1 XmAb20717
trial in solid tumor
patients
5 11/1/18
Positive results
announced for
XmAb14045 P1
trial
Partial clinical hold was placed
on XmAb14045 in Feb. 2019
after two patient deaths
Outside of the bispecific space,
Xencor has entered
collaborations with companies
such as Alexion and Morphosys
Bispecific Antibody Development Case Study
$1.86 B
Market Cap
32
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