Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (May 2021)
31 slides from Pds Biotechnology's investor presentation, May 20, 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 a pipeline of 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 HPV-cancer trial surpassed initial efficacy requirement prompting expansion to full enrollmentNovel COVID-19 vaccine candidate being dev
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 has demonstrated success in drug development and commercialization
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 is designed to induce a robust and 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 immunotherapies
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: Investigator-led 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 tumor regression with PDS0101 triple combination
13 Bintrafusp alfa (bi-functional checkpoint inhibitor)+ M9241 (immuno-cytokine (NHS-IL12)) 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 Immu
Slide 14: PDS0101 Phase 1 trial: CD8+ T-cell response and regression of CIN cervical lesions
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: Triple combination works synergistically to induce targeted T-cells to attack the tumor
Triple combination of PDS0101, Binstrafusp alfa and M9241 works synergistically to induce targeted T-cells to attack and infiltrate the tumor 15 Bintrafusp alfa exposes the tumor to attack and M9241 issues a signal calling T-cells to the tumor Reference: Smalley Rumfield C, Pellom ST, Morillon II YM
Slide 16: 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 17: Checkpoint inhibitor naive patients: 83% ORR among 6 HPV16-positive patients
Checkpoint inhibitor naïve patients (Relapsed or refractory advanced cancer)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 17 HPV16 positive subjects CurrentStandard
Slide 18: Checkpoint inhibitor refractory patients: 63% ORR among 8 HPV16-positive patients
Checkpoint inhibitor refractory patientsTumor 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 monotherapy, even in immunologically lim
Slide 19: Phase 2 trial of PDS0101 and KEYTRUDA for first-line head and neck cancer
19 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 20: Phase 2 trial of PDS0101 with chemoradiation in advanced cervical cancer
20 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 21: 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 21 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune
Slide 22: PDS0203 Phase 1/2 Clinical Development
PDS0203 Phase 1/2 Clinical Development
Slide 23: Mt. Sinai data shows Versamune promotes neutralizing antibodies at lowest antigen doses
Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1 23 1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file PDS Biotech preclinical data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2
Slide 24: 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 25: Looking Forward
Looking Forward
Slide 26: Approximately 43,000 patients diagnosed with HPV-associated cancers annually in the US
26 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 27: 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 and regulatory procedures,
Slide 28: 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 29: Versamune immunological compatibility 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 We believe that Versamune®’s unique flexibility means it may work well with a wide ra
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 preliminary efficacy data anticipated in Q2 2021 and P
Slide 31: PDS Biotechnology
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies