Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (November 2021)
38 slides from Pds Biotechnology's investor presentation, Nov 10, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO NOVEMBER 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 biotechnology company developing immunotherapies
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 3 Interim data from NCI-led PDS0101 Phase 2 trial showed tumor reduction in ~70% of patients who had failed prior treatmentNo new or elevated toxicities observe
Slide 4: Versamune-based immunotherapies designed to promote CD8+ killer T-cell response
4 PDS Biotech’s Versamune®-based immunotherapies are designed to promote a powerful in vivo tumor-specific CD8+ killer T-cell response Generate the right type and quantity of effective CD8+ killer T-cells Generate potency without systemic side effects Generate memory T-cells, to enhance durability o
Slide 5: Versamune designed to induce robust and targeted anti-tumor response
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen 5 References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induct
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: 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 7 Reference: Data on file.
Slide 8: Pipeline developed with leaders in infectious disease
PDS Biotech’s Versamune® -based pipeline is being developed in partnership with leaders in infectious disease 8 Reference: Data on file. *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (“MC
Slide 9: Introduction to PDS0101
Introduction to PDS0101
Slide 10: HPV-associated cancer incidence and unmet need
10 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1Cancers caused by HPV include anal, cervical, head and neck, penile vaginal and vulvar cancersIncidence rate of HPV-related anal and head and neck cancer is growing and remains a significant unmet medical n
Slide 11: References
11 References: Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018. Hernandez et al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research, Strauss J. et al. 2021 ASCO Annual Meeting Abstract: 2501. human papillomavirus (HPV)-16 cancers represents 70-80% of
Slide 12: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Greater quantity & quality of Versamune®-induced killer (CD8+) T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose 12 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies Single trea
Slide 13: PDS0101 monotherapy induced HPV16-specific CD8+ T-cells in Phase 1
Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific CD8+T-cells in Phase 1 clinical trial 13 2-4 Patient 2-5 3-1 3-2 5-7 2-7 High HLA Type A2 A2 A3 A74 A2 HPV-specific T-cell ResponseIFN-γ ELISPOT Patient 5-1 5-4 2-1 2-3 Low Medium HLA Type A2 A1, A2, A3, 30
Slide 14: NCI-led trial of triple combination in advanced HPV-associated cancer
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer 14 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional checkpoint inhibitor-“TGF-
Slide 15: ASCO 2021: triple combination achieved 83% ORR in CPI naive patients
ASCO 2021: PDS0101 triple combination achieved 83% ORR among six advanced HPV16-positive CPI naive patients, suggesting potential efficacy 15 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancie
Slide 16: ASCO 2021: 58% tumor reduction in CPI refractory patients
ASCO 2021: Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients 16 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: America
Slide 17: ASCO 2021: durability of anti-cancer efficacy in CPI naive patients
17 ASCO 2021: Triple combination shows promising durability of potential for anti-cancer efficacy in HPV16-positive checkpoint inhibitor naïve patients PDS0101 + Bintrafusp alfa + M9241 Standard of Care(Checkpoint Inhibitors) HPV16-positive Number of checkpoint inhibitor naïve patients 6 Ongoing obj
Slide 18: Results in HPV16-negative patients suggest role of CD8+ T-cells
ASCO 2021: Results in HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction 18 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malig
Slide 19: VERSATILE-002: PDS0101/KEYTRUDA in head and neck cancer
19 Phase 2 trial evaluating the combination of PDS0101/KEYTRUDA® for treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Indication Treatment of patients with HPV16-positive head and neck cancer whose cancer has spread or returned Clinical Agents KEYTRUDA® (Standard
Slide 20: IMMUNOCERV: PDS0101 with chemoradiation in cervical cancer
20 Phase 2 investigator-led trial evaluating the combination of PDS0101 and chemoradiation in patients with locally advanced cervical cancer (IMMUNOCERV) Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Agents Chemoradiotherapy (CRT – Standard of Care)
Slide 21: Preclinical Pipeline Data
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Slide 22: Versamune demonstrated potent CD8+ T-cell responses with different tumor antigens
22 Reference: Data on file. In preclinical studies, Versamune® has demonstrated potential for potent CD8+ (killer) T-cell responses with different tumor antigens 22 PDS0101 Phase 2 interim results demonstrate promising link between targeted CD8+ killer T-cell response and anti-tumor response Versamu
Slide 23: Development of PDS0102
(Development of PDS0102 ao
Slide 24: Patients diagnosed annually with TARP-associated cancers
24 24 Approximately 470,000 patients are diagnosed annually with AML, prostate or breast cancer, most of which are associated with target T-cell receptor gamma alternate reading frame protein (TARP) Acute Myeloid Leukemia (AML)Almost 20,000 cases in the US annuallyTARP expressed in 100% of AML Prost
Slide 25: PDS0102 may provide superior induction of TARP-specific T-cells
25 25 PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer T-cells Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8)CFA – Complete Freund’s Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity PRE-CLINICAL OPTIMIZATIO
Slide 26: Development of PDS0103
(Development of PDS0103 ao
Slide 27: Clinical trial design for PDS0103 in MUC1-expressing tumors
Clinical trial design will seek to evaluate PDS0103 in tumor types with the highest expression of MUC1 and the greatest differences in MUC1 expression between malignant and healthy tissue PDS0103 is designed to treat cancers caused by mucin-1 (MUC1), which is highly expressed in solid tumors and is
Slide 28: Versamune-induced T-cells may eradicate MUC1-positive tumors
28 28 Greater quantity and quality of Versamune®-induced CD8+ killer T-cells may result in ability to eradicate MUC1-positive tumors Induced a >10-fold number of polyfunctional MUC1 specific CD8+ T-cells *Adjuvant = cytokine GMCSFReferences: J. Immunology, 2019 (202), 1215; Studies in TC-1 tumor mod
Slide 29: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 30: Projected milestones through 2022
Projected milestones through 2022* *Based on current enrollment and forecast modeling as of November 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) Prelimin
Slide 31: PDS Biotechnology
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies
Slide 32: Appendix
Appendix
Slide 33: Preclinical triple combination showed higher targeted T-cell response
33 Bintrafusp alfa (M7824 - bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHS IL-12) Tumor Regression: 13/16 (81%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Canc
Slide 34: Versamune induces CD8+ T-cells that infiltrate tumors
34 Reference: Data on file. Versamune® induces high quantity and quality of CD8+ killer T-cells that infiltrate the tumors and make them more susceptible to killing Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment PDS0101 treatment alters the t
Slide 35: PDS0104 preclinical studies in B16 melanoma
35 Reference: Data on file. PDS0104 preclinical studies: Potent TRP2-specific CD8+ killer T-cells demonstrate potential to break immune tolerance in difficult-to-treat B16 melanoma 35 14 days after single injection treatment Potential potent activity with different tumor antigens
Slide 36: Immunotherapeutics ORR in HPV-associated malignancies
Immunotherapeutics ORR in HPV-associated malignancies 36 Taken from J. Strauss, ASCO 2021 (Revised to show CPI status) Agents(s) Cervical (CPI Naïve) H&N SCC (CPI Naïve) All HPV (CPI Naïve) All HPV (CPI refractory) References Pembroluzimab (Keytruda®) 14% 24% Keynote 012, Siewert TY, 2016 Nivolumab
Slide 37: Adverse Event Summary
37 Adverse Event Summary All patientsN=25* Grade ≥2 Treatment-related adverse events (TRAEs) 23 (92%) TRAEs leading to discontinuation of ≥ 1 drug(s) 5 (20%) Treatment-related serious AEs 7 (28%) TRAEs in ≥5% of patients Anemia 12 (48%) Lymphocyte decrease 7 (28%) Flu like symptoms 6 (24%) Injection
Slide 38: HPV-related cancers in interim data study population
Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the interim data study population PDS0101 interim Phase 2 trial data presented by the NCI at ASCO 2021: Most HPV-associated cancers are represented - >95% of all US cases 38 Cervical(40%) Anal(
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