PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (May 2021)
29 slides from PDS Biotechnology's investor presentation, May 2021
Slide 1: Corporate Overview May 2021
CORPORATE OVERVIEW MAY 2021 Frank Bedu-Addo Ph.D. President & CEO Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Slide 2: Forward-Looking Statements
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 activi
Slide 3: The most significant barrier to effective immunotherapy
PDS Biotech’s Versamune®-based The most significant immunotherapies promote a powerful in barrier to effective vivo tumor-specific CD8+ killer T-cell response immunotherapy has Versamune®-based therapies also: been their inability to Generate a strong CD8+ T-cell memory promote adequate response res
Slide 4: PDS Biotech is a clinical stage biotechnology company developing immunotherapies
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform CORPORATE OVERVIEW VERSAMUNE® PLATFORM PIPELINE • Biopharma developing novel cancer • NCI-initiated phase 2 HPV-cancer trial treatments and T-cell-activating va
Slide 5: Versamune-based pipeline developed in partnership with leaders in immuno-oncology
PDS Biotech’s robust Versamune®-based pipeline is being developed in partnership with the leaders in immuno-oncology and infectious disease * *Consortium of PDS Biotech, Farmacore and Blanver. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (MCTI) Nasdaq: PDSB Refere
Slide 6: PDS Biotech executive team
PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products • Senior executive experience with management of strategy and execution at both large pharma and biotechs Frank Bedu-Addo, PhD • Notable drug development: Chief Executive O
Slide 7: Introduction to the Versamune Platform
Introduction to the ® Versamune Platform
Slide 8: Versamune designed to induce robust targeted anti-tumor response in vivo
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen Versamune® + Tumor- associated proteins (antigens) Promotes uptake of vaccine Promotes antigen processing Activates Type I Interferon or immunotherapy and and presenta
Slide 9: 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 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies 500 # of Antigen-Re
Slide 10: Phase 1 trial: CD8+ T-cell response and regression of CIN cervical lesions
Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response resulted in regression of CIN cervical lesions & supported continued clinical studies Overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs. pre-treatment at day
Slide 11: Versamune possesses key characteristics of safe and effective immunotherapeutic
Initial data suggests Versamune® possesses the key characteristics of a safe and effective immunotherapeutic treatment Versamune®-based Checkpoint Traditional Cancer CAR-T Immunotherapies* Inhibitors Vaccines Induction of high levels of active CD8+ (killer) T-cells ✓ ✓ Induction of high levels of CD
Slide 12: PDS0101 Phase 2 Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 13: Clinical strategy: PDS0101 in combination with established therapies
Clinical strategy: Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation Combinations of PDS0101 with FDA-approved Novel combinations of PDS0101 with promising, standard of care investigational immunotherapeutic agents − First line treatment of recu
Slide 14: Phase 2 trial of PDS0101, M7824 and NHS-IL12 in HPV-associated cancer
Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer Indication Patients with advanced HPV-associated cancer who have failed prior treatment Bintrafusp alfa (M7824): Bifunctional “trap” fusion protein (ORR ~30%) Cli
Slide 15: Preclinical model: PDS0101 enhanced tumor-specific T-cells
In a preclinical model, PDS0101 demonstrated enhanced ability to train tumor-specific T-cells to be effective in infiltrating and killing tumors Combination of PDS0101 with M9241 or Bintrafusp alfa generated superior targeted T-cell response; triple combination demonstrated superior efficacy Bintraf
Slide 16: Phase 2 triple combination trial in advanced HPV-related cancer
PDS0101 phase 2 triple combination trial: Evaluate demonstration of superior preclinical tumor regression in advanced HPV-related cancer • Relapsed or refractory advanced HPV-related cancer presents a high bar for evaluation and also represents a significant unmet medical need – Patients who fail ch
Slide 17: Phase 2 trial of PDS0101 and KEYTRUDA in head and neck cancer
PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line treatment of HPV-associated metastatic/recurrent head and neck cancer Indication First line treatment of patients with HPV-associated head and neck cancer whose cancer has spread or returned KEYTRUD
Slide 18: Phase 2 trial of PDS0101 with chemoradiation in advanced cervical cancer
A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with chemoradiation therapy in patients with advanced cervical cancer Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Chemoradiotherapy (CRT – Standard of Care): Cisplatin & rad
Slide 19: Studies designed to demonstrate efficacy and broad applicability of PDS0101 and Versamune
Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform Potential to treat all types of HPV-cancer: PDS0101 Phase 2 clinical studies address all types of HPV-associated cancers. Potential to enhance anti-cancer efficacy of various
Slide 20: PDS0203 Phase 1/2 Clinical Development
PDS0203 Phase 1/2 Clinical Development
Slide 21: Versamune-based COVID-19 vaccine candidate
Developing a Versamune®-based COVID-19 vaccine candidate with the goal of promoting CD8+ T-cell responses and neutralizing antibodies Mt. Sinai data shows Versamune® promotes PDS Biotech generated data shows induction of neutralizing antibodies with induction of SARS-CoV-2 specific CD8+ lowest doses
Slide 22: PDS0203 potential advantages as second generation COVID-19 vaccine
Development of PDS0203 may offer potential advantages as a second generation COVID-19 vaccine May be effective against multiple COVID-19 variants Demonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be effective against
Slide 23: Looking Forward
Looking Forward
Slide 24: PDS0101 designed to treat cancers caused by HPV
PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) US annual HPV-associated cancer incidence1 • Approximately 43,000 patients are diagnosed with HPV-associated cancers Females (24,391) Males (18,280) annually in the US • Incidence rate is growing despite increased use of HPV p
Slide 25: PDS0203 another option to address COVID-19 global health crisis
PDS0203 may offer another option to address the COVID-19 global health crisis • Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3 clinical development and manufacturing scale-up • Phase 1/2 study anticipated to start in Q2/Q3 of 2021 pending approval
Slide 26: Projected milestones through 2022
Projected milestones through 2022* PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim Data from HPV- associated Cancer trial (NCI) PDS0101 expected Preliminary
Slide 27: Versamune compatibility with wide array of tumor and pathogenic antigens
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor and pathogenic antigens • Versamune®’s unique flexibility means it may work well with a wide range of identified tumor and infectious disease antigens • Today, 4 tumor antigens are being utilized wit
Slide 28: Rapid commercialization strategy: potential advantages and differentiators
Rapid commercialization strategy Potential Advantages and Differentiators • Promising early data in both oncology and infectious disease: Early clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platform • Near-term milestones: PDS0101 preliminary
Slide 29: Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies