Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (October 2021)
38 slides from Pds Biotechnology's investor presentation, Oct 18, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO OCTOBER 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 clinical stage company with Versamune platform
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 promote tumor-specific 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 induces 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 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: Versamune pipeline developed with immuno-oncology leaders
PDS Biotech’s robust Versamune® -based pipeline is being developed in partnership with leaders in immuno-oncology and infectious disease 7 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science, Technology
Slide 8: Introduction to PDS0101
Introduction to PDS0101
Slide 9: HPV-associated cancers diagnosed annually in the US
9 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 ne
Slide 10: References
10 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 11: Versamune-induced killer T-cells eradicate HPV-positive tumors after 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 11 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 12: PDS0101 monotherapy Phase 1 T-cell responses
Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific CD8+T-cells in Phase 1 clinical trial 12 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 13: NCI-led trial of PDS0101, Bintrafusp alfa and M9241 triple combination
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer 13 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional checkpoint inhibitor-“TGF-
Slide 14: ASCO 2021: 83% ORR among CPI naive patients
ASCO 2021: PDS0101 triple combination achieved 83% ORR among six advanced HPV16-positive CPI naive patients, suggesting potential efficacy 14 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 15: ASCO 2021: 58% tumor reduction in CPI refractory patients
ASCO 2021: Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients 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 malignancies. Presented at: America
Slide 16: ASCO 2021: Durability of potential anti-cancer efficacy
16 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 17: ASCO 2021: Results in HPV16-negative patients
ASCO 2021: Results in HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction 17 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 18: PDS0101/KEYTRUDA trial in head and neck cancer (VERSATILE-002)
18 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 19: PDS0101 and chemoradiation in cervical cancer (IMMUNOCERV)
19 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 20: Preclinical Pipeline Data
& aed Pe © Preclinical Pipeline Data Qe
Slide 21: Versamune potent CD8+ T-cell responses with different tumor antigens
21 Reference: Data on file. In preclinical studies, Versamune® has demonstrated potential for potent CD8+ (killer) T-cell responses with different tumor antigens 21 PDS0101 Phase 2 interim results demonstrate promising link between targeted CD8+ killer T-cell response and anti-tumor response Versamu
Slide 22: Development of PDS0102
(Development of PDS0102 ao
Slide 23: Patients diagnosed annually with TARP-associated cancers
23 23 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 24: PDS0102 superior induction of TARP-specific CD8+ T-cells
24 24 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 25: Development of PDS0103
(Development of PDS0103 ao
Slide 26: PDS0103 clinical trial design targeting MUC1
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 27: Versamune-induced CD8+ T-cells may eradicate MUC1-positive tumors
27 27 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 28: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 29: Projected milestones through 2022
Projected milestones through 2022* *Based on current enrollment and forecast modeling as of October 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) Prelimina
Slide 30: PDS Biotechnology: Developing powerful, safe, versatile immunotherapies
”) PDS Biotechnology Nasdaq: PDSB Developing powertul, safe, versatile immunotherapies
Slide 31: Appendix
Appendix
Slide 32: Oncology pipeline developed with immuno-oncology leaders
PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the leaders in immuno-oncology 32 Reference: Data on file.
Slide 33: Preclinical triple combination 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 CD8+ T-cells infiltrate tumors and reduce Tregs
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(
PDS Biotechnology — Investor Presentation (October 2021) on 6ix