Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (January 2020)
65 slides from Pds Biotechnology's investor presentation, Jan 13, 2020
Slide 1: Corporate Presentation
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO JANUARY 2020
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development acti
Slide 3: Leadership team has demonstrated success in developing and commercializing pharmaceutical products
PDS Biotechnology leadership team has demonstrated success in the development and commercialization of leading pharmaceutical products 3 Frank Bedu-Addo, PhDChief Executive Officer Lauren V. Wood, MDChief Medical Officer Andrew SaikChief Financial Officer Gregory Conn, PhDChief Scientific Officer Se
Slide 4: PDS Biotech well-poised to transform cancer treatment with immuno-oncology
PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology 4 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline 3 Demonstrated potential for strong clinical efficacy and durability of the response w
Slide 5: Clinical stage company developing immunotherapies based on the Versamune platform
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 5 Versatile and potent T-cell-activating platformClinically validated induction of active antigen-specific killer and helper T-cells in vivoPromising clinical e
Slide 6: Pipeline combining Versamune with proprietary tumor antigens
6 Reference: Data on file. PDS Biotech’s pipeline combines the Versamune® platform with proprietary & validated tumor antigens across several cancer types
Slide 7: Versamune Platform
Versamune® Platform
Slide 8: Versamune is a proprietary T-cell activating platform
v Versamune® is based on proprietary, positively charged and immune activating lipids that form spherical nanoparticles in aqueous media The nanoparticles are sized to mimic viruses, which promotes excellent uptake by dendritic cells of the immune systemActivates the important Type I interferon immu
Slide 9: Versamune may overcome the challenges of immunotherapy
Inability to perform necessary steps to induce a therapeutic T-cell response in-vivo Versamune® design and novel immunological mechanisms of action promote a powerful anti-tumor T-cell response Versamune® has demonstrated the potential to overcome the challenges of immunotherapy 9 Challenges of Immu
Slide 10: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose 10 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies Single treatment dose Results typical of cur
Slide 11: PDS0101
PDS0101
Slide 12: PDS0101 designed to treat HPV-caused cancers
12 PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) Approximately 43,000 patients are diagnosed with HPV-associated cancers each year, a number unlikely to be impacted by increased use of HPV preventive vaccines in the next decade References: Markowitz et al. 2016. Centers f
Slide 13: Versamune and antigen combination engineered for ease of administration
13 The combination of Versamune® and a proprietary antigen is engineered for simplicity and ease of administration Vials of HPV16 mix (L)and Versamune® (R) Versamune® formulationis mixed before injection* Delivered viasubcutaneous injection *Electron microscopy picture
Slide 14: PDS0101 Phase 1: high levels of HPV-specific killer T-cells in blood
14 PDS0101 Phase 1 clinical trial: Unique in vivo demonstration of high levels of HPV-specific killer T-cells in circulating blood 14x 24x Total Activated T-Cells 26x Order of magnitude increase over baseline Versamune® Dose Reference: Data on file. INF-γ Elispot Granzyme-b Elispot Clinical Study Re
Slide 15: Follow-up showed promising clinical responses at all three doses
15 Follow-up of patients in PDS0101 Phase 1 study demonstrated promising clinical responses at all three tested doses A post-hoc, retrospective analysis, demonstrated complete lesion regression in at least 60% of evaluable patients (6/10) as early as 1-3 months after treatmentNo lesion recurrence oc
Slide 16: Clinical strategy in advanced cancer with checkpoint inhibitors
Checkpoint inhibitors have shown confirmed clinical efficacy and have demonstrated clinical benefit in late stage cancerCheckpoint inhibitors block a key immunological defense mechanism for cancer cells, and are reported to work primarily in patients whose immune systems are already generating tumor
Slide 17: Versamune may enhance checkpoint inhibitor efficacy in B16 melanoma
The robust T-cell response induced by Versamune® results in the potential for enhancement of efficacy of checkpoint inhibitors in immune suppressive B16 melanoma 17 Early clinical studies showed the checkpoint inhibitor to be ineffective in treating B16 melanoma, a notoriously difficult model to tre
Slide 18: PDS0101 selected by Merck for combination with KEYTRUDA
18 PDS0101 is the only compound selected by Merck for evaluation in combination with KEYTRUDA® as first line cancer therapy PDS0101 + KEYTRUDA®Keytruda® first immunotherapy approved as standard of care for first line treatment of cancer (recurrent or metastatic head and neck cancer)PDS0101 first T-c
Slide 19: Phase 2 study of PDS0101 with KEYTRUDA in head and neck cancer
19 PDS Biotechnology-sponsored study with KEYTRUDA ® supplied by MerckPrimary endpoints: Efficacy, safety and tolerabilityStudy design: Phase 2 open-label studyInclusion criteria: Recurrent/metastatic head and neck cancer and HPV16 infection A Phase 2 study of PDS0101 in combination with KEYTRUDA ®
Slide 20: Investigator-led Phase 2 studies in advanced HPV cancers
20 Investigator-Led Phase 2 studies of PDS0101 in combination therapy will evaluate efficacy and safety in treatment of advanced HPV cancers Funded By Phase 2 Open Label Study (Safety and Efficacy) Important Considerations Expected Initiation Advanced HPV-related cancers – all typesTriple combinatio
Slide 21: PDS0102
PDS0102
Slide 22: PDS0102 combines NCI-developed TARP antigen with Versamune
22 PDS0102 combines a proven NCI-developed TARP antigen with Versamune® to promote the robust induction of prostate- and breast-specific killer T-cells PDS Biotech collaboration with the National Cancer Institute (NCI)The TARP antigen was discovered by the NCI to be present in over 85% of prostate c
Slide 23: Intellectual Property and Financials
Intellectual Property and Financials
Slide 24: Intellectual property protection through mid-2030s
24 Intellectual property provides multiple layers of technology and product protection for Versamune®-related products through mid-2030s Versamune® and associated patents are owned and licensed by PDS BiotechPatents cover methods and compositions stimulating/promoting an immune response with Versamu
Slide 25: Financial position supports near-term milestones
PDS Biotech is in a financial position to support critical near-term milestones 25 Nasdaq: PDSB Shares Outstanding1 5.2M Cash1 $17.4M Share Price2 $2.53 Market Cap2 $14.6M Debt1 --- 1H 2020: Initiation of PDS Biotech-Merck Phase 2 combination study in head and neck cancer 1H 2020: Initiation of PDS
Slide 26: PDS Biotech well-poised to transform cancer treatment with immuno-oncology
PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology 26 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline 3 Demonstrated potential for strong clinical efficacy and durability of the response
Slide 27: PDS Biotechnology
PDS Biotechnology Anew generation of multi-functional cancer immunotherapies x om
Slide 28: Appendix
Appendix
Slide 29: Versamune is a proprietary T-cell activating platform
Versamune® is a proprietary T-cell activating platform designed to induce a robust, targeted anti-tumor response in vivo 29 Potential mechanism of action as currently understood. R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium-propane
Slide 30: Versamune summary flow chart of multi-functional mechanisms
Versamune® Summary Flow Chart: The multi-functional mechanisms that lead to effective anti-tumor response 30
Slide 31: Lipid enantiomeric specificity on immune activation
31 First demonstration of lipid enantiomeric specificity on immune activation SC injection of the active enantiomer (R-DOTAP) results in activation of type I interferons and induces monocyte infiltration to injection site SC injection of the weakly biologically active enantiomer (S-DOTAP) results in
Slide 32: Efficient uptake by dendritic cells
Early clinical studies with Versamune® demonstrate efficient and exclusive uptake by dendritic cells 32 Reference: Data on file. Positively-charged particles are designed to be spherical and sized similarly to viruses for optimal uptake Dendritic cells or epithelial cell line incubated with DQ-OVA a
Slide 33: Versamune taken up predominantly by dendritic cells
Versamune® is designed to be taken up predominantly by dendritic cells 33 Mice injected subcutaneously show high Versamune® uptake in vivo by dendritic cells in draining lymph nodes when evaluated at 4 hoursFlow cytometry plot shows the lipid uptake by CD11c cells (dendritic cells) Mice were injecte
Slide 34: Antigen processing and presentation
Versamune® demonstrates promising antigen processing and presentation 34 The positive charge of the liposome destabilizes the endosomes allowing the antigen to enter the cytoplasm of the dendritic cells and facilitates cross-presentation to CD8+ killer T-cells Versamune® induced protein uptake and p
Slide 35: Antigen presentation to CD8+ and CD4+ T-cells
Preclinical studies show that Versamune® demonstrates effective antigen presentation to both CD8+ killer and CD4+ helper T-cells 35 Reference: Data on file. Effective presentation of peptides via both the major histocompatibility complex (MHC) Class I pathway to CD8+ killer T-cells and via the MHC C
Slide 36: Versamune upregulates Type I Interferon genes
Mechanism of Immune Activation: Versamune® upregulates Type I Interferon genes for effective CD8+ killer T-cell induction 36
Slide 37: PDS0101 proprietary formulation promotes superior killer T-cell response
PDS0101 Proprietary formulation: Mixture of peptide micelles with Versamune® promotes superior CD8+ killer T-cell response 37 Comparison of Micellar vs. Traditional Encapsulation Methods - IFN- ELISPOT Shows Superior Potency of the PDS Biotech Micellar Approach – EU Patent Received DOPC and DOTMA (
Slide 38: Strong HPV16 T-cell responses independent of genetic sub-type
PDS0101 Phase 1 clinical study demonstrated strong in-vivo induction of HPV16 T-cell responses independent of patient genetic sub-type 38 2-4 Patient 2-5 3-1 3-2 5-7 2-7 High HLA Type A2 A2 A3 A74 A2 HPV-specific T-cell ResponseIFN-γ ELISPOT Patient 5-1 5-4 2-1 2-3 Low Medium HLA Type A2 A1, A2, A3,
Slide 39: Versamune upregulates danger signals in human cells
Mechanism of Immune Activation: Similar to murine dendritic cells Versamune® upregulates critical “danger signals” in human cells 39 In an independent NCI study R-DOTAP showed strong induction of cytokines and chemokines as well as the upregulation of important “danger signals”. Danger signals relea
Slide 40: Sustained chemokine induction in draining lymph nodes
Sustained activity of Versamune®: Prolonged and localized induction of chemokines in draining lymph nodes 40 Elevated chemokine levels persist for 5 days in LN after 1 subcutaneous injection – LN localization promotes superior CD8+ killer T-cell activation & proliferation CCL2 (MCP-1) is a chemokine
Slide 41: Versamune induces maturation of dendritic cells
Versamune® induces the maturation of dendritic cells, leading to a more robust T-cell response 41 Reference: Data on file. Versamune® and a positive control known to induce maturation of dendritic cells were incubated with human dendritic cells from donors and compared with the untreated cells. Vers
Slide 42: Type I interferons and chemokines recruit T-cells in lymph nodes
Chemokine CxCl10 Interferon-alpha1 (IFNα1) Interferon-beta1 (IFNβ1) 0 5Expression relative to Versamune®-based treatment 10 Induction of Type I interferons and associated chemokines in the lymph nodes leads to powerful and sustained recruitment of T-cells 42 Elevated T-cell levels persist in lymph n
Slide 43: Upregulation of CD69 on T-cells for superior priming
Efficiency of Versamune®: Upregulates CD69 on T-cells to sequester in lymph nodes for superior T-cell priming 43 Elevated upregulation of Type I Interferons results in CD69 induction and facilitates dendritic cell - T-cell interactions in the draining lymph nodes Wild Type miceIFN knock out mice
Slide 44: Localized cytokine induction may minimize systemic toxicity
The localized and sustained cytokine induction in the lymph nodes of Versamune® has the potential to minimize the risk of systemic toxicity 44 Reference: Data on file. Versamune® alone Versamune® alone Negligible increases above baseline in systemic cytokine levels with Versamune® alone or PDS0101
Slide 45: Superior antigen-specific T-cells via Type I interferon induction
Versamune® induces potentially superior levels of antigen specific T-cells, primarily via Type I interferon induction 45 Versamune® uniquely activates a specific immunological pathway that promotes effective CD8 killer T-cell induction Evaluation of HPV-specific CD8+ killer T-cell response Wild Type
Slide 46: Type I interferons upregulated via Myd88 pathway
Specificity of the Versamune® effect: Type I interferons are upregulated via activation of the Myd88 pathway 46 Versamune® mediates its CTL-inducing effects by activating type I interferons in a Myd88-dependent manner The T-cell responses were eliminated only in Myd88 or IFNAR (Type 1 IFN) knockout
Slide 47: Potent TRP2-specific T-cells break tolerance in B16 melanoma
Versatility of Versamune®: Potent TRP2-specific CD8+ killer T-cells break immune tolerance in difficult-to-treat B16 melanoma 47 Metastatic melanoma (Pre-clinical): Single injection of Versamune® + melanoma-specific antigen leads to potent T-cell attack against tumors 14 days after treatment
Slide 48: Superior antigen processing versus traditional adjuvants
Versamune® may promote superior antigen processing and endosomal accumulation vs. traditional adjuvants 48 Superior processing and endosomal accumulation Negative Control DQ-OVA DQ-OVA + Versamune® DQ-OVA + LPS Incubation of DQ-OVA, DQ-OVA + Versamune® or DQ-OVA + LPS with dendritic cellsenhances up
Slide 49: Reducing immunosuppression in the tumor microenvironment
Versamune® may increase the ratio of cytotoxic regulatory T-cells to reduce immunosuppression within the tumor microenvironment 49 Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment In Versamune® formulations almost 50% of CD8+ T-cells are antige
Slide 50: Tumor infiltration with helper and killer T-cells
Versamune® + TRP2 antigen TRP2 antigen alone Untreated Versamune® has demonstrated the ability to infiltrate the tumor with both antigen-specific helper and killer T-cells in early clinical studies 50 Reference: Vasievich EA, Ramishetti S, Zhang Y, Huang L. 2012. Trp2 peptide vaccine adjuvanted with
Slide 51: PDS0101 pre-clinical activity versus published HPV data
Inovio* ISA** Genexine*** PDS Biotech Antigen Technology DNA Peptides DNA Peptides Method of administration Electroporation Subcutaneous Electroporation Subcutaneous Pre-clinical regression of advanced/large TC-1 tumors Partial(3 doses)* No** No*** Complete(Single dose) Pre-clinical CD8+ T-cells (EL
Slide 52: PDS0101 may be superior to competitive products in tumor regression
Pre-clinical tumor regression studies: PDS0101 may be superior to the competitive products 52 Vaccine +Anti-PD-11 MIT Multi-combo3 PDS01014 Technologies Used/Combined Live vector/DNA vaccine +Checkpoint inhibitor TLR-agonist vaccine +Long-acting IL-2 +Checkpoint inhibitor +Tumor-targeting antibody P
Slide 53: Versamune may overcome key limitations in immuno-oncology
Versamune® may overcome key limitations in immuno-oncology 53 The Promise of Versamune® Design and composition facilitates uptakeComposition allows for efficient antigen cross-presentationLipid structure allows for powerful antigen-specific T-cell induction via localized activation of type 1 interfe
Slide 54: PDS0101 well-tolerated in Phase 1 dose ranging study
54 In Phase 1 dose ranging study, PDS0101 was well-tolerated with minimal toxicity Primary Endpoint: Safety, tolerability and immunogenicityStudy design: Phase 1 open-label studyInclusion criteria: CIN and high-risk HPV infection Results:Safe and well-toleratedNo dose limiting toxicities observedAll
Slide 55: Strategic priorities balancing speed and risk mitigation
Drive clinical development of PDS0101 in multiple advanced HPV-related cancersExploit demonstrated unique ability to promote in-vivo killer (CD8+) T-cell induction and resulting strong synergy between Versamune® and checkpoint inhibitors in combination therapyAdvance PDS0102 into the clinicLeverage
Slide 56: NCI and large pharma combination with PDS0101
National Cancer Institute + Unnamed Large Pharma: PDS0101 + 2 Novel ImmunotherapiesIndependent study of PDS0101 combinations by leading immuno-oncology experts (in advanced HPV-associated cancer)Independent demonstration of strong anti-tumor synergy of combinations including PDS0101All three agents
Slide 57: PDS0101 with chemo-radiotherapy at cancer research institute
Leading Cancer Research Institute: PDS0101 + Chemo-radiotherapyChemo-radiotherapy is the standard of care for the treatment of pre-metastatic cervical cancer (Stage IIb-IVa cervical cancer)Chemo-radiotherapy has been seen to potentially be much more effective in patients with tumor infiltrating T-ce
Slide 58: pals}
P/ , pals} Ear Pa
Slide 59: PDS0102 developed to treat TARP-associated cancers
59 PDS0102 is being developed to treat TARP-associated cancers including breast and prostate cancers Approximately 450,000 patients are diagnosed annually with prostate or breast cancer, most of which are associated with target T-cell receptor gamma alternate reading frame protein (TARP) Prostate ca
Slide 60: TARP antigen validated for cancer immunotherapy
60 The TARP antigen used in PDS0102 has been validated for use in cancer immunotherapy Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) Patients with Stage D0 prostate cancer vaccinated with TARP showed a significant decrease in tumor growth rate based on PSA levels*
Slide 61: PDS0102 may provide superior TARP-specific killer T-cells
61 PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer T-cells Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8)CFA – Complete Freund’s Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity PRE-CLINICAL OPTIMIZATION S
Slide 62: pals}
P/ , pals} Ear Pa
Slide 63: pals}
P/ , pals} Ear Pa
Slide 64: PDS0104 designed to target TRP2 antigen in melanoma
PDS0102 is designed to target Tyrosinase-related Protein 2 (TRP2), an antigen associated with melanoma 64 MelanomaAbout 96,480 new melanomas will be diagnosed this yearMore than 7,000 of which will prove fatalRates of melanoma have been rising rapidly over the past few decades. References: Fritzche
Slide 65: PDS0104 demonstrated regression within 14 days in pre-clinical studies
In pre-clinical studies, PDS0104 demonstrated clinical regression within 14 days of treatment 65 *Positive control = Complete Freund’s Adjuvant TRP2-specific killer T-cell induction after a single injection of Versamune® + TRP2 (PDS0104) Treatment started Treatment NaiveAnti PD-1 checkpoint inhibito
PDS Biotechnology — Investor Presentation (January 2020) on 6ix