Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (January 2021)
24 slides from Pds Biotechnology's investor presentation, Jan 7, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO JANUARY 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: PDS Biotech is a clinical stage immunotherapy company built on the Versamune platform
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 in-vivo induction of
Slide 4: Robust Versamune-based pipeline developed with leaders in immuno-oncology
PDS Biotech’s robust Versamune®-based pipeline being developed in partnership with the leaders in immuno-oncology 4 Reference: Data on file.
Slide 5: PDS Biotech executive team
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-Intro
Slide 6: Introduction to the Versamune Platform
Introduction to the Versamune® Platform
Slide 7: 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 7 Reference: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel inducti
Slide 8: 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 8 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose Single treatment dose Results typical of
Slide 9: Phase 1 trial: CD8+ T-cell response results in regression of CIN cervical lesions
Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response results in regression of CIN cervical lesions – supports preclinical studies 9 * 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 + H
Slide 10: PDS0101 with M7824 and NHS-IL12 tumor regression data
10 Saline Tumor Regression: 0/16 (0%)T-cell Clones: 18 M7824 (bi-functional checkpoint inhibitor)+ NHS-IL12 (immuno-cytokine) Tumor Regression: 8/16 (50%)T-cell Clones: 18 PDS0101 + M7824 + NHS-IL12 Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II
Slide 11: Versamune-based immunotherapies compared with other cancer treatments
11 Versamune®-basedImmunotherapies* Checkpoint Inhibitors Traditional Cancer Vaccines CAR-T Chemotherapy 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
Slide 12: Mt. Sinai data on Versamune with SARS-CoV-2 antigen
Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1 12 1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file PDS generated data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2 Preclinica
Slide 13: Versamune compatible with a wide array of tumor and pathogenic antigens
13 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
Slide 14: PDS0101 Phase 2 Clinical Development
PDS0101 Phase 2 Clinical Development
Slide 15: PDS0101 designed to treat cancers caused by HPV
15 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
Slide 16: Combinations of PDS0101 with standard of care and novel 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 16 Novel combinations of PDS0101 with promising immunoth
Slide 17: 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 17 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents M7824: Bifunctional fusion protein - checkpoint inhibit
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 Enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune®’s versatili
Slide 21: Looking Forward
Looking Forward
Slide 22: Financial position to support PDS0101 milestones through mid-2022
Financial position to support PDS0101 projected milestones through mid-2022* 22 *Based on current enrollment and forecast modeling as of November 2020. Subject to change.
Slide 23: Positioned for accelerated development
Positioned for accelerated development 23 Enhanced anti-cancer efficacy: Early clinical data and preclinical data suggest potentially superior efficacy, safety and versatility of the platformNear-term milestone: PDS0101 preliminary data Q1-Q2 2021Validation of approach: All three on-going phase 2 cl
Slide 24: PDS Biotechnology
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies
PDS Biotechnology — Investor Presentation (January 2021) on 6ix