Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — JPM Healthcare Conference 2024
35 slides from Nykode Therapeutics Asa's conference presentation, Jan 10, 2024
Slide 1: JPM Healthcare Conference
JPM Healthcare Conference San Francisco | January 10, 2024
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 antigen presenting cell (APC)-targeted immunotherapy technology
Global leader in antigen presenting cell (APC)-targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$625M1) Differentiated immunotherapies targeting antigens to Antigen-Presenting Cell (APC) to direct tailor-made immune responses with focus on oncology and autoimmune diseases Onc
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 valued at more than $1.64bn plus royalties
Top-tier collaborations for cancer and infectious disease vaccines valued at more than $1.64bn plus royalties Partner Collaboration Terms Clinical Development $925M~ Regeneron to develop and potentially Multi-target license and $30M upfront commercialize products collaboration agreement to $20M
Slide 6: Rich and diversified pipeline
Rich and diversified pipeline Upcoming Asset Indication Rights Preclinical Phase 1 Phase 2 Phase 3 Catalyst Oncology 1 Initiate trial HPV16+ cervical cancer C-02, C-04 (Q1 2024) 2 Dose level VB10.16 HPV16+ head and neck cancer C-03 recommendation (H2 2024) 2 Off-the-shelf HPV16+ locally advanced Pro
Slide 7: Balanced portfolio designed to address all stages of disease from pre-malignant to late-stage cancer
Balanced portfolio designed to adress all stages of disease from pre-malignant to late-stage cancer treatment Strategic expansion of vaccine candidate portfolio Recurrent and/or Metastatic Locally advanced Pre-Malignant Off-the-shelf C-02 HPV16+ Cervical C-05 C-01 Cancer C-04 VB10.16 HPV16+ C-03 SCC
Slide 8: Vaccibody vaccine induces a rapid, robust and long-lasting CD8 T cell response against cancer cells
Vaccibody vaccine induces a rapid, robust and long-lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 8
Slide 9: VB10.16 in HPV16+ cancers
VB10.16 in HPV16+ cancers Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 9
Slide 10: 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 Off-the-shelf vaccine Targeting the cancer-specific full-length HPV16 E7 target
Slide 11: HPV16+ cervical cancer is a significant unmet need
HPV16+ cervical cancer is a significant unmet need Cervical cancer incidence worldwide ~130,000 new HPV16+ cancer cases per year • 4th most common cancer in (U.S. and Europe1) women worldwide • 4th leading cause of cancer- 23% related death • Prognosis is poor for recurrent and/or metastatic Anal/Vu
Slide 12: HPV+ cancer incidence is expected to increase despite prophylactic HPV vaccination
HPV+ cancer incidence is expected to increase despite prophylactic HPV vaccination U.S. + EU5 + China + Japan HPV+ CERVICAL CANCER HPV+ HNSCC DIAGNOSED INCIDENT CASES1 DIAGNOSED INCIDENT CASES2 +74% 222,412 163,982 +65% 128,051 112,081 99,250 67,794 2010 2020 2030 2010 2020 2030 1 GlobalData Cervica
Slide 13: VB10.16 C-02 data compare strongly to CPI monotherapy as well as expected SoC in 2L r/m cervical cancer
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 in Pembrolizumab Cemiplimab in Tisotumab vedotin atezolizumab PD-L1+††† in PD-L1+** PD-L1+ †† (PD-L1 agnostic) ‡ ‡ in PD-L1+ Skyscraper-04, Empo
Slide 14: Maximizing addressable patient populations by diversifying offerings and broadening therapeutic scope
Maximizing addressable patient populations by diversifying offerings and broadening therapeutic scope Building a cancer vaccine franchise following strong clinical validation Validation Today Future Opportunities C-05 Adjuvant Settings Move earlier to expand patient population and Indication Expansi
Slide 15: Creating a portfolio of targeted vaccines for HPV16+ cancers
Creating a portfolio of targeted vaccines for HPV16+ cancers VB10.16 portfolio C-02 C-03 C-04 C-05 r/m head and neck r/m Cervical Cancer, ≥2L r/m Cervical Cancer, Locally Advanced Indication cancer (HNSCC), PD-L1+, 2L Cervical Cancer (LACC) PD-L1+, 1L Up to 9 mg in 3 mg in combination with combinati
Slide 16: VB10.NEO Individualized cancer vaccine
VB10.NEO Individualized cancer vaccine Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 16
Slide 17: Nykode's individualized cancer vaccine is designed to target a broad range of tumours
Nykode’s individualized cancer vaccine is designed to target a broad range of tumours Vaccine design Key clinical results • APC-targeted vaccine technology leverages targeting unit to enhance CD8+ response ♦ 2 clinical trials in more • Induces immune response in hard-to-treat patients with low TMB t
Slide 18: VB10.NEO data to date
VB10.NEO data to date Safety clearance of 9 mg dose with no safety concerns and no dose limiting toxicities observed N-01 N-02 r/m Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial Indication r/m cancer, covering more than ten indications cancer or squamous cell ca
Slide 19: Broad and durable neoantigen-specific T cell responses
Broad and durable neoantigen-specific T cell responses DURABLE NEO-AG SPECIFIC T CELL BROAD T CELL RESPONSES IN ALL PATIENTS RESPONSES, ALSO POST VACCINATION Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 19
Slide 20: NYK011: Vaccine aimed at reducing the burden of colorectal cancer
NYK011: Vaccine aimed at reducing the burden of colorectal cancer Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 20
Slide 21: Pipeline expansion aims at addressing patients ranging from high-risk pre-cancerous polyps to colorectal cancer
Pipeline expansion aims at addressing patients ranging from high- risk pre-cancerous polyps to colorectal cancer • Colorectal cancer develops from premalignant polyps on the colon or rectum’s mucosal surface • Disease development and screening programs represent an Broad patient population opportuni
Slide 22: Potential first-in-class program built on Nykode's unique technology creating customized immune responses
Potential first-in-class program built on Nykode’s unique technology creating customized immune responses • NYK011 is a potential first-in-class oncology vaccine program based on careful selection and novel combination of tumor-associated antigens (TAA) • Leverages Nykode’s expertise to elicit stron
Slide 23: Autoimmunity and further platform potential
Autoimmunity and further platform potential Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 23
Slide 24: Induction of antigen specific tolerance can be achieved by targeting disease causing epitopes to tolerogenic APCs
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 Effector DNA plasmid B cell vaccine Tol CD4+ Treg APC CD4+ Treg Tol APC Effector Effector T cell T
Slide 25: DNA vaccination with Vaccibody targeting tolerogenic APCs prevents type 1 diabetes in a spontaneous mice model
DNA vaccination with Vaccibody targeting tolerogenic APCs prevents type 1 diabetes in a spontaneous mice model Type 1 diabetes is an autoimmune disease where the immune system attacks insulin producing cells in the pancreas Day 0 day 7 day 14 The Non-Obese Diabetic (NOD) model is a mouse diabetes mo
Slide 26: DNA vaccination with Vaccibody induces long-lasting efficacy post treatment
DNA vaccination with Vaccibody induces long-lasting efficacy post treatment Dosing once weekly until week 16 Week 16 of treatment Wk 0 Wk 1 Wk2 Wk 3 Wk 4 Wk 5……… Weekly monitoring Remove treatment Still ongoing 9 wk old mice NOD DIABETES MODEL (ONGOING STUDY) VB vaccine Incidence of of Incidence dia
Slide 27: Recombinant Vaccibodies targeting tolerogenic DCs prevents serious disease in a mouse model of multiple sclerosis
Recombinant Vaccibodies targeting tolerogenic DCs prevents serious disease in a mouse model of multiple sclerosis EXPERIMENTAL AUTOIMMUNE ENCEPHALOMYELITIS (EAE) MODEL Daily clinical scores Paralysis ✱✱✱ 4 ✱✱ day -7 day -3 day 0 Day 29 80 3 Disease Termination 60 EAE score induction AUC (5-29) 2 40
Slide 28: Dose-dependent decrease in disease associated cytokines induced by Nykode's inverse vaccines
Dose-dependent decrease in disease associated cytokines induced by Nykode’s inverse vaccines, differentiated from Ag alone EAE MODEL Immune parameter read-out at day 15 (at peak of disease) day -7 day -3 day 0 day 15 MOG(35-55) recall assay using splenocytes Disease Termination and ✱✱✱ induction imm
Slide 29: mRNA oncology vaccine
mRNA oncology vaccine Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 29
Slide 30: Nykode's APC targeting technology can leverage mRNA vaccines and presents opportunity for platform expansion
Nykode’s APC targeting technology can leverage mRNA vaccines and presents opportunity for platform expansion • mRNA vaccines have recently proven to have clinical potential in adjuvant melanoma compared to SoC (KEYNOTE-942) • Targeted delivery via APCs using Nykode’s technology has been shown to ind
Slide 31: Nykode's APC targeting technology leads to faster, stronger and broader T cell responses in mRNA vaccines
NYKODE’S VACCIBODY TECH Nykode’s APC targeting technology leads IMPROVES mRNA VACCINES to faster, stronger and broader T cell Stronger & broader T cell response after prime responses in mRNA vaccines 2000 ✱ N01 N02 N03 N04 N05 1500 IFNg SFU/million cells N06 • Preclinical data shows that using APC t
Slide 32: Financial overview & outlook
Financial overview & outlook Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential 32
Slide 33: Strong financial foundation for achieving our vision
Strong financial foundation for achieving our vision Cash position of $159m end Q3 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 | JPM Hea
Slide 34: Upcoming milestones
Upcoming milestones Q1 VB10.16 Initiate potentially registrational VB-C-04 trial in the U.S. in patients with 2024 Cervical Cancer recurrent/metastatic disease and PD-L1 positive tumors Q1 VB10.16 2024 Cervical Cancer Updated survival data from VB-C-02 Phase 2 trial Oncology H2 VB10.16 Recommended P
Slide 35: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Alexandra Deschner Head of Investor Relations IR@nykode.com Nykode Therapeutics | JPM Healthcare Conference | Non-Confidential