Slide 1: Head and Neck Cancer KOL Roundtable
Head and Neck Cancer KOL Roundtable NASDAQ: PDSB | October 26, 2022
Slide 2: Forward Looking Statements
Forward Looking Statements Certain information in this presentation may include 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) concernin
Slide 3: Disclaimer
Disclaimer PDS Biotech is the sponsor of this roundtable Each panelist is speaking on behalf of PDS Biotech under the terms of a consulting agreement Information presented is consistent with FDA guidelines
Slide 4: Introducing our Panel
Introducing our Panel Dr. Katharine A. Price Co-chair, Head and Neck Disease Group Mayo Clinic Comprehensive Cancer Center Dr. Neil D. Gross Department of Head and Neck Surgery MD Anderson Dr. Jared Weiss Head and Neck Cancer Section Chief UNC School of Medicine
Slide 5: Today's Agenda
Today’s Agenda 5 Welcome and Introductions Dr. Lauren V. Wood Current Treatment of Head and Neck Cancer Dr. Neil Gross Unmet Medical Needs in Head and Neck Cancer Dr. Katharine Price PDS0101 for the treatment of HPV16-Positive Head and Neck Cancer Dr. Jared Weiss Panel Discussion Moderated by Dr. La
Slide 6: Current Treatment of Cancer
Current Treatment of Head and Neck Cancer Dr. Neil Gross
Slide 7: Cancer Epidemiologic Shift
Head and Neck CancerEpidemiologic Shift Ulysses S. Grant HPV-associated HNSCC
Slide 8: HPV-Positive Cancer Increasing Incidence
HPV-Positive Head and Neck CancerIncreasing Incidence Tota JE et al. J Clin Oncol 2019
Slide 9: HPV-Positive Cancer Increasing Incidence
HPV-Positive Head and Neck CancerIncreasing Incidence Cancer Statistics, 2022 Siegel, RL CA CANCER J CLIN 2022;72:7–33. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21708
Slide 10: Cancer Different Biologic Behavior
Head and Neck CancerDifferent Biologic Behavior 3.2013 7.2014 10.2014 4.2015 6.2015
Slide 11: HPV-Positive Cancer Current Treatments
HPV-Positive Head and Neck CancerCurrent Treatments NCCN Guidelines 2022
Slide 12: HPV-Positive Cancer Toxicity of Treatment
HPV-Positive Head and Neck CancerToxicity of Treatment Photographing His Own Cancer Treatment: ‘A Hell I Wasn't Ready For’ New York Times 7.7.2018
Slide 13: Increased Focus on Quality of Life (QOL)
HPV-Positive Head and Neck CancerIncreased Focus on Quality of Life (QOL)
Slide 14: Cancer De-escalation Strategies
Head and Neck CancerDe-escalation Strategies RTOG 1016 Gillison M et al. Lancet 2019 DART J Clin Oncol 2019 De-ESCALaTE Lancet 2019 J Clin Oncol 2021 Yom SS et al. J Clin Oncol 2021
Slide 15: Recurrent HPV-Positive Cancer Opportunity for Improved Intervention
Recurrent HPV-Positive Head and Neck CancerOpportunity for Improved Intervention Farhoud F et al. Laryngoscope Investig Otolaryngol 2017 Baseline incidence # Treatment failures Protracted disease Earlier detection HPVctDNA
Slide 16: Unmet Medical Needs in Cancer
Unmet Medical Needs in Head and Neck Cancer Dr. Katharine Price
Slide 17: Survival Outcomes for HPV-Positive HNSCC
Survival Outcomes for HPV-Positive HNSCC Overall prognosis for HPV-positive HNSCC is significantly improved compared with HPV-negative HNSCC1 Despite improved cure rates, approximately 20-30% of patients will develop a recurrence after curative intent treatment ↑ # involved lymph nodes & T4 tumors s
Slide 18: Survival Outcomes in the Recurrent/Metastatic Setting
Long-term analysis of patients treated with pembrolizumab does not suggest significant difference in response between patients with HPV-positive and HPV-negative tumors1 Survival Outcomes in the Recurrent/Metastatic Setting Pembrolizumab 1 year OS 2 year OS Median OS (mo) Total 49% 27% 11.6 CPS ≥ 1
Slide 19: No Improvement in PFS with Pembrolizumab Alone or with Chemotherapy
No Improvement in Progression Free Survival (PFS) with Pembrolizumab Alone or with Chemotherapy Burtness et al., Lancet, 2019
Slide 20: Changing Face of Patients with HNSCC
Changing of Face of Patients with HNSCC Younger patient population Predominantly male Less tobacco and alcohol use Fewer comorbidities
Slide 21: Better QOL with Immunotherapy Compared with Chemotherapy
Better QOL with Immunotherapy Compared with Chemotherapy Ferris et al., N Engl J Med 2016;375:1856-67
Slide 22: Unmet Needs for Patients with Recurrent/Metastatic HPV-Positive HNSCC
Unmet Needs for Patients with Recurrent/Metastatic HPV-Positive HNSCC Curative treatments Improved therapies allowing patients to live longer with their disease with good QOL Better immunotherapy-based treatments to delay need for cytotoxic chemotherapy Preservation of QOL and function while on trea
Slide 23: Prevention is the Best Cure of All
Prevention is the Best Cure of All
Slide 24: PDS0101 for the Potential Treatment of HPV16-Positive Cancer
PDS0101 for the Potential Treatment of HPV16-Positive Head and Neck Cancer Dr. Jared Weiss
Slide 25: Phase 2: PDS0101 in Combination with KEYTRUDA (VERSATILE-002)
Phase 2: PDS0101 in Combination with KEYTRUDA®For the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002)
Slide 26: VERSATILE-002 Response Data
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 (35.3%) PD 4 (23.5%) CR+PR+SD 13 (76.5%) * * * * * * * Indicates CPS>20 All others CPS 1-19 Phase 2: PDS0101 in Combination with KE
Slide 27: Treatment Emergent Adverse Events
Treatment Emergent Adverse Events (TEAEs) Safety Population (N=19) CPI Naïve Subjects (N=19) N (%) : Events Subjects with any TEAEs Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 18 (94.7%) : 371 3 (15.8%) : 3038 (42,1%) : 51 5 (26.3%) : 110 (0.0%) : 4 2 (10.5%) : 2 ≥ Grade 3 TEAEs Attributed to Study Trea
Slide 28: Panel Discussion
Panel Discussion
Slide 29: Closing Remarks
Closing Remarks Dr. Lauren V. Wood