Nykode Therapeutics ASA · OSL:NYKD
Nykode Therapeutics ASA — Investor Presentation (May 2024)
79 slides from Nykode Therapeutics ASA's investor presentation, May 2024
Slide 1: Company Presentation May 2024
Company Presentation May 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 ~$436M1) 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 KLAUS EDVARDSEN HARALD GURVIN ULRICH BLASCHKE Chief Executive Officer Chief Scientific Officer & Chief Research & Chief Financial Officer Chief Technology Business Development Development Offic
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: 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 Finalize enrolment Pt 1 HPV16+ cervical cancer C-02, C-04 (Q4 2024) 2 Dose level VB10.16 HPV16+ head and neck cancer C-03 recommendation (H2 2024) 2
Slide 7: Balanced portfolio addressing all stages of disease
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: 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 9: Cancer vaccine platform induces rapid, robust, long-lasting 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 - May 2024 9
Slide 10: 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 11: 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 12: VB10.16 in HPV16+ cancers
VB10.16 in HPV16+ cancers Nykode Therapeutics | Company Presentation - May 2024 12
Slide 13: 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 14: 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 15: HPV+ cancer incidence expected to increase despite 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 16: 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 17: Recent progress in advanced cervical cancer, but 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 18: 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 19: 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 20: 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 21: 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 - May 2024 21
Slide 22: 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 23: 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 24: 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 25: 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 26: 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 27: 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 28: Maximizing addressable patient populations by 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 29: 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 cancer r/m Cervical Cancer, ≥2L r/m Cervical Cancer, Locally Advanced Cervical Indication (HNSCC), PD-L1+, 2L Cancer (LACC) PD-L1+, 1L Up to 9 mg in combination 3 mg in combination wi
Slide 30: VB-C-04 trial in advanced HPV16-positive cervical cancer
VB-C-04 trial in advanced HPV16-positive cervical cancer Randomized Phase 2 selection trial in recurrent cervical cancer progressing on 1st line SOC (pembrolizumab + chemotherapy +/- bevacizumab) ♦ Dosing schedule VB10.16 vaccine (i.m.) ♦ Key eligibility criteria ♦ Q3W for 5 cycles (induction period
Slide 31: VB-C-04 randomized Phase 2 selection design
VB-C-04 VB10.16+atezolizumab or placebo in 2L recurrent CC Overview: randomized Phase 2 selection design Part 1 Part 2 a) b) Arm A: Enroll Final analysis ( n = 100) VB10.16 + another 70 atezolizumab pts in Interim for futility recurrant (stage IVB) CC (n = 60) (n = 30) superior arm • HPV-16+ • PD-L1
Slide 32: Locally advanced cervical cancer represents a new opportunity
Locally advanced cervical cancer represents a new opportunity for immunotherapy Press release Nykode Therapeutics | Company Presentation - May 2024 32
Slide 33: VB C-05: VB10.16+CPI with CRT in Locally Advanced Cervical Cancer
VB C-05: VB10.16+CPI as concurrent treatment to CRT in Locally Advanced Cervical Cancer Randomized Phase 2 PoC trial in a HPV16+ LACC setting Concurrent Adjuvant HPV 16+ High-risk locally advanced cervical cancer CRT + CPI + CPI + Primary endpoint (FIGO 2018) defined as VB10.16 VB10.16 PFS and OS st
Slide 34: NYK011: Vaccine aimed at reducing burden of colorectal cancer
NYK011: Vaccine aimed at reducing the burden of colorectal cancer Nykode Therapeutics | Company Presentation - May 2024 34
Slide 35: Pipeline expansion from 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 36: Potential first-in-class program with 4th module 2nd generation technology
Potential first-in-class program including Nykode’s 4th module 2nd generation technology • 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 strong and broad CD8 T
Slide 37: Vaccibodies induce potent T cell responses against targets with central tolerance
Vaccibodies induce potent T cell responses against targets subject to various degrees of central tolerance Potential immunogenicity High thymic expression Low thymic expression No thymic expression Mouse melanocyte genes Mouse MAGE-like genes Mouse PRAME-like genes Nykode Therapeutics | Company Pres
Slide 38: VB10.NEO - Individualized cancer immunotherapy
VB10.NEO- Individualized cancer immunotherapy Nykode Therapeutics | Company Presentation - May 2024 38
Slide 39: Individualized cancer vaccine designed to target 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 40: 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 41: 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 42: 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 43: Majority of neoepitopes activates 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 cells 53% 100% 75% 100% 100% 80% The majority of tested 01-001 01-
Slide 44: 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 45: Vaccine-specific T cells remain functional up to 1-year after last 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 - May 2024 45
Slide 46: 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 - May 2024 46
Slide 47: 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 48: Autoimmunity and further platform potential
Autoimmunity and further platform potential Nykode Therapeutics | Company Presentation - May 2024 48
Slide 49: 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 DNA plasmid vaccine CD4+ Treg Tol APC CD4+ Treg Tol APC Effector T Effector T cell cell 1 Cells enc
Slide 50: 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 51: 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 52: 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 53: Disease prevention in EAE model by targeting two 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 54: 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 55: Vaccibody vaccine prevents EAE in early therapeutic setting
Vaccibody vaccine prevents EAE disease in an early therapeutic setting EAE MODEL – EARLY THERAPEUTIC DELIVERY TV004 5 ✱✱✱ TV004 100 4 PBS 80 EAE score AUC (5-28) MOG (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 induc
Slide 56: DNA vaccination shows durable effect in NOD mice
56 DNA vaccination with Vaccibody targeting tolerizing APCs show durable effect post treatment in NOD mice Bi-weekly glucose monitoring Week 16 of Week 26 termination Wk 0 Wk 1 Wk2 Wk 3 Wk 4 Wk 5 treatment of study Dosing once weekly Weekly glucose monitoring Remove treatment 9 wk old mice NOD DIABE
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: mRNA oncology vaccine
mRNA oncology vaccine Nykode Therapeutics | Company Presentation - May 2024 59
Slide 60: 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 61: APC-targeted technology offers improvement of mRNA based vaccines
Nykode’s APC-targeted technology offers improvement of mRNA based vaccines Stronger T cell responses to a wider variety of MC38 T cell epitopes Prime vaccination only (D14) Prime + boost vaccination (D28) ✱ p=0.0473 ✱ p=0.0192 25000 2000 N01 N01 N02 N02 N03 N03 N04 N04 20000 N05 N05 1500 N06 N06 N07
Slide 62: Strong responses driven by broad CD8 T cell specificity
The strong responses by Nykode’s APC-targeted technology is primarily driven by broad CD8 T cell specificity The strong responses by Nykode’s vaccine are primarily CD8 driven and includes both effector and memory subtypes Nykode pDNA vs Ag mRNA Nykode mRNA vs Ag mRNA Nykode pDNA mRNA-Ag 80μg 5μg 800
Slide 63: Unlocking the full potential of cancer vaccines
Unlocking the full potential of cancer vaccines Nykode Therapeutics | Company Presentation - May 2024 63
Slide 64: 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 THAT TAKE UP THEANTIGEN AND HOW IT IS PRESENTED TO T CELLS THROUGHAPC-TARGETING Superior immunogenicity • Broad response to multiple epitopes and reduced risk of tumor escape • Proven abilit
Slide 65: 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 Viral Antigens Tumor-specific Tumor-associated Neoantigens Antigens VB10.16 Undisclosed Undisclosed VB10.NEO Future in house and partnered
Slide 66: 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 67: Financial overview & outlook
Financial overview & outlook Nykode Therapeutics | Company Presentation - May 2024 67
Slide 68: Upcoming milestones
Upcoming milestones Q1 ‘24 VB10.16 Cervical Cancer Updated survival data from VB-C-02 Phase 2 trial Q2 ‘24 VB10.16 Cervical Cancer Initiate potentially registrational VB-C-04 trial in the U.S. in patients with recurrent/metastatic disease and PD-L1 positive tumors Oncology H2 ‘24 VB10.16 Recomme
Slide 69: Our conviction in Nykode's platform has never been stronger
Our conviction in Nykode’s platform has never been stronger Differentiated APC targeting immunotherapy platform validated and de-risked through clinical data and top tier US biopharma partnerships Clinical durability and survival data further supported today by long lasting immune response with both
Slide 70: Unlocking the future of medicine
UNLOCKING THE FUTURE OF MEDICINE Contact: Alexandra Deschner Head of Investor Relations [email protected] Nykode Therapeutics | Company Presentation - May 2024
Slide 71: VB-C-01
VB-C-01
Slide 72: VB C-01: First trial with VB10.16 as monotherapy for 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 73: 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 74: 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 75: Significant correlation between T cell responses and lesion size
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 76: 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 77: VB-C-03
VB-C-03
Slide 78: VB-C-03 trial in advanced HPV16+ HNSCC
VB-C-03 trial in advanced HPV16+ HNSCC Combination treatment of VB10.16+pembrolizumab* in 1L HPV16+ R/M HNSCC Dose-escalation (Phase 1) with randomized dose-expansion (Phase 2a) trial ♦ Key eligibility criteria ♦ Dosing schedule VB10.16 vaccine ♦ Recommended Phase 2 set (RP2S): Randomization (1:2) o
Slide 79: 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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