Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (May 2021)
29 slides from Pds Biotechnology's investor presentation, May 13, 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: Clinical stage biotech 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 4 NCI-initiated phase 2 HPV-cancer trial surpassed initial efficacy requirement prompting expansion to full enrollmentNovel COVID-19 vaccine being developed in
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 a 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: Phase 1 trial: CD8+ T-cell response resulted in 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 10 * 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 11: Versamune-based immunotherapies compared with checkpoint inhibitors, cancer vaccines and CAR-T
Versamune®-basedImmunotherapies* Checkpoint Inhibitors Traditional Cancer Vaccines CAR-T 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
Slide 12: PDS0101 Phase 2 Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 13: 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 13 Novel combinations of PDS0101 with promising, investi
Slide 14: Phase 2 trial of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer
Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer 14 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa (M7824): Bifunctional “trap” fusion pro
Slide 15: Preclinical tumor regression with PDS0101 triple combination
15 Bintrafusp alfa (bi-functional checkpoint inhibitor)+ M9241 (immuno-cytokine) Tumor Regression: 8/16 (50%)T-cell Clones: 18 PDS0101 + Bintrafusp alfa + M9241 Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy o
Slide 16: Relapsed or refractory advanced HPV-related cancer presents high bar and unmet need
Relapsed or refractory advanced HPV-related cancer presents a high bar for evaluation and significant unmet medical needPatients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% reported efficacy of standard of care checkpoint inhibitorsAn experimental immunother
Slide 17: Phase 2 trial of PDS0101 and KEYTRUDA in head and neck cancer
17 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 18: Phase 2 trial of PDS0101 with chemoradiation in advanced cervical cancer
18 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 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 19 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune
Slide 20: PDS0203 Phase 1/2 Clinical Development
PDS0203 Phase 1/2 Clinical Development
Slide 21: Versamune promotes neutralizing antibodies and SARS-CoV-2 specific CD8+ T-cells
Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1 21 1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file PDS Biotech generated data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2 Pr
Slide 22: Potential advantages of PDS0203 as a 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 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 effective against c
Slide 23: Looking Forward
Looking Forward
Slide 24: Approximately 43,000 patients diagnosed with HPV-associated cancers annually in the US
24 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 pat
Slide 25: 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-upPhase 1/2 study anticipated to start in Q2/Q3 of 2021 pending approval from Anvisa, Brazilian regulatory agencyPending results, PDS0203 could be commerci
Slide 26: Projected milestones through 2022
Projected milestones through 2022* *Based on current enrollment and forecast modeling as of April 2021. Subject to change.**Consortium funding provided by MCTI, Brazil 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim Data from
Slide 27: 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 28: Rapid commercialization strategy and potential advantages
Rapid commercialization strategy 28 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 preliminary efficacy data anticipated in Q2 2021 and P
Slide 29: PDS Biotechnology
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies