Nykode Therapeutics ASA · OSL:NYKD
Nykode Therapeutics ASA — Investor Presentation (September 2023)
46 slides from Nykode Therapeutics ASA's investor presentation, September 2023
Slide 1: Company Presentation September 2023
Company Presentation September, 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: Global leader in APC-targeted immunotherapy technology
Global leader in APC-targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$800M) Proprietary immunotherapies targeting antigens to Antigen-Presenting Cell (APC) and generating strong CD8 killer T cell responses correlated with clinical responses in solid tumors Modular, versatile
Slide 4: Nykode executive management
Nykode executive management Experienced and international management team MICHAEL ENGSIG AGNETE FREDRIKSEN MIKKEL W. PEDERSEN KLAUS EDVARDSEN HARALD GURVIN Chief Executive Officer Chief Business Officer & Chief Scientific Officer Chief Development Officer Chief Financial Officer Co-founder Nykode Th
Slide 5: Top-tier collaborations for cancer and infectious disease vaccines
Top-tier collaborations for cancer and infectious disease vaccines valued potentially more than $1.64 billion plus royalties Partner Collaboration Terms Clinical Development $925M~ Regeneron to develop and potentially Multi-target license and $30M upfront commercialize products collaboration agree
Slide 6: 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 3 Regeneron Undisclosed programs Internal Undisclosed 4 Melanoma, lung, bladder, renal, VB10.NEO head and neck cance
Slide 7: Unique APC targeted modular immunotherapy Vaccibody technology
Unique antigen presenting cell (APC) 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 b
Slide 8: Vaccibody vaccine induces a rapid, robust and long-lasting CD8 T cell response
Vaccibody vaccine induces a rapid, robust and long-lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | Company Presentation 8
Slide 9: Controlled cross-presentation induces broader and stronger CD8 responses
Controlled cross-presentation by specific APC receptor targeting induces broader & stronger CD8 responses than non-targeted technologies such as mRNA- and peptide vaccines Comparison with peptide and RNA vaccination strategies shows broader CD8 Addition of strong CD8 responses to epitopes and CD4 re
Slide 10: VB10.16 in HPV16+ cancers
VB10.16 in HPV16+ cancers Nykode Therapeutics | Company Presentation 10
Slide 11: 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 12: 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 HPV+ cervical cancer HPV-related cancer incidence is expected to grow • 4th most common cancer in women worldwide HPV+ cervical cancer HPV+ HNSCC • 4th leading cause of can
Slide 13: VB C-02: VB10.16 plus atezolizumab 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 14: Recent clinical progress has increased survival outcomes in advanced cervical cancer
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 15: 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 16: 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 17: 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 patients2 PD-L1+ 3 Value 95% CI Value 95% CI Strong and durable anti-tumor efficacy ORR 19% (9%-33%) 29% (13%-51%) across
Slide 18: 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 | Company Presentation 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
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: VB10.16 Ph2 data 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 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
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: VB10.NEO - Individualized cancer immunotherapy
VB10.NEO- Individualized cancer immunotherapy Nykode Therapeutics | Company Presentation 26
Slide 27: VB10.NEO: Individualized neoantigen immunotherapy for solid tumors
VB10.NEO: Individualized neoantigen immunotherapy for the treatment of broad range of solid tumor indications ONGOING. REPORTED POSITIVE INTERIM DATA. ONGOING IN >10 INDICATIONS, COLLABORATION WITH GENENTECH N-01 N-02 ◆VB10.NEO in combination with CPI ◆Dose escalation 3-9 mg VB10.NEO in ◆Melanoma, l
Slide 28: VB10.NEO: leading technology for individualized cancer neoantigen immunotherapy
VB10.NEO: leading technology for individualized cancer neoantigen immunotherapy Strong in-house bioinformatic competences and proprietary neoantigen selection method Trained on Vaccibody’s data and unique broad CD8 dominated immune response Focus on clonal and clinically relevant epitopes High
Slide 29: T-cell responses to the majority of selected neoepitopes
T-cell responses to the majority of selected neoepitopes % immunogenic Neoepitopes per patient 100% of patients across five indications showed a response to at least three Indication neoepitopes (at least one time point) UC 60 51% % of neoepitopes SCCHN 35% On average, 53% of selected 40 24% neoepit
Slide 30: VB10.NEO amplifies pre-existing T-cell responses and induces novel specificities
VB10.NEO amplifies pre-existing T-cell responses and induces multiple novel T-cell specificities Expansion of pre-existing and induction of novel T cells De novo response Expansion of both pre-existing and novel Amplified response T-cell responses in most patients (at least Indication Stable respons
Slide 31: Majority of neoepitopes activate CD8 T cells
Preliminary immune phenotyping shows that the majority of neoepitopes activate CD8 T cells CD8 T cells response detected No CD8 T cells response detected T cell responses are characterized by both CD8 and CD4 T cells 53% 100% 75% 100% 100% 80% (at week 22) 01-001 01-005 01-002 01-004 01-006 02-003 C
Slide 32: Autoimmunity and Further platform potential
Autoimmunity and Further platform potential Nykode Therapeutics | Company Presentation 32
Slide 33: Building a new therapeutic area focusing on Autoimmunity
Building a new therapeutic area focusing on Autoimmunity Opening up a new therapeutic market with high unmet medical need • Differentiated platform technology, IP protected • Building on the unique APC-targeted competence for cancer vaccines • Focusing on dampening the antigen-specific immune Henrik
Slide 34: Tolerance induction
Tolerance induction MECHANISM OF ACTION – TOLERANCE INDUCTION Cells transfected with DNA plasmid vaccine CD4+ Treg Tol APC CD4+ Treg Tol APC Effector T Effector T cell cell Cells encode and secrete Tol APC-targeted The Tol APCs present vaccine antigens in a tolerogenic milieu The Tregs inhibit or de
Slide 35: Modular platform designed to unlock multiple applications
Nykode’s modular platform is designed to unlock multiple applications across targets and therapeutic areas APC-specific Ag delivery and stimulation Expanded use of modularity Infectious Building Novel Cancer disease additional combinations and immunotherapies immunotherapies modules structures Immun
Slide 36: Financial overview
Financial overview Nykode Therapeutics | Company Presentation 36
Slide 37: Rich calendar of milestones expected in the next months
Rich calendar of milestones expected in the next 12 months VB10.16 ✓ H1 2023 Final results from VB-C-02 Phase 2 study; 12 month treatment follow-up Cervical Cancer First patient dosed in C-03 trial with KEYTRUDA® in patients with PD-L1 positive 1st Q3 VB10.16 2023 line unresectable recurrent or meta
Slide 38: Global leader in APC-targeted immunotherapy technology
Global leader in APC-targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$800M) Proprietary immunotherapies targeting antigens to Antigen-Presenting Cell (APC) and generating strong CD8 killer T cell responses correlated with clinical responses in solid tumors Modular, versatile
Slide 39: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $174m end Q2 2023 Financially well positioned to execute the Company’s strategy over the next years Nykode continues to explore a potential listing on the Nasdaq Global Market in the United States Nykode Therapeutics | Company
Slide 40: Save the Date: Capital Markets Days
SAVE THE DATE! Nykode to a host a Capital Markets Days in NYC and Oslo. Members of the Management Team and a Key Opinion Leader will present latest updates on the Vaccibody platform and its clinical programs: • NYC - September 20, 2023 • Oslo - September 27, 2023 Stay tuned! Nykode Nykode Therapeuti
Slide 41: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@nykode.com Nykode Therapeutics | Company Presentation
Slide 42: VB C-01: First trial with VB10.16 as monotherapy in precancerous lesions
VB C-01: First trial with VB10.16 as monotherapy for treatment of HPV16+ precancerous lesions VB C-01 Exploratory, open labelled, multi-centre study in patients with HPV16+ High Grade Cervical Intraepithelial Neoplasia (HSIL, CIN 2/3) Dosing phase (3mg per dose) Expansion phase 8 patients Cohort 1:
Slide 43: Correlation of immune response strength and lesion size reduction
VB10.16: Strong correlation with strength of induced HPV16- specific immune response and lesion size reduction 13 of 14 patients showed COHORT 1: COHORT 2: LESION SIZE REGRESSION increased T cell responses 0 – 3 – 6 WEEKS 0 – 4 – 12 WEEKS CORRELATES WITH STRONG after vaccination with HPV-16 SPECIF
Slide 44: Homologous booster dose induced strong T cell responses
VB10.16: homologous booster dose induced strong T cell responses in all patients in the expansion cohort HOMOLOGOUS BOOST ENSURE STRONG AND LONG-LASTING T STRONG HPV16-SPECIFIC T CELL REPSONSES IN ALL CELL RESPONSE PATIENTS IN THE EXPANSION COHORT The vaccination regimen from cohort 1 (Q3W) plus a
Slide 45: Correlation between T cell responses and lesion size across all cohorts
VB10.16: highly significant correlation between vaccine induced HPV16-specific T cell responses and lesion size across all cohorts LESION SIZE REGRESSION SIGNIFICANT CORRELATION OBSERVED WITH % LESION SIZE REDUCTION AND CORRELATES WITH HPV-16 SPECIFIC # SFU/MILL RESPONSES • Cohort 1 • Cohort 2 • Exp
Slide 46: Promising clinical data as monotherapy in pre-cancerous lesions
Promising clinical data as monotherapy in pre-cancerous lesions Lesion size reduction observed in majority of subjects (16 of 17) in the Expansion cohort CIN regression to CIN1 or no CIN in 10 subjects HPV16 and/or p16 clearance in 8 subjects Upregulation of PD-L1 in lesions post-vaccination
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