Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (May 2023)
40 slides from Pds Biotechnology's investor presentation, May 17, 2023
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | May 2023
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This communication contains 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 Cor
Slide 3: About PDS Biotechnology Company Overview
3 About PDS Biotechnology Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease 1 3 Clinical Partnerships: Merck, National Cancer Institute, MD Anderson
Slide 4: Experienced Management Team
4 Experienced Management Team Historical success in 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 manag
Slide 5: Platform Overview
5 Platform Overview Versamune® Induces powerful, long-lasting anti-tumor response by promoting uptake of tumor-specific proteins by the immune system and activates a specific signaling pathway that promotes the production of active tumor-infiltrating multifunctional killer T cells Overcomes tumor’s
Slide 6: Pipeline: Versamune Based Oncology
6 Pipeline: Versamune® Based Oncology Developed in partnership with leaders in immuno-oncology Reference: Data on file. PDS Biotech Funded Partner Co-Funded Combination PDS0104 (TRP2) TBD Arm 1: ICI naïve 1st line treatment Arm 2: ICI refractory 2nd or 3rd line treatment VERSATILE-002 IMMUNOCERV PDS
Slide 7: Clinical Pipeline: PDS0301 Focused Oncology
1 Clinical Pipeline: PDS0301 Focused Oncology Investigator initiated trials with National Cancer Institute Localized High and Intermediate Risk Prostate Cancer PDS0301 (Combination Radiation Therapy) Candidate Indication PC P1 P2 P3 R Partner Advanced Kaposi Sarcoma PDS0301 (Monotherapy) PDS0301 (Co
Slide 8: Versamune Oncology Platform
Versamune® Oncology Platform
Slide 9: Versamune Based Immunotherapy
9 Versamune® Based Immunotherapy Versamune® is based on proprietary, positively charged and immune-activating lipids that form spherical nanoparticles in aqueous media* The nanoparticles are sized to mimic viruses, which promotes uptake by dendritic cells of the immune system Activates the important
Slide 10: Versamune Mechanism of Action
10 Versamune® Mechanism of Action Comprised of cationic lipids (R-DOTAP) co-administered with proprietary HPV16-specific tumor antigens, delivered via subcutaneous injection Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctional T cell re
Slide 11: PDS0101: Lead Asset
11 PDS0101: Lead Asset Designed to treat human papillomavirus (HPV16)-positive cancers More than 54,4002 patients were estimated to have been diagnosed last year with HPV16-positive cancers in the US1,2. This represents 70-80% of all HPV-positive cancers. HPV vaccination is not expected to impact th
Slide 12: PDS0101 Phase 1 Monotherapy Data
12 PDS0101 Phase 1 Monotherapy Data In vivo CD8 T cell responses appear to correlate with regression of CIN cervical lesions supporting preclinical studies CIN Lesion Regression at 1-3 Months (Retrospective) 60% 20% 20% Phase 1 trial results showed no serious or dose-limiting toxicities All patients
Slide 13: IMMUNOCERV Phase 2 Clinical Trial: PDS0101 + CRT Cervical Cancer
13 IMMUNOCERV Phase 2 Clinical Trial: PDS0101 + CRT Cervical Cancer 13 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA approved standard of care Chemo-radiotherapy (CRT) Preliminary Efficacy Preliminary efficacy data (Society for Immunother
Slide 14: IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial T Cells
14 IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial T Cells Induction of activated CD8 killer T cells correlates with elimination of circulating tumor DNA1 1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemothera
Slide 15: HNSCC is a Devastating Group of Cancers
15 HNSCC is a Devastating Group of Cancers Reference: Noseyaba et al. 2018. Cancer. Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html Genotyp
Slide 16: The Incidence of HNSCC is Sizeable and Growing
16 The Incidence of Head and Neck Squamous Cell Carcinoma (HNSCC) is Sizeable and Growing Largely attributed to the high rate of oral HPV infections in men HPV cancer incidences continue to increase despite preventive HPV vaccine Est. U.S. Oral and Pharyngeal Cancer Est. U.S. HPV Positive Oral and P
Slide 17: Standard of Care for Recurrent/Metastatic HNSCC
17 Standard of Care for Recurrent/Metastatic HNSCC – Published Results Significant unmet needs remain KEYTRUDA® KEYTRUDA® plus chemo Chemotherapy +/- EGFR Route of Administration IV IV IV Objective Response Rate (ORR) 19% 36% 41% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos Median Overall
Slide 18: VERSATILE-002 Phase 2 Clinical Trial: PDS0101 + KEYTRUDA
18 VERSATILE-002 Phase 2 Clinical Trial: PDS0101 + KEYTRUDA® Recurrent or metastatic HPV16-positive head and neck cancer 18 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA-Approved Standard of Care KEYTRUDA® (pembrolizumab) owned by Merck1,
Slide 19: VERSATILE-002 Phase 2: PDS0101 + KEYTRUDA
19 VERSATILE-002 Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial in HPV16-positive metastatic or recurrent head and neck cancer Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/imaging data – confirmed and unconfirmed OR (2 CR + 5PR) 7 (4
Slide 20: VERSATILE-003 Phase 3 Study Design
20 VERSATILE-003 Phase 3 Study Design World-wide Randomized, Controlled Clinical Study– Potential for Accelerated Approval – Potential for Accelerated Approval Primary endpoints Progression free survival (PFS) and overall survival (OS) Planned Interim Analysis: PFS and OS Planned Interim Analysis: O
Slide 21: VERSATILE-003 Timeline to Registrational Trial Initiation
21 VERSATILE-003 Timeline to Registrational Trial Initiation World-wide randomized, controlled clinical study to be initiated Q4 2023 with an overall estimated 90-100 sites Q 2022 FDA Fast Track designation for PDS0101 + KEYTRUDA® Q1 2023 Complete Phase 3 clinical manufacturing of PDS0101 Obtain vis
Slide 22: Versamune + Antibody-Conjugated IL-12 Oncology Platform
Versamune® + Antibody-Conjugated IL-12 Oncology Platform
Slide 23: PDS0301 Promotes IL-12 Accumulation in Tumors
23 PDS0301 Promotes IL-12 Accumulation in Tumors PDS0301 turns tumors more immunogenic (“hot”) after subcutaneous injection Panel A shows superior targeting and accumulation of fluorescence-conjugated PDS0301 (NHS-muIL12) into lung cancer tumors in athymic mice, turning tumors “hot” compared to trad
Slide 24: PDS0301 + PDS0101 + ICI: Promotes Tumor Shrinkage & Survival
24 PDS0301 + PDS0101 + ICI: Promotes Tumor Shrinkage & Survival Preclinical data translated to Phase 2 human results in advanced HPV-positive cancer Immune checkpoint inhibitor (ICI) PDS0301+ICI PDS0301 + PDS0101 + ICI Mouse HPV-positive tumors CD8 T cells CD4 T cells Treatment Tumor Vol. <300mm3 0/
Slide 25: PDS0301 + HDAC Inhibitor Effective in aPD-L1 Resistant Tumors
25 PDS0301 + HDAC Inhibitor Effective in aPD-L1 Resistant Tumors Potent CD8+ T cells and Natural Killer cells demonstrated in tumors in preclinical studies Phase 2 Study in Progress Preclinical study provides rationale for combining PDS0301 with a histone deacetylase (HDAC) inhibitor for patients un
Slide 26: Versamune + Antibody-Conjugated IL-12 Oncology Platform
26 Versamune® + Antibody-Conjugated IL-12 Oncology Platform PDS0301 targets tumors and enhances T cell infiltration and proliferation in the tumor Tumor Site PDS0301 travels direct to tumor 1 Increased tumor inflammation from PDS0301 2 PDS0301 increases T cell infiltration and expansion in tumor 3 C
Slide 27: NCI-led Triple Combination: PDS0101 + PDS0301 + ICI
27 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancer patients who are ICI refractory Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA approved standard o
Slide 28: NCI-led Triple Combination: ICI Refractory Patients
28 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive ICI refractory cancer patients Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC *Strauss J, et al. J Immunother Cancer 2020;8:e001395
Slide 29: NCI-led Triple Combination: ICI Naïve Patients
29 NCI-led Triple Combination: PDS0101 + PDS0301 + ICI Advanced HPV16-positive ICI naïve cancer patients Phase 2 Results in Recurrent Metastatic ICI Naïve HPV Positive Cancer (CPS>0; PD-L1 agnostic) Plots Include Published Data in HPV Positive Cancer (Head and Neck) Median OS not yet reached *Data f
Slide 30: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 31: Infectimune Pipeline
31 InfectimuneTM Pipeline Developed in partnership with leaders in infectious disease Prevention of tuberculosis PDS0201 (M-tuberculosis) Candidate Indication PC P1 P2 P3 R Partner Universal prevention of influenza PDS Biotech Funded Partner Co-Funded PDS0202 (influenza) PDS0203 (SARS-CoV-2) Prevent
Slide 32: Infectimune Pipeline Highlights: Universal Influenza Vaccines
32 InfectimuneTM Pipeline Highlights Universal Influenza Vaccines 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 r
Slide 33: PDS0202: Universal Prevention of Influenza
33 PDS0202: Universal Prevention of Influenza Provided Full Protection Against Lethal Challenge with H1N1 Pandemic Strain in Preclinical Study Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune™+ COBRA) Universal flu formulation. Flu Protein 3ug + Infectimune™ Flu Prote
Slide 34: Projected Milestones Through 3Q24
34 Projected Milestones Through 3Q24 Trials are investigator-initiated trials and data read-outs are outside the control of the Company. 2Q23 3Q23 4Q23 1Q24 PDS0101 Anticipate preliminary efficacy data from Mayo Clinic IIT 2Q24 Initiate registrational trial for PDS0101 (VERSATILE-003) 3Q24 File amen
Slide 35: About PDS Biotechnology Company Overview
35 About PDS Biotechnology Company Overview T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease 1 3 Clinical Partnerships: Merck, National Cancer Institute, MD Anderson
Slide 36: Appendix
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | May 2023 Appendix
Slide 37: 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 Preclinical Optimization Studies1: TARP-Specific T cell Induction after 2 injections of PDS0102 1 Reference: Wood LV et al, Oncoimmunology, 2016,
Slide 38: 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, colon and other cancers *References: Surveillance Research Pro
Slide 39: Mayo Clinic: PDS0101 Monotherapy & in Combination with KEYTRUDA
39 Mayo Clinic: PDS0101 Monotherapy & in Comb. with KEYTRUDA® HPV-associated oropharyngeal cancer with high risk of recurrence Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA Approved Standard of Care Study Goals Safety, rate of regression
Slide 40: PDS0301 + Chemo or Radiation Promotes Tumor Shrinkage
40 PDS0301 + Chemo or Radiation Promotes Tumor Shrinkage Preclinical models of lung cancer (LLC) and colon cancer (MC38) PDS0301 (NHS-muIL12) with radiotherapy enhances the anti-tumor response. Beginning on day 0, LLC tumor-bearing mice were randomized (n = 9 mice per group) and treated with PBS, fr