PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — NetScientific PLC 2nd Annual Capital Markets Day 2016
28 slides from PDS Biotechnology's conference presentation, Jun 14, 2016
Slide 1: Altering the landscape of immunotherapy
2nd Annual Capital Markets Day Dr Frank Bedu-Addo CEO, PDS Biotechnology Corporation Altering the landscape of immunotherapy
Slide 2: Next-Generation Cancer Immunotherapies
Protein Delivery Sciences Next-Generation Cancer Immunotherapies NetScientific PLC Capital Markets Day - June 14 2016
Slide 3: Investment and Partnership Highlights
Investment and Partnership Highlights Innovative immunotherapy platform technology harnessing immune system’s power to fight disease Immunotherapy • Innovative T-cell activating platform – Versamune® 1 Platform • Advantages over current approaches already valued in $billions Differentiated • Simple
Slide 4: Experienced management team with stellar track record
Experienced management team with stellar track record Sir Richard Sykes • Chairman and CEO of Glaxo 1995-2000, and Chairman GSK until 2002 • Sr. exec.- KBI BioPharma & Cardinal Health Frank Bedu-Addo, PhD • Development - Abelcet® (Liposome Company/ President, CEO Elan), PEG-Intron® (Schering-Plough/
Slide 5: Cancer immunotherapy: Significant emerging clinical potential
Cancer immunotherapy: Significant emerging clinical potential 4
Slide 6: Immunotherapy goal: shift balance of attackers vs. defenders
Immunotherapy Goal: Shift balance of “attackers” vs. “defenders” to favor ability of “attackers” to overcome “defenders” T-cell induction is critical to the anti-tumor effect Killer T-cells T “The attackers” T Ultimate goal T “Enable” a sufficient number of potent or Cancer “strong” killer T- cell c
Slide 7: Immunotherapy – Current key approaches and technologies
Immunotherapy – Current key approaches and technologies Current technologies present significant advancements with some limitations • Cancer vaccines • Overview: Prime the immune system to generate tumor specific T-Cells • Positioning: Key additions to checkpoint inhibitors as combinations to enhanc
Slide 8: Immunotherapy: Limitations and opportunities
Immunotherapy: Limitations and opportunities • Critical Limitations • Checkpoint inhibitors and CAR T-cells too unsafe for early stage cancer • Complexity and cost also prevent application to early stage cancer Opportunity: A safe and effective immunotherapy could dominate the larger and potentially
Slide 9: The Value Proposition: The first true multi-mechanism platform
The Value Proposition: The first true multi-mechanism platform Overcomes “bottlenecks” and facilitates safer, simpler and more effective immunotherapy 8
Slide 10: Versamune® T-Cell activating platform
Versamune® T-Cell activating platform Cross-section of Versamune® Nanoparticles: 100-200nm in size Versamune® is combined with specific protein/peptides unique to particular cancers Administered by subQ injection Ingredient: A simple positively charged synthetic lipid (fatty acid) called R-DOTAP Ver
Slide 11: Critical steps required for full therapeutic T-cell mediated immune response
Critical steps required for full therapeutic T-cell mediated immune response (Versamune® is the only proven to facilitate all four) Cytoplasm of DC 10
Slide 12: Versamune®: Activation of all critical pathways leads to superior killer T-cells
Versamune®: Activation of all critical pathways leads to superior induction of active killer T-cells (ELISPOT study – HPV cancer) 250 1,000 Active HPV-Specific Killer T-cells Steps 1-4 200 800 (per million cells) 150 600 100 400 Strong T-cell Steps 1 & 2 Steps 1 & 3 response level 50 200 0 KF18 Alon
Slide 13: Clinical data: Human Proof-of-Principle
Clinical data Human Proof-of-Principle Human HPV-specific T-cell Induction (PDS product # 1 - PDS0101) 12
Slide 14: Phase 1 trial: 100% T-cell induction efficacy in small patient population
Phase 1 human trial - 100% T-cell induction efficacy in small patient population Strongly activated T-cells in the 4 of 6 patients who had low pre-treatment T-cells (Cohorts 1 & 2) Excellent T-Cell responses* in Phase I clinical trial: Versamune® Max peak responses 2 weeks after administration Creat
Slide 15: Versamune® demonstrated excellent safety profile in Phase 1 clinical trial
Versamune® demonstrated excellent safety profile in Phase 1 clinical trial PDS0101 clinical trial data: No safety issues, even at the highest doses Versamune® HPV-Positive and CIN-Positive Patients Dose Phase 1 Phase 2 Completed 1.0 mg (3 subjects) Completed 3.0 mg (3 subjects) Completed 10.0 mg (6
Slide 16: Drug Development Strategy and Pipeline
Drug Development Strategy and Pipeline PDS0101 Target Markets Head-to-head comparisons with top competitors 15
Slide 17: PDS pipeline selection strategy
PDS pipeline selection strategy Focus on maximizing opportunities for clinical and commercial success • Select indications and targets where the cancer proteins (antigens) and • immune response to the disease or cancer is well understood • Relevant preclinical models • Highly expressed antigens on t
Slide 18: PDS Drug Development Pipeline: Phase 2 clinical trials in HPV cancers
PDS Drug Development Pipeline: Phase 2 clinical trials in HPV cancers PDS0101: Broad application in HPV related cancers and pre-cancers Current projected timetable, subject to change: 2016 2017 2018 2019 CIN2/3 (Pre-cervical cancer) In funding discussions with NIH/NCI The outlined AIN2/3, CIN2/3 in
Slide 19: PDS Drug Development Pipeline: Phase 2 Trials in Non-viral Cancers
PDS Drug Development Pipeline: Phase 2 Trials in Non-viral Cancers Phase 2 clinical trials to be funded by partners – Annual revenues for each > $1 B Current projected timetable, subject to change: 2016 2017 2018 2019 PDS0102: PDS0102: Stage D0 Prostate Cancer Breast, prostate To be funded by NIH/NC
Slide 20: PDS0101: Excellent probability for clinical & commercial success
PDS0101: Excellent probability for clinical & commercial success PDS0101 unique combination of safety, potency low COGs presents excellent opportunity • No approved therapy to treat the HPV induced pre-cancer (neoplasia) • High-grade neoplasia is treated by surgery – over 80% effective • Severe side
Slide 21: PDS0101 Phase 1 study suggests superiority to best human HPV T-cell data
PDS0101 Phase 1 study – Suggests superiority to best human HPV T-cell data PDS “Best in Class” advantages in T-cell potency, safety and overcoming immune suppression Comparison of HPV-Specific T-Cell Induction – Max. responses PDS0101 vs. ISA Pharma & Inovio (Previous “Successful” Phase II HPV Progr
Slide 22: Versamune®: Multi-action mechanism leads to superior cancer treatment
Versamune®: Multi-action mechanism leads to superior cancer treatment Superior pre-clinical HPV tumor regression vs. ISA Pharma and leading T-Cell activators Versamune®+ E7 Untreated (1 dose) Montanide + HPV16-E7 (ISA Pharma) - 20ug Versamune® + HPV16-E7 PDS0101 - 20ug • CD8+ (killer) T-cells infilt
Slide 23: NCI studies suggest PDS0101 is superior to Advaxis product
NCI studies suggest PDS0101 is superior to Advaxis “successful” product Significantly superior pre-clinical T-cell induction by PDS0101 (Independent study) 14000 Excellent T-cell induction 12000 Average Number of Killer T-cells and safety in Phase 1 Successful in PDS Biotech’s Phase 2 cervical per m
Slide 24: Regression of established TC-1 HPV-positive tumors (mouse model)
Regression of established TC-1 HPV-positive tumors (mouse model) Advaxis Listeria bacteria T-cell activating immunotherapy 23
Slide 25: PDS0101 market size and projected revenues
PDS0101 market size and projected revenues (excluding licensing) Year 5 peak sales revenues for US, EU and Japan could be $2-5 billion High grade neoplasia US, EU, JP Target size = 950,000 $1.1 billion Low grade neoplasia Cancer markets US, EU, JP US, EU, JP Target size = 9,500,000 Target size = 31,
Slide 26: Results of PDS0101 human clinical trials and comparative analysis
Results of PDS0101 human clinical trials and comparative analysis Human data was accurately predicted by preclinical studies 1 Safety • First effective cancer immunotherapy with a safety profile suitable to address early stage cancer & pre-cancer 2 Potency • Significantly superior T-cell potency to
Slide 27: Investment and Partnership Highlights
Investment and Partnership Highlights Innovative immunotherapy platform technology harnessing immune system’s power to fight disease Immunotherapy • Innovative T-cell activating platform – Versamune® 1 Platform • Advantages over current approaches already valued in $billions Differentiated • Simple
Slide 28: Questions?
Protein Delivery Sciences Questions?
PDS Biotechnology — NetScientific PLC 2nd Annual Capital Markets Day 2016 on 6ix