PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (September 2021)
27 slides from PDS Biotechnology's investor presentation, September 2021
Slide 1: Corporate Overview September 2021
CORPORATE OVERVIEW SEPTEMBER 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 on the Versamune platform
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+ killer 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: PDS Biotech executive team has demonstrated success in developing and commercializing pharmaceutical products
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 6: Versamune-based pipeline is being 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 7: In preclinical studies, Versamune has demonstrated potential for potent CD8+ T-cell responses
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 8: Introduction to PDS0101
Introduction to PDS0101
Slide 9: PDS0101 is designed to treat advanced HPV16 cancers
PDS0101 is designed to treat advanced human papillomavirus (HPV)-16 cancers which represents 70-80% of the HPV-associated cancer market FIRST LINE • 20-30% of patients either progress or • Approximately 43,000 patients are Radiation and/or have a recurrence of cancer and are diagnosed with HPV-assoc
Slide 10: Sub-cutaneous PDS0101 monotherapy induced high quantity of potent HPV16-specific CD8+ T-cells in Phase 1
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 11: 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 12: PDS0101 interim Phase 2 data presented by the 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 Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the interim data study population Vaginal/ Vulvar (12%)
Slide 13: ASCO 2021: Triple combination achieved 83% ORR among six 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) Bintafusp alfa + M9241 1 patient had no evidence of diseas
Slide 14: ASCO 2021: Triple combination achieved 58% tumor reduction among 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 15: ASCO 2021: Promising durability of anti-cancer efficacy in CPI naive patients
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 HPV16-positive (Checkpoint Inhibitors) Number of checkpoint inhibitor naïve patients 6 Ongoing objective resp
Slide 16: ASCO 2021: Results in HPV16-negative patients suggest role of PDS0101-induced T-cells
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 17: Phase 2 trial of PDS0101/KEYTRUDA 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 18: Phase 2 trial of PDS0101 and chemoradiation 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 19: Development of PDS0102
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Slide 20: PDS0102 is designed to treat cancers caused by TARP, including AML, prostate and breast cancers
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 21: 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) 21 CFA – Complete Freund’s Adjuvant a highly potent i
Slide 22: Development of PDS0103
“Development.of PDS0103 ° = . oa
Slide 23: PDS0103 is designed to treat cancers caused by MUC1
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 24: Greater quantity and quality of Versamune-induced CD8+ killer 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 25: PDS0101 Near-Term Milestones and Market Opportunities
PDS0101 Near-Term Milestones and Market Opportunities
Slide 26: 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 27: Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
Nasdaq: PDSB Developing powerful, safe, versatile immunotherapies
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