Full Press Release Details
Head and Neck Cancer KOL Roundtable NASDAQ: PDSB | October 26, 2022
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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
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
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.
Lauren V. Wood Closing Remarks Dr. Lauren V. Wood
Current Treatment of Head and Neck Cancer Dr. Neil Gross
Head and Neck CancerEpidemiologic Shift Ulysses S. Grant HPV-associated HNSCC
HPV-Positive Head and Neck CancerIncreasing Incidence Tota JE et al. J Clin
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
Head and Neck CancerDifferent Biologic
Behavior 3.2013 7.2014 10.2014 4.2015 6.2015
HPV-Positive Head and Neck CancerCurrent Treatments NCCN Guidelines 2022
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
HPV-Positive Head and Neck CancerIncreased Focus on Quality of Life (QOL)
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
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
Unmet Medical Needs in Head and Neck Cancer Dr. Katharine Price
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 significantly
increases risk of recurrence2 1Ang et al., NEJM, 2010, Jul 1;363(1):24-35. 2O'Sullivan et al., Lancet Oncology, Volume 17, Issue 4, April 2016, pages 440-451
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 51% 30% 12.3 CPS 20 57% 38% 14.9 Pembrolizumab + chemotherapy 1 year OS 2 year OS Median OS (mo) Total 53% 29% 13.0 CPS 1 55% 31% 13.6 CPS 20 57% 35% 14.7 KEYNOTE-048 Burtness et al., Lancet 2019, Vol 394,
issue 10212, p1915-1928 1Mehra et al., Br J Cancer 119, 153-159 (2018).
No Improvement in Progression Free Survival (PFS) with Pembrolizumab Alone or
with Chemotherapy Burtness et al., Lancet, 2019
Changing of Face of Patients with HNSCC Younger patient
population Predominantly male Less tobacco and alcohol use Fewer comorbidities
Better QOL with Immunotherapy Compared with Chemotherapy Ferris et al., N Engl
J Med 2016;375:1856-67
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 treatment
Prevention is the Best Cure of All
PDS0101 for the Potential Treatment of HPV16-Positive Head and Neck Cancer Dr.
Phase 2: PDS0101 in Combination with KEYTRUDA For the potential treatment of
HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002)
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
KEYTRUDA For the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002)
Treatment Emergent Adverse Events (TEAEs) Safety Population (N=19) CPI Na ve
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 Treatment
by Investigator No subjects met this criteria 0 Grade 3 & 4 Treatment Related TEAEs No subjects met this criteria 0 At 9 Months of Follow Up (Median PFS not yet Achieved) % of Patients Alive at Median 9 Months 89% Progression
Free Survival Rate (PSF) 55.2% Overall Survival Rate (OS) 87.2% Phase 2: PDS0101 in Combination with KEYTRUDA For the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002)
Closing Remarks Dr. Lauren V. Wood