Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (January 2023)
33 slides from Pds Biotechnology's investor presentation, Jan 3, 2023
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | January 2023
Slide 2: Forward-looking statements
2 Certain information in this presentation may include forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corpo
Slide 3: Company Overview
1 2 4 5 6 Company Overview Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease Versamune® based platforms leverage the body’s own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer Exclusi
Slide 4: Versamune is designed to promote CD8+ killer T cell responses in vivo
Versamune® is designed to promote CD8+ killer T cell responses in vivo Top Line Phase 2 Clinical Data 4 Versamune® Technology Platform: In-vivo tumor-specific killer (CD8+) T cell induction HPV-positive head and neck cancer: PDS0101 + KEYTRUDA® (standard of care) in patients whose cancer has returne
Slide 5: HPV-associated cancers in the US: $6B market opportunity
More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in the US1,2 HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3 Existing immunotherapies cost $150,000+ annually per patient1 US HPV-associated cancer i
Slide 6: Versamune Oncology Platform
Versamune® Oncology Platform
Slide 7: Designed to address limitations of current immunotherapy
Designed to address limitations of current immunotherapy Versamune® based Immunotherapies 7 PDS Biotech believes that there are 2 key obstacles that limit broad efficacy of immunotherapy in the treatment of cancer Limited ability to induce the type of immune response that promotes the production of
Slide 8: Locally advanced cervical cancer: PDS0101 + Chemo-Radiotherapy Phase 2
Locally advanced cervical cancer: Tumor size > 5cm and/or spread to lymph nodes Phase 2 Clinical Trial: PDS0101 + Chemo-Radiotherapy 1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101 2In agreement with published preclinical findings th
Slide 9: Induction of activated CD8+ killer T cells correlates with elimination of circulating tumor DNA
Induction of activated CD8+ killer T cells correlates with elimination of circulating tumor DNA1 PDS0101 Appears to Induce Clinically Beneficial T Cells 1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiati
Slide 10: Recurrent or metastatic HPV16-positive head and neck cancer Phase 2: PDS0101 + KEYTRUDA
Potential Treatment for Recurrent or metastatic HPV16-positive head and neck cancer Phase 2 Clinical Trial: PDS0101 + KEYTRUDA® 119% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 212-month overall survival of 49% with KEYTRUDA® monotherapy reported in KEYNOTE-048 s
Slide 11: Phase 2: PDS0101 + KEYTRUDA VERSATILE-002
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 11 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41
Slide 12: Phase 2: PDS0101 Monotherapy and in Combination with KEYTRUDA
KEYTRUDA® PDS0101: Versamune® based immunotherapy generating HPV-specific CD8+ and CD4+ T cells 3 Phase 2: PDS0101 Monotherapy and in Comb. with KEYTRUDA® Investigator-led trial evaluating treatments in patients with HPV-associated oropharyngeal cancer with high risk of recurrence Timing Enrollment
Slide 13: Versamune IL-12 Oncology Platform
Versamune® IL-12 Oncology Platform
Slide 14: PDS0301 Tumor Targeted IL-12 Immunotherapy
Synergy with Versamune® by promoting T cell infiltration and expansion in the tumor PDS0301 (Tumor Targeted IL-12 Immunotherapy) 14 IL-12 is a well-documented T cell stimulating cytokine, which can enhance growth and function of T cells PDS0301 is a fusion protein of IL-12 that targets the tumor, en
Slide 15: Versamune generates right type, potency and quantity of killer T cells
References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536. Smalley R umfield C et al. 2020. Immunomodulation to enhance the efficacy
Slide 16: PDS0301 targets tumors and enhances T cell infiltration and proliferation
Versamune® IL-12 Oncology Platform PDS0301 targets tumors and enhances T cell infiltration and proliferation in the tumor 16
Slide 17: PDS0101 HPV16-Targeted Immunotherapy Triple Combination Interim Results
1Objective response rates with standard of care < 10% 2No tumor shrinkage in HPV16-negative subjects (ASCO 2021) – Suggests critical role of PDS0101-induced HPV16-specific CD8+ T cells 3Historical median overall survival in the population is 3-4 months 17 Phase 2 Trial Interim Results Efficacy data
Slide 18: Phase 2 Trial Interim Results vs KEYNOTE-048
136% objective response with Keytruda + chemotherapy reported in KEYNOTE-048 study 212-month overall survival of 51% with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 373% treatment related grade 3 and higher adverse events with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 18 Par
Slide 19: PDS0101 Immune Correlates in Advanced HPV Cancer Patients
Induction of activated HPV16-specific CD8+ killer T cells correlates with clinical efficacy1 PDS0101 Immune Correlates in Advanced HPV Cancer Patients 1M. Goswami et al; Immune correlates associated with clinical benefit in patients with immune checkpoint refractory HPV-associated malignancies treat
Slide 20: PDS0101 Designed to Promote Efficacy in HPV16 Cancers
PDS0101 Designed to Promote Efficacy in HPV16 Cancers Studies appear to show key contributions of PDS0101, PDS0301 & Bintrafusp alfa* to clinical response to date 20 *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec
Slide 21: Triple Combination Active Against HPV16 Cancer
Best Overall Response Active Against Diverse HPV16 Cancers PDS0101: Triple Combination Active Against HPV16 Cancer Responses to date across tumor types and higher PDS0301 dose show the potential to result in greater clinical efficacy 21 *HNSCC – head and neck squamous cell carcinomas Higher PDS0301
Slide 22: Potential for best-in class immunotherapy
Potential for best-in class immunotherapy Versamune® IL-12 platform in combination with Checkpoint Inhibitor* 22 Improved Safety & Tolerability Enhanced Efficacy Potential for increased efficacy and safety over CPI’s and CPI’s plus chemo CPI plus chemo CPI monotherapy Demonstrated efficacy against r
Slide 23: Versamune based oncology pipeline developed with immuno-oncology leaders
Combination PDS Biotech Funded Partner Co-Funded Versamune® Platform Versamune® based oncology pipeline is being developed in partnership with the leaders in immuno oncology PDS0104 (TRP2) TBD Arm 1: CPI naïve 1st line treatment Arm 2: CPI refractory 2nd or 3rd line treatment PDS0101 (HPV16) VERSATI
Slide 24: PDS0102: TARP Antigen
CFA + TARP (1-20) X PDS0102: TARP Antigen Versamune® induced CD8+ killer T cells may result in the ability to treat TARP positive AML and prostate cancers Pre-Clinical Optimization Studies1: TARP-Specific T cell Induction after 2 injections of PDS0102 1 Reference: Wood LV et al, Oncoimmunology, 2016
Slide 25: PDS0103: MUC1 Antigen
Induced a >10-fold number of polyfunctional (highly potent) MUC1 specific CD8+ T cells PDS0103: MUC1 Antigen Greater quantity and quality of Versamune® induced CD8+ killer T cells may result in the ability to treat breast, ovarian, lung, and colon cancers *References: Surveillance Research Program,
Slide 26: Projected Milestones Through 3Q 2023
Projected Milestones Through 3Q 2023* *Based on current enrollment and forecast modeling as of December 2022. Subject to change. 26 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 PDS0101 Completed enrollment of HPV- associated cancer trial CPI refractory arm (NCI) Preliminary data from IMMUNOCERV (MD Anderson) Estim
Slide 27: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 28: PDS Biotech's Infectimune Pipeline
PDS Biotech’s Infectimune™ Pipeline Developed in partnership with leaders in infectious disease Prevention of tuberculosis PDS0201 (M-tuberculosis) Candidate Indication PC P1 P2 P3 R Partner(s) Universal prevention of influenza PDS Biotech Funded Partner Co-Funded PDS0202 (influenza) PDS0203 (SARS-C
Slide 29: Infectimune Pipeline Highlights
20 Infectimune™ Pipeline Highlights License agreement with University of Georgia for proprietary influenza antigens Top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate neutralizing antibody responses to all flu strains te
Slide 30: PDS0202 Universal Prevention of Influenza preclinical protection
Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu formulation. PDS0202 Universal Prevention of Influenza Appeared to Provide Protection in Preclinical Study in Keeping Animals Alive and Healthy Against Challenge with Flu Virus Control High-Dose F
Slide 31: PDS Biotech Management
PDS Biotech Management Historical success in the development and commercialization of leading pharmaceutical products Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Frank Bedu-Addo, PHD Chief Executive Officer Senior executive experience with manageme
Slide 32: Company Overview
1 2 4 5 6 Company Overview Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease Versamune® based platforms leverage the body’s own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer Exclusi
Slide 33: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | January 2023
PDS Biotechnology — Investor Presentation (January 2023) on 6ix