Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Vaccibody AS — Investor Presentation (February 2019)
43 slides from Nykode Therapeutics Asa's investor presentation, February 2019
Slide 1: Vaccibody AS Company presentation
Vaccibody AS Company presentation February 2019 Non-confidential
Slide 2: Important information
Important information The information in this presentation (the "Presentation") has been prepared by Vaccibody AS (“Vaccibody” or the “Company”) solely for information purposes and may not be disclosed, reproduced or redistributed, in whole or in part, to any other person. By reading this Presentati
Slide 3: Vaccibody highlights
Vaccibody highlights Clinical data shows promising immunogenicity and efficacy in precancerous cervical cancer and provides strong proof of principle for the platform - Proven immunogenicity and efficacy of VB10.16 in phase I/IIa - Strong scientific rationale and evidence for combination with anti
Slide 4: Vaccibody and Roche to collaborate in treatment of cervical cancer
Vaccibody and Roche to collaborate in treatment of cervical cancer by combining anti-PD-L1 and VB10.16 Background • Strong data in phase IIa with VB10.16 in patients with precancerous cervical lesions provides rational for expanding use of VB10.16 in HPV16+ cancers in combination with a PD-1/PD-L1 i
Slide 5: Opportunity to open expansion cohorts for the VB10.NEO study in 2H 2019
Opportunity to open expansion cohorts for the VB10.NEO study in 2H 2019 • Protocol for expansion cohorts (part B) already integrated in protocol approved by regulatory authorities • First expansion cohort(s) could be initiated in H2, 2019 5
Slide 6: Vaccibody pipeline – two expanding programmes
Vaccibody pipeline – two expanding programmes with high quality international collaborators and several shots on goal PROGRAM DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III MELANOMA LUNG (NSCLC) BLADDER VB10.NEO RENAL HEAD AND NECK HEAD AND NECK VB10.NEO + NKTR-214 PRECANCEROUS VB10.16 CERVICAL L
Slide 7: Programmes
Content Vaccibody Technology Platform VB10.16 VB10.NEO Well-positioned to be a leading player in the field of personalized neoantigen vaccines Therapeutic HPV16-vaccine finalizing phase IIa Programmes Strong preclinical data from combining the company’s Interim data shows excellent safety, s
Slide 8: Vaccibody – Proprietary vaccine technology platform
Vaccibody – Proprietary vaccine technology platform, uniquely suited for personalisation, including a strong rapid and long-lasting immune response The Vaccibody technology platform is based on the concept of targeting antigen to antigen presenting cells in order to create more efficacious vaccines.
Slide 9: Mechanism of action: Intrinsic adjuvant for direct targeting
Mechanism of action: Intrinsic adjuvant for direct targeting Administration In vivo protein Target – Attract – Mature – Deliver – Cross-present (i.m.) of DNA expression and plasmid secretion Skewing the immune system to a CD8+ killer T-Cell response Deltoid Direct targeting & attraction of antigen
Slide 10: VB10.16 for the treatment of HPV16 positive infections and malignancies
VB10.16 for the treatment of HPV16 positive infections and malignancies – CIN 2/3 pre-cancerous lesions as a proof of concept model Persistent infection / Progression to pre-cancer 2-5 4-5 years years HPV Healthy CIN 1 CIN 2/3 Cervical cancer Infection Spontaneous clearance rate of CIN 2/3 for HPV16
Slide 11: Clinical experience with VB10.16 allowed for further optimization
Clinical experience with VB10.16 allowed for further optimization The dosing schedule was optimized in phase I, benefiting all ongoing and future trials VB C-01 VB10.16 VB C-01: Exploratory, open, prospective multi-centre study in patients with HPV16+ High Grade Cervical Intraepithelial Neoplasia (H
Slide 12: Preliminary phase IIa results: Deepening of the immune response over time
Preliminary phase IIa results: Deepening of the immune response over time Reduction in affected area and CIN grading • Strong immune response in all 17 patients, induced by the vaccine in 16 patients • Excellent safety profile in all 18 patients Data at 6 months Data at 12 months no CIN (as reported
Slide 13: VB10.16 vaccination induces strong clinical efficacy with excellent safety
VB10.16 vaccination induces strong clinical efficacy with excellent safety Lesion size reduction, CIN regression, HPV16 clearance Best response data (At enrollment: 10 CIN3 and 7 CIN2 patients) 100 no CIN % c h a n g e le s io n s iz e 50 CIN1 CIN2 CIN3 0 conizated -5 0 HPV16 clearance -1 0 0 VB10.1
Slide 14: VB10.16 upregulates PD-L1, suggesting beneficial effect of combination therapy
VB10.16 upregulates PD-L1, suggesting beneficial effect of combination therapy Strong rationale for combination of VB10.16 with a checkpoint inhibitor E x p a n s io n P h a s e P e r c e n t a g e P D L 1 + t u m o r c e ll s % P D L 1 e x p r e s s io n o n t u m o r c e lls CIN2/3 patients at 12
Slide 15: The opportunity in HPV16 positive cervical cancer
The opportunity in HPV16 positive cervical cancer Limited efficacy of CPI monotherapy has been shown in HPV-linked cancer indications Combined EU & US annual cancer incidences Cervical cancer is the fourth most common cancer in women 188.729 Current Standard of Care (US): S Surgery; Radiation
Slide 16: Proposed study design for VB10.16 + Tecentriq
Proposed study design for VB10.16 + Tecentriq® In patients with advanced or recurrent, non-resectable HPV16+ cervical cancer • Dosing of VB10.16 in combination with Atezolizumab (Tecentriq®) • Purpose is to assess the safety/tolerability, immunogenicity and the efficacy of multiple doses of 3 mg VB1
Slide 17: Neoantigens: New tumour-specific antigens
Neoantigens: New tumour-specific antigens «Recognition of random somatic mutations is the «final common pathway» explaining cancer regression from immune oncology therapies for solid tumors»* Neoantigens: New tumour-specific antigens Are cancer neoantigen platforms the most promising new asset in im
Slide 18: Vaccibody aims to be best-in-class in personalized vaccines
Vaccibody aims to be best-in-class in personalized vaccines Uniquely positioned and well-differentiated from competitors VB10.NEO specific - Robust, rapid, cost-effective - Needle-free delivery proprietary selection manufacturing - Rapid, strong, long- method: NeoSELECTTM - Stable, safe DNA plasmid
Slide 19: VB10.NEO leads to a unique CD8 dominated neoepitope response
VB10.NEO leads to a unique CD8 dominated neoepitope response VB10.NEO induces a strong and broad immune Peptide + poly I:C vaccination has been response dominated by CD8+ T cells reported to induce dominantly CD4 T cell responses VB10.NEO Peptide + poly I:C 900 900 800 800 700 700 600 600 500 500 40
Slide 20: Neoepitope-specific CD8 T cells are crucial for tumour protection
Neoepitope-specific CD8 T cells are crucial for tumour protection Average growth, all groups Individual growth curves VB10.NEO VB10.NEO + anti-CD4 VB10.NEO+ anti-CD8 2 .5 PBS In d iv id u a l m o u s e in m m , V B In4d0iv6id 1 u a l m o u s e in m m , V B 4 0 6 1 + a n ti-C D 4 w it m e s u rm e n
Slide 21: Successful development of proprietary neoepitope selection method NeoSELECT
Successful development of a strong proprietary neoepitope selection method NeoSELECTTM Immunogenic neoepitopes identified by different prediction methods during development 60% Immunogenic neoepitopes 50% Strongly immunogenic neoepitopes 40% 30% 20% 10% 0% Version 1 Version 2 Vaccibody's NeoSELECT •
Slide 22: Vaccibody's first neoantigen trial is enrolling and on track
Vaccibody’s first neoantigen trial is enrolling and on track Enrolling patients at three high-quality and dedicated sites in Germany VB N-01: An open labelled first human dose phase 1/2a study to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy
Slide 23: Enrolment statistics per site and tumor entity
Enrolment statistics per site and tumor entity - on track to initiate 1-2 expansion cohorts H2 2019 Status 30 Jan 2019 10 12 9 8 10 7 6 # of patients # of patients 8 Sum of screened 5 Sum of enrolled Sum of in-screening 4 6 Sum of in-trial pt Sum of in-trial pt 3 Sum of v1 4 2 Sum of wk10 1 2 0 0 FR
Slide 24: Timely preparation desired/necessary to secure timely execution
Timely preparation desired/necessary to secure timely execution Key activities in the next 6 months to secure timely execution of expansion cohort and path towards registration study - Secure manufacturing capacity with CMOs - Open additional clinical sites for speedy patient recruitment and enrol
Slide 25: Vaccibody pipeline 2019-2022
Vaccibody pipeline 2019-2022 News flow from an increasing number of ongoing studies – more shots on goal! Activity ‘19 ‘20 ‘21 ‘22 ‘23 VB10.16 (precancerous lesions) Final data LPI VB10.16 + Atezolizumab VB10.NEO DIRECT study (Part A) LPI LPLD VB10.NEO + NKTR-214 LPI VB10.NEO DIRECT (Expansion cohor
Slide 26: Upcoming milestones
Upcoming milestones Recent 2019 2020 achievements VB10.NEO VB10.NEO Deal with Nektar on combo trial • Q2: First immune response read-outs • 12 months data clinical response data with NKTR-214 in Sep 2018 • Q3: Interim 6 months clinical response • Immune response data from expansion Neoantigen data
Slide 27: Vaccibody has a lean and experienced management team
Vaccibody has a lean and experienced management team Martin Bonde, PhD Agnete Fredriksen, PhD Mads Axelsen, MD Mette Husbyn, PhD Chief Executive Officer President and Chief Scientific Officer Chief Medical Officer Chief Technical Officer Joined Vaccibody in August 2015 Co-founder; Joined Vaccibody i
Slide 28: Board of Directors
Board of Directors Tom E. Pike Chairman of the Board Life science industry professional Jan Haudemann-Andersen Erlend Skagseth Sole owner of Datum and Datum Partner at Sarsia Seed Management AS invest > 20 years experience from R&D, IPR, project and business Extensive investment experience developme
Slide 29: Ownership and financials
Ownership and financials Top 20 Shareholders Key financials # Investor Shares % Cash on hand (Dec 31, 2018): 1 Sarsia Seed AS 6,074,800 12.53% 144 MNOK (€ 14.8 mill) 2 Radiumhospitalets Forskningsstiftelse 4,811,400 9.92% 3 Datum Invest AS 4,152,600 8.57% 4 Arctic Funds Plc 2,929,140 6.04% Cash spen
Slide 30: Glossary and terms
Glossary and terms Antigen An antigen is a molecule recognized by the immune system. “Non-self" antigens are identified as intruders and attacked by the immune system. Proteins that are generated in response to antigens, found in blood or other bodily fluids. Antibodies are used by the immune system
Slide 31: Risk factors (1/3)
Risk factors (1/3) An investment in the Offer Shares involves inherent risk. Before making an investment decision with respect to the Offer Shares, investors should carefully consider the risk factors outlined below. The risks and uncertainties described are the principal known risks and uncertainti
Slide 32: Risk factors (2/3)
Risk factors (2/3) • The financial success of Vaccibody requires obtaining acceptable prices and reimbursements, which are regulated or influenced by authorities, other healthcare providers insurance companies or health maintenance providers. Reimbursements might be limited or unavailable in certain
Slide 33: Risk factors (3/3)
Risk factors (3/3) • The Company could become subject to liability claims in connection with clinical trials or otherwise in connection with the use or misuse of the Company's products after commercialization. Any claims against the Company, regardless of their merit, could materially and adversely
Slide 34: APPENDIX
APPENDIX www.vaccibody.com
Slide 35: Vaccibody AS in summary
Vaccibody AS in summary • Founded in 2007 in Oslo, Norway • Privately held clinical stage immuno-oncology company, spun-out from Oslo University • Proprietary, patented vaccine technology 35
Slide 36: Board of directors and organization
Board of directors Martin Bonde PhD CEO Tom Pike (Chairman) Anders Tuv Hans Petter Tjeldflaat MSc Bernd Seizinger CFO (part time) Erlend Skagseth Ingrid Alfheim Hege Juliane Odd BSc Jan Haudemann-Andersen Office Manager (part time) Lars Lund-Roland Caspar Foghsgaard Director, BD Agnete B. Fredriksen
Slide 37: VB10.16 elicited strong, long-lasting immune responses to HPV16
VB 10.16 elicited strong, long-lasting immune responses to HPV16 0 4 t im e a ft e r 1 s t d o s e ( w e e k ) 8 12 16 20 24 The dosing schedule 0 was optimized in phase I, benefiting all ongoing and future trials 800 1000 0 1/ U F S 2500 1500 PBMCs D o s in g C o h o r t 1 (N = 7 ) 6 2000 Dosing Ph
Slide 38: Limited efficacy of CPI monotherapy in HPV linked cancer indications
Limited efficacy of CPI monotherapy in HPV linked cancer indications – cervical cancer as an example PD-L1 is capable of strongly modulating the immune Cercival system by reducing the proliferation and activity of the Name Target Company cancer Phase cytotoxic CD8 T cells' response to both viral o
Slide 39: Cervical cancer
Cervical cancer The cervix is the lower part of the uterus that connects to the vagina Cervical cancer (CC) is the fourth most common cancer in women and is most commonly diagnosed in between 35 and 44. The average age for diagnosis is 49. There are two main types of CC: - Squamous cell cancer
Slide 40: VB10.16 vaccination and generation of E6/E7-specific T cells
VB10.16 vaccination and generation of E6/E7- specific T cells: Addition of CPI enables hot tumour environment enhancing efficacy 1. VB10.16 vaccination and tumour specific T cell response In vivo Tumour expression of Vaccibody protein VB10.16 drives production of E6/E7- specific T cells Administrati
Slide 41: Vaccibody's first neoantigen clinical study currently ongoing
Vaccibody’s first neoantigen clinical study currently ongoing At three high-quality and dedicated sites in Germany Prof Dr med Jürgen Krauss* Head of Clinical Immunotherapy National Centre for Tumour Diseases (NCT), Medical Oncology Heidelberg, Germany Prof Dr med Angela Krackhardt Director Tumour I
Slide 42: Headlines for Nektar collaboration
Headlines for Nektar collaboration Clinical Trial «No strings Collaboration in attached» – will Nektar and Will jointly own evaluate 10 patients with Vaccibody clinical data outcome and squamous cell maintain relating to the then eventually carcinoma of the ownership to combination of continue head
Slide 43: www.vaccibody.com
www.vaccibody.com