ABGSC Seminar -
Autoimmunity,
Transplantation &
Inflammation
June 11, 2024
Forward-looking statement
This announcement and any materials distributed in connection with this presentation may contain certain forward- looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company's current expectations and assumptions as to future events and circumstances that may not prove accurate.
A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 2 |
Global leader in antigen presenting cell (APC)-targeted immunotherapy technology
NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$500M1)
Differentiated immunotherapies targeting antigens to Antigen-Presenting Cell (APC) to direct tailor-made immune responses with focus on oncology and autoimmune diseases
Broad pipeline de-risked through strong durability and survival data
- Lead asset VB10.16 in potential registrational trial in r/m cervical cancer. Expanding into additional indications with high unmet need including r/m Head and Neck
Strategic partnerships with top tier US biopharma companies2
♦ Personalized cancer vaccine in partnership with Genentech
♦ Multiprogram (oncology and infectious diseases) collaboration with Regeneron
Autoimmune disease constitute a potential new therapeutic vertical in high-unmet need indications (e.g., MS, T1D)
Well-capitalized with a cash position of $147.3m at March 31, 2024
- Based on closing share price of NOK 16.08 on June 3, 2024 and USD/NOK exchange rate of 10.50.
- Note: Genentech has an exclusive license to VB10.NEO. Collaboration and license to 5 programs with Regeneron. Collaboration and license with Adaptive Biotechnologies on SARS-CoV-2 T cell vaccine. Roche supplies atezolizumab. Merck (MSD) supplies pembrolizumab
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 3 |
Broad pipeline targeting early to late-stage cancer treatment
Upcoming | |||||||||
Asset | Indication | Rights | Preclinical | Phase 1 | Phase 2 | Phase 3 | Catalyst | ||
Oncology | |||||||||
HPV16+ cervical cancer | 1 | C-02,C-04 | Finalize enrolment Pt 1 | ||||||
(Q4 2024) | |||||||||
HPV16+ head and neck cancer | 2 | Dose level | |||||||
VB10.16 | C-03 | recommendation | |||||||
(H2 2024) | |||||||||
Off-the-shelf | HPV16+ locally advanced | 2 | |||||||
C-05 | Protocol in development | ||||||||
cervical cancer | |||||||||
Regeneron | Undisclosed | 3 | Selection of lead | ||||||
programs | candidate | ||||||||
NYK011 | Colorectal: pre-cancerous | Update | |||||||
polyps to cancer | (H2 2024) | ||||||||
Melanoma, lung, bladder, renal, | 4 | ||||||||
Individua- | head and neck cancer; locally | N-01 | |||||||
advanced and metastatic tumors | |||||||||
lized | VB10.NEO | ||||||||
Incurable locally advanced and | 4 | N-02 | |||||||
metastatic tumors | |||||||||
Infectious Disease | 3 | ||||||||
Regeneron programs | Undisclosed | ||||||||
Autoimmune | |||||||||
Internal | Undisclosed | Update | |||||||
(H1 2024) | |||||||||
1. Wholly-owned by Nykode. Potentially registrational. Roche supplies atezolizumab; 2. Wholly-owned by Nykode. Merck (MSD) supplies pembrolizumab; 3. Collaboration with Regeneron; 4. Genentech has an exclusive license to VB10.NEO.
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 4 |
Strong rationale for moving into Immune Tolerance
Autoimmune disease therapy relies on broadly immunosuppressive therapies which leaves a great unmet medical need in a growing market
Inverse vaccines present a new promising avenue with potential for long- lasting efficacy and limited side effects
The field is gaining traction and partnership interest from major players, yet to see first regulatory approval
Nykode's proprietary APC | ||
Nykode's unique approach leveraging APC-targeting technology offers a differentiated | ||
targeting technology | ||
solution that could become a first- or best-in-class therapypresents. | a differentiated | |
approach able to become | ||
Nykode Therapeutics | | the first- or best-in-class | |
Modular design with multiple targeting and 4th modules able to ensure antigen-specific immune tolerance
+/-
Cytokine/
immune modulator
Module 1: Multiple targeting units for receptors on tolerizing APCs identified including natural ligands and other targeting molecules
Module 3: Auto-antigens or allergens known to elicit unwanted immune responses identified
Module 4: Cytokines or modulators playing key roles in mediating anti-inflammatory immune responses
- Numerous exploratory vaccines built on above modules and evaluated experimentally
- Several patent applications covering these concepts filed
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential
Induction of antigen specific tolerance can be achieved by targeting disease causing epitopes to tolerogenic APCs
MECHANISM OF ACTION - TOLERANCE INDUCTION (INVERSE VACCINATION)
Cells
transfected with
DNA plasmid
vaccine
Tol
APC
Effector
B cell
CD4+
Treg
CD4+
Treg
Tol
APC
Effector | Effector |
T cell | T cell |
1 Cells encode and secrete Tol APC-targeted Vaccibody proteins together with immunosuppressive molecules/modulators to enhance tolerogenic APC function.
2 The Tol APCs present vaccine antigens in a tolerogenic milieu supported by the vaccine co-encoded suppressive molecules, and prime regulatory T cell (Treg) activation and expansion.
3 | The Tregs inhibit or delete disease- |
specific effector T cells and inhibit |
effector B cells
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential
APC targeting is required for effective disease protection
EAE MODEL
Tol.
APC
TV004 | 30 µg | |||
5 | TV042 | |||
PBS | ||||
score | 4 | |||
3 | ||||
EAE | 2 | |||
1 | ||||
0 | ||||
6 | 8 | 10 12 14 16 18 20 22 24 26 28 |
3 µg | ||||
5 | 5 | |||
score | 4 | score | 4 | |
3 | 3 | |||
EAE | 2 | EAE | 2 | |
1 | 1 | |||
0 | 0 | |||
6 | 8 | 10 12 14 16 18 20 22 24 26 28 |
0.3 µg | ||
6 | 8 | 10 12 14 16 18 20 22 24 26 28 |
MOG MOG
(27-63)(27-63)
Days post EAE induction
Days post EAE induction | Days post EAE induction |
TV004 TV042
Daily clinical scores
day -7 day -3day 0 | day 28 |
AUC (5-28)
110
90
70
50
30
✱✱✱
✱
✱✱
AUC (5-28)
110
90
70
50
30
✱✱
✱
110 | |
(5-28) | 90 |
70 | |
50 | |
AUC | |
30 | |
10 |
i.v.
EAE Termination induction
10
10
PBS | TV042 | TV004 |
Pertussis toxin
Mann-Whitney test,
*p<0.05, **p<0.001, ***p<0.0001
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 8 |
Vaccibody delivers Ag-specific suppression of EAE
EAE MODEL - OVA CONTROL
TV004 TV043
MOGOVA
(27-63)(323-339)
Daily clinical scores
day -7 day -3day 0 | day 28 |
5 | ||
score | 4 | |
3 | TV004 | |
EAE | 2 | TV043 |
PBS | ||
1 | ||
i.v.
EAE Termination induction
0 | ||
6 | 8 | 10 12 14 16 18 20 22 24 26 28 |
Pertussis toxin
Days post EAE induction
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 9 |
Vaccibody vaccine prevents EAE disease in an early therapeutic setting
EAE MODEL - EARLY THERAPEUTIC DELIVERY | ||||||||
TV004 | ||||||||
5 | TV004 | 100 | ✱✱✱ | |||||
4 | ||||||||
scoreEAE | PBS | 28)-(5AUC | 80 | |||||
MOG | ||||||||
3 | ||||||||
(27-63) | 60 | |||||||
Daily clinical scores (5-28) | 2 | 40 | ||||||
day 28 | 1 | 20 | ||||||
Termination | 0 | 0 | ||||||
EAE | 0 | 2 | 4 6 8 10 12 14 16 18 20 22 24 26 28 | PBS | TV004 | |||
i.v. | ||||||||
induction | Days post EAE induction | Mann-Whitney test, ***p<0.0001 | ||||||
Pertussis toxin | ||||||||
Nykode Therapeutics | ABGSC Seminar 2024 | Non-Confidential | 10 |
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Nykode Therapeutics AS published this content on 11 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 June 2024 11:04:07 UTC.