PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (May 2021)
30 slides from PDS Biotechnology's investor presentation, May 19, 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: Barrier to effective immunotherapy and Versamune-based approach
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: Clinical stage biotech developing immunotherapies on the Versamune platform
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 treatment candidates and T-cell- su
Slide 5: Versamune-based pipeline developed in partnership with leaders
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 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 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: PDS0101 Phase 2 Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 11: 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 12: Phase 2 trial of PDS0101, M7824 and NHS-IL12 in advanced HPV cancer
Phase 2 investigator-led 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 Clinical Agents M924
Slide 13: Preclinical PDS0101 trains tumor-specific T-cells to infiltrate and kill tumors
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 (M7824) generated superior targeted T-cell response; triple combination demonstrated superior efficacy
Slide 14: PDS0101 Phase 1: CD8+ T-cell response and CIN lesion regression
PDS0101 Phase 1 clinical trial: Powerful CD8+ T-cell response resulted in regression of CIN cervical lesions & supported continued clinical studies Monotherapy overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs. pre-treat
Slide 15: PDS0101 phase 2 triple combination trial design and ORR benchmarks
PDS0101 phase 2 triple combination trial: Evaluated potential for superior preclinical tumor regression in advanced HPV-related cancer • Objective response rate is measured by RESCIST 1.1 and represents at least a 30% reduction in tumor size • Advanced recurrent/refractory HPV-related cancer that is
Slide 16: Triple combination achieved 83% ORR in HPV16-positive patients
Triple combination achieved 83% ORR among 6 HPV16-positive patients Checkpoint inhibitor naïve patients (Relapsed or refractory advanced cancer) HPV16 positive Current subjects Standard of Care (Checkpoint Inhibitors) Number of subjects 6 Number of objective responses (tumor reduction) 5 Percentage
Slide 17: Triple combination achieved 63% ORR in checkpoint refractory patients
Triple combination achieved 63% ORR among 8 HPV16-positive checkpoint inhibitor refractory patients Checkpoint inhibitor refractory patients HPV16 positive Current subjects Standard of Care Number of subjects 8 Number of objective responses (tumor reduction) 5 Percentage of objective responses 63% 5
Slide 18: 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 19: Phase 2 trial of PDS0101 with chemoradiation in 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 20: Studies designed to demonstrate efficacy and broad applicability of PDS0101
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 21: PDS0203 Phase 1/2 Clinical Development
PDS0203 Phase 1/2 Clinical Development
Slide 22: 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 preclinical data shows induction of neutralizing antibodies with induction of SARS-CoV-2 specific CD8+ lowest dos
Slide 23: PDS0203 potential advantages as second generation COVID-19 vaccine
Development of PDS0203, if successful, 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 ef
Slide 24: Looking Forward
Looking Forward
Slide 25: PDS0101 designed to treat HPV-caused cancers
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 26: PDS0203 could offer another option for COVID-19 health crisis
PDS0203, if development is successful, could 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
Slide 27: 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 28: Versamune compatibility with wide array of antigens
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor and pathogenic antigens • We believe that 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 be
Slide 29: Rapid commercialization strategy and potential advantages
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 30: Nasdaq: PDSB
Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies