Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — 41st Annual J.P. Morgan Healthcare Conference (January 2023)
35 slides from Nykode Therapeutics Asa's conference presentation, Jan 9, 2023
Slide 1: 41st Annual J.P. Morgan Healthcare Conference
41st Annual J.P. Morgan Healthcare conference January 9, 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: 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 5: Pipeline
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 cancer; locally Individu
Slide 6: 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 7: Technology platform
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Slide 8: Unique APC targeted immunotherapy technology for cancer, infectious disease and autoimmunity
Unique Antigen Presenting Cell (APC) targeted immunotherapy technology for cancer, infectious disease and autoimmunity MODULAR IMMUNOTHERAPY INCLUDES THREE DISTINCT COMPONENTS Nykode’s immunotherapies may be delivered through DNA, mRNA, viral vectors or as recombinant proteins DNA plasmid encoding V
Slide 9: Vaccine induces a rapid, robust and long-lasting CD8 T cell response
Vaccine induces a rapid, robust and long-lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential 9
Slide 10: Controlled cross-presentation by specific APC receptor targeting induces broader 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 11: Nykode's modular platform unlocks multiple applications across targets and therapeutic areas
Nykode’s modular platform unlocks multiple applications across targets and therapeutic areas APC-specific Ag delivery and Expanded use of modularity stimulation Building additional Novel Cancer Infectious disease modules combinations and immunotherapies immunotherapies structures Immunotherapies aga
Slide 12: VB10.16 in HPV16+ cancers
VB10.16 in HPV16+ cancers Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential 12
Slide 13: HPV16+ cancers represent significant unmet need
HPV16+ cancers represent significant unmet need Prophylactic HPV vaccination program coverages suggest a continued need Approximately 58,500 new HPV16+ cancer cases per HPV vaccination program is not expected to impact year in the U.S. and EU51 the rate of HPV related cancer incidence for the next d
Slide 14: VB10.16: HPV16-targeted immunotherapy with broad potential across HPV-driven cancers
VB10.16: HPV16-targeted immunotherapy with broad potential across HPV-driven cancers FINALIZED. REPORTED ONGOING. REPORTED EXPANSION PLANNED FOR 2023 FURTHER POTENTIAL POSITIVE DATA POSITIVE INTERIM DATA C-01 Pre- C-02 C-03 C-04 Other HPV+ cancerous Cervical Head and Cervical driven cancers Cervical
Slide 15: C-02 included a heavily pre-treated population with advanced cervical cancer
C-02 included a heavily pre-treated population with advanced cervical cancer Study design Characteristic N (%) Age (mean) 48.9 yrs Age (median) 47.0 yrs Fully enrolled with 52 patients Prior systemic treatment lines 1 12 (31%) Conducted in Europe in 6 countries 2 15 (39%) Enrolled patients rec
Slide 16: Positive interim results from Phase 2 study of VB10.16 with TECENTRIQ in advanced cervical cancer
Positive interim results from Phase 2 study of VB10.16 in combination with TECENTRIQ® in advanced cervical cancer ► Heavily pre-treated (1-5 lines of prior systemic therapy) recurrent/metastatic cervical cancer patient population Anti-tumor activity observed in majority of patients including 2 CRs a
Slide 17: Anti-tumor activity in patients with positive and negative baseline PD-L1 status
Anti-tumor activity was observed both in patients with positive and negative baseline PD-L1 status Tumor regression in PD-L1 +/- 1 0 0 PD-L1 pos PD-L1 ORR (n/N) DCR (n/N) PD-L1 neg status 5 0 % change lesion size 20 Positive 27% (6/22) 77% (17/22) 0 (TIC 1-2) -30 -5 0 Negative N=33 17% (2/12) 58% (7
Slide 18: Strong HPV16-specific T cell responses associated with clinical response
Strong HPV16-specific T cell responses were associated with clinical response in advanced cervical cancer patients PROGRESSION FREE SURVIVAL IN T CELL VS BEST OVERALL RESPONSE HIGH/LOW T CELL RESPONDERS Best Overall Response 1000 Strong HPV16-specific IFN-g T cell response associated SFU/106 PBMC 10
Slide 19: Safety and tolerability
Safety and tolerability VB10.16 was generally well-tolerated and has a favorable safety profile TRAEs considered related to VB10.16 System Organ Class Any Grade 3 Grade 4-5 Preferred Term Grade N=50 (%) N=50 (%) VB10.16 in combination with atezolizumab was N=50 (%) generally well-tolerated All TRAEs
Slide 20: VB10.NEO - Individualized cancer immunotherapy
VB10.NEO- Individualized cancer immunotherapy Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential 20
Slide 21: VB10.NEO: Individualized neoantigen immunotherapy for broad range of solid tumor indications
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 22: 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 23: VB N-01 - Population and baseline characteristics
VB N-01 – Population and baseline characteristics VB N-01 included a population with various pre-treated and advanced cancer types Population* N Characteristic N (%) Characteristic N (%) VB10.NEO dosed patients (safety population) 41 Mean Age (range) 62.6 yrs (33-81 ys) Prior systemic treatment line
Slide 24: 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 25: VB10.NEO amplifies pre-existing T-cell responses and induces novel T-cell 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 26: 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 27: T cells express multiple cytotoxic cytokines with anti-tumor activity
The T cells express multiple cytotoxic cytokines known to have effective anti-tumor activity Polyfunctional CD8 and CD4 T cell responses RCC SCCHN Melanoma VB10.NEO induced the CD4 CD8 CD4 CD8 CD4 CD8 desired T cell cytokine profile: • Polyfunctional • Th1/Tc1 cytokine 0 1 -0 0 1 C D 4 01-001 CD8 01
Slide 28: VB10.COV2
VB10.COV2 Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential 28
Slide 29: VB10.COV2: Pan-variant T-Cell COVID vaccine
VB10.COV2: Pan-variant T-Cell COVID vaccine Immunotherapy for SARS-CoV2 targeting Spike and conserved T cell epitopes, collaboration with Adaptive Study design Dose escalation study with T cell candidate D-01 VB10.2210 (0.3, 1 and 3 mg) Healthy individuals previously vaccinated with 2-3 mRNA Spi
Slide 30: Financial overview
Financial overview Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential 30
Slide 31: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $212m end 3Q 2022 Key financials 9M 2022: Successful listing on main list of Revenues: $5.7m Oslo Stock Exchange in June 2022 Total operating expenses: $44.5m Included in Oslo Børs Benchmark Index (OSEBX) and Oslo Børs N
Slide 32: 2022 Achievements
2022 Achievements VB10.16 VB10.2210 VB10.NEO All Cervical Head and COVID Individualized Manufacturing Cancer Neck Cancer Cancer Vaccine Reported positive Entered into an Reported positive Reported positive Entered into interim results from agreement with results from Ph 1/2 immunogenicity results st
Slide 33: Upcoming Milestones
Upcoming Milestones 1H VB10.16 Updated durability results from Phase 2 study; minimum 2023 Cervical Cancer 12 month follow-up 1H VB10.16 First patient dosed in C-03 trial with KEYTRUDA® in 2023 Head and Neck Cancer patients with unresectable recurrent or metastatic disease Initiate potentially regis
Slide 34: Global leader in APC-targeted vaccine technology
Global leader in APC-targeted vaccine technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$800M) Proprietary vaccines targeting antigens to Antigen-Presenting Cell (APC) and generate strong CD8 killer T cell responses correlated with clinical responses in cervical cancer and other solid tumors Modular
Slide 35: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Agnete Fredriksen CBO IR@nykode.com Nykode Therapeutics | J.P. Morgan Healthcare Conference | Non-confidential
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