Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (September 2021)
36 slides from Pds Biotechnology's investor presentation, Sep 9, 2021
Slide 1: Developing powerful, safe, versatile immunotherapies: Corporate Overview
Nasdaq: PDSBDeveloping powerful, safe, versatile immunotherapies CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO SEPTEMBER 2021
Slide 2: Forward-Looking Statements
2 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 acti
Slide 3: PDS Biotech is a clinical stage biotechnology company developing immunotherapies
Nasdaq: PDSB Nasdaq: PDSB PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 3 Interim data from NCI-led PDS0101 Phase 2 trial showed tumor reduction in ~70% of patients who had failed prior treatmentNo new or e
Slide 4: Versamune-based immunotherapies promote CD8+ killer T-cell response
4 PDS Biotech’s Versamune®-based immunotherapies are designed to promote a powerful in vivo tumor-specific CD8+ killer T-cell response A significant barrier to effective immunotherapy has been the inability to promote adequate CD8+ killer T-cell responses in vivo 70-90% of cancer patients fail check
Slide 5: PDS Biotech executive team has demonstrated success in drug development
Nasdaq: PDSB Nasdaq: PDSB PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products 5 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposo
Slide 6: Versamune-based pipeline developed in partnership with leaders in immuno-oncology
Nasdaq: PDSB PDS Biotech’s robust Versamune® -based pipeline is being developed in partnership with leaders in immuno-oncology and infectious disease 6 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquimica. Funding provided by The Ministry of Science
Slide 7: Versamune demonstrated potent CD8+ T-cell responses in preclinical studies
Nasdaq: PDSB Reference: Data on file. In preclinical studies, Versamune® has demonstrated potential for potent CD8+ (killer) T-cell responses with different tumor antigens 7 PDS0101 Phase 2 interim results demonstrate promising link between targetedCD8+ killer T-cell response and anti-tumor response
Slide 8: Introduction to PDS0101
Introduction to PDS0101
Slide 9: Approximately 43,000 patients diagnosed with HPV-associated cancers annually in the US
Nasdaq: PDSB Nasdaq: PDSB 9 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US alone1 Cancers caused by HPV include anal, cervical, head and neck, penile vaginal and vulvar cancers Incidence rate of HPV-related head and neck and anal cancer is growing and rema
Slide 10: PDS0101 monotherapy induced HPV16-specific CD8+ T-cells in Phase 1 trial
Nasdaq: PDSB 10 Sub-cutaneous injection of PDS0101 monotherapy induced high quantity of potent HPV16-specific CD8+T-cells in Phase 1 clinical trial 0Patient 50 100 150 200 250 2-4 2-5 3-1 3-2 5-7 2-7 A2 HPV-specific T-cell Response IFN-γ ELISPOT 0Patient 200 400 600 800 1000 1200 1400 1600 1800 2000
Slide 11: Phase 2 NCI-led trial of PDS0101, Bintrafusp alfa and M9241
Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional checkpoint inhibitor-“TGF-β trap” fusion proteinM9241: Antibody-conjugated immuno-cytokinePDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ T-cells
Slide 12: PDS0101 interim Phase 2 data presented by NCI at ASCO 2021
PDS0101 interim Phase 2 trial data presented by the NCI at ASCO 2021: Most HPV-associated cancers are represented - >95% of all US cases 12 Cervical (40%) Anal (24%) Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the interim data study popu
Slide 13: ASCO 2021: 83% ORR among CPI naive patients
12 – 24% 83% (5/6)1 patient had no evidence of disease by ASCO 2021 (complete response) 0 10 20 80 90 100 30 40 50 60 70Percentage of patients who experienced >30% tumor reduction Historical standard of care (checkpoint inhibitor) PDS0101 +Bintafusp alfa + M9241 Percentage of CPI Naïve Patients Who
Slide 14: ASCO 2021: 58% tumor reduction among CPI refractory patients
58% (7/12)1 patient had no evidence of disease by ASCO 2021 (complete response) 5 – 12% 0 10 70 80 90 100 20 30 40 50 60Percentage of patients who experienced tumor reduction Historical standard of care (checkpoint inhibitor) PDS0101 +Bintafusp alfa + M9241 ASCO 2021: Triple combination achieved 58%
Slide 15: Triple combination shows durability in HPV16-positive CPI naive patients
15 ASCO 2021: Triple combination shows promising durability of the anti- cancer efficacy in HPV16-positive checkpoint inhibitor naïve patients PDS0101 + Bintrafusp alfa + M9241 Standard of Care(Checkpoint Inhibitors) HPV16-positive Number of checkpoint inhibitor naïve patients 6 Ongoing objective re
Slide 16: Results in HPV16-negative patients suggest role of HPV16-specific CD8+ T-cells
ASCO 2021: Results in HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction 16 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16positive malign
Slide 17: VERSATILE-002: PDS0101/KEYTRUDA in head and neck cancer
Nasdaq: PDSB Nasdaq: PDSB 17 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 hasspread or returned Clinical A
Slide 18: IMMUNOCERV: PDS0101 and chemoradiation in cervical cancer
Nasdaq: PDSB Nasdaq: PDSB 18 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 ClinicalAgents Chemoradiotherapy
Slide 19: Development of PDS0102
Development of PDS0102
Slide 20: Approximately 470,000 patients diagnosed annually with TARP-associated cancers
20 Approximately 470,000 patients are diagnosed annually with AML, prostate or breast cancer, most of which are associated with target T-cell receptor gamma alternate reading frame protein (TARP) Acute Myeloid Leukemia (AML)Almost 20,000 cases in the US annuallyTARP expressed in 100% of AML Prostate
Slide 21: PDS0102 may provide superior induction of TARP-specific CD8+ T-cells
21 PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer T-cells Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8)CFA – Complete Freund’s Adjuvant a highly potent immune activator not used in humans due to potentially lethal toxicity PRE-CLINICAL OPTIMIZATION S
Slide 22: Development of PDS0103
Development of PDS0103
Slide 23: PDS0103 trial design to target tumors with highest MUC1 expression
0 1 2 Clinical trial design will seek to evaluate PDS0103 in tumor types with the highest expression ofMUC1 and the greatest differences in MUC1 expression between malignant and healthy tissueMUC1 Expression by Tumor Type3 PDS0103 is designed to treat cancers caused by mucin-1 (MUC1), which is highl
Slide 24: Versamune-induced CD8+ T-cells may eradicate MUC1-positive tumors
24 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-cells500450400350300250200150100500 Adjuvant* + MUC1 Antigen 4-Combo Adjuvant + MUC1 Antigen Versamune +
Slide 25: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 26: Projected milestones through 2022
Nasdaq: PDSB Nasdaq: PDSB Projected milestones through 2022* *Based on current enrollment and forecast modeling as of September 2021. Subject to change. 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 PDS0101 26 PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials PDS0103 PDS0102 Preliminary
Slide 27: Developing powerful, safe, versatile immunotherapies
Nasdaq: PDSBDeveloping powerful, safe, versatile immunotherapies
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Slide 29: Oncology pipeline developed in partnership with leaders in immuno-oncology
Nasdaq: PDSB PDS Biotech’s robust Versamune® -based oncology pipeline is being developed in partnership with the leaders in immuno-oncology 29 Reference: Data on file.
Slide 30: Versamune designed to induce robust targeted anti-tumor response
Nasdaq: PDSB Nasdaq: PDSB Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen 30 References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL res
Slide 31: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Nasdaq: PDSB Nasdaq: PDSB Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose 31 Single treatment dose Results typical of current top clinical-stage HPV cancer vaccines Tumor rechallenge at Day 60; comple
Slide 32: Preclinical triple combination demonstrated higher targeted T-cell response
Nasdaq: PDSB Nasdaq: PDSB 32 Bintrafusp alfa (M7824 -bi-functional checkpoint inhibitor)Tumor Regression: 0/16 (0%)T-cell Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHS IL-12)Tumor Regression: 13/16 (81%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal fo
Slide 33: Versamune induces CD8+ T-cells that infiltrate tumors
Nasdaq: PDSB Nasdaq: PDSB 33 Reference: Data on file. 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 PDS0
Slide 34: PDS0104 preclinical studies in B16 melanoma
Nasdaq: PDSB Nasdaq: PDSB Reference: Data on file. PDS0104 preclinical studies: Potent TRP2-specific CD8+ killer T-cells break immune tolerance, with efficacy in difficult-to-treat B16 melanoma 34 Black stainsdueto tumors Healthy animals Versamune® Formulation 1Versamune® Formulation 2 Negative Cont
Slide 35: ORR in HPV-associated malignancies by immunotherapeutic
Nasdaq: PDSB Nasdaq: PDSB Immunotherapeutics ORR in HPV-associated malignancies 35 Taken from J. Strauss, ASCO 2021 (Revised to show CPI status) Agents(s) Cervical (CPI Naïve) H&N SCC(CPI Naïve) All HPV (CPI Naïve) All HPV (CPI refractory) References Pembroluzimab (Keytruda®) 14% 24% Keynote 012,Sie
Slide 36: Adverse Event Summary
Nasdaq: PDSB Nasdaq: PDSB Adverse Event Summary All patients N=25* Grade ≥2 Treatment-related adverse events (TRAEs) 23 (92%) TRAEs leading to discontinuation of ≥ 1 drug(s) 5 (20%) Treatment-related serious AEs 7 (28%) TRAEs in ≥5% of patients Anemia 12 (48%) Lymphocyte decrease 7 (28%) Flu like sy
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