Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (April 2023)
32 slides from Pds Biotechnology's investor presentation, Apr 6, 2023
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | April 2023
Slide 2: Forward-looking statements
2 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 Corporation (the “Company”) an
Slide 3: Company Overview
1 2 4 Company Overview Who we are: Leveraging our first-in-class T cell activating platform and our antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease Clinical Partnerships: Merck, National Cancer In
Slide 4: Oncology Platform Overview
Designed to address limitations of current immunotherapy with potential efficacy over immune checkpoint inhibitors (ICI) and ICIs in combination with chemotherapy Versamune® Versamune® + Antibody Conjugate IL-12 PDS0301 (tumor-targeting, antibody conjugated IL-12) turns “cold tumors” into “hot tumor
Slide 5: Versamune® Oncology Platform
Versamune® Oncology Platform
Slide 6: PDS0101 and Mechanism of Action
3 6 PDS0101 and Mechanism of Action Comprised of cationic lipids (R-DOTAP) co-administered with proprietary HPV16-specific tumor antigens, delivered via subcutaneous injection R-DOTAP spontaneously assembles into virus-like nanoparticles promoting efficient uptake by immune system Delivers antigen t
Slide 7: Favorable Data to Date from Multiple Clinical Trials
Favorable Data to Date from Multiple Clinical Trials 7 Trial / Sponsor Indication Population Treatment Response Survival Phase 2 Data Triple Combo / NCI HPV-Associated cancers ICI refractory 3rd line PDS0101 + PDS0301 + Checkpoint inhibitor 63% (5/8) ORR in optimal dose group Median OS of 21 months
Slide 8: PDS0101 HPV16-Targeted Immunotherapy Phase 1 Monotherapy
CIN lesion regression at 1-3 months (retrospective) 60% 20% 20% 8 PDS0101 HPV16-Targeted Immunotherapy * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®) References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent
Slide 9: Versamune Oncology Pipeline
Combination PDS Biotech Funded Partner Co-Funded PDS0104 (TRP2) TBD Arm 1: ICI naïve 1st line treatment Arm 2: ICI refractory 2nd or 3rd line treatment PDS0101 (HPV16) VERSATILE-002 Fast Track Designation PDS0101 (HPV16) IMMUNOCERV PDS0102 (TARP) PDS0103 (MUC1) Candidate Indication PC P1 P2 P3 R Par
Slide 10: PDS0101: Lead Asset, $7B Market Opportunity
More than 54,0002 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 the rate of HPV-positive cancer incidence for decades Existing immunotherapies cost $150,
Slide 11: 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 radiation for treatment of locally advanced cervical cancers (NCT04580771); SITC 2022 11 PDS0101 activates the immune system to generate killer T cells (CD8+ T
Slide 12: PDS0101 + KEYTRUDA Preliminary Results
19% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 212-month overall survival of 49% with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 317% of patients had treatment related grade 3 and higher adverse events with KEYTRUDA® monotherapy reported in KEYNOTE-048
Slide 13: Phase 2: PDS0101 + KEYTRUDA (VERSATILE-002)
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial in HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 13 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41.2%) SD (reduction in 4/6) 6
Slide 14: Versamune® + Antibody Conjugate IL-12 Oncology Platform
Versamune® + Antibody Conjugate IL-12 Oncology Platform
Slide 15: PDS0301: Tumor-Targeted IL-12 Immuno-Cytokine
15 PDS0101 HPV16-Targeted Immunotherapy 60% 20% 20% Tumor sections revealed that IgG1 IL-12 binds to exposed cell nuclei within necrotic regions of murine tumors. PDS0301 (Antibody Conjugate IL-12) is a first-in-class immuno-cytokine fusion protein composed of two molecules of IL-12 fused to each of
Slide 16: Phase 1 PDS0301 Monotherapy Trial Results
16 PDS0101 HPV16-Targeted Immunotherapy 20% Safety Results - PDS0301 Most adverse events were low grade self-limiting (Grade 1 & 2 toxicities) Grade 3 toxicities included aspartate transaminase/alanine transaminase [AST/ALT] elevation (1/13), flu-like symptoms (1/13), decreased white blood cell coun
Slide 17: Triple Combination Safety and Immunology Results
*73% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7 Goswami 2022 http://dx.doi.org/10.1136/jitc-2022-SITC2022.0695 17 Immunology/immune correlates, (SITC), November 2022: Greater than two-fold increase in HPV16-specific T cells i
Slide 18: Results in ICI Refractory HPV-Positive Cancer
18 Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Compared to Published Data Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor Advanced HPV16-positive cancer patients who are checkpoint inhibitor refractory N=29 Objective Response (ORR)
Slide 19: Results in ICI Naïve Head and Neck Cancer
19 PDS0101 HPV16-Targeted Immunotherapy Phase 2 Results in Recurrent Metastatic ICI Naïve Head and Neck Cancer (CPS>0; PD-L1 agnostic) Compared to Published Data Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor Advanced HPV16-positive cancer patients who are checkpoint inhibitor naive *D
Slide 20: 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 21: 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 22: Projected Milestones Through 4Q 2023
Projected Milestones Through 4Q 2023 *These trials are investigator-initiated trials and data read-outs are outside the control of the Company. 22 3Q22 4Q22 1Q23 2Q23 PDS0101 Preliminary data from IMMUNOCERV (MD Anderson) Estimated IND filing in MUC1-related cancers PDS0103 Anticipate preliminary ef
Slide 23: Infectimune™ Infectious Disease Platform
Infectimune™ Infectious Disease Platform
Slide 24: Infectimune™ Pipeline Highlights
20 Infectimune™ Pipeline Highlights License agreement with University of Georgia for proprietary universal influenza antigens Preclinical data published in Viruses 2023:15,432 Shows broadly reactive neutralizing antibodies against all influenza strains tested. Complete protection when challenged wit
Slide 25: PDS0202 Universal Prevention of Influenza
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 26: Infectimune™ Pipeline
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-CoV-2) Preventi
Slide 27: Experienced Management Team
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 managem
Slide 28: Company Overview
1 2 4 Company Overview Who we are: Leveraging our first-in-class T cell activating platform and our antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease Clinical Partnerships: Merck, National Cancer In
Slide 29: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | April 2023
Slide 30: PDS0101-0301 Combination Efficacy in Advanced HPV Cancers
PDS0101-0301 Combination on Efficacy in advanced HPV Cancers 30 *Bintrafusp alfa monotherapy showed 30% ORR in ICI naïve and 10% ORR in ICI refractory HPV-positive cancers (Strauss et al, 2020, Dec 8(2) **All HPV16 negative and 80% of HPV16 positive patients had high dose PDS03011 Tumor reduction on
Slide 31: Best Overall Response Active Against Diverse HPV16 Cancers
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 31 *HNSCC – head and neck squamous cell carcinomas Higher PDS0301
Slide 32: PDS0101 Immune Correlates in Advanced HPV Cancer Patients
Group Developed HPV16-Specific T cell Responses All Patients 11/14 (79%) Responders (n=5) 5/5 (100%) Non-Responders (n=9) 6/9 (67%) 1M. Goswami et al; Immune correlates associated with clinical benefit in patients with immune checkpoint refractory HPV-associated malignancies treated with triple comb
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