Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (December 2023)
54 slides from Pds Biotechnology's investor presentation, Dec 4, 2023
Slide 1: Developing Transformational Immunotherapies for Cancer
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB December 2023
Slide 2: Forward-Looking Statements
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 Corpo
Slide 3: Executive Summary: Positioned for Market Leadership
PDS0101 to enter Phase 3 registrational trial in Q1 2024 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS01ADC
Slide 4: Experienced Management Team
Experienced Management Team Historical success in development and commercialization of leading pharmaceutical products Frank Bedu-Addo, PhD Chief Executive Officer Senior executive experience with management of strategy and execution at both large pharma and biotechs Notable drug development: Abelce
Slide 5: Proprietary Investigational Drug Assets Focused on Targeting the Immune Response to the Tumor
Proprietary Investigational Drug AssetsFocused on Targeting the Immune Response to the Tumor Water-insoluble Fatty acids/hydrocarbon chains Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium-propane (R-DOTAP) Water-soluble and positively charged head-group coats the particle surf
Slide 6: Profile of PDS01ADC
Profile of PDS01ADCIL-12 fused antibody drug conjugate (tumor targeted) PDS01ADC (M9241, NHS-IL12) immunocytokine is administered by subcutaneous injection Recombinant fusion protein consisting of the human monoclonal IgG1 antibody NHS76 fused to two molecules of the human IL-12 heterodimer at each
Slide 7: Profile of Versamune
Profile of Versamune® Designed to direct powerful CD4 (helper) and CD8 (killer) T cells into tumors PLATFORM: 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
Slide 8: Versamune Induces the Right Type, Potency and Quantity of Killer and Helper T Cells
Versamune® Induces the Right Type, Potency and Quantity of Multifunctional Killer and Helper T Cells Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor-specific proteins, delivered via subcutaneous injection Presents antigen to CD4 and CD8 T cells. Activates the T
Slide 9: IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells
IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells PDS0101 activates the immune system to generate active killer T cells (CD8 T) cells that induce a critical mediator of the T cell’s tumor-killing function called granzyme-B Multifunctional killer T cells target, infiltr
Slide 10: HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market Size
Slide 11: HPV16-Positive HNSCC Presents a Significant Market Opportunity
Est. HPV16Locally Advanced,Unresectable andMetastatic HPV16-Positive HNSCC Presents a Significant Market Opportunity Largely Attributed to the High Rate of Oral HPV Infections in Men Data sources: 1 PD-L1 negative and PD-L1 positive populations (> 9000 incidence PD-L1 Positive) https://seer.cancer.g
Slide 12: Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC
Targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes Novel MOA that is clinically effective in a broader patient population and provides more durable responses Safer and more effective treatments that may be used with or in place of current standar
Slide 13: PDS0101 for HPV16-Positive HNSCC Phase 2 Clinical Studies
PDS0101 for HPV16-Positive HNSCC Phase 2 Clinical Studies
Slide 14: VERSATILE-002 Phase 2 Clinical Trial Results Support Phase 3
VERSATILE-002 Phase 2 Clinical Trial – Results Support Initiation of Phase 3 Clinical Trial in ICI Naïve R/M HNSCC Objective: To assess the combination of PDS0101 and KEYTRUDA® in ICI naïve subjects with recurrent or metastatic HPV-positive HNSCC KEYTRUDA® (pembrolizumab) FDA Approved Standard of Ca
Slide 15: Disease Stabilization or Tumor Reduction in 81% of Patients
Disease Stabilization or Tumor Reduction in 81% of Patients Tumor Shrinkage in 60% (31/52) with Confirmed Objective Response in 27%1 (14/52) to Date No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Assessments based on Investigator assessment per REC
Slide 16: PDS0101 and KEYTRUDA Combination Demonstrates Promising Patient Survival
PDS0101 and KEYTRUDA® Combination in ICI Naïve HNSCC Demonstrates Promising Patient Survival to Date Median OS Not Yet Estimable Data on File. 08/02/23 Data Cut. Kaplan-Meier Estimates of Overall Survival (OS) (Intent-to-Treat Population) No. of Subjects at Risk (Events) 55 (0) 53 (2) 50 (3) 42 (5)
Slide 17: Overall Survival is Primary Endpoint in Planned Phase 3 Study
PDS0101 and KEYTRUDA® Combination in ICI NaïveHNSCC Demonstrates Promising Patient Survival to Date Overall Survival is Primary Endpoint in Planned Phase 3 Study VERSATILE-003 * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 D
Slide 18: Promising Survival with PDS0101 + KEYTRUDA
Promising Survival with PDS0101 + KEYTRUDA® 81% of Subjects Remain Alive and Continue to be Followed for Survival Data on File. 08/02/23 Data Cut Assessments were based on Investigator assessment per RECIST 1.1 OS and PFS (mITT Population) Time to PFS OS Alive
Slide 19: Survival Rates Demonstrate Potential Contribution of PDS0101
Survival Rates Demonstrate Potential Contribution of PDS0101 to Survival in Advanced Head and Neck Cancer PDS0101 + KEYTRUDA® Shows Promising Survival Benefit Even in ICI Resistant Patients * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on F
Slide 20: Addition of PDS0101 to KEYTRUDA Does Not Appear to Compound Toxicity
Addition of PDS0101 to KEYTRUDA® Does Not Appear to Compound Toxicity * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 Data CutBurtness B et al., Lancet. 2019; 394:1915-1928 Ferris RL, et al. NEJM. 2016;375:1856-67. Only 8 ICI
Slide 21: PDS0101 with KEYTRUDA Well Tolerated in VERSATILE-002
PDS0101 with KEYTRUDA® Well Tolerated in VERSATILE-002 to Date with Few Serious Toxicities Serious (Grade 3–5) Treatment-Related Adverse Events (ICI Naïve Population) *No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on File. 08/02/23 Data Cut B
Slide 22: Data Continues to Hold Up as More Patients are Enrolled
Data Continues to Hold Up as More Patients are Enrolled and Follow-up Time is Extended Data Summary Table Shows Consistency in Results PDS0101 KEYNOTE-048 Comments ASCO 2023 (06/05/23) KOL event (09/27/23) Cut-off Date January 13, 2023 August 02, 2023 Patients with CPS 1-19 50% 60% 48% Aug 02 cut of
Slide 23: Combination Continues to Show Promising Safety and Survival Outcomes
Combination of PDS0101 & KEYTRUDA® Continues to Show Promising Safety and Survival Outcomes VERSATILE-002 Study Shows Potential of PDS0101 to Safely Modify the Tumor Microenvironment to Promote Patient Survival The 24-month OS rate in the ICI naïve cohort is 74%; Published results of 29% in KEYNOTE-
Slide 24: Timeline to Registrational Trial Initiation
Timeline to Registrational Trial Initiation Worldwide Randomized, Controlled Clinical Study to Be Initiated Q1 2024 PDS0101 + KEYTRUDA® in Recurrent or Metastatic HPV16-Positive HNSCC 2Q 2022 3Q 2022 1Q 2023 2Q 2023 3Q 2023 1Q 2024 FDA Fast Track designation for PDS0101 + KEYTRUDA® Successful EOP2 m
Slide 25: Versamune Based Oncology Pipeline
Versamune® Based Oncology Pipeline Partnerships with World-Class Institutions in Immuno-Oncology Reference: Data on file. PDS Biotech Funded Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) Clinical (Lead) PDS0101 (HPV)/ VERSATILE-002 Recurrent or metastatic HPV16-positive head and n
Slide 26: VERSATILE-003 Phase 3 Study Design
VERSATILE-003 Phase 3 Study Design Global Randomized, Controlled Clinical Study with Estimated 90–100 Sites Overall survival (OS) Primary Endpoint For the treatment of recurrent or metastatic HPV16-positive HNSCC Targeted Indication Randomization 2:1 PDS0101 +KEYTRUDA® PDS0101 + KEYTRUDA® KEYTRUDA®
Slide 27: Antibody-Drug Conjugate (ADC) IL-12 (PDS01ADC) Phase 2 Clinical Studies
Antibody-Drug Conjugate (ADC) IL-12 (PDS01ADC) Phase 2 Clinical Studies
Slide 28: PDS0101+PDS01ADC+ICI: Optimal Antitumor Response
PDS0101+PDS01ADC+ICI: Optimal Antitumor Response Preclinical: Increased T Cells and T Cell Uniformity with Tumor Shrinkage NHS-IL12 + ICI PDS0101 + NHS-IL12 + ICI A) Immunohistochemistry for CD4+ and CD8+ T cells in TC-1 tumors. Combination treatment with PDS0101, NHS-IL12 (IL-12 ADC), and ICI (bint
Slide 29: NCI-led Triple Combination: PDS01ADC + PDS0101 + ICI
Phase 2 NCI-led Triple Combination: PDS01ADC + PDS0101 + ICI Advanced HPV16-Positive Anal, Cervical, Head and Neck, Penile, Vaginal, Vulvar Cancer Patients Who Are ICI Resistant 172% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7
Slide 30: Triple Combination: Promising ORR in ICI Naïve Patients
Triple Combination: Promising Objective Response Rate (ORR) ICI Naïve Patients Percent of Patients (%) 19% 27% 75% 1 2 3 27% 75% 1 1. Burtness B et al., Lancet. 2019; 394:1915-1928 2. VERSATILE-002 Phase 2 trial (NCT04260126), Investigator assessment (10/2023) 3. Triple combination Phase 2 trial (NC
Slide 31: Overall Survival Rates – Durable Survival with PDS0101
Overall Survival Rates – Durable Survival with PDS0101ICI Naïve Patients OS Rate (%) 50 55 80 25% 31 74 75 75% 29% 22% 1 1 2 3 74% 75% 1. Burtness B et al., Lancet. 2019; 394:1915-1928 2. VERSATILE-002 Phase 2 trial (NCT04260126), Investigator assessment (10/2023) 3. Triple combination Phase 2 trial
Slide 32: Triple Combination: ORR in ICI Resistant Patients
Triple Combination: Compelling Objective Response Rate (ORR)ICI Resistant Patients 1. Strauss J et al, Journal for ImmunoTherapy of Cancer 2020;8:e001395 doi:10.1136/jitc-2020-001395 2. Pestana et al, Oral Oncology 101 (2020) 104523 3. VERSATILE-002 Phase 2 trial (NCT04260126), Investigator assessme
Slide 33: Triple Combination: 1-Year Overall Survival Rate ICI Resistant Patients
Triple Combination: 1-Year Overall Survival Rate ICI Resistant Patients 30% 56% 72% Surviving Patients (%) 1 3 2 36% 72% 56% PDS0101+PDS01ADC+ICI 3 PDS0101+KEYTRUDA® 2 Systemic Therapies 1 1. Pestana et al, Oral Oncology 101 (2020) 104523 2. VERSATILE-002 Phase 2 trial (NCT04260126), Investigator as
Slide 34: Triple Combination Shows Promising Safety, ORR and Survival Outcomes
Combination of PDS0101, PDS01ADC and Immune Checkpoint Inhibitor (ICI) Shows Promising Safety, ORR and Survival Outcomes Triple Combination Study Shows Potential PDS0101 and PDS01ADC to Safely Modify TME to Promote both Patient Survival and Objective Responses in HPV-Positive Cancers The 36-month OS
Slide 35: PDS01ADC + Docetaxel Phase 2 Clinical Study in Advanced Prostate Cancer
IL-12 ADC Cytokine TherapyPDS01ADC + Docetaxel Phase 2 Clinical Study: PDS01ADC + Docetaxel in Advanced Prostate Cancer
Slide 36: PDS01ADC (IL-12 ADC) + Docetaxel: Optimal Tumor Control
PDS01ADC (IL-12 ADC) + Docetaxel: Optimal Tumor ControlPreclinical studies show PDS01ADC accumulation in tumor with efficacy Cancer Immunology, Immunotherapy (2023) 72:2783–2797 Colon cancer (MC38) average tumor volumes of animals treated with docetaxel (red line; n = 11), PDS01ADC (blue line; n = 1
Slide 37: PDS01ADC+Docetaxel: Well Tolerated at All Tested Dose Levels
PDS01ADC+Docetaxel: Well Tolerated at All Tested Dose LevelsCastration-Sensitive and Castration-Resistant Prostate Cancer Patients Adverse Event 6.0mcg/kg NHS-IL12 N=6 12.0mcg/kg NHS-IL12 N=6 16.8mcg/kg NHS-IL12 N=6 Grade 2 Grade 3 Grade 4 Grade 2 Grade 3 Grade 4 Grade 2 Grade 3 Grade 4 Fatigue 33%
Slide 38: PDS01ADC + Docetaxel: 61% Average PSA Decline
PDS01ADC + Docetaxel: 61% Average PSA DeclineImmune Responses and PSA Decline Seen at All Dose Levels -4 -22 -46 -62 -75 -86 -14 -27 -40 8.0mcg/kg 12.0mcg/kg 16.8mcg/kg CRPC CSPC CRPC = castration-resistant prostate cancer; CSPC = castration-sensitive prostate cancer; PSA = prostate-specific antigen
Slide 39: Antibody-Drug Conjugate (PDS01ADC) Pipeline
Antibody-Drug Conjugate (PDS01ADC) Pipeline Reference: Data on file. Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) IIT Studies PDS01ADC/ NCI-led Triple Combination HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Arm 1: ICI naive Arm 2: ICI resistant PDS
Slide 40: Projected Milestones Through 3Q24
4Q23 1Q24 2Q24 3Q24 PDS0101 Submit protocol to FDA for triple combination in HNSCC Update on ICI naïve/resistant data in HNSCC – KOL Event (VERSATILE-002) Updated OS data from PDS0101-PDS01ADC based triple combination in HPV-Positive Cancer Immune response data (VERSATILE-002) (ESMO 2023) Initiate r
Slide 41: Infectimune Infectious Disease Platform
Infectimune® Infectious Disease Platform
Slide 42: PDS0202: Universal Influenza Vaccine
License agreement with University of Georgia for proprietary computer-designed 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 tested in animals Pr
Slide 43: PDS0202 Promotes Induction of Antibodies that Neutralize Broad Range of Influenza Strains
PDS0202 Promotes Induction of Antibodies that Neutralize a Broad Range of Influenza Viral Strains in Ferret Studies Proprietary Computationally Designed Influenza Protein Studies in Ferrets – Model Viewed as Gold Standard in Preclinical Influenza Research
Slide 44: PDS0202 Promotes Antibodies and T Cells that Prevent Viral Replication in Lungs
PDS0202 Promotes Induction of Antibodies and T Cells that Prevent Viral Replication in Lungs of Ferrets Proprietary Computationally Designed Influenza Protein
Slide 45: Executive Summary: Positioned for Market Leadership
PDS0101 to enter Phase 3 registrational trial in Q1 2024 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS01ADC
Slide 46: Thank You
Thank You
Slide 47: Appendix
Appendix
Slide 48: FDA Requires OS as Primary Endpoint
FDA Requires OS as Primary Endpoint PFS and ORR will not support a BLA approval From FDA’s Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics White Paper1: “In the 1970’s, the FDA usually approved cancer drugs based on objective response rate (ORR), determined by tumor assessmen
Slide 49: VERSATILE-002 ICI Naïve Key Demographics and Treatment Exposure
VERSATILE-002 ICI Naïve Key Demographics and Treatment Exposure Majority of Patients Are CPS 1-19 Demographic ITT Population (N=55) mITT Population (N=52) Age, Median (Min, Max) 64.0 (46, 83) 64.0 (46, 83) Sex, n (%) Male Female 51 (92.7) 4 (7.3) 48 (92.3) 4 (7.7) Race, n (%) American Indian or Alas
Slide 50: Expanding Evidence of Consistent and Durable PDS0101 Clinical Results
Expanding Evidence of Consistent and Durable PDS0101 Clinical Results Across Multiple Phase 2 Trial Indications PDS0101 is an HPV16-targeted immunotherapy PDS0101 is providing strong proof of concept data for the Versamune® technology platform Efficacy data in >90 patients to date Strong agreement b
Slide 51: HNSCC is a Devastating Group of Cancers
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 *Human Pap
Slide 52: Antibody Drug Conjugate IL-12: PDS0301 Targets Tumors
Antibody Drug Conjugate IL-12: PDS0301 Targets Tumors and Enhances T Cell Infiltration and Proliferation in the Tumor Tumor Site Injection Site Non-Immunogenic (Cold Tumor) Immunogenic (Hot Tumor) Tumor Site PDS0301 travels direct to tumor Increased tumor inflammation from PDS0301 PDS0301 increases
Slide 53: PDS0101: A Novel Investigational HPV-Targeted Immunotherapy
PDS0101: A Novel Investigational HPV-Targeted Immunotherapy PDS0101 is given by subcutaneous injection and stimulates a potent targeted T cell attack against HPV-positive cancers Interim VERSATILE-002 data suggests PDS0101 generates clinically effective immune responses The combination of PDS0101 wi
Slide 54: PDS01ADC (NHS-IL12)+Docetaxel: Optimal Tumor Control
PDS01ADC (NHS-IL12)+Docetaxel: Optimal Tumor ControlPreclinical Studies Show Necrosis and IL-12 Accumulation in TME (A) Quantification of percent necrosis of MC38 tumor-bearing animals that were untreated (black symbols; n = 3) or received docetaxel monotherapy (red symbols; n = 2), NHS-IL-12 monoth
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