Q1 2024
Results Presentation
May 14, 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 | Q1 '24 webcast | Non-confidential | 2 |
Today's presenters from Nykode management
International management team with solid drug development experience
MICHAEL ENGSIG | AGNETE FREDRIKSEN | HARALD GURVIN | KLAUS EDVARDSEN |
Chief Executive Officer | Chief Scientific Officer & | Chief Financial Officer | Chief Research & |
Business Development | Development Officer |
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 3 |
Q1 2024 Highlights
- Presented top line conclusions from the updated analysis from the Phase 2 VB-C-02 trial in advanced cervical cancer, affirming prolonged benefits and indicating a synergistic treatment effect of VB10.16 and atezolizumab (Tecentriq®).
- Announced advances in the inverse vaccine platform, showing promising results in treating autoimmune diseases and underscoring the platform's potential.
- Presented additional preclinical data on the inverse vaccine platform, demonstrating long-term protection against diabetes following treatment withdrawal.
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 4 |
Post-period end Highlights
- Initiated Phase 2 VB-C-04 trial in second line HPV16-positive cervical cancer in patients with HPV16-positive,PD-L1-positive, recurrent, or metastatic cervical cancer.
- Concluded enrollment of the 6 mg cohort in the VB-C-03 (VB10.16) trial in first-line head and neck cancer patients.
- Presented new preclinical data from our collaboration with Genentech, focusing on the differentiation of our proprietary vaccine technology.
- Announced clinical collaboration with MSD to evaluate VB10.16 in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positivehigh-risk locally advanced cervical cancer
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 5 |
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 | Q1 '24 webcast | Non-confidential | 6 |
R&D update
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 7 |
VB10.16 C-02 data compare strongly to CPI monotherapy as well as expected SoC in ≥2L r/m cervical cancer
CPI Monotherapy in r/m CC
VB10.16 plus | |
atezolizumab | Atezolizumab in |
in PD-L1+ | |
PD-L1+††† | |
(analysis from April 2023*) |
Pembrolizumab
in PD-L1+**
Cemiplimab in | Tisotumab vedotin |
PD-L1+†† | (PD-L1 agnostic) ‡ ‡ |
Trial name | C-02 | Skyscraper-04, | Keynote-158 | Empower-Cervical 1, | InnovaTV 301, | ||
atezolizumab arm | cemiplimab arm | tisotumab vedotin arm | |||||
ORR | 29% | 16% | 17% | 18% | 18% | ||
mPFS | 6.3 mo | 1.9 mo | 2.1 mo | 3.0 mo | 4.2 mo | ||
mOS | Not reached | 10.6 mo | 11.0 mo | 13.9 mo | 11.5 mo | ||
(25.0+ mo) | |||||||
*Updated analysis (March 2024) closely mirrors previously reported positive outcome.
Notes: The data shown on this slide represents third-party clinical trials involving different trial designs and patient populations. These trials are not head-to-head evaluations of VB10.16 against standard of care
-
Salani et al. Efficacy and safety results from Skyscraper-04: An open-label randomized phase 2 trial of tiragolumab plus atezolizumab for PD-L1-positive recurrent cervical cancer. IGCS 2023. ** Chung et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: Results from the phase II KEYNOTE-158 study. J Clin Oncol 2019
†† Tewari et al. Survival with cemiplimab in recurrent cervical cancer. N Engl J Med 2022
‡ ‡ Confirmatory phase 3 RCT evaluating tisotumab vedotin vs. investigator's choice chemotherapy (topotecane, vinorelbine, gemcitabine, irinotecan, or pemetrexed). Ignace Vergote: innovaTV 301/ENGOT-cx12/GOG-3057: A Global, Randomized, Open-Label, Phase 3 Study of Tisotumab Vedotin vs Investigator's Choice of Chemotherapy in 2L or 3L Recurrent or Metastatic Cervical Cancer. ESMO 2023.
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 8 |
Maximizing addressable patient populations by diversifying offerings and broadening therapeutic scope
Building a cancer vaccine franchise following strong clinical validation
Validation Today
Future Opportunities
Adjuvant Settings
C-05
2L Cervical Cancer | C-04 |
C-02 data validates
opportunity and
creates fast to market
opportunity
C-02
2L Cervical Cancer
Fast to market
strategy
Indication Expansions C-03
Expansion into other
solid tumor types, including head and neck cancer, in front- line settings
1L SCCHN
Expand indications and into front-line settings
Move earlier to expand patient population and explore long-term efficacy with RFS
Adjuvant Cervical,
SCCHN
Anal, vulvar, | PD-L1 negative |
vaginal, penile | patients |
Expand to target the broad
addressable patient population
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 9 |
VB10.NEO Individualized cancer immunotherapy
Nykode Therapeutics | Q1 '24 webcast | Non-confidential | 10 |
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Nykode Therapeutics AS published this content on 14 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2024 14:01:04 UTC.