Stimulating Immune Response With Neoadjuvant Human Papilloma Virus (HPV)-16 Specific Vaccination in HPV-Oropharyngeal Squamous Cell Carcinoma (HPV-OPSCC)

This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Start Date16 Jun 2022

Sponsor / Collaborator

Mayo Clinic

NCT04260126 / Active, not recruitingPhase 2

A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects With Recurrent and/or Metastatic HNSCC and High-Risk HPV16 Infection

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Start Date29 Mar 2021

Sponsor / Collaborator

PDS Biotechnology Corp.

[+1]

NCT04580771 / Active, not recruitingPhase 2IIT

IMMUNOCERV: Evaluating the Safety of Chemoradiation Combined With PDS0101 Immunotherapy in Treating Locally Advanced Cervical Cancer

This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to boost the immune system's response against the HPV viral proteins and the second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical cancer.

Start Date14 Oct 2020

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Pexipepimut-S

100 Translational Medicine associated with Pexipepimut-S

100 Patents (Medical) associated with Pexipepimut-S

Literatures (Medical) associated with Pexipepimut-S

01 Oct 2023·International journal of radiation oncology, biology, physics

HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation.

Article

Author: Venkatesan, A ; Xiao, W ; Lynn, E J ; Sammouri, J ; Klopp, A H ; Court, K ; Napravnik, T Cisneros ; Seo, A ; Joyner, M M ; Jhingran, A ; Gjyshi, O ; Gillison, M ; Lin, L L ; Colbert, L

PURPOSE/OBJECTIVE(S):

The human papilloma virus (HPV) is a significant cause of cervical cancer and viral DNA can be detected in the blood of patients with cervical cancer (cfHPV-DNA). We hypothesized that detecting HPV cfDNA before, during and after chemoradiation (CRT) could provide insights into disease extent, clinical staging, and treatment response.

MATERIALS/METHODS:

Forty-seven patients with cervical cancer were enrolled on this study between 2017 and 2022, either as part of a standard-of-care (SOC) treatment banking protocol (33 patients) or as part of a clinical trial combining a therapeutic HPV vaccine (PDS0101; Immunocerv, 14 patients). Longitudinal plasma samples were collected from each patient as baseline, during week 1, 3 or 5 of CRT. cfHPV-DNA was quantified using droplet digital PCR targeting the HPV E6/E7 oncogenes of 13 high-risk types based on analysis of cervical tumor genotype (AmpFire). Clinical covariates, including FIGO stage, primary tumor size, and treatment response were studied using appropriate statistical tests.

RESULTS:

All 47 patients had detectable HPV cfDNA during CRT with 38 out of 47 having HPV type 16 detected. The median cfDNA at baseline was 24.5 copies/mL, with a range of 0 to 157,638 copies/mL. Of the 35 patients with at least three measurements, 20 (57%) had peak cfDNA counts at week 3, and 30 out of 35 showed a decline in cfDNA counts at week 5 compared to week 3. The proportion of patients who cleared cfDNA (<16 copies/mL) increased with each week of CRT, reaching 75% at week 5. Baseline cfDNA counts were associated with para-aortic nodal involvement (p<0.0001) but not with FIGO stage or gross tumor volume. A greater proportion of patients treated with therapeutic HPV-directed vaccine had clearance of cfDNA counts as compared to those treated with SOC (at week 3, 38% vs 5%, P = 0.02 and week 5, 79% vs 22%, P = 0.0054) CONCLUSION: HPV cfDNA levels change dynamically throughout definitive CRT and peak during the first 3 weeks for the majority of patients. Treatment with a therapeutic HPV vaccine was associated with a more rapid decline in cfHPV DNA. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and clinical outcomes.

01 Jun 2020·Journal for immunotherapy of cancerQ2 · MEDICINE

Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine

Q2 · MEDICINE

ArticleOA

Author: Jochems, Caroline ; Morillon Ii, Y Maurice ; Schlom, Jeffrey ; Smalley Rumfield, Claire ; Pellom, Samuel T

Background:

While prophylactic human papillomavirus (HPV) vaccines will certainly reduce the incidence of HPV-associated cancers, these malignancies remain a major health issue. PDS0101 is a liposomal-based HPV therapeutic vaccine consisting of the immune activating cationic lipid R-DOTAP and HLA-unrestricted HPV16 peptides that has shown in vivo CD8+ T cell induction and safety in a phase I study. In this report, we have employed the PDS0101 vaccine with two immune modulators previously characterized in preclinical studies and which are currently in phase II clinical trials. Bintrafusp alfa (M7824) is a first-in-class bifunctional fusion protein composed of the extracellular domains of the transforming growth factor-β receptor type II (TGFβRII) fused to a human IgG1monoclonal antibody blocking programmed cell death protein-1 ligand (PDL1), designed both as a checkpoint inhibitor and to bring the TGFβRII ‘trap’ to the tumor microenvironment (TME). NHS-interleukin-12 (NHS-IL12) is a tumor targeting immunocytokine designed to bring IL-12 to the TME and thus enhance the inflammatory Th1 response.

Methods:

We employed TC-1 carcinoma (expressing HPV16 E6 and E7 and devoid of PDL1 expression) in a syngeneic mouse model in monotherapy and combination therapy studies to analyze antitumor effects and changes in immune cell types in the spleen and the TME.

Results:

As a monotherapy, the PDS0101 vaccine generated HPV-specific T cells and antitumor activity in mice bearing HPV-expressing mEER oropharyngeal and TC-1 lung carcinomas. When used as a monotherapy in the TC-1 model, NHS-IL12 elicited antitumor effects as well as an increase in CD8+ T cells in the TME. When used as a monotherapy, bintrafusp alfa did not elicit antitumor effects or any increase in T cells in the TME. When all three agents were used in combination, maximum antitumor effects were observed, which correlated with increases in T cells and T-cell clonality in the TME.

Conclusion:

These studies provide the rationale for the potential clinical use of combinations of agents that can (1) induce tumor-associated T-cell responses, (2) potentiate immune responses in the TME and (3) reduce immunosuppressive entities in the TME.

15 Jun 2019·Journal of immunology (Baltimore, Md. : 1950)Q2 · MEDICINE

Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response

Q2 · MEDICINE

Article

Author: Woodward, Jerold G. ; Bush, John Peyton C. ; Gandhapudi, Siva K. ; Ward, Martin ; Conn, Greg ; Bedu-Addo, Frank

Abstract:

Certain types of cationic lipids have shown promise in cancer immunotherapy, but their mechanism of action is poorly understood. In this study, we describe the properties of an immunotherapeutic consisting of the pure cationic lipid enantiomer R-1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP) formulated with modified viral or self-peptide Ags. R-DOTAP formulations with peptide Ags stimulate strong cross-presentation and potent CD8 T cell responses associated with a high frequency of polyfunctional CD8 T cells. In a human papillomavirus tumor model system, a single s.c. injection of tumor-bearing mice with R-DOTAP plus human papillomavirus Ags induces complete regression of large tumors associated with an influx of Ag-specific CD8 T cells and a reduction of the ratio of regulatory/Ag-specific CD8 T cells. R-DOTAP also synergizes with an anti-PD1 checkpoint inhibitor, resulting in a significant inhibition of B16 melanoma tumor growth. We found that R-DOTAP stimulates type I IFN production by dendritic cells in vivo and in vitro. s.c. injection of R-DOTAP results in an IFN-dependent increase in draining lymph node size and a concomitant increase in CD69 expression. Using knockout mice, we show that type I IFN is required for the induction of CD8 T cell activity following administration of R-DOTAP plus Ag. This response requires Myd88 but not TRIF or STING. We also show that R-DOTAP stimulates both TLR7 and 9. Collectively, these studies reveal that R-DOTAP stimulates endosomal TLRs, resulting in a Myd88-dependent production of type I IFN. When administered with Ag, this results in potent Ag-specific CD8 T cell responses and antitumor activity.

133

News (Medical) associated with Pexipepimut-S

22 Oct 2024

·www.globenewswire.com

PDS Biotech Announces Presentation of Rationale and Design of First Recurrent Prostate Cancer Trial to Combine an Androgen Receptor Pathway Inhibitor with an Immunocytokine

Study to evaluate PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone to be presented by Dr. Ravi Madan, National Cancer Institute at Cytokines 2024PRINCETON, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the rationale and trial design for a study evaluating PDS01ADC for the treatment of recurrent prostate cancer will be discussed during an oral presentation at the 12th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2024) in Seoul, South Korea. Details of the presentation are as follows: Date: Wednesday, October 23, 2024Session time: 08:30-10:10 Korean Standard Time (KST)Session title: Symposium 20 - Cytokine-mediated Translational Approaches of Human DiseasesPresentation time: 09:20-09:32 KSTPresentation title: A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide without Testosterone Lowering Therapy in Biochemically Recurrent Prostate CancerPresenter: Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis communication contains 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 among others. 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 PDS01ADC, Versamune® HPV (formerly 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 PDS01ADC, Versamune® HPV, 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 the Company’s 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; 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; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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.   Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Xtandi® is a registered trademark of Astellas Pharma, Inc. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com

ImmunotherapyClinical Study

02 Oct 2024

·www.globenewswire.com

PDS Biotech Announces 36-Month Overall Survival Rate of 84.4% in Locally Advanced Cervical Cancer Patients Treated with Versamune® HPV and Chemoradiation

100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune® HPV combined with chemoradiation (N=8)88% (15/17) of patients had a complete metabolic responseIMMUNOCERV Phase 2 clinical trial results presented at ASTRO Annual Meeting 2024 PRINCETON, N.J., Oct. 02, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV (formerly PDS0101) with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024 in an oral presentation by Adam Grippin, M.D., Ph.D., of The University of Texas MD Anderson Cancer Center. The abstract was granted Basic/Translational Science Award from the ASTRO Annual Meeting Steering Committee. “HPV is responsible for virtually all cervical cancers and presents an opportunity for immunologic targeting1. However, there are currently no FDA-approved HPV-targeted immunotherapies to treat cervical cancer,” said Ann Klopp, M.D., Ph.D., Professor of Radiation Oncology and Head of the Gynecologic Section at MD Anderson. “These data suggest that further investigation is warranted into the safety and efficacy of Versamune® HPV in combination with standard of care in the treatment of locally advanced cervical cancer.” The IMMUNOCERV Phase 2 clinical trial (NCT04580771) evaluated the efficacy, safety and tolerability of Versamune® HPV in combination with standard-of-care chemoradiotherapy for the treatment of locally advanced cervical cancer. The investigator-initiated study enrolled 17 newly diagnosed high-risk patients with large tumors of at least 5 cm in size. Highlights from the presentation include: All patients received at least 2 doses of Versamune® HPV.Median follow-up was 19 months.36-month overall survival (OS) rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month OS rate with chemoradiation in this population of approximately 64%.236-month progression free survival (PFS) rate was 74.9%, among all patients and 100% for the eight patients who received all five doses of Versamune® HPV. Historical published data show 36-month PFS rate with chemoradiation in this population of approximately 61%.2Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.Versamune® HPV appeared to be safe and well-tolerated. The most common treatment-related toxicities were injection site reactions in twelve patients (71%). “We are pleased that data from the Phase 2 IMMUNOCERV trial demonstrate compelling clinical activity and a promising safety profile,” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. “Based on our continued research in various HPV-positive cancers, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with minimal toxicity. We look forward to the next steps in the development of Versamune® HPV for locally advanced cervical cancer.” National Cancer Institute, Cervical Cancer Causes, Risk Factors and Prevention. https://www.cancer.gov/types/cervical/causes-risk-preventionRose PG, et al. Concurrent Cisplatin-Based Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer. N Engl J Med. 1999;340:1144-53. About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis communication contains 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 among others. 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 PDS01ADC, Versamune® HPV (formerly 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 PDS01ADC, Versamune® HPV, 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 the Company’s 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; 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; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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. Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Janine McCargo6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com

Clinical ResultPhase 2ImmunotherapyASCO

16 Sep 2024

·www.globenewswire.com

PDS Biotech Announces Updated Results from VERSATILE-002 Phase 2 Clinical Trial Presented at ESMO 2024

Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77% 11/53 (21%) of patients experienced 90-100% tumor shrinkage VERSATILE-003 Phase 3 clinical trial planned to begin this year PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced updated data from the VERSATILE-002 trial evaluating Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune® HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following: Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months1,2Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%1,2Disease Control Rate (DCR) is 77% (41/53)21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%9% (5/53) of patients had a complete responseTreatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1) “The updated response data we presented at ESMO show the strong clinical activity and durability of Versamune® HPV plus pembrolizumab,” said Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. “Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC.” A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune® HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year. “We’re encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune® HPV induced anti-tumor immune response,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year.” Versamune® HPV has been granted Fast Track designation by the FDA. Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI https://doi-org.libproxy1.nus.edu.sg/10.1200/JCO.21.02508Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01 No head-to-head studies have been performed comparing Versamune® HPV with other treatments About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. For more information, please visit www.pdsbiotech.com. Forward Looking StatementsThis communication contains 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 among others. 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 PDS01ADC, Versamune® HPV (formerly 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 PDS01ADC, Versamune® HPV, 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 the Company’s 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; 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; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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.   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, N.J., USA. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Gina Mangiaracina6 DegreesPhone +1 (917) 797-7904Email: gmangiaracina@6degreespr.com

ImmunotherapyClinical ResultPhase 2Fast TrackPhase 3

100 Deals associated with Pexipepimut-S

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Penile Neoplasms	Phase 2	US	National Cancer Institute	19 Oct 2021
Vaginal Neoplasms	Phase 2	US	National Cancer Institute	17 Oct 2021
Anus Neoplasms	Phase 2	US	National Cancer Institute	13 Oct 2021
Rectal Cancer	Phase 2	US	National Cancer Institute	05 Oct 2021
Head and neck cancer metastatic	Phase 2	US	PDS Biotechnology Corp.	29 Mar 2021
Head and neck cancer metastatic	Phase 2	IE	PDS Biotechnology Corp.	29 Mar 2021
Head and neck cancer metastatic	Phase 2	PR	PDS Biotechnology Corp.	29 Mar 2021
Head and neck cancer metastatic	Phase 2	GB	PDS Biotechnology Corp.	29 Mar 2021
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	US	PDS Biotechnology Corp.	29 Mar 2021
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	IE	PDS Biotechnology Corp.	29 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04580771 (IMMUNOCERV, GlobeNewswire) Manual	Phase 2	Locally Advanced Cervical Carcinoma HPV16-positive	17	Versamune® HPV + Chemoradiation (at least 2 doses)	wmpudozzhc(fgicrizxll) = usrrajquzp sakkqzombl (lufaknfujc ) View more	Positive	02 Oct 2024
				Versamune® HPV + Chemoradiation (five doses)	wmpudozzhc(fgicrizxll) = urhjaxkkol sakkqzombl (lufaknfujc ) View more
NCT04260126 (VERSATILE-002, ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	-	PDS0101 + pembrolizumab	krgikvmdbg(zdmlrynrrk) = irqquzqhqk xknaycwpcp (qybhvavnyb, 18.4 - NE) View more	Positive	14 Sep 2024
NCT04260126 (VERSATILE-002, GlobeNewswire) Manual	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	53	Versamune® HPV + KEYTRUDA® (pembrolizumab) (CPS ≥1)	seknhsskyv(cztvsiawid) = ittaajttgh zaimaluqos (vujmnyzvhj ) Met View more	Positive	09 May 2024
				Versamune® HPV + KEYTRUDA® (pembrolizumab) (CPS≥20)	seknhsskyv(cztvsiawid) = bpxajibqol zaimaluqos (vujmnyzvhj ) Met View more
NCI-Led (GlobeNewswire) Manual	Phase 2	Human Papillomavirus-16 Positive	-	PDS0101+PDS0301+Bintrafusp-alfa (ICI naïve group)	dcnxczuwvb(zuhrjqdtlz) = dauxgntwab flmghvleqq (dgqjbumbfo ) View more	Positive	09 Nov 2023
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	chrdftuyqg(yhfuurmstu) = yrjiwskxpl hgnemhxwwq (qbyklybigt ) View more
NCT04260126 (VERSATILE-002 , Corporate Publications) Manual	Phase 2	Head and Neck Neoplasms	-	PDS0101+pembrolizumab (ICI naïve pts)	ujgrnvcjds(lrgmbkgwye) = xcpveukydw nowtihnipi (cucgabpcfm ) View more	Positive	03 Oct 2023
				PDS0101+pembrolizumab (ICI Refractory pts)	ujgrnvcjds(lrgmbkgwye) = gnlxigavsf nowtihnipi (cucgabpcfm ) View more
NCT04260126 (VERSATILE002, ASCO2023) Manual	Phase 2	Human Papillomavirus-Related Squamous Cell Carcinoma of Head and Neck HPV16 Positive	48	PDS0101+pembrolizumab	rtbnvuuaok(qiefgjjgyh) = ytxbfionbn srysqbmkwr (gimbixlxao ) View more	Positive	31 May 2023
NCT04580771 (IMMUNOCERV, GlobeNewswire) Manual	Phase 2	Uterine Cervical Cancer	9	chemoradiotherapy+PDS-0101	qfbdbynbxh(dkgahxabuk) = low-grade local injection site reactions vstaayxogb (engtjlhqmn )	Positive	14 Nov 2022
NCT04580771 (IMMUNOCERV, SITC2022)	Phase 2	Locally Advanced Cervical Carcinoma HPV16	17	PDS0101	eyzgjkawzr(pzwrsnujji) = tdztzfcsuq nsooclbifo (bupfovptkc ) View more	Positive	07 Nov 2022
NCT04287868 (Biospace) Manual	Phase 2	Neoplasms HPV Positive	37	NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI refractory)	rqjifegyiy(zazwvowkzb) = szabagpvko xtjfjbupqn (jumwsxuspn )	Positive	11 Oct 2022
				NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI naïve)	jmdnsojihe(sxublatqcq) = koowynsqdy hosblxekqd (qvfhcfxunl ) View more
NCT04260126 (VERSATILE-002, ASCO2022) Manual	Phase 2	Human Papillomavirus-Related Squamous Cell Carcinoma of Head and Neck HPV Positive	18	PDS 0101+Pembrolizumab	hdypbjqdti(izrfujvkho) = lqstxivrrd jiphaqbuyo (dzwwkdsgqk ) View more	Positive	02 Jun 2022

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