Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Investor Presentation (October 2024)
77 slides from Nykode Therapeutics Asa's investor presentation, Oct 1, 2024
Slide 1: Company Presentation
Company Presentation October 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 APC-targeted immunotherapy technology
Global leader in antigen presenting cell (APC)-targeted immunotherapy technology NYKODE THERAPEUTICS (NYKD-OL, MKT CAP ~$140M1) Differentiated immunotherapies targeting antigens to Antigen-Presenting Cells (APCs) direct tailor-made immune responses with focus on oncology and autoimmune diseases Broa
Slide 4: Nykode executive management
Nykode executive management Experienced and international management team Michael Engsig Agnete Fredriksen Klaus Edvardsen Harald Gurvin Louise Stubbe Ulrich Blaschke CEO CSO & BD Chief R&D Officer CFO CLO CTO Nykode Therapeutics | Company Presentation - October 2024
Slide 5: Top-tier collaborations for cancer and infectious disease vaccines
Top-tier collaborations for cancer and infectious disease vaccines valued at potentially >$1.64 bn plus royalties Partner Collaboration Terms Clinical Development $925M~ Regeneron to develop and potentially Multi-target license and $30M upfront commercialize products collaboration agreement to $
Slide 6: Broad pipeline targeting early to late-stage cancer treatment
Broad pipeline targeting early to late-stage cancer treatment Upcoming Asset Indication Rights Preclinical Phase 1 Phase 2 Phase 3 Catalyst Oncology 1 HPV16+ cervical cancer C-02 Publication of final data 2 Dose level HPV16+ head and neck cancer C-03 recommendation VB10.16 (2H 2024) Off-the-shelf 2
Slide 7: Modular vaccine technology allows APC-targeting to direct immune responses
Modular vaccine technology allows APC-targeting to direct immune responses DNA plasmid Targeting unit to attract and bind APCs encoding Ability to tailor the targeting unit enables induction of different immune response Nykode vaccine profiles to specific diseases1 Dimerization unit for crosslinking
Slide 8: Cancer vaccine platform induces rapid, robust CD8 T cell response
Nykode’s cancer vaccine platform induces a rapid, robust and long-lasting CD8 T cell response against cancer cells MECHANISM OF ACTION – T CELL INDUCTION Nykode Therapeutics | Company Presentation - October 2024 8
Slide 9: APC receptor targeting induces broader and stronger CD8 responses
APC receptor targeting induces broader and stronger CD8 responses than non-targeted mRNA and peptide vaccines Comparison with peptide and RNA vaccination strategies shows broader CD8 Addition of strong CD8 responses to epitopes and CD4 responses with Nykode’s technology non/weakly-immunogenic with o
Slide 10: APC targeted vaccine induce potentiated CD8 T cell phenotypes
APC targeted vaccine induce potentiated CD8 T cell phenotypes cell cycle • Prominent increased expression of cell cycle, checkpoint and effector genes with VB10.NEO compared to peptide + adjuvant checkpoint vaccines • CD8 T cell transcription factor profile consistent with higher chemokine receptors
Slide 11: VB10.16 in HPV16+ cancers
VB10.16 in HPV16+ cancers Nykode Therapeutics | Company Presentation - October 2024 11
Slide 12: 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 13: HPV16+ cervical cancer is a significant unmet need
HPV16+ cervical cancer is a significant unmet need Cervical cancer incidence in US and continental Europe ~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
Slide 14: HPV16+ incidence expected to rise despite preventive vaccination
HPV16+ incidence expected to rise despite preventive vaccination efforts HPV16+ incidence is slowly increasing in CC and HNSCC • The preventive vaccines do not exert therapeutic effects in patients with pre-existing HPV infections and HPV- +1% associated lesions, as neither infected basal epithelial
Slide 15: 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 16: Recent clinical progress in advanced cervical cancer, room for improvement
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 17: 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 18: 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 19: VB10.16 C-02 data compare strongly to CPI monotherapy and SoC
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 Pembrolizumab Cemiplimab in Tisotumab vedotin in PD-L1+ PD-L1+††† in PD-L1+** PD-L1+ †† (PD-L1 agnostic) ‡ ‡ (analysis from Apr
Slide 20: 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 - October 2024 20
Slide 21: VB10.16 led to prolonged overall survival
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 22: 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 500 250 SFU/106 PBMC 10 Fold c
Slide 23: HPV16 circulating tumor DNA dynamics associated with clinical response
HPV16 circulating tumor DNA dynamics is associated with clinical response ALL PATIENTS WITH CLINICAL RESPONSE PER RECIST 1.1 EARLY CTDNA DYNAMICS (WEEK 9-11) ASSOCIATED WITH HAVE MOLECULAR RESPONSE IMPROVED CLINICAL OUTCOME DCR PD Increase Decrease Disease control N=16 5 (31%) 11 (69%) All patients
Slide 24: T cell responses remain strong and long-lasting
T cell responses remain strong and long-lasting T cell clonotype analysis EXPANSION OF NOVEL AND EXPANDED RAPID AND PERSISTENT EXPANSION OF T CELL CLONES CLONES ON TREATMENT • Novel expanded clones constituted a median of • Rapid and persistent on-treatment T cell expansion 0.66% of the peripheral T
Slide 25: Patient case: longitudinal T cell clonal expansion
Patient case: longitudinal T cell clonal expansion Persistent expansion of novel and pre-existing clones throughout the treatment FREQUENCY OF EXPANDED CLONOTYPES NUMBER OF EXPANDED CLONES A persistent expansion of Pre-exising expanded novel and pre-existing Novel clones throughout the treatment p
Slide 26: C-02 data supports expanding clinical development of VB10.16
C-02 data strongly supports expanding clinical development of VB10.16 in combination with ICI 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 competiti
Slide 27: VB10.16: Finalized / ongoing trials and upcoming catalysts
VB10.16: Finalized / ongoing trials and upcoming catalysts Asset Indication Dose Phase 1 Phase 2 Phase 3 Next Milestone VB10.16 High Grade Cervical Final data presented C-01 Intraepithelial 3 mg monotherapy Final Neoplasia (HSIL; CIN 2/3) and published Final data to be 3 mg in combination with C-02
Slide 28: VB-C-05 locally advanced cervical cancer
VB-C-05 locally advanced cervical cancer • Clinical collaboration with MSD to evaluate VB10.16 in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive high-risk locally advanced cervical cancer • Incorporate VB10.16 into the existing treatment Clinical collaboration regimen of
Slide 29: VB10.NEO - Individualized cancer immunotherapy
VB10.NEO- Individualized cancer immunotherapy Nykode Therapeutics | Company Presentation - October 2024 29
Slide 30: Individualized cancer vaccine 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 31: New Patent Granted for VB10.NEO
New Patent Granted for VB10.NEO • VB10.NEO: Nykode’s fully individualized neoantigen based vaccine. • U.S. Patent No. 12,059,459: entitled, “Therapeutic Anticancer Neoepitope Vaccine.” • Patent Expiration: The 20-year expiration date of this U.S. Patent No. patent is January 5, 2037. 12,059,459 • Re
Slide 32: VB10.NEO programs
VB10.NEO programs 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 carcin
Slide 33: T cell responses to majority of selected neoepitopes
T cell responses to majority of % immunogenic Neoepitopes per patient selected neoepitopes Indication UC All patients across five indications SCCHN 60 51% showed a response to at least one % of neoepitopes neoepitope 35% 40 24% RCC On average, 53% of selected 20 15% 10% neoepitopes were immunogenic,
Slide 34: 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 35: Immune phenotyping shows neoepitopes activate CD8 T cells
Preliminary immune phenotyping shows that the majority of neoepitopes activates CD8 T cells CD8 T cells response detected Selected patients No CD8 T cells response detected T cell responses are characterized by both CD8 and CD4 T 53% 100% 75% 100% 100% 80% cells 01-001 01-005 01-002 01-004 01-006
Slide 36: Multiple vaccinations boost breadth and magnitude of T cell responses
Multiple vaccinations boost the breadth and magnitude of functional T cell responses Patients completing 1-Year of treatment Breadth Magnitude 20 40000 Increase in the breadth and 30000 magnitude of functional T cell responses observed over time. Number of increased neoantigens 15 15000 Stacked SFU/
Slide 37: Vaccine-specific T cells remain functional up to 1-year after vaccination
Vaccine-specific T cells remain functional and immunogenic up to 1-year after last vaccination VB10.NEO induces a favorable and long-lasting T cell memory phenotype Nykode Therapeutics | Company Presentation - October 2024 37
Slide 38: T cell responses per patient
T cell responses per patient Total T cell responses De novo T cell responses Patients grouped in lower and higher than median immune responses Patients included are overlapping between EFR and FAS (N=32). Nykode Therapeutics | Company Presentation - October 2024 38
Slide 39: VB10.NEO key differentiators
Solid manufacturing chain Safety Safety profile similar to 100% successful checkpoint inhibitor monotherapy vaccine production No increase in immune-related Robust supply chain adverse events NeoSELECT Immune response High fraction of VB10.NEO Induces broad and strong immunogenic neoanti
Slide 40: mRNA oncology vaccine
mRNA oncology vaccine Nykode Therapeutics | Company Presentation - October 2024 40
Slide 41: APC targeting technology can leverage mRNA vaccines
Nykode’s APC targeting technology can leverage mRNA vaccines and presents opportunity for platform expansion Targeted delivery via APCs using Nykode’s technology has been shown to induce broader and stronger CD8+ immune responses vs. existing ‘antigen-alone’ approaches. Preclinical studies have demo
Slide 42: The Nykode vaccine elicits stronger T cell responses
The Nykode vaccine elicits stronger T cell responses The Nykode vaccine elicits stronger T cell responses across a range of mRNA-LNP doses single (prime) vaccination prime + boost vaccination C57BL/6 n=5 per group | Vaccination (1ug) on day 0 & 21 | IFN-g fluorospot on day 7 (prime) & 28 (prime + bo
Slide 43: The Nykode vaccine elicits broader T cell responses
The Nykode vaccine elicits broader T cell responses that are biased toward cytotoxic CD8+ T cells Nykode vaccine targets more neoantigens Induction of Cytotoxic CD8+ T Cells prime + boost vaccination 1ug dose 40000 N01 Number of neoantigen responses N02 16 35000 N03 +6 +6 IFNγ SFU/million cells N04
Slide 44: The Nykode vaccine provides superior tumor control
The Nykode vaccine provides superior tumor control The Nykode vaccine led to efficient tumor rejection, slowed tumor growth, and increased survival Average Tumor Volume (mm3) 2000 Control Nykode Control Nykode Antigen Tumor Volume (mm3) 1500 Antigen 2000 2000 2000 1500 1500 1500 1000 1000 1000 1000
Slide 45: Autoimmunity and further platform potential
Autoimmunity and further platform potential Nykode Therapeutics | Company Presentation - October 2024 45
Slide 46: Strong rationale for moving into Immune Tolerance
Strong rationale for moving into Immune Tolerance Autoimmune disease Inverse vaccines present The field is gaining therapy relies on broadly a new promising avenue traction and partnership immunosuppressive with potential for long- interest from major therapies which leaves a lasting efficacy and pl
Slide 47: Recent autoimmunity updates substantiate potential of APC-targeted platform
Recent autoimmunity updates further substantiate the potential of Nykode’s APC-targeted platform • New data highlight the versatility and effectiveness of Nykode’s APC-targeting technology within the broad field of immune tolerance • Efficacy in therapeutic setting with two different APC-targeting u
Slide 48: Antigen specific tolerance by targeting 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 49: Modular design able to ensure antigen-specific immune tolerance
Modular design with multiple targeting and 4th modules able to ensure antigen-specific immune tolerance Module 1: Multiple targeting units for receptors on tolerizing APCs identified including natural ligands and other targeting molecules Module 3: Auto-antigens or allergens known to elicit unwanted
Slide 50: APC targeting is required for effective disease protection
APC targeting is required for effective disease protection EAE MODEL 30 µg 3 µg 0.3 µg Tol. TV004 TV042 5 5 APC 5 PBS 4 4 4 EAE score EAE score EAE score 3 3 3 2 2 2 1 1 1 0 0 0 6 8 10 12 14 16 18 20 22 24 26 28 6 8 10 12 14 16 18 20 22 24 26 28 6 8 10 12 14 16 18 20 22 24 26 28 MOG MOG Days post EA
Slide 51: Vaccibody delivers Ag-specific suppression of EAE
Vaccibody delivers Ag-specific suppression of EAE EAE MODEL – OVA CONTROL TV004 TV043 OVA control 5 4 MOG OVA EAE score (27-63) (323-339) 3 TV004 2 TV043 Daily clinical scores PBS day -3 day 0 day 28 1 day -7 EAE Termination 0 induction i.v. 6 8 10 12 14 16 18 20 22 24 26 28 Pertussis toxin Days pos
Slide 52: Disease prevention in EAE model by targeting two different receptors
Disease prevention in the EAE model can be achieved by targeting two different receptors on tolerizing APCs MS MODEL Paralysis ✱✱✱ TV004 5 TV004 80 4 PBS Target 1 60 EAE score AUC (5-29) 3 40 Target 1 2 Daily clinical scores 20 MOG 1 day 28 (27-63) day -7 day -3 day 0 0 0 Tol. 6 8 10 12 14 16 18 20
Slide 53: Dose-dependent decrease in disease associated cytokines
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 54: Nykode vaccine prevents EAE disease in an early therapeutic setting
Nykode vaccine prevents EAE disease in an early therapeutic setting EAE MODEL – EARLY THERAPEUTIC DELIVERY TV004 5 ✱✱✱ TV004 100 4 PBS 80 EAE score MOG AUC (5-28) (27-63) 3 60 2 40 Daily clinical scores (5-28) 1 20 day 28 0 0 Termination EAE 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 PBS TV004 inductio
Slide 55: Unique benefits of APC-targeted platform for autoimmunity treatment
55 Advancements highlighting the unique benefits of Nykode’s APC-targeted platform for autoimmunity treatment Demonstrated Protection 2. Drug Loading Dependent on APC and Delivery - R&D targeting 3. Partnerships Versatile Format Nykode's inverse vaccines The effects were shown to The potent tolerizi
Slide 56: Autoimmune indications are an attractive platform expansion category
Autoimmune indications are an attractive platform expansion category Scientific Greenfield opportunity of APC- therapeutic Attractive Ability to add targeted vaccines to opportunity with commercial sizeable commercial drive antigen- broad range of opportunity; Top 10 potential to specific immune pot
Slide 57: Business model validated and ready to accelerate in autoimmune diseases
Nykode’s successful business model validated and ready to accelerate development in autoimmune diseases Expand candidate to all addressable Expansion into the First in patients broad potential of house candidate autoimmune disorders, towards the allergies and organ Clinical market transplantation Po
Slide 58: Tolerance Highlights
Competition Opportunities Autoimmune disease Limited competition within antigen specific tolerance Allergies Organ transplantation Partnership opportunities Medical Need New platform allows product Tolerance High unmet medical need areas specific collaborations Existing therapies are b
Slide 59: Unlocking the full potential of cancer vaccines
Unlocking the full potential of cancer vaccines Nykode Therapeutics | Company Presentation - October 2024 59
Slide 60: Dedicated to fill the gaps and offer a sustainable cancer vaccine platform
Nykode is dedicated to fill the gaps and offer a sustainable cancer vaccine platform CONTROL OF WHICH CELLS TAKE UP THE ANTIGEN AND HOW IT IS PRESENTED TO T CELLS THROUGH APC-TARGETING Superior immunogenicity • Broad response to multiple epitopes and reduced risk of tumor escape • Proven ability t
Slide 61: Future offering all cancer patients a vaccine at diagnosis
Unlocking possibilities for a future offering all cancer patients a vaccine at diagnosis Exploring the full range of cancer antigens INDIVIDUALIZED OFF-THE-SHELF Tumor-specific Tumor-associated Viral Antigens Neoantigens Antigens VB10.NEO VB10.16 Undisclosed Undisclosed Future in-house and partnered
Slide 62: 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 63: Financial overview & outlook
Financial overview & outlook Nykode Therapeutics | Company Presentation - October 2024 63
Slide 64: Income Statement
Income Statement Revenue from contracts with customers Amounts in USD ‘000 Q2 2024 Q2 2023 YTD 2024 YTD 2023 • R&D activities under Genentech and Regeneron Revenue from contracts with customers 544 5,000 1,371 8,126 agreements Other income 40 100 229 281 • $0.5m (Q2 2024) and $1.2m (H1 2024) under T
Slide 65: Balance Sheet
Balance Sheet Cash and cash equivalents Amounts in USD ‘000 30/06/2024 31/12/2023 • Strong cash position of $136.5m at June 30, 2024 ASSETS Non-current assets Other non-current receivables Property, plant and equipment 4,058 4,413 • Mainly reflects the NOK 325 million payment to the Right-of-use ass
Slide 66: Balance Sheet - contd.
Balance Sheet - contd. Amounts in USD ’0008 31/03/2024 31/12/2023 Equity EQUITY AND LIABILITIES • Total equity of $152m as per June 30, 2024 Equity Share capital 367 367 • Equity ratio of 85% Share premium 128,986 128,986 Other capital reserves 18,043 15,395 Other components of equity (3,044) (3,048
Slide 67: Upcoming milestones
Upcoming milestones Oncology • Recommended Phase 2 dose in PD-L1+ patients with 1st line recurrent/metastatic advanced head and neck cancer (C-03 trial) • H2 2024 Autoimmune • Update on Nykode’s inverse vaccine technology platform • Q4 2024 Other • Update on Nykode’s APC targeted vaccine technology
Slide 68: Our conviction in Nykode's platform has never been stronger
Our conviction in Nykode’s platform has never been stronger Differentiated immunotherapies targeting antigens to Antigen-Presenting Cells (APCs) direct tailor-made immune responses with focus on oncology and autoimmune diseases Clinical durability and survival data further supported today by long la
Slide 69: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Alexandra Deschner Head of Investor Relations IR@nykode.com Nykode Therapeutics | Company Presentation - October 2024
Slide 70: VB-C-01
VB-C-01
Slide 71: 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 72: 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 73: 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 74: Correlation between T cell responses and lesion size across 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 75: 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
Slide 76: VB-C-03
VB-C-03
Slide 77: VB-C-03 Clinical trial design
VB-C-03 Clinical trial design Combination treatment of VB10.16+pembrolizumab in 1L HPV16+ R/M HNSCC Phase 1 Dose escalation phase Phase 2a Dose expansion phase 9 9m 9 mg g mg Cohort A: RP2D* Interim analysis OBD** Final analysis No DLT RP2S VB10.16 9 9 9 mg mg mg VB10.16 dosing R No DLT 6 6 6 DLT 6
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