Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (December 2022)
30 slides from Pds Biotechnology's investor presentation, Dec 12, 2022
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | December 2022
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 Phase 2
Slide 4: Versamune Oncology Platform
Versamune® Oncology Platform
Slide 5: 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 1Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine, Journal for ImmunoTherapy of Cancer, June 2020 5 2 Bintrafusp alfa, a bifunctional functional fusion protein targeting TGF- β
Slide 6: Designed to address limitations of current immunotherapy
Designed to address limitations of current immunotherapy Versamune® based Immunotherapies 6 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 7: PDS0101: Lead Asset for HPV16-associated cancers, $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 8: Locally advanced cervical cancer: Phase 2 PDS0101 + Chemo-Radiotherapy
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: PDS0101 Appears to Induce Clinically Beneficial T Cells
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: 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: Advanced HPV16-positive cancer Phase 2 interim results
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 12 Pa
Slide 13: PDS0101 HPV16-Targeted Immunotherapy Phase 2 Trial 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 13 Phase 2 Trial Interim Results Efficacy data
Slide 14: Phase 2: Extended Interim Data – Efficacy and Safety
Phase 2: Extended Interim Data – Efficacy and Safety Extended interim data continue to appear to show clinical signs of efficacy, durability and safety 14 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positiv
Slide 15: 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 16: PDS0101 Designed to Promote Efficacy in HPV16 Cancers
PDS0101 Designed to Promote Efficacy in HPV16 Cancers Studies appear to show key contributions of PDS0101, NHS-IL12 & Bintrafusp alfa* to clinical response to date 16 *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec
Slide 17: PDS0101: 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 NHS-IL12 dose show the potential to result in greater clinical efficacy 17 *HNSCC – head and neck squamous cell carcinomas Higher M9241 D
Slide 18: 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 19: Versamune Platform Designed to Recruit, Train and Arm 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 20: 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 21: 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 22: 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 23: Projected Milestones Through 3Q 2023
Projected Milestones Through 3Q 2023* *Based on current enrollment and forecast modeling as of June 2022. Subject to change. 23 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 PDS0101 Completed enrollment of HPV- associated cancer trial CPI refractory arm (NCI) Preliminary data from IMMUNOCERV (MD Anderson) Estimated
Slide 24: Infectimune Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 25: 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 26: 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 27: PDS0202 Universal Prevention of Influenza Preclinical Study
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 28: 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 29: 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 Phase 2
Slide 30: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | December 2022
PDS Biotechnology — Investor Presentation (December 2022) on 6ix