Nykode Therapeutics Asa · OSL:NYKD
Nykode Therapeutics Asa — Vaccibody — Investor Day (April 2018)
35 slides from Nykode Therapeutics Asa's investor day presentation, Apr 3, 2018
Slide 1: Vaccibody Capital Markets Day
Vaccibody CAPITAL MARKETS DAY Oslo, tirsdag den 3. April, 2018 Agnete Fredriksen, PhD President & CSO abfredriksen@vaccibody.com Martin Bonde, BComm, PhD CEO mbonde@vaccibody.com
Slide 2: Agenda
Agenda Background 1. 2. Vaccibody’s Cancer Vaccine Strategy 3. Neoantigen Prediction Tools Vaccibody’s Clinical Trial Experience 4. and Future Plans Confidential 2
Slide 3: Immunotherapy: The next Wave of Cancer Therapy
Immunotherapy: The next Wave of Cancer Therapy Checkpoint Inhibitors Various Immuno-Therapy Modalities Vaccines Cell Therapies Others, e.g. Oncolytic viruses Cytokines Bi-specific antibodies Small molecules Adjuvants Vaccination is best suited to stimulate a controlled and TRULY specific individuali
Slide 4: CheckPoint Inhibitors – Their Promise and their Limitations
CheckPoint Inhibitors – Their Promise and their Limitations • Strong relationship between number of mutations (neoantigens) and response to CPI • Limits response to already existing neoantigen-specific T cell repertoire • Reveals an important role of immune response to neoantigens in cancer immunoth
Slide 5: The Workflow of Personalised Cancer Treatment
The Workflow of Personalised Cancer Treatment 3. Vaccine 4. Vaccine 1. Tumour biopsy 2. Neoepitope manufacturing administration and and sequencing selection (TSNA) (n=1) immunogenicity Time, cost, efficacy? Non-Confidential 5
Slide 6: Proof of Concept published in Nature Letters July 2017
Proof of Concept published in Nature Letters July 2017 • 6 patients with melanoma (stage III/IV) • 13 patients with melanoma (stage III/IV) • 97 neoepitopes delivered as long-peptides • 125 neoepitopes delivered as ivt-RNA with polyICLC (SC) (intranodal) • 7 vaccinations per patient • 8 (+12) vaccin
Slide 7: Deals, fundings and collaborations in the neoantigen field
Deals, fundings and collaborations in the neoantigen field Size/Upfront Max. deal value Date Company/Inst. Comments Phase Acquirer/Licensor Deal type (USDm) (USDm) Oct Spun out from Broad Inst & Dana Faber USD 55m Preclinical NA PP (series A) NA 2015 Backed by Third Rock Ventures From MSKCC (US) & K
Slide 8: Vaccibody strongly engaged in key conferences
Vaccibody strongly engaged in key conferences
Slide 9: Agnete invited speaker at numerous conferences
ngns2oze Agnete invited speaker at numerous conferences • Drug Discovery Virtual Event, Feb 2 • Live podcast Radforsk + Kreftforeningen, March 16 • European Neoantigen Summit, Amsterdam, April 24-26 • Annual Cancer Vaccines Summit, Prague, April 26-27 • 3rd Annual Advances in Immuno-Oncology Congres
Slide 10: Agenda
Agenda Background 1. 2. Vaccibody’s Cancer Vaccine Strategy 3. Neoantigen Prediction Tools Vaccibody’s Clinical Trial Experience 4. and Future Plans Confidential 10
Slide 11: Vaccibody Product Pipeline
Vaccibody Product Pipeline PROGRAM DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III Precancerous VB C-01 (VB10.16) cervical lesions MELANOMA LUNG (NSCLC) BLADDER VB N-01 (VB10.NEO)* RENAL HEAD AND NECK * Clinical Trial Application (CTA) approved March 2018. Non-Confidential 11
Slide 12: Vaccibody – Proprietary Vaccine Technology Platform
Vaccibody – Proprietary Vaccine Technology Platform The Vaccibody Technology Platform was developed based on the concept of targeting antigen to APC in order to create more efficacious vaccines. Target to Antigen Presenting Cell In vivo expression Dimerization for crosslinking target receptor n=x An
Slide 13: Mechanism of Action – Intrinsic Adjuvant
Mechanism of Action – Intrinsic Adjuvant Administration In vivo protein Chemokine MIP-1α (i.m.) of DNA expression and plasmid secretion Target – Attract –Mature –Deliver-Cross-present Deltoid Tumour Confidential 13
Slide 14: Simple Vaccine Delivery
Simple Vaccine Delivery ✓ Needle free injection ✓ Small, handy, easy to use ✓ Minimal pain compared to electroporation ✓ Cost effective ✓ Applicable for multiple immunizations Non-Confidential 14
Slide 15: VB10.NEO – A Robust Vaccine Format
VB10.NEO – A Robust Vaccine Format VB10.NEO-III VB10.NEO-X VB10.NEO-XV VB10.NEO-XX >70 different VB10.NEO constructs with ~300 neoepitopes constructed to date Non-Confidential 15
Slide 16: VB10.NEO induces Rapid, Broad and Strong responses to multiple Neoepitopes
VB10.NEO induces Rapid, Broad and Strong responses to multiple Neoepitopes by single Vaccination • VB10.NEO induces a broader and stronger s p le n o c y te s 1000 P epM 10 response than Peptide + Poly (I:C) Adjuvant 800 PepM 9 PepM 8 vaccines after a single immunization. 600 PepM 7 6 IF N - s p o
Slide 17: VB10.NEO generates a broader immune response profile than competing technologies
VB10.NEO generates a broader immune response profile dominated by CD8+ T cells than competing technologies 3125 CD8+ T cells CD4+ T cells 625 IFNg spots/106 125 splenocytes 25 5 1 M1 1 Pep M2 2 Pep M3 3 Pep M4 4 Pep M5 5 Pep M6 6 Pep M7 Pep 7 M8 Pep 8 M9 Pep 9 M10 Pep10 Peptide* CD4 CD8 RNA* CD4 CD8
Slide 18: 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, broad immune response Peptide + poly I:C vaccination with the identical dominated by CD8+ T cells neoepitopes have been reported to induce no or weak immune responses VB10.NEO Peptide + poly I:C 900 900 800 800 7
Slide 19: Vaccibody Induces Tumor Protection as Monotherapy
Vaccibody Induces Tumor Protection as Monotherapy d ) T u m o r ta k e in r e c h a lle n g e d m ic e v a c c in a te d CT26 colon w ith V B 1 0 .N E O C T 2 6 -X X v 2 a lo n e o r in carcinoma model Control Vaccibody Monotherapy Vaccibody Combination Therapy Re-challenged c o m b in a tio n w ith
Slide 20: Agenda
Agenda Background 1. 2. Vaccibody’s Cancer Vaccine Strategy 3. Neoantigen Prediction Tools Vaccibody’s Clinical Trial Experience 4. and Future Plans Confidential 20
Slide 21: Development of VB10.NEO neoepitope prediction tool
Development of VB10.NEO neoepitope prediction tool Data to train algorithm Clinical data Core tissue VB N-01 Proteome expression Neoepitope prediction Neoepitope model calling ➢ Trained on in vivo data Ranking VB10.NEO In vivo mouse synthesis experiments IFNγ ELISpot > 400 neoepitopes Anti-tumour ef
Slide 22: Verification of VB10.NEO neoepitope prediction tool
Verification of VB10.NEO neoepitope prediction tool LL2 L -p e p M 3 0 L -p e p M 2 8 2500 L -p e p M 2 5 L -p e p M 2 4 L -p e p M 2 2 s p le n o c y te s VB10.NEO specific Neo-epitope 2000 L -p e p M 2 0 L -p e p M 1 8 L -p e p M 1 5 L -p e p M 1 3 Selection Tool employed in LL2 lung cancer tumour
Slide 23: Agenda
Agenda Background 1. 2. Vaccibody’s Cancer Vaccine Strategy 3. Neoantigen Prediction Tools Vaccibody’s Clinical Trial Experience 4. and Future Plans Confidential 23
Slide 24: Vaccibody Product Pipeline
Vaccibody Product Pipeline PROGRAM DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III Precancerous VB C-01 (VB10.16) cervical lesions MELANOMA LUNG (NSCLC) BLADDER VB N-01 (VB10.NEO)* RENAL HEAD AND NECK * Clinical Trial Application (CTA) approved March 2018. Non-Confidential 24
Slide 25: Clinical Learnings – Vaccibody platform
Clinical Learnings – Vaccibody platform VB10.16 SAFETY: No drug-related SAEs observed • HPV16 specific therapeutic DOSING: 3 week vaccination intervals induces strongest DNA vaccine (against viral responses neoantigens E6 and E7) EFFECT: Clinical efficacy correlates strongly with T cell • First indi
Slide 26: Clinical Trial VB N-01 planned FPI Q1 2018
Clinical Trial VB N-01 planned FPI Q12018 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 in patients with locally advanced or metastatic melanoma, NSCLC, clear renal cell carcinoma
Slide 27: Study Design and Treatment Schedule VB N-01
Study Design and Treatment Schedule VB N-01 12 months 24 months 6 weeks Sequencing, Vaccination Vaccination Synthesis & Follow Up Prime Boost Manufacturing CPI Consent Week 0 3 6 10 14 18 22 26 30 34 38 42 46 50 treatment + >12 weeks Biopsy Dose # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Non-Confidential 27
Slide 28: Renowned, International Clinical Sites
Renowned, International Clinical Sites 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 Immunology and Translational Immunotherapy University Hospital Klinikum Recht
Slide 29: Vaccibody’s Solution to Personalised Cancer Treatment
Vaccibody’s Solution to Personalised Cancer Treatment VB10.NEO specific -Robust, rapid, cost- -Needle-free delivery proprietary selection effective manufacturing -Rapid, strong, long-lasting method - stable, safe DNA plasmid -Broad and CD8 dominated format -hold up to 20 neoepitopes 3. Vaccine 4. Va
Slide 30: 2017 Annual accounts – P&L
2017 Annual accounts – P&L (KNOK) ➢ Operating revenue: 9,763 ➢ Revenue 486 from Evaxion ➢ BIA-grant 3,897 ➢ Skattefunn: 5,102 ➢ EU, SAPHIR: 278 ➢ Operating expenses: 43,731 ➢ External R&D, lab expenses and IP-expenses: 22,844 ➢ Personnel expenses: 14,372 ➢ Rent, admin. and bus. dev.: 6,515 ➢ Net fin
Slide 31: 2017 Annual accounts – Balance Sheet
2017 Annual accounts – Balance Sheet (MNOK) ➢Cash and equivalents: 207 ➢ Equity: 203 (95%) ➢Receivables, mainly grants: 7 ➢ Current liabilities: 11 ➢Fixed assets: 0.4 Confidential 31
Slide 32: Important milestones 2018-2020
Important milestones 2018-2020 2016 2017 2018 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 VB C-01 Phase I Inclusion Treatment
Slide 33: Conclusions – take home messages
Conclusions – take home messages • Vaccibody has established itself as a leader in the rapidly developing field of cancer neoantigen vaccines • Vaccibody has built a strong team over the last 15 months and filled key positions within medical, production and research – now 16 employees • Vaccibody ha
Slide 34: Vaccibody team ready to execute and deliver
Vaccibody team ready to execute and deliver 34
Slide 35: www.vaccibody.com
body www.vaccibody.com