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PDS0101 in HPV16+ Head and Neck Cancer KOL Roundtable NASDAQ: PDSB

Key Takeaway: PDS Biotech's roundtable discussion highlighted the ongoing developments of PDS0101, focusing on its potential in treating HPV16+ head and neck cancer. Experts from various oncology institutions presented findings and anticipated the initiation of further clinical trials. The conversation also addressed current treatment approaches and the unmet needs within the HPV16+ cancer landscape. The company's success will heavily depend on upcoming trials and the management of funding and operational challenges.

Market Sentiment Analysis

POSITIVE FACTORS

  • PDS0101 is being discussed as a promising treatment option for HPV16+ head and neck cancer.
  • The roundtable includes notable experts which may add credibility to the findings.
  • Future clinical trials for PDS0101 are planned, indicating potential progress in development.

CONCERNS & RISKS

  • The company's future performance is uncertain and subject to various risks.
  • Funding challenges may restrict operations and impact product candidate development.

Full Press Release Details

PDS0101 in HPV16+ Head and Neck Cancer KOL Roundtable NASDAQ: PDSB October 3,
Forward Looking Statements Versamune and Infectimune are registered trademarks
of PDS Biotechnology Corporation.KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 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) concerning PDS Biotechnology Corporation (the "Company") and
other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company's management, as well as
assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as
"may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," "forecast," "guidance", "outlook" and other similar expressions. Forward-looking statements are based on current beliefs and
assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including,
without limitation: the Company's ability to protect its intellectual property rights; the Company's anticipated capital requirements, including the Company's anticipated cash runway and the Company's current expectations regarding its plans
for future equity financings; the Company's dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict
the Company's operations or require the Company to relinquish rights to the Company's technologies or product candidates; the Company's limited operating history in the Company's current line of business, which makes it difficult to evaluate
the Company's prospects, the Company's business plan or the likelihood of the Company's successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and
other Versamune and Infectimune based product candidates; the future success of such trials; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning
PDS0101, PDS0203 and other Versamune and Infectimune based product candidates and the Company's interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future
success of the Company's product candidates; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of
initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations
at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company's ongoing
clinical trials; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, PDS0101, PDS0203 and other Versamune and Infectimune
based product candidates; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration
studies; and other factors, including legislative, regulatory, political and economic developments not within the Company's control, including unforeseen circumstances or other disruptions to normal business operations arising from or related
to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere,
including the risk factors included in the Company's annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company
undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
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 regulations and guidelines
Welcome and Introductions Dr. Lauren V. Wood
Dr. John Kaczmar Associate Professor Medical University of South Carolina Dr.
Ricard Mes a Head of Medical Oncology Catalan Institute of Oncology Introducing Our Panel Dr. Glenn Hanna Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute Dr. Katharine Price Associate
Professor Mayo Clinic Comprehensive Cancer Center
Today's Agenda Welcome and Introductions Dr. Lauren V. Wood Current Treatment
of HPV16+ HNSCC and Unmet Needs Dr. Ricard Mes a PDS0101 for the Treatment of HPV16+ HNSCC Data to Date Dr. John Kaczmar Plans for Phase 3 Study Dr. Katharine Price Emerging Use of ctDNA in Treatment of HPV+ HNSCC Dr. Glenn
Hanna PDS0101 + KEYTRUDA in ICI Refractory Subjects Dr. Lauren V. Wood Panel Discussion (including Q&A from audience) Moderator: Dr. Lauren V. Wood Closing Remarks Dr. Lauren V. Wood
Current Treatment of HPV16+ HNSCC and Unmet Needs Dr. Ricard Mes a
CPS Tumor burden and growth rate Standard-of-Care in Recurrent/Metastatic HNSCC:
ECOG 0-1 Mesia R, Clin Transl Oncol 2021 Ferris RL, et al. NEJM. 2016;375:1856-67 Burtness B et al., Lancet. 2019; 394:1915-1928 OS 12-14 m PFS 3-5 m CT POST-IO OS 8 m PFS 2 m PD-L1 CPS 1 PD-L1 CPS<1 Performance Score
(ECOG) Comorbidities, age Patient Tumor Platinum-sensitive Platinum-refractory PEMBROLIZUMAB PEMBROLIZUMAB + CT EXTREME/TPEX NIVOLUMAB CT POST-IO NIVOLUMAB CT POST-IO 1L R/M HNSCC KEY R/M: recurrent/metastatic HNSCC: head and
neck squamous cell carcinoma CPS: combined positive score IO: immuno-oncology ECOG: Eastern Cooperative Oncology Group TPEX: cisplatin, docetaxel, and cetuximab combination EXTREME: platinum, 5-fluorousracil, and cetuximab combination CT:
What Happened with CPS<1? CT: chemotherapy Burtness B, et al. J Clin Oncol.
2022. Pembrolizumab vs EXTREME Pembrolizumab + CT vs EXTREME CPS < 1: pembrolizumab alone is detrimental and pembrolizumab + CT is not superior
Baseline Characteristics, KEYNOTE-048 Burtness B et al., Lancet. 2019;
394:1915-1928 Characteristic, n (%) Pembrolizumab Alone vs EXTREME Pembrolizumab + Chemo vs EXTREME Characteristic, n (%) Pembro N = 301 EXTREME N = 300 Pembro + Chemo N = 281 EXTREME N = 278a Age, median (range), years 62
(22-94) 61 (24-84) 61 (20-85) 61 (24-84) Male 250 (83.1) 261 (87.0) 224 (79.7) 242 (87.1) ECOG PS 1 183 (60.8) 183 (61.0) 171 (60.9) 170 (61.2) Current/former smoker 239 (79.4) 234 (78.0) 224 (79.7) 215 (77.3) p16 positive
(oropharynx) 63 (20.9) 67 (22.3) 60 (21.4) 61 (21.9) Sum of target lesions, median (range), mm 54.1 (10-430) 58.7 (10-419) 67.3 (12-385) 58.7 (10-419) PD-L1 status TPS 50% 67 (22.3) 66 (22.0) 66 (23.5) 62 (22.3) CPS 20 133
(44.2) 122 (40.7) 126 (44.8) 110 (39.6) CPS 1 257 (85.4) 255 (85.0) 242 (86.1) 235 (84.5) Disease statusb Metastatic 261 (71.8) 203 (67.7) 201 (71.5) 187 (67.3) Recurrent only 82 (27.2) 94 (31.3) 76 (27.0) 88 (31.7)
The Actual Goals of Therapy in Recurrent/Metastatic Disease IO: immuno-oncology
therapy 1. Tahara M ESMO 2022 Treatment Goal 5-yr OS: 15-18% with IOsin CPS 1 Recurrent/Metastatic Improve long-survivors rate The complete cure of the recurrent/metastatic patient? Palliative intent = Only??? Survival Response
rates Symptom control QoL
Treatment After 1st Line Recurrent/Metastatic: Expectations Harrington K. et al.
ASCO Annual meeting 2020 Haddad J Clin Oncol 2023 Only 50 to 60% will receive a second line therapy based on what, they received first
Treatment After 1st Line Recurrent/Metastatic: Expectations Psyrri A. et al.
Annals of Oncology, 2023, Harrington K. et al. ASCO Annual meeting 2020 mOS Can Be Predicted by Response to First Line mPFS to 2L May Range Between 3-6m
Unmet Needs in 1st Line Recurrent/Metastatic - HPV16+ HNSCC: Head and neck
squamous cell carcinoma IO: Immuno-oncology therapy To improve the rate of long-term survival To reduce the toxicity of the actual treatments, to improve QoL To define the best sequence of treatment for specific HPV-related patients with
recurrent/metastatic disease. The best option of treatment should be administered in 1st line, because up to 50% may not receive a 2nd line To date standard of care chemotherapy or IOs alone is not enough in most of HPV-related HNSCC
PDS0101 for the Treatment of HPV16+ HNSCC Data to Date Dr. John Kaczmar
VERSATILE-002 Key Goal: Improve Survival with PDS0101 Targeted
Immunotherapy Burtness B et al., Lancet. 2019; 394:1915-1928 Mehra R et al., Br J Cancer 2018; 119:153-159 Overall Survival with KEYTRUDA or KEYTRUDA + chemo is only 12-14 months in KEYNOTE-048 24-month survival rate with KEYTRUDA or
KEYTRUDA + chemo is only 29% - 31% in KEYNOTE-048 No difference in survival between HPV-positive and -negative patients in the recurrent/metastatic setting There is no specific therapy targeting the type of HPV which represents a majority of
head and neck cancers Goal of PDS0101 is to target HPV16 to treat the disease and improve overall survival and enhance quality of life, while maintaining safety Limitations: This presentation shows data from a snapshot of an ongoing study as
of August 2, 2023. Final results may differ for reasons including: new outcomes from existing subjects, delays in data entry at the research site, ongoing monitoring and clarification of data queries.
VERSATILE-002 Phase 2 Clinical Trial Objective: To Assess the Combination of
PDS0101 and KEYTRUDA in ICI Na ve Subjects with Recurrent or Metastatic HPV-positive HNSCC KEYTRUDA (pembrolizumab) FDA Approved Standard of Care Partner StudyDesign Open-label, non-randomized, adaptive design study N=54 Enrollment
complete Key Entry Criteria for ICI Na ve Subjects Recurrent or metastatic HNSCC 18 years of age HPV16-Positive tumor Combined positive score (CPS) 1 Pembrolizumab 200mg IV Q3W up to 35 Cycles (2 years) PDS0101 1 mL subcutaneous
injection at Cycles 1, 2, 3, 4 and 12 Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1 Key Secondary: Progression Free Survival (PFS) per RECIST 1.1
Overall Survival (OS) Safety and tolerability Achievement of Statistical Threshold for efficacy Endpoints Fast Track Designation
VERSATILE-002 ICI Na ve Key Demographics and Treatment Exposure Majority of
Patients Are CPS 1-19 Demographic ITT Population (N=55) mITT Population (N=52) Age, Median (Min, Max) 64.0 (46, 83) 64.0 (46, 83) Sex, n (%) Male Female 51 (92.7) 4 (7.3) 48 (92.3) 4 (7.7) Race, n (%) American Indian or
Alaska Native Asian Black or African American Pacific Islander White Other 0 1 (1.8) 1 (1.8) 0 52 (94.5) 1 (1.8) 0 1 (1.9) 1 (1.9) 0 49 (94.2) 1 (1.9) ECOG, n (%) 0 1 32 (58.2) 23 (41.8) 29 (55.8) 23
(44.2) CPS, n (%)* <1 1-19 20 0 33 (60.0) 22 (40.0) 0 31 (59.6) 21 (40.4) Data on File. 08/02/23 Data Cut. Treatment Exposure(ITT Population) Median number of PDS0101 doses: 4 (range 1-5) 72.7% received 4 doses25.5%
received 5 doses (5th dose is 6 months after dose 4) Median number of KEYTRUDA doses: 7 (range 1-33) 32.7% received 10 doses
PDS0101 and KEYTRUDA Combination in ICI Na ve HNSCC Demonstrates Promising
Patient Survival to Date Median OS Not Yet Estimable Data on File. 08/02/23 Data Cut. Kaplan-Meier Estimates of Overall Survival (OS) (Intent-to-Treat Population) No. of Subjects at Risk (Events) 55 (0) 53 (2) 50 (3) 42 (5) 41 (6) 36
(7) 32 (8) 27 (8) 24 (8) 21 (8) 19 (9) 17 (9) 17 (9) 17 (9) 15 (9) 14 (9) 11 (10) 11 (10) 11 (10) 9 (10) 8 (10) 7 (10) 6 (10) 4 (10) 2 (10) 0 (10) 12 Month OS Rate - 80% 24 Month OS Rate - 74%
PDS0101 and KEYTRUDA Combination in ICI Na veHNSCC Demonstrates Promising Patient
Survival to Date Overall Survival is Primary Endpoint in Planned Phase 3 Study VERSATILE-003 * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 Data CutBurtness B et al.,
Lancet. 2019; 394:1915-1928 OS Rate (%) VERSATILE-002 VERSATILE-002 KEYNOTE-048(CPS 1) KEYNOTE-048(CPS 1) 12-month OS Rate 24-month OS Rate
Disease Stabilization or Tumor Reduction in 81% of Patients Tumor Shrinkage in
60% (31/52) with Confirmed Objective Response in 27% (14/52) to Date Assessments based on Investigator assessment per RECIST 1.1 Data on File. 08/02/23 Data Cut. Burtness B et al., Lancet. 2019; 394:1915-1928. Best Percentage Change from
Baseline in Target Lesions (mITT population) VERSATILE-002 Months (95% CI) PDS0101+KEYTRUDA 8.1 KEYNOTE-048 (CPS 1) Months (95% CI) KEYTRUDA Monotherapy 3.2 KEYTRUDA + Chemo 5.0 EXTREME Chemo 5.0 Progression Free Survival
No ICI Na ve Subjects Have Grade 4 or 5 Combination Treatment Related Adverse
Events (N=62) Safety Population: All enrolled subjects who received at least 1 dose of pembrolizumab or PDS0101. Includes subjects who became ineligible, for example due to lack of central confirmation of HPV16-positivity. Used for all safety
analyses Data on File. 08/02/23 Data Cut. Preferred Term n (%) Any Combination-TRAE 49 (79.0) Injection site pain 32 (51.6) Injection site swelling 17 (27.4) Injection site erythema 11 (17.7) Injection site discoloration 9
(14.5) Injection site warmth 9 (14.5) Injection site inflammation 7 (11.3) Injection site pruritus 7 (11.3) Injection site reaction 4 (6.5) Preferred Term n (%) Fatigue 23 (37.1) Headache 9 (14.5) Pruritis 7 (11.3) Pain 5
(8.1) Diarrhea 5 (8.1) Rash 5 (8.1) Alanine aminotransferase increased 5 (8.1) Aspartate aminotransferase increased 4 (6.5) Cough 4 (6.5) Arthralgia 4 (6.5) 13% (8/62) Subjects have Grade 3 Combination Treatment Related Adverse
Events No Grade 3-5 Injection Site Specific AEs Injection Site Specific AEs Other AEs
PDS0101 with KEYTRUDA Well Tolerated in VERSATILE-002 to Date Grade 3-5
Treatment Related Adverse Events *No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on File. 08/02/23 Data Cut Burtness B et al. Lancet. 2019;394:1915-1928 VERSATILE-002 No
Grade 4 or 5 TRAE Subjects (%) KEYNOTE-048(CPS 1)
Combination of PDS0101 & KEYTRUDA Continues to Show Promising Survival
Outcomes in ICI Na ve subjects PDS0101 with KEYTRUDA Combination Data Shows Potential Of PDS0101 to Safely Modify the Tumor Microenvironment and Target HPV16-positive HNSCC to Promote Survival The 24-month OS rate in the ICI na ve cohort is
74%; published results of 29% in KEYNOTE-048 The 12-month OS rate in the ICI na ve cohort is 80%; published results of 50% in KEYNOTE-048 The addition of PDS0101 to KEYTRUDA does not appear to compound toxicity in ICI na ve patients 13%
(8/62) Grade 3 and 0% Grade 4 & 5 Treatment Related Adverse Events * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on File. 08/02/23 Data Cut. Burtness B, et al. Lancet.
Plans for Phase 3 Study Dr. Katharine Price
VERSATILE-003 Designed to Be Confirmatory Trial for ICI Na ve Cohort of Phase 2
VERSATILE-002 Study with Overall Survival as Primary Endpoint A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Na ve Subjects with
Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC)
VERSATILE-003 Phase 3 Study Design Global Randomized, Controlled Clinical Study
with Estimated 90-100 Sites Overall survival (OS) Primary Endpoint For the treatment of recurrent or metastatic HPV16-positive HNSCC Targeted Indication Randomization 2:1 PDS0101 +KEYTRUDA PDS0101 + KEYTRUDA
KEYTRUDA KEYTRUDA Planned Interim Analysis: OS Final Analysis:OS Enrollment Follow-up
Primary and Secondary Objectives Primary Objective Overall survival (OS) between

Frequently Asked Questions

What is PDS0101 used for in medical treatment?

PDS0101 is being explored for treating HPV16+ head and neck squamous cell carcinoma.

What information do forward-looking statements provide?

They discuss the company's goals, expectations, and plans regarding future operations.

What is the significance of CPS in treatment planning?

CPS, or combined positive score, helps determine the effectiveness of immunotherapy options.

Who sponsored the KOL roundtable?

PDS Biotech sponsored the KOL roundtable discussion.

What does ECOG refer to in clinical assessments?

ECOG stands for Eastern Cooperative Oncology Group, assessing patient performance status.

Last updated: Oct 3, 2023