Evaxion A/S · NASDAQ:EVAX
Evaxion A/S — Evaxion Biotech — Investor Presentation (June 2023)
30 slides from Evaxion A/S's investor presentation, June 2023
Slide 1: June, 2023
June, 2023 evaxion-biotech.com
Slide 2: Forward-looking statements
Forward-looking This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” sta
Slide 3: We aspire to lead the exploration of AI to develop superior immunotherapies
We aspire to lead the exploration of AI to develop superior immunotherapies for patients in need Driving the development of AI platforms for target discovery in cancer and infectious diseases Advancing a clinical pipeline of personalized cancer immunotherapies Accelerating the development of novel v
Slide 4: Personalized cancer immunotherapy – a new drug optimized for each patient
Personalized cancer immunotherapy – a new drug optimized for each patient PIONEER DNA Sample from identifies Manufacturing Treatment in sequencing for tumor and optimal of personalized combination Anti-tumor tumor mutation healthy tissue neoantigens for cancer with standard effect identification tar
Slide 5: PIONEER – Clinically validated AI platform for personalized cancer immunotherapy
PIONEER – Clinically validated AI platform for personalized cancer immunotherapy Step 1: Identifying Step 4: Neoantigen tumor-specific processing and mutations presentation in MHC PIONEER identifies optimal neoantigens for T cell (neoantigens) activation in each patient Key biological steps simulate
Slide 6: PIONEER outperforms public tools
PIONEER outperforms public tools PIONEER vs. best public tools PIONEER 8.7 à The best publicly available tools are only capable of identifying 2.6 correct neoantigens in the top 10 à In comparison, PIONEER identified 8.7 correct neoantigens in the top 10 Public 2.6 à A superior prediction is anticip
Slide 7: Business model
Business model Evaxion royalties Commercialization by partner Out-licensing: upfront and milestones Pre-clinical or clinical proof of concept Discovery based on AI 7
Slide 8: Immunotherapy pipeline oncology
Immunotherapy pipeline oncology Internal development of oncology programs while advancing infectious disease programs in partnerships 8
Slide 9: EVX-01 Strong interim data in clinical phase 1/2a
EVX-01 Individual patient Strong interim data in clinical phase 1/2a Study in brief • Metastatic melanoma • EVX-01 biweekly x 6 + anti-PD-1 • Interim data from 9 patients • Neoantigen-specific immune response in all patients • Tumor reduction in 6 out of 9 patients • Good safety and tolerability 9
Slide 10: EVX-01 Promising efficacy data in Phase 1/2a
EVX-01 Promising efficacy data in Phase 1/2a 76% of the administered neoantigens induced reactive T cells of which 83% were de novo responses Correlation between EVX-01 activated T cells and clinical response 10
Slide 11: EVX-01 A patient case
EVX-01 A patient case Patient Status Scan at enrollment 64 years Stable disease after 10 L 10mm months with anti-PD1 Effect Strong immune activation Scan 1 year after by EVX-01 starting EVX-01 L 0mm Diagnosis Result Stage IV metastatic melanoma Complete response (CR) 11
Slide 12: EVX-01 Global clinical Phase 2 trial started
EVX-01 Global clinical Phase 2 trial started Locations: Clinical sites in Australia and Europe Trial Population: 20 patients with metastatic melanoma Status: Enrollment started in Australia in September 2022 In partnership with Merck & Co., Inc (MSD) Interim readout H2 2023 12
Slide 13: EVX-01 Phase 2 trial design & projected timelines
EVX-01 Phase 2 trial design & projected timelines 13
Slide 14: EVX-02 A personalized DNA-based cancer immunotherapy in Phase 1/2a
EVX-02 Interim A personalized DNA-based cancer readout immunotherapy in Phase 1/2a Well tolerated in all patients Neoantigen-specific T-cell responses in all patients EVX-02 + nivolumab as adjuvant therapy T-cell responses robust after melanoma and long lasting resection Proof of mechanism for new D
Slide 15: EVX-02 Clinical readout
EVX-02 Clinical readout A personalized DNA-based cancer All 10 EVX-02 completers relapse- immunotherapy in Phase 1/2 free at last assessment Well tolerated in all patients Neoantigen-specific T-cell responses in all patients T-cell responses robust and long lasting EVX-02 + nivolumab as adjuvant the
Slide 16: EVX-03 – First ever personalized ERV immunotherapy
EVX-03 – First ever personalized ERV immunotherapy DNA-based personalized immunotherapy armed with genetic immune adjuvant, neoantigens and ERVs Genetic immune adjuvant attracts antigen presenting cells (APCs) and augments antigen presentation The unique technology is fully owned, patent protected,
Slide 17: EVX-03 Highly effective and safe in pre-clinical models
EVX-03 Highly effective and safe in pre-clinical models Highly effective in pre-clinical models • Strong antitumor effect* • Superior potency to 1st generation DNA vaccine • Durable neoantigen-specific T- cell responses • GLP toxicology completed without concerns • Start of clinical Phase 1a planned
Slide 18: Oncology pipeline in brief
Oncology pipeline in brief Three personalized cancer immunotherapies, Partnership opportunities generated with the PIONEER AI platform • EVX-01 Phase 2 for metastatic melanoma – • Co-development of clinical assets 67 % ORR in Phase 1/2a • Out-licensing of APC-targeting DNA • EVX-02 Phase 1/2a ongoin
Slide 19: Addressing a large and growing market
Addressing a large Increased deal-making for and growing market therapeutic cancer vaccines Cancer immunotherapy market est. Gritstone-BMS clinical trial collaboration (2018) No financials to USD 277 billion in 2030* disclosed NSCLC market est. to USD 33 billion Nykode-Roche out-licensing deal (2020
Slide 20: Immunotherapy pipeline infectious disease
Immunotherapy pipeline infectious disease Internal development of oncology programs while advancing infectious disease programs in partnerships 21
Slide 21: EDEN - trained to recognize shared protective features
EDEN - trained to recognize shared protective features Truly protective proteins EDEN – Trained to recognize shared protective features Bacterial protein Training of neural sequences network Data curation Validated public data on truly protective and non-protective antigens Non-protective proteins 2
Slide 22: EDEN – from platform to product
EDEN – from platform to product 1. Input: Any bacterial proteome Preclinical Discovery Pre-clinically validated in: 2. EDEN: Probability assesment of immunogenicity dev. • Staphylococcus aureus (EVX-B1) 3. Output: Ranking list of novel protective proteins • Neisseria gonorrhoeae (EVX-B2) • Pseudomon
Slide 23: EVX-B1
EVX-B1 S. aureus vaccine candidate demonstrating protection in challenge models Four-component S. aureus vaccine Mouse sepsis model (USA300) for prevention of skin and soft tissue infections (SSTI) Highly significant protection in lethal USA300 sepsis model High IgG titers and potent T-cell response
Slide 24: EVX-B2
EVX-B2 N. gonorrhoeae vaccine candidate demonstrating broad protection Multi-component N. gonorrhoeae vaccine candidate Protection against different N. gonorrhoeae strains (MS11 shown) in vaginal colonization model High level of immunogenicity Broad neutralization capacity demonstrated in panel with
Slide 25: RAVEN - Proprietary AI platform for the design of superior viral vaccines
RAVEN - Proprietary AI platform for the design of superior viral vaccines RAVEN Viral Vaccine T-cell epitopes The RAVEN platform designs broadly protective vaccines containing T-cell epitopes HLA-matched to the target Viral proteomic and genomic data human population Ability to induce: Optimized B-c
Slide 26: Vaccines against infectious diseases
Vaccines against infectious diseases Two proprietary AI platforms (EDEN and Additional bacterial and viral vaccine targets RAVEN) identifies superior vaccine candidates maturing in discovery pipeline: • EVX-B2 (N. gonorrhoeae ) and portfolio of • Novel vaccine antigens with high and many other bacte
Slide 27: Business model with multiple partnering opportunities
Business model with multiple partnering opportunities Evaxion royalties Commercialization by partner Out-licensing: upfront and milestones Pre-clinical or clinical proof of Personalized cancer concept immunotherapies EVX-01 EVX-03 Discovery Bacterial and viral vaccines based on AI EVX-B1 EVX-B2 EVX-
Slide 28: Milestones
Milestones Q2 2023 Full readout EVX-01 Phase 1/2a Q2 2023 Readout EVX-02 Phase 1/2a Q4 2023 Interim clinical readout EVX-01 Phase 2 Q4 2023 Start of clinical phase 1 of EVX-03* * Subject to additional funding 29
Slide 29: Key facts
Key facts à Strong clinical pipeline in oncology à Broad preclinical pipeline in infectious diseases à 15 years of pioneering AI development à Strong IP portfolio securing lead candidates and AI à Proprietary APC-targeting à Multiple partnering opportunities à DNA technology 34
Slide 30: Thank You
For more information Visit our website: Follow us on LinkedIn: evaxion-biotech.com evaxion-biotech.com @Evaxion Biotech NON-CONFIDENTIAL Thank You AI-Powered Immunotherapies