PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (October 2021)
38 slides from PDS Biotechnology's investor presentation, Oct 18, 2021
Slide 1: Corporate Overview
CORPORATE OVERVIEW OCTOBER 2021 Frank Bedu-Addo Ph.D. President & CEO Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activi
Slide 3: PDS Biotech is a clinical stage biotechnology company developing immunotherapies
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform CORPORATE OVERVIEW VERSAMUNE® PLATFORM PIPELINE • Biopharma developing novel T-cell • Interim data from NCI-led PDS0101 Phase activating cancer treatment candid
Slide 4: A significant barrier to effective immunotherapy has been the inability to promote CD8+ T-cell responses
PDS Biotech’s Versamune®-based A significant barrier to immunotherapies are designed to effective immunotherapy promote a powerful in vivo tumor- specific CD8+ killer T-cell response has been the inability to promote adequate CD8+ Versamune®-based therapies also show promising potential to: killer T
Slide 5: Versamune is designed to induce a robust and targeted anti-tumor response in vivo
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen Versamune® + Tumor- associated proteins (antigens) Recruits T-cells to lymph nodes: Trains T-cells to target tumors: Arms T-cells to kill tumor cells: Promotes uptake
Slide 6: PDS Biotech executive team has demonstrated success in drug development and commercialization
PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products • Senior executive experience with management of strategy and execution at both large pharma and biotechs Frank Bedu-Addo, PhD • Notable drug development: Chief Executive O
Slide 7: Versamune-based pipeline developed in partnership with leaders in immuno-oncology and infectious disease
PDS Biotech’s robust Versamune® -based pipeline is being developed in partnership with leaders in immuno-oncology and infectious disease * *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (“
Slide 8: Introduction to PDS0101
Introduction to PDS0101
Slide 9: PDS0101 is designed to treat cancers caused by HPV-16
PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)-16, which represents 70-80% of the HPV-associated cancer market US annual HPV-associated cancer incidence1 • Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1 Females (24,391) Males (1
Slide 10: HPV-16 cancers represent 70-80% of the HPV-associated cancer market
human papillomavirus (HPV)-16 cancers represents 70-80% of the HPV- associated cancer market FIRST LINE • 20-30% of patients either progress or have a Treatment: recurrence of cancer and are considered to have Radiation and/or Chemotherapy advanced cancer ADVANCED CANCER • Objective response rate (O
Slide 11: Greater quantity and quality of Versamune-induced killer T-cells may eradicate HPV-positive tumors
Greater quantity & quality of Versamune®-induced killer (CD8+) T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies 3000 ** ** 250
Slide 12: PDS0101 monotherapy induced HPV16-specific CD8+ T-cells in Phase 1 trial
Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific CD8+T-cells in Phase 1 clinical trial Responses were evaluated on Days 14-19 after SC injection Predominant CD8+ T-cell responses confirmed by Granzyme-b ELISPOT HPV-specific HPV-specific 2000 250 T-cell Re
Slide 13: Phase 2 NCI-led trial of PDS0101, Bintrafusp alfa and M9241
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer Indication Patients with advanced HPV-associated cancer who have failed prior treatment Bintrafusp alfa: Bifunctional checkpoint inhibitor-“TGF-β trap” fusion prot
Slide 14: ASCO 2021: triple combination achieved 83% ORR among CPI naive patients
ASCO 2021: PDS0101 triple combination achieved 83% ORR among six advanced HPV16-positive CPI naive patients, suggesting potential efficacy Percentage of CPI Naïve Patients Who Experienced Objective Response with Treatment PDS0101 + 83% (5/6) Bintrafusp alfa + M9241 1 patient had no evidence of disea
Slide 15: ASCO 2021: Triple combination achieved 58% tumor reduction in CPI refractory patients
ASCO 2021: Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients • 5 patients had already achieved an objective response (>30% tumor reduction) Percentage of CPI Refractory Patients Who Experienced Tumor Reduction with Treatment PDS0101 + 58% (7/12)
Slide 16: ASCO 2021: Promising durability of anti-cancer efficacy in HPV16-positive patients
ASCO 2021: Triple combination shows promising durability of potential for anti-cancer efficacy in HPV16-positive checkpoint inhibitor naïve patients PDS0101 + Bintrafusp alfa + M9241 Standard of Care HPV16-positive (Checkpoint Inhibitors) Number of checkpoint inhibitor naïve patients 6 Ongoing objec
Slide 17: ASCO 2021: Results in HPV16-negative patients
ASCO 2021: Results in HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction Percentage of HPV16-Positive and HPV16-Negative Patients Who Experienced Tumor Reduction at Median 8 Months HPV16-Positive 67% (12/18) (n=18) HPV16-Negativ
Slide 18: Phase 2 PDS0101/KEYTRUDA trial in head and neck cancer (VERSATILE-002)
Phase 2 trial evaluating the combination of PDS0101/KEYTRUDA® for treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Indication Treatment of patients with HPV16-positive head and neck cancer whose cancer has spread or returned KEYTRUDA® (Standard of Care): Anti-PD1
Slide 19: Phase 2 PDS0101 and chemoradiation trial in cervical cancer (IMMUNOCERV)
Phase 2 investigator-led trial evaluating the combination of PDS0101 and chemoradiation in patients with locally advanced cervical cancer (IMMUNOCERV) Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Chemoradiotherapy (CRT – Standard of Care): Cisplati
Slide 20: Preclinical Pipeline Data
Preclinical Pipeline Data
Slide 21: Versamune demonstrated potent CD8+ T-cell responses with different tumor antigens
In preclinical studies, Versamune® has demonstrated potential for potent CD8+ (killer) T-cell responses with different tumor antigens PDS0101 Phase 2 interim results demonstrate promising link between targeted CD8+ killer T-cell response and anti-tumor response Versamune®-induced T-cells • High quan
Slide 22: Development of PDS0102
“Development. of PDS0102 ° = . oa
Slide 23: PDS0102 is designed to treat TARP-related cancers including AML, prostate and breast
PDS0102 is designed to treat cancers caused by T-cell receptor gamma alternate reading frame protein (TARP), including AML, prostate and breast cancers Approximately 470,000 patients are diagnosed annually with AML, prostate or breast cancer, most of which are associated with target T-cell receptor
Slide 24: PDS0102 may provide superior induction of TARP-specific CD8+ killer T-cells
PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer T-cells PRE-CLINICAL OPTIMIZATION STUDIES: TARP-Specific T-cell Induction after 2 injections of PDS0102 Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) 24 CFA – Complete Freund’s Adjuvant a highly potent i
Slide 25: Development of PDS0103
“Development.of PDS0103 ° = . oa
Slide 26: PDS0103 is designed to treat MUC1-expressing solid tumors
PDS0103 is designed to treat cancers caused by mucin-1 (MUC1), which is highly expressed in solid tumors and is associated with poor prognosis Clinical trial design will seek to evaluate PDS0103 in tumor types with the highest expression of MUC1 and the greatest differences in MUC1 expression betwee
Slide 27: Versamune-induced CD8+ T-cells may eradicate MUC1-positive tumors
Greater quantity and quality of Versamune®-induced CD8+ killer T-cells may result in ability to eradicate MUC1-positive tumors • Induced a >10-fold number of polyfunctional MUC1 specific CD8+ T-cells 500 # of Antigen-Recognizing CD8+ T-Cells 450 IFN-γ Spot Forming Cells/1X106 Spleen Cells 400 350 30
Slide 28: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 29: Projected milestones through 2022
Projected milestones through 2022* PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 Preliminary efficacy data from advanced HPV-associated cancer trial (NCI) Interim data from HPV-associated cancer trial (NCI) PDS0101 Expected completion of
Slide 30: Developing powerful, safe, versatile immunotherapies
Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Slide 31: Appendix
Appendix
Slide 32: Versamune-based oncology pipeline developed with leaders in immuno-oncology
PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the leaders in immuno-oncology Nasdaq: PDSB Reference: Data on file. 32
Slide 33: Preclinical triple combination demonstrated higher targeted T-cell response
Preclinical study: Triple combination of PDS0101, Bintrafusp alfa (M7824) and M9241 (NHS-IL12) demonstrated higher targeted T-cell response Combination of PDS0101 with M9241 or Bintrafusp alfa generated superior targeted T-cell response; triple combination demonstrated superior efficacy Bintrafusp a
Slide 34: Versamune induces CD8+ killer T-cells that infiltrate tumors
Versamune® induces high quantity and quality of CD8+ killer T-cells that infiltrate the tumors and make them more susceptible to killing Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment A-antigen, R-Versamune® (R-DOTAP); G-GM-CSF; S-Sucrose; N-
Slide 35: PDS0104 preclinical studies in B16 melanoma
PDS0104 preclinical studies: Potent TRP2-specific CD8+ killer T-cells demonstrate potential to break immune tolerance in difficult-to-treat B16 melanoma Potential potent activity with different tumor antigens Healthy animals 14 days after single injection treatment Versamune® Formulation 1 Versamune
Slide 36: Immunotherapeutics ORR in HPV-associated malignancies
Immunotherapeutics ORR in HPV-associated malignancies Agents(s) Cervical H&N SCC All HPV All HPV References (CPI Naïve) (CPI Naïve) (CPI Naïve) (CPI refractory) Pembroluzimab 14% 24% Keynote 012, (Keytruda®) Siewert TY, 2016 Nivolumab (Opdivo®) 13% Checkmate 154, Ferris RL, 2018 Atezolizumab 22% Col
Slide 37: No new or elevated toxicities observed from the addition of PDS0101
No new or elevated toxicities observed from the addition of PDS0101 to the combination; PDS0101 only caused transient injection site reactions All patients N=25* • Grade 3 TRAEs occurred in 10 (40%) patients Adverse Event Summary Grade ≥2 • Anemia due to gross hematuria (n=4), Treatment-related adve
Slide 38: PDS0101 interim Phase 2 data: HPV-associated cancers represented
PDS0101 interim Phase 2 trial data presented by the NCI at ASCO 2021: Most HPV-associated cancers are represented - >95% of all US cases Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the interim data study population Vaginal/ Vulvar (12%)
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