Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (May 2021)
31 slides from Pds Biotechnology's investor presentation, May 25, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO MAY 2021
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: Versamune-based immunotherapies promote a powerful tumor-specific CD8+ killer T-cell response
3 PDS Biotech’s Versamune®-based immunotherapies promote a powerful in vivo tumor-specific CD8+ killer T-cell response Generate a strong CD8+ T-cell memory response resulting in long-lasting efficacy Are versatile and shown to be effective on their own or in combination with other drugs to improve t
Slide 4: PDS Biotech is a clinical stage biotechnology company developing Versamune-based immunotherapies
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 4 NCI-initiated phase 2 trial in advanced HPV-cancer reported preliminary efficacy in 83% (5 of 6) of HPV16-positive patients who failed both chemotherapy and/o
Slide 5: Versamune-based pipeline developed in partnership with leaders in immuno-oncology and infectious disease
PDS Biotech’s robust Versamune®-based pipeline is being developed in partnership with the leaders in immuno-oncology and infectious disease 5 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore and Blanver. Funding provided by The Ministry of Science, Technology and Innovation of Brazil
Slide 6: PDS Biotech executive team
PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products 6 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intro
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 8 Reference: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel inducti
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 9 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies Single treatment
Slide 10: PDS0101 Phase Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 11: Combinations of PDS0101 with standard of care and investigational agents
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 11 Novel combinations of PDS0101 with promising, investi
Slide 12: Phase 2 trial of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer
Phase 2 investigator-led clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer 12 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa (M7824): Bifunctional “trap” fusion proteinM9
Slide 13: Preclinical triple combination tumor regression
13 Bintrafusp alfa (M7824 - bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHH IL-12) Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Canc
Slide 14: PDS0101 Phase 1 trial: 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 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
Slide 15: PDS0101 phase 2 triple combination trial: objective response rate context
Objective response rate is measured by RESCIST 1.1 and represents at least a 30% reduction in tumor sizeAdvanced recurrent/refractory HPV-related cancer that is checkpoint inhibitor naïve:Patients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% ORR with standard
Slide 16: Triple combination achieved 83% ORR among 6 HPV16-positive patients
Checkpoint inhibitor naïve patients who failed both chemotherapy and/or radiation treatment)Tumor types represented in checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vaginal Triple combination achieved 83% ORR among 6 HPV16-positive patients 16 HPV16 positive subjects
Slide 17: Triple combination achieved 63% ORR among 8 checkpoint inhibitor refractory patients
Patients who failed chemotherapy, radiation and checkpoint inhibitor therapyTumor types represented in checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vulvar Preliminary results suggest the triple combination may provide superior efficacy over checkpoint inhibitor mono
Slide 18: Phase 2 trial of PDS0101 and KEYTRUDA in head and neck cancer
18 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 Clin
Slide 19: Phase 2 trial of PDS0101 with chemoradiation in advanced cervical cancer
19 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 Clinical Agents Chemoradiotherapy (CRT – Standard of Car
Slide 20: 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 20 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune
Slide 21: PDS0101 Near-term Milestones & Market Opportunities
PDS0101 Near-term Milestones & Market Opportunities
Slide 22: Projected PDS0101 milestones through 2022
Projected PDS0101 milestones through 2022* *Based on current enrollment and forecast modeling as of May 2021. Subject to change. 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim Data from HPV-associated Cancer trial (NCI) expec
Slide 23: Approximately 43,000 patients diagnosed with HPV-associated cancers annually in the US
23 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1Existing immunotherapies cost $120,000+ annually per patient2Incidence rate is growing and remains a significant unmet medical need 1Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.2
Slide 24: Versamune compatible with a wide array of tumor and pathogenic antigens
Versamune® has demonstrated the potential for 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 Versamune®’s unique flexibility means it may work well with a wide range of identifie
Slide 25: Versamune-based oncology pipeline developed in partnership with immuno-oncology leaders
PDS Biotech’s robust Versamune®-based oncology pipeline is being developed in partnership with the leaders in immuno-oncology 25 Reference: Data on file.
Slide 26: Farmacore License Agreement for Versamune-Based COVID Vaccine
Farmacore License Agreement for Versamune®-Based COVID Vaccine
Slide 27: PDS0203 may offer advantages as a 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 variantsDemonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be eff
Slide 28: Consortium commitment of up to ~US$60 million from MCTI, Brazil
Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3 clinical development and manufacturing scale-upPDS Biotech has licensed Versamune® technology to Farmacore to develop a COVID-19 vaccine candidate Farmacore is responsible for antigen manufacturing an
Slide 29: Final Comments
Final Comments
Slide 30: Rapid commercialization strategy
Rapid commercialization strategy 30 Promising early data in both oncology and infectious disease: Early clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platformNear-term milestones: PDS0101 interim efficacy data presented at ASCO in NCI-led Pha
Slide 31: PDS Biotechnology
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies