Slide 1: VB10.16 Final Phase 2 data readout – 12 month treatment follow up
VB10.16 Final Phase 2 data readout – 12 month treatment follow up April 18 2023
Slide 2: Forward-looking statement
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 assumpt
Slide 3: Positive results from VB C-02 – Executive Summary
Positive results from VB C-02 – Executive Summary Durable anti-tumor activity VB10.16 in combination with atezolizumab showed sustained overall survival and durable responses: mOS1 16.9 months, mPFS2 4.1 months and mDOR3 17.1 months In PD-L1+ patients, this was further enhanced with mOS not reac
Slide 4: Global leader in antigen presenting cell (APC)-targeted immunotherapy technology
Global leader in antigen presenting cell (APC)- targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$700M) Proprietary immunotherapies targeting antigens to Antigen-Presenting Cell (APC) and generating strong CD8 killer T cell responses correlated with clinical responses in soli
Slide 5: Unique antigen presenting cell targeted modular immunotherapy Vaccibody technology
Unique antigen presenting cell targeted modular immunotherapy Vaccibody technology MODULAR IMMUNOTHERAPY INCLUDES THREE DISTINCT COMPONENTS Nykode’s immunotherapy candidates may be delivered through DNA, mRNA, viral vectors or as recombinant proteins DNA plasmid Targeting unit to attract and bind AP
Slide 6: Vaccibody technology induces a rapid, robust and long-lasting CD8 T cell response
Vaccibody technology induces a rapid, robust and long- lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | VB C-02 Data Presentation | Non-confidential 6
Slide 7: Rich and diversified pipeline
Rich and diversified pipeline Asset Indication Preclinical Phase 1 Phase 2 Phase 3 Rights Oncology 1 VB10.16 HPV16+ cervical cancer 2 VB10.16 HPV16+ head and neck cancer Off-the-shelf Regeneron 3 Undisclosed programs 1 Internal Undisclosed Melanoma, lung, bladder, renal, 4 VB10.NEO head and neck can
Slide 8: VB10.16: Therapeutic vaccine candidate for HPV16+ cancers
VB10.16: Therapeutic vaccine candidate for HPV16+ cancers Targeting unit Off-the-shelf therapeutic cancer DNA vaccine CCL3L1 against HPV16 induced malignancies HPV16 is the most prevalent oncogenic HPV strain VB10.16 Targeting the cancer-specific full-length HPV16 E7 and E6 Off-the-shelf vaccine
Slide 9: HPV16+ cancers are a significant unmet need
HPV16+ cancers are a significant unmet need Despite prophylactic HPV vaccination, HPV+ cancer incidence is expected to increase • 4th most common cancer in women worldwide HPV-related cancer incidence is expected to grow • 4th leading cause of cancer-related death HPV+ cervical cancer HPV+ HNSCC • P
Slide 10: Recent clinical progress has increased survival outcomes in advanced cervical cancer, but room for improvement remains
Recent clinical progress has increased survival outcomes in advanced cervical cancer patients, but room for significant improvement remains Patients that have failed 1 or more line of systemic treatment have limited Progression Free Survival and Overall Survival with current approved treatments Sign
Slide 11: VB C-02: VB10.16 plus atezolizumab (Tecentriq®) in advanced cervical cancer
VB C-02: VB10.16 plus atezolizumab (Tecentriq®) in advanced cervical cancer A Multi-Centre, Single Arm, Open-label Phase 2a Trial of the Combination of VB10.16 and atezolizumab in Patients with Advanced or Recurrent, Non-resectable HPV16 Positive Cervical Cancer (NCT04405349) Objectives: Safety/to
Slide 12: VB10.16 evaluated in pretreated advanced cervical cancer patients
VB10.16 evaluated in pretreated advanced cervical cancer patients, with ~40% PD-L1 negative Baseline characteristics PATIENT CHARACTERISTICS1 SAF2 (n = 52) Median age, years (range) 47.5 (27-83) Histology Squamous cell carcinoma 81% (42/52) Adenocarcinoma 15% (8/52) Adenosquamous carcinoma 2%
Slide 13: VB10.16 was generally well-tolerated
VB10.16 was generally well-tolerated VB10.16 plus atezolizumab tolerability profile was consistent with checkpoint inhibitor monotherapy1 Treatment-related Adverse Events assessed as related to VB10.16 VB10.16 in combination with atezolizumab was generally (n = 52) well-tolerated and showed a favour
Slide 14: Strong anti-tumor effect leading to prolonged overall survival
Strong anti-tumor effect leading to prolonged overall survival (compared to CPI alone)1 High mOS of >25 months (not reached) and mPFS 6.3 months in PD-L1+ patients Endpoint All patients (n = 472) PD-L1+ (n = 243) Value 95% CI Value 95% CI Strong and durable anti-tumor efficacy ORR 19% (9%-33%) 29%
Slide 15: Observed ORR of 19% and DCR of 60% in all comers, 29% ORR in PD-L1+
Observed ORR of 19% and DCR of 60% in all comers, and 29% ORR and 75% DCR in PD-L1+ advanced cervical cancer patients Best overall response (n = 47) Best overall response PD-L1+ (n = 24) 100% CR: 6% (n = 3) 100% CR: 8% (n = 2) 90% 90% ORR: 19% (n = 9) 80% ORR: 29% (n = 7) Change from baseline to sma
Slide 16: VB10.16 coupled with CPI led to lasting responses
VB10.16 coupled with CPI led to lasting responses All (n = 47) By PD-L1 status (n = 40) Note: 7 out of 47 responders had PD-L1 unknown status, 40 out of 47 had known PD-L1 status Nykode Therapeutics | VB C-02 Data Presentation | Non-confidential 16
Slide 17: Prolonged duration of disease control particularly in PD-L1+ patients
Prolonged duration of disease control particularly in PD-L1+ patients Duration of disease control, DODC1 (n = 28) • Lasting disease control observed Treatment control and disease events – Stable patients • 28 patients experienced disease control ➢ 14 patients completed treatment phase of 48 weeks ➢
Slide 18: mDOR > 17 months driven by PD-L1+ patients
mDOR > 17 months driven by PD-L1+ patients Duration of response (n = 9) Duration of response (PD-L1+ vs. PD-L1-) mDOR 17.1 months mDOR 2.6 months mDOR 17.1 months Nykode Therapeutics | VB C-02 Data Presentation | Non-confidential 18
Slide 19: Progression free survival reached 6.3 months in PD-L1+ patients
Progression free survival reached 6.3 months to date in PD-L1+ patients irrespective of prior number of treatments Progression-free survival Progression-free survival (PD-L1+ vs. PD-L1-) mPFS 6.3 months mPFS 4.1 months mPFS 2.8 months Note: 7 out of 47 patients had PD-L1 unknown status Nykode Therap
Slide 20: VB10.16 led to prolonged overall survival in advanced cervical cancer patients
VB10.16 led to prolonged overall survival in advanced cervical cancer patients Median overall survival of 16.9 months in overall population, mOS not reached (> 25 months) in PD-L1+ patients Overall survival Overall survival (PD-L1+ vs. PD-L1-) mOS N.R. (> 25 months) mOS 16.9 months mOS 7.3 months No
Slide 21: VB10.16 induced HPV16-specific T cell responses correlated with clinical response
VB10.16 induced HPV16-specific T cell responses that are significantly correlated with clinical response HIGHER FOLD INCREASED T CELL HIGHER PEAK T CELL RESPONSES IN RESPONSES IN PATIENTS WITH DISEASE PATIENTS WITH DISEASE CONTROL CONTROL 1500 p=0.0113 50 p=0.0346 1000 500 SFU/106 PBMC250 10 Fold ch
Slide 22: Data from the VB10.16 Ph2 trial compared with current and future SoC
Data from the VB10.16 Ph2 trial compared with relevant current and future SoC as evaluated in third-party trials Cemiplimab in PD-L1+ Tisotumab vedotin VB10.16 plus atezolizumab Pembrolizumab in PD-L1+ Endpoint (Empower-Cervical 1, (PD-L1 agnostic) in PD-L1+ (n = 24) (Keynote-158, n = 82)** n = 82,
Slide 23: C-02 data supports patient population selection for potentially registrational study
C-02 data supports patient population selection for potentially registrational study Clinical activity observed across all endpoints, with strongest results in PD-L1+ patients with 1 prior line of systemic therapy Duration of response data in PD-L1+ patients show potential for competitive positi
Slide 24: VB10.16 has broad potential across HPV-driven cancers
VB10.16 has broad potential across HPV-driven cancers FINALIZED. REPORTED ONGOING. REPORTED EXPANSION PLANNED FOR 2023 FURTHER POTENTIAL POSITIVE DATA POSITIVE INTERIM DATA C-01 C-02 C-03 Earlier lines Ph 1/2a Pre- C-04 Ph 2a Ph 1/2a Head and other cancerous Ph 2 Cervical Cervical and Neck HPV+ driv
Slide 25: VB10.16 with atezolizumab showed promising clinical profile with favorable tolerability
VB10.16 in combination with atezolizumab showed promising clinical profile with favorable tolerability in patients with advanced HPV16+ cervical cancer, an area of high unmet medical need Clinically relevant endpoint mPFS was 4.1, 6.3 and 16.9 months for all, PD-L1+ and PD-L1+ with one prior treat
Slide 26: Acknowledgement
Acknowledgement We would like to thank the patients, their families as well as investigators for their participation in the trial Atezolizumab was supplied by 12 12 MONTHS Roche MONTHS Advanced or recurrent, non-respectable HPV16-positive cervical cancer Nykode Therapeutics | VB C-02 Data Presentati
Slide 27: VB10.16 Market: ~130,000 new HPV16+ cancers in U.S. / EU per year
VB10.16 Market: ~130,000 new HPV16+ cancers in U.S. / EU per year Potential for VB10.16 expansion into significant untapped patient populations Cervical Cancer Head and Neck Anal, Vulvar, Cervical Cancer 2nd line and PD-L1+ Adjuvant Adjuvant & Advanced Vaginal, Penile Estimated Total Market ~130,0
Slide 28: Rich calendar of milestones expected in the next months
Rich calendar of milestones expected in the next 12 months 1H Updated durability results from Phase 2 study; minimum 2023 VB10.16 Cervical Cancer 12 month follow-up ✓ VB10.16 First patient dosed in C-03 trial with KEYTRUDA® in 1H 2023 Head and Neck patients with PD-L1 positive 1st line unresectable
Slide 29: Appendix – additional materials
Appendix – additional materials Nykode Therapeutics | VB C-02 Data Presentation | Non-confidential 29
Slide 30: GRIm score at Screening confirmed as a relevant prognostic biomarker
The Gustave Roussy Immune (GRIm) score at Screening confirmed as a relevant prognostic biomarker for future trials Patients with a high-risk GRIm score (2 or 3 risk factors) have high risk of early death < 3 months. A low-risk GRIm score (0 or 1 risk factor) will be inclusion criterion in C-04. Nyko
Slide 31: Duration in the relevant subgroup patient populations selected for future studies
Duration in the relevant subgroup patient populations selected for future studies Prolonged PFS: PD-L1+ and 1 prior line of SACT (n = 15) High efficacy across all endpoints, with strongest results in PD-L1+ patients with 1 prior line of systemic therapy Duration of response data in PD-L1+ patien
Slide 32: Further platform improvement by adding a 4th module
Further platform improvement by adding a 4th module TC-1 tumor model PBS VB-HPV VB-HPV-GM 2 µg dose GM: GM-CSF FL: FLT3L Nykode Therapeutics | VB C-02 Data Presentation | Non-confidential 32
Slide 33: 4th module also applicable for infectious diseases
4th module also applicable for infectious diseases Different 4th modules boost both antibody and T cell responses VB-COV2 VACCINE INDUCED IFNg T CELL RESPONSES VACCINE INDUCED ANTIBODY RESPONSES T cell responses RBD RBD RBD RBD + VB-COV2+IL12a/b VB-COV2+GM-CSF VB-core VB-COV2 VB-COV2-IL21 VB-COV2+GM
Slide 34: APC-targeted technology and 4th module offers unique ability to induce Ag-specific immune tolerance
APC-targeted technology and 4th module offers unique ability to induce Ag-specific immune tolerance TOLERIZING NYKODE VACCINE EXAMPLES EXAMPLES OF EFFECT OF TOLERIZING NYKODE VACCINE IL-10 IFN-γ Selected targeting units 200 • αDEC205 Construct Description SFU/106 splenocytes 200 • PD1 ✱ • IL-10 150
Slide 35: The DNA platform provides further opportunities
The DNA platform provides further opportunities • 2022 (F) Global therapeutic protein sales • Modular and flexible antigen presenting cell ~USD 300bn1 targeted vaccines • In situ production of recombinant • Clinically proven technology for therapeutic proteins highly attractive inducing dominating C
Slide 36: Fold increase of HPV16-specific T cell responses highest in responders
Fold increase of HPV16-specific T cell responses is highest in responders and lowest in progressive disease patients HIGHER T CELL RESPONSES IN PATIENTS WITH DISEASE CONTROL 50 10 Fold change (peak) 8 6 4 2 0 CR/PR SD PD (n=8) (n=16) (n= 12) Kruskal-Wallis test Nykode Therapeutics | VB C-02 Data Pre
Slide 37: Swimmers' plot of responders with baseline information
Swimmers’ plot of responders with baseline information1 Duration of response, DOR (n = 9) Further background: 8 responder patients have a squamous cell carcinoma histology, 1 unknown The responders have received standard prior chemotherapies, including some patients with additional bevacizumab a