Adjuvance 2021: Progressing adjuvant and vaccine development
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Adjuvance 2021:
Progressing adjuvant and vaccine
development
Adjuvance at a glance
• Developing next-generation • Dual value
saponin adjuvants and • Adjuvant platform out-licensing
vaccines • Internal vaccine development
• Strong immune stimulation • Adjuvant platform discussions
• Favorable tolerability and with > 20 partners
manufacturing
• Adjuvant & vaccine expertise on
• TQL-1055 Phase 1 results
team & boards
with pertussis vaccine; Phase
1 with shingles vaccine in • Series B financing H1 2022
2022
Saponin adjuvants are proven in
high-value and global health vaccines
Saponin
MATRIX-M™ QS-21 TQL-1055
TLR4+liposome
>$2
Adjuvance
AS01
billion lead candidate
sales
COVID-19 /
Influenza / Shingles /
malaria Malaria / TB
Shingles: GSK annual report
Some saponin adjuvants present
a mixed profile
Highly effective Poor tolerability
Shingles vaccine efficacy comparison Shingles vaccine tolerability comparison
100
90 Adverse
80 Placebo Shingrix®
Event (AE)
Vaccine efficacy
70
60
50 Any solicited 34% 84%
40 AE (32-35) (83-86)
30
20
10 Solicited local 12% 81%
0 AE (11-13) (80-82)
1 2 3 4 5 6 7 8
Years since vaccination
Grade 3
Live attenuated Recombinant AS01 adjuvant 3.1% 16.5%
Zostavax® Shingrix®
AE
TQL-1055: Optimized saponin adjuvant • Simplified, stabilized version of QS-21 • Semi-synthetic entity designed to improve tolerability QS-21 TQL-1055
Sustainability and manufacturing
efficiency limits
Saponin
MATRIX-M™ QS-21 TQL-1055
Limited by TLR4+liposome
terminal bark
harvest AS01 Sustainable,
efficient,
scalable
TQL-1055 has multiple advantages
Other saponins TQL-1055
Adjuvanticity Excellent Excellent
Tolerability Poor Improved
Source materials Limited Expanded
Yield Low Increased
Purity Mixed High
Stability Limited Increased
Manufacturing Low Increased
efficiency
Doses per year ? ~3B
Regulatory Accepted Phase 1 clinical results
Foundation of value is next generation
saponin adjuvant, TQL-1055
Vaccines Immuno-oncology
Pertussis Malaria,
Available Shingles
COVID TB, etc.
vaccine
Adjuvants flu
Multiple out- Multiple out-
Antigen gE Combination
licensed licensed
adjuvant
Other Multiple TLR9 agonist
adjuvant available (?)
Combination adjuvant
TLR4
Multiple TLR4 agonist
agonist
available
adjuvant
Saponin QS-21 /
TQL-1055
adjuvant Matrix-M
TQL-1055: Improved tolerability • Hemolysis associated with QS-21, but not TQL-1055 • Weight loss associated with QS-21 containing vaccines, but not vaccine containing TQL-1055 • NOAEL of > 2000 mcg/dose
TQL-1055: Functional response in COVID
SARS-CoV-2 sVNT IC 50 Inhibition:
S.C. Injection
16384
IC 5 0 In h i b it io n (1 / d il u ti o n )
4096
1024
256
64
16
4
1
SARS-CoV-2 FL 1μg 1μg + 1μg + 1μg +
10μg 1055 30μg 1055 100μg 1055
After a second dose
TQL1055: PRO-5-01-001TQL-1055: Influenza response with
128-fold less
Anti-H3N2 Total antigen
IgG Endpoint
Post Dose 2
Titers
✱
10 8
✱
✱✱
10 7 ✱✱
Endpoint Titer
Post Dose 2 (D28)
Influenza A/H3N2
(1/dilution)
10 6
Anti-H3N2
IgG 10 5
10 4
Initial Dilution
10 3
A/H3N2 HA dose, mcg 4.5 0.28 0.14 0.07 0.03
L1 CS
µg L10 S
L1 CS
S
k
lo
C
C
- 16x 32x 64x 128x
uB
55
5
TQ 55
5
HA Dose reduction
05
05
10
Fl
TQL1055 dose, mcg - 30 30 30 30
L
µg
TQ
Q
Geometric Mean Titer 290627 Q 932868 1276401 1197516 861372
T
T
****P ≤ 0.0001; ***P ≤ 0.001; **P ≤ 0.01; *P ≤ 0.05
5
4.
µg
µg
g
ok 0 µ
30
30
30
3
+
+
+
+
ok
ok
okTQL-1055 combined with TLR4
elicits response similar to AS01
gE Antigen dose, mcg 5 5 5 5
TQL1055 dose, mcg - low high -
TLR4 agonist - + + -
AS01 - - - + *P ≤ 0.05
GMT 949 336323 524413 475612Pipeline of vaccine candidates
Pre-
Discovery Phase 1
clinical
Pertussis
✓ ✓ ✓2021
(PAVA)
Shingles ✓ ✓ 2022Pertussis acellular vaccine adjuvanted (PAVA)
Phase 1
Interim Data Summary and Conclusions
• Study enrolled 72 healthy adults 18 – 50 years of age; >3 year post pertussis booster
• Escalating TQL-1055 doses from 25 – 800 mcg with a commercial pertussis vaccine
• Control = commercial pertussis vaccine alone
• PAVA was well tolerated at doses up to 800 mcg
• PAVA’s safety profile was similar to the commercial vaccine
• Local and systemic reactions were predominantly mild
• An anti-pertussis toxin response was observed in all groups 28 days after the single doseShingles vaccine
Our promise: Our progress:
Better tolerated shingles vaccine Phase 1 planned for 2022
Adverse
Placebo Shingrix®
Event (AE) Pre-IND ✓ 2020
meeting
Any solicited 34% 84%
AE (32-35) (83-86)
Solicited local 12% 81% Toxicology ✓ 2021
AE (11-13) (80-82)
Solicited
Grade 3 3.2% 17.0%
AE Phase 1 • 2022Experienced Management Team
Tyler Martin, MD, CEO
Accomplished adjuvant and vaccine developer
FluAd® with MF59; Heplisav® with CpG 1018
Sean Bennett, MD/PhD, CMO
Aeras, Dynavax, Aimmune, PaxVax, Emergent
Pat Frenchick, PhD, CSO
Adjuvant immunologist
Melissa Malhame, MBA, VP Business Development
Merck, Dynavax, Gavi, The Vaccine Alliance
Stephan Schulze, MBA, CFO
Experience with public and private life science companiesScientific Advisory Board Stanley Plotkin, MD, Chairman Margaret Liu, MD •Formerly Professor, Penn & Wistar Institute •Pioneer of nucleic-acid vaccine development •Executive Advisor, Sanofi Pasteur •Adjuvance director •Chair, Infectious Disease Committee, AAP •Chair, MID Research Committee, NIH •Editor, Vaccines •Developer of rubella vaccine •Co-Developer: polio, rabies, varicella, rotavirus, cmv Greg Poland, MD Phil Livingston, MD •Director, Mayo Clinic Vaccine Research Group •Cancer Vaccine Pioneer, MSKCC •Editor in Chief, Vaccine •Adjuvance Co-Founder
Board of Directors
Tyler Isaac Margaret Stephen Ken Kelley
Martin, MD, Cheng, MD Liu, MD Dilly, • Former CEO
Chairman • Morningside • Nucleic-acid MBBS/PhD PaxVax
Ventures vaccine • CEO Sierra
pioneer, Oncology,
global health Former CEO
expert Aimmune,
Former
CMO ChironCompany Value
Dual approach to value creation:
Out-
Internal Vaccine
licensing
Development
adjuvants
Upfront,
Sales revenue milestones, Infectious
royalties disease,
Infectious
disease
Immuno-
Supply oncology
Licensing fees, agreement
royalties revenueDevelopment Plan
TQL-1055 TQL-1055 combination adjuvant(s)
✓ IND enabling studies ✓ IND enabling studies
✓ GMP manufacture ✓ GMP manufacture
✓ First in human trial • First in human trial (planned 2022)
✓ Dose escalating RCT in infectious disease • Dose escalating RCT in infectious disease
• Available for out-licensing partnerships • Internal product development focused
• Several under discussion • Potential out-license with supply agreement
• Out-license with supply agreement • Targets: infectious disease, immuno-oncology,
• Target: infectious diseases neurobiology, substance abuse vaccines,
allergy vaccinesFinances • Adjuvance is pre-revenue • Awarded $3.5 M in non-dilutive grants/contracts • Out-licensing partnerships under discussion • Closed $24 M paid-in capital ($20 M Series A round in 2019)
Thank you!
Tyler Martin, MD
Chairman, President & CEO
tyler@adjuvancetechnologies.com
Tel: (402) 817.5050You can also read
