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| EX-99.2 - EXHIBIT 99.2 - PDS Biotechnology Corp | brhc10017044_ex99-2.htm |
| 8-K - 8-K - PDS Biotechnology Corp | brhc10017044_8k.htm |
Exhibit 99.1
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO NOVEMBER 2020
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 activities and timelines and market
opportunities. All statements other than statements of historical facts included in this presentation are forward-looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,”
“likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk
Factors” in the documents filed with the Securities and Exchange Commission from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date of this presentation. Except to the extent required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included
in this presentation to reflect subsequent events or circumstances.
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on
the proprietary Versamune® platform 3 Versatile, potent T-cell-activating platform demonstrating efficacy without dose limiting toxicity in clinical trialsClinically supported induction of active antigen-specific killer and helper T-cells
in vivoLong term potential to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030s Biopharma developing novel treatments for cancer and T-cell activating infectious
disease vaccinesThree phase 2 oncology clinical trials in progressPublicly listed on NASDAQ: PDSB~15 employees with headquarters in Florham Park and Princeton, NJDebt free with approximately $33.5M in cash as of
9/30/20 Pipeline Versamune® Platform Corporate Overview
4 Reference: Data on file. PDS Biotech’s robust Versamune®-based pipeline being developed in
partnership with the leaders in immuno-oncology
PDS Biotech executive team has demonstrated success in the development and commercialization of leading
pharmaceutical products 5 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck) Senior
executive experience with over 20 years of experience in pharma and drug developmentIn-depth experience with M&A transactions, capital markets, and investor relations >30 years of translational clinical research experienceFormer
Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and
manufacturing Frank Bedu-Addo, PhDChief Executive Officer Gregory Conn, PhDChief Scientific Officer Lauren V. Wood, MDChief Medical Officer Michael KingChief Financial Officer (Interim)
Introduction to the Versamune® Platform
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered
with a tumor-associated antigen 7 Reference: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol.
202 (12): 3524-3536.Smalley Rumfield C et al.. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612. Promotes uptake of vaccine or immunotherapy and entry into lymph
nodes Promotes antigen processing and presentation to T-cells via MHC I and II pathways Activates Type I Interferon pathway, enabling a powerful anti-tumor killer CD8+ T-cell response Versamune® + Tumor-associated proteins (antigens)
8 Versamune®-basedImmunotherapies Checkpoint Inhibitors Traditional Cancer Vaccines Induction of
high levels of active CD8+ (killer) T-cells Induction of high levels of CD4+ (helper) T-cells Ability to overcome tumor immune suppression Induction of long-term memory CD8+ T-cells Low systemic toxicity
risk Versamune® posses the key characteristics of a safe and effective immunotherapeutic treatment Reference: J. Immunology, 2019 (202), 1215; PDS0101 clinical trial report (CSR U10-02-11-001)
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to
eradicate HPV-positive tumors after a single dose 9 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies Single treatment dose Results typical of current topclinical-stage HPV
cancer vaccines Tumor rechallenge at Day 60; complete and sustained cure of cancer *Adjuvant = cytokine GMCSFReferences: J. Immunology, 2019 (202), 1215; Studies in TC-1 tumor model with other immunotherapies reported in: Vaccine 2009,
January 14, 27 (3): 431; Science Translational Medicine 2016, 13 April, Vol 8 Issue 334; Vaccine 2009, September 25, 27 (42): 5906. (PDS0101)
Preclinical T-cell induction and regression efficacy replicated in Phase 1 study, demonstrating
powerful in-vivo CD8+ T-cell response in humans 10 Overcomes key limitation of immuno-oncology: > 15-fold increase in IFN-γ inducing T-cells and > 20-fold increase in circulating dual INF-γ and Granzyme-b inducing killer T-cells vs.
pre-treatment at day 14* * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®)References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent Antigen-Specific
CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papillomavirus Infection. Nov 8, 2019. SITC. Presentation O17. Most patients infected with multiple strains of HPV CIN lesion regression at 1-3 months 60% 20% 20%
11 Versamune® has demonstrated immunological compatibility with a wide array of tumor and pathogenic
antigens Reference: Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737 Today, 4 tumor antigens are being utilized with the Versamune® platform, more than 75 tumor antigens have been identifiedWe are currently
progressing two Versamune®-based infectious disease vaccines, one for SARS-COVID-19, and one for universal influenzaVersamune®’s unique flexibility means it may work well with a wide range of identified tumor and pathogenic antigensLong term
potential to continuously expand development of Versamune®-based products through partnerships and licensing
PDS0101 Clinical Development
13 PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) Approximately 43,000
patients are diagnosed with HPV-associated cancers annually in the USIncidence rate is growing despite increased use of HPV preventative vaccinesSignificant unmet medical need across the spectrum of HPV-associated cancerExisting
immunotherapies cost $120,000+ annually per patient2 1Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.2Hernandez et al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research Females
(24,391) Males (18,280) US annual HPV-associated cancer incidence1
Combinations of PDS0101 with FDA-approved standard of careFirst line treatment of recurrent/metastatic
HPV-positive head and neck cancerCombination with Keytruda®Treatment of advanced localized cervical cancerCombination with chemoradiotherapy Value creation strategy: Focus on combination studies for rapid proof-of-concept and risk
mitigation 14 PDS0101 has demonstrated strong potential for efficacy as a monotherapyPDS0101 is being investigated in two Phase 2 trials in combination therapies to enhance the clinical benefit of treatments that have been FDA-approved for
the specific indications, and demonstrated to be safe, well tolerated and effective Novel combinations of PDS0101 with promising immunotherapeutic agentsTreatment of advanced HPV-associated cancers (anal, cervical, vaginal, head and neck
etc.)Triple combination with Bintrafusp-alpha (bi-functional checkpoint inhibitor - M7824) and NHS-IL12 (antibody conjugated immuno-cytokine)
15 Phase 2 studies of PDS0101 in combination therapy will evaluate efficacy and safety in a range of
advanced HPV cancers Partner Phase 2 Open Label Study (Safety and Efficacy) Important Considerations Initiation Recurrent/metastatic HPV16-associated head & neck cancer – First lineCombination with Merck’s Keytruda®96
subjects Objective is to evaluate if combination demonstrates improvement over standard of care Keytruda® alone November 2020 Advanced, localized cervical cancer– all HPV types (Stage II-IVa)Combination with chemo-radiotherapy (CRT)35
subjects Objective is to evaluate if combination demonstrates improvement over standard of care CRT alone October 2020 Advanced HPV-associated malignancies – all HPV typesCombination with EMD Serono’s Bintrafusp-alfa (M7824) + NHS-IL1240
subjects NCI-published preclinical data shows potent anti-tumor synergy and CD8 T-cell induction with PDS0101*All three agents have demonstrated potential efficacy as monotherapies in early trials June 2020 *Reference: Smalley Rumfield C,
Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi: 10.1136/jitc-2020-000612
Looking Forward
Financial position to support PDS0101 projected milestones through mid-2022* 17 *Based on current
enrollment, modeling, enrollment and forecast modeling as of November 2020. Subject to change.
Well positioned for near-term value appreciation 18 Enhanced anti-cancer efficacy: Early clinical
data and preclinical data suggest potentially superior efficacy, safety and versatility of the platformPotential for near-term value appreciation: PDS0101 preliminary data Q1-Q2 2021Validation of approach: All three on-going phase 2 clinical
trials supported and partnered with leading and top-tier institutions in the field of cancer and immuno-oncologyCommercialization path: Clinical studies evaluating the potential to safely enhance the clinical efficacy of FDA-approved
anti-cancer products presents a potentially rapid path to commercializationRapid adoption strategy: Evaluation of PDS0101 in combination with standard of care in multiple HPV-associated cancers Pipeline Key Advantages and Differentiators
