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Last update 16 May 2025

Pexipepimut-S

Last update 16 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Shared antigen vaccine, Liposomal Drug

Synonyms

Liposomal HPV-16 E6/E7 Multipeptide Vaccine, mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7(PDS Biotechnology)

+ [10]

Target

HPV E6 x HPV E7

Action

inhibitors

Mechanism

E7 inhibitors(HPV E7 inhibitors), HPV E6 inhibitors(HPV E6 inhibitors)

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [4]

Active Indication

Head and neck cancer metastaticHPV positive oropharyngeal squamous cell carcinomaRecurrent Head and Neck Carcinoma+ [9]

Inactive Indication

Uterine Cervical Dysplasia

Originator Organization

PDS Biotechnology Corp.

Active Organization

National Cancer Institute

PDS Biotechnology Corp.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationFast Track (United States)

Structure/Sequence

Sequence Code 11611

Source: *****

Sequence Code 11634

Source: *****

Sequence Code 1031376292

Source: *****

Sequence Code 1031377996

Source: *****

Sequence Code 1031378456

Source: *****

Clinical Trials associated with Pexipepimut-S

NCT06790966

/ RecruitingPhase 3

A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.

Start Date01 Apr 2025

Sponsor / Collaborator

PDS Biotechnology Corp.

NCT05232851

/ RecruitingPhase 1/2IIT

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

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 Apr 2025·JAMA Oncology

Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers

Article

Author: Strauss, Julius ; Manu, Michell ; Kackley, Mary ; Floudas, Charalampos S. ; Steinberg, Seth M. ; Francis, Deneise C. ; Pastor, Danielle M. ; Krauss, Elizabeth ; Redman, Jason M. ; Marté, Jennifer L. ; Manukyan, Manuk ; Cordes, Lisa M. ; Donahue, Renee N. ; Goswami, Meghali ; Schlom, Jeffrey ; Turkbey, Evrim B. ; Lamping, Elizabeth ; Brownell, Isaac ; Gulley, James L. ; Jochems, Caroline

IMPORTANCE:

Patients who experience progression of advanced human papillomavirus (HPV)–associated cancers and who have previously received first-line systemic treatment have a poor prognosis and limited therapeutic options.

OBJECTIVE:

To assess the clinical activity of the combination of the HPV type 16 therapeutic vaccine PDS0101, the tumor-targeting interleukin 12 antibody-drug conjugate PDS01ADC, and the bifunctional anti–programmed cell death ligand 1 (PD-L1)/transforming growth factor β (TGF-β) bintrafusp alfa in advanced HPV-associated cancers.

DESIGN, Setting, and Participants:

This nonrandomized clinical trial was phase 1/2 and investigator initiated, and was conducted at a single US cancer research center between June 2020 and July 2022. Patients with advanced or metastatic HPV-associated cancers were eligible, including patients who were both immune checkpoint blockade (ICB) naive and ICB resistant. The cutoff date for data analysis was May 13, 2024.

INTERVENTION:

Patients received 1 mL of PDS0101 subcutaneously every 4 weeks for 6 doses then every 12 weeks for 2 additional doses, PDS01ADC, 16.8 µg/kg, subcutaneously every 4 weeks or PDS01ADC, 8 µg/kg, subcutaneously every 2 weeks, and bintrafusp alfa, 1200 mg, intravenously every 2 weeks.

MAIN OUTCOMES AND MEASURES:

Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 in ICB-naive patients.

RESULTS:

Of the 50 eligible patients, 26 (52%) were men and the median age was 56 years (range, 28-80 years). The median (IQR) follow-up was 37.7 (30.6-42.0) months. Fourteen patients (28%) were ICB naive, with an ORR of 35.7% (95% CI, 12.8%-64.9%), and median overall survival (OS) 42.4 months (95% CI, 8.3 months-not estimable); in ICB-resistant patients, the ORR was 16.7% (6 of 36 patients; 95% CI, 6.4%-32.8%) and median OS was 15.8 months (95% CI, 9.0-21.3 months). Among patients with HPV-16–positive tumors (37 patients [74%]), in the ICB-naive group (8 patients [21.6%]) the ORR was 62.5% (95% CI, 24.5%-91.5%) and a median OS measure was not reached. Grade 3 and 4 treatment-related adverse events occurred in 26 of 50 patients (52%). There were no treatment-related deaths.

CONCLUSIONS AND RELEVANCE:

In this trial, the combination of PDS0101, PDS01ADC, and bintrafusp alfa showed an acceptable safety profile and promising antitumor activity and improved OS in patients with HPV-16–positive cancers, in both ICB-naive and ICB-resistant patients, warranting further evaluation of the combination of PDS0101 and PDS01ADC with simultaneous PD-L1/TGF-β inhibition in these populations.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04287868

17 Feb 2025·CLINICAL CANCER RESEARCH

Human Papilloma Virus Circulating Cell-Free DNA Kinetics in Patients with Cervical Cancer Undergoing Definitive Chemoradiation

Article

Author: Jacobsen, Megan C. ; Colbert, Lauren E. ; Venkatesan, Aradhana M. ; Sammouri, Julie ; Wei, Peng ; Gillison, Maura L. ; Seo, Aaron ; Swanson, David ; Napravnik, Tatiana Cisneros ; Lin, Lilie L. ; Yoshida-Court, Kyoko ; Gjyshi, Olsi ; Jhingran, Anuja ; Fuentes, David T. ; Grippin, Adam ; Joyner, Melissa ; Xiao, Weihong ; Lynn, Erica ; Klopp, Ann H.

Abstract:

Purpose::

Human papillomavirus (HPV) is a significant cause of cervical cancer. We hypothesized that detecting viral cell-free HPV DNA (cfDNA) before, during, and after chemoradiation (chemoRT) could provide insights into disease extent, clinical staging, and treatment response.

Experimental Design::

A total of 66 patients with locally advanced cervical cancer were enrolled between 2017 and 2023, with 49 receiving standard-of-care treatment and 17 participating in a clinical trial combining a therapeutic HPV vaccine (PDS0101; IMMUNOCERV). Plasma was collected at baseline, weeks 1, 3, and 5 of chemoRT, and 3 to 4 months after chemoRT. HPV cfDNA was quantified using droplet digital PCR targeting the HPV E6/E7 oncogenes of 13 high-risk types. MRI was performed at baseline and before brachytherapy.

Results::

The median follow-up was 23 months, with recurrence-free survival (RFS) of 78.4% at 2 years. Baseline nodal disease extent correlated with HPV cfDNA levels. HPV cfDNA levels peaked in week 1 of radiation and decreased through treatment. Patients receiving the PDS0101 vaccine had a higher rate of undetectable HPV type 16 cfDNA compared with those who received standard-of-care therapy. HPV cfDNA clearance correlated with better 2-year RFS (92.9% vs. 30%, log-rank; P = 0.0067). The strongest predictor of RFS was HPV cfDNA clearance in follow-up achieving a concordance index score of 0.83, which improved when combined with MRI response (concordance index, 0.88).

Conclusions::

HPV cfDNA levels change dynamically during chemoRT. HPV cfDNA levels at follow-up predict RFS, and delivery of therapeutic HPV vaccine with chemoRT was linked to rapid HPV cfDNA decline. Monitoring HPV cfDNA during and after chemoRT may guide tailoring of personalized treatment.

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.

150

News (Medical) associated with Pexipepimut-S

14 May 2025

·www.globenewswire.com

PDS Biotech Reports First Quarter 2025 Financial Results and Provides Clinical Programs and Corporate Update

VERSATILE-003 Phase 3 Site Initiations Underway Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 (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, today provided a clinical and corporate update and reported financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 and recent weeks have been productive for PDS Biotech, highlighted by the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in recurrent/metastatic (“R/M”) HPV16-positive head and neck squamous carcinoma (“HNSCC”),” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. “We are pleased to announce that site activation is progressing, and that Mayo Clinic sites have recently been added to the trial. HPV16-positive HNSCC represents a large, rapidly growing patient population in need of targeted therapies to treat the underlying cause of the cancer, and our Versamune® HPV investigational therapy is currently the only targeted therapy in a Phase 3 trial specifically for HPV-16 positive tumors.” Clinical and Corporate Update On April 23, 2025, the Company announced that three abstracts on Versamune® HPV (PDS0101) were selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 30-June 3, 2025, in Chicago, IL.On May 8, 2025, the Company announced that preclinical efficacy and immune response data with a novel investigational Infectimune® based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium at the American Association of Immunologists’ IMMUNOLOGY2025™ Annual Meeting, held May 3-7, 2025, in Honolulu, Hawaii.On March 13, 2025, the Company announced U.S. Food and Drug Administration (“FDA”) clearance of an Investigational New Drug (“IND”) application for the combination of Versamune® MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma in patients who failed previous treatment. The National Cancer Institute (“NCI”), under its Cooperative Research and Development Agreement (“CRADA”), will lead the Phase 1/2 clinical trial evaluating the combination of Versamune® MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.On March 7, 2025, the Company announced the initiation of its VERSATILE-003 Phase 3 trial in HPV16-positive first-line recurrent and/or metastatic HNSCC. Trial is designed to include approximately 350 patientsPDS Biotech is aligned with the FDA on the design of the registrational trial and clinical endpoints. Two-arm controlled trial with 2:1 randomizationMedian overall survival is the primary endpointInterim readouts included in the study design The Company received FDA Fast Track designation for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC.For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966). On February 27, 2025, the Company announced that it had entered into securities purchase agreements with new and existing healthcare-focused institutional investors, as well as participation from certain directors of the Company, for the purchase and sale of 7,330,121 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,330,121 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules at a combined purchase price of $1.50 for the institutional investors and $1.66 for certain directors of the Company. Approximately $11 million was funded upon the closing of the offering, and up to an additional $11 million may be funded upon full cash exercise of the warrants. First Quarter 2025 Financial Results Reported net loss was approximately $8.5 million, or $0.21 per basic and diluted share, for the three months ended March 31, 2025, compared to $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024. The decrease was due to increased benefit from income taxes and lower operating expenses. Research and development expenses were $5.8 million for the three months ended March 31, 2025, compared to $6.7 million for the three months ended March 31, 2024. The decrease was primarily due to lower clinical trial expenses. General and administrative expenses were $3.3 million for the quarter ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2024. Total operating expenses were $9.1 million for the quarter ended March 31, 2025, compared to approximately $10.1 million for the three months ended March 31, 2024. Net interest expenses were $0.6 million compared to approximately $0.5 million for the three months ended March 31, 2024. The Company’s cash balance as of March 31, 2025 was $40 million, compared to $41.7 million as of December 31, 2024. Conference Call Details Date: May 14, 2025Time: 8:00 a.m. Eastern TimeDial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)Webcast Registration: Click HereCall Me™ Registration: Click Here (Available 15 minutes prior to call) About PDS BiotechnologyPDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial 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 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 conduct clinical trials for Versamune® HPV, PDS01ADC, Versamune® MUC1 and other Versamune® 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 Versamune® HPV, PDS01ADC, Versamune® MUC1 and other Versamune® 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 ---financial tables to follow--- PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYCondensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development expenses $5,830,999 $6,704,164 General and administrative expenses 3,274,759 3,393,463 Total operating expenses $9,105,758 $10,097,627 Loss from operations $(9,105,758) $(10,097,627) Interest income (expense) Interest income $377,849 $668,895 Interest expense (930,878) (1,174,745)Interest income (expense), net $(553,029) $(505,850) Loss before income taxes $(9,658,787) $(10,603,477)Benefit for income taxes 1,169,820 - Net loss and comprehensive loss $(8,488,967) $(10,603,477) Per share information: Net loss per share, basic and diluted $(0.21) $(0.30)Weighted average common shares outstanding basic and diluted 40,521,001 34,815,870 PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYSelected Balance Sheet Data(Unaudited) March 31, December 31, 2025 2024 Cash and cash equivalents $39,978,674 $41,689,591 Working capital $28,474,112 $27,967,242 Total assets $47,028,542 $45,358,657 Long term debt $6,352,333 $9,204,755 Accumulated deficit $(190,599,966) $(182,110,999)Total stockholders’ equity $22,362,209 $19,004,848

Phase 3ImmunotherapyASCOFinancial StatementFast Track

23 Apr 2025

·www.globenewswire.com

PDS Biotech Announces Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

PRINCETON, N.J., April 23, 2025 (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, today announced that three abstracts on Versamune® HPV (PDS0101) have been accepted for presentation at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 30-June 3, 2025, in Chicago, Illinois. Details of the presentation are as follows: Title: VERSATILE-003: A Phase 3, Randomized, Open-label Trial of PDS0101 and Pembrolizumab compared with Pembrolizumab for First-Line Treatment of Patients with HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaAbstract Number for Publication: TPS6111Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDTSession Type and Title: Poster Session – Head and Neck CancerPoster Board Number: 518aPresenter: Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center, and Principal Investigator of the VERSATILE-003 clinical trial Title: VERSATILE-002: Overall Survival of HPV16 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and PembrolizumabAbstract Number for Publication: 6037Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDTSession Type and Title: Poster Session – Head and Neck CancerPoster Board Number: 445Presenter: Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial Title: Initial results of MC200710 investigating therapeutic vaccine (PDS0101) alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV associated oropharyngeal carcinoma, a Phase 2 window of opportunity trial.Abstract Number for Publication: 6061Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDTSession Type and Title: Poster Session – Head and Neck CancerPoster Board Number: 469Presenter: David M. Routman, M.D., Department of Radiation Oncology, Mayo Clinic About PDS Biotechnology PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial 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 Versamune® HPV, PDS01ADC and other Versamune® 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 Versamune® HPV, PDS01ADC and other Versamune® 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® is a registered trademark 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

Phase 2ImmunotherapyASCOClinical ResultPhase 3

16 Apr 2025

·www.globenewswire.com

PDS Biotech Announces Preclinical Influenza Data to be Presented in Symposium at IMMUNOLOGY2025™ Annual Meeting

Update on American Association for Cancer Research Annual Meeting 2025 presentationPRINCETON, N.J., April 16, 2025 (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, today announced that preclinical immune response data with a novel Infectimune® based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association of Immunologists’ IMMUNOLOGY2025™ Annual Meeting, taking place May 3-7, 2025, in Honolulu, Hawaii. Details of the presentation are as follows: Title: Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza VaccinesSession Type: Guest Symposium Session Title: International Society of Influenza and Other Respiratory Viruses (ISIRIV) SymposiumDate, Time and Location: Sunday, May 4, 2025, 8:30–10:30 a.m. HST. Room 314 Presenter: Andrea Sant, Ph.D., Professor of Microbiology and Immunology at the University of Rochester Medical Center Separately, PDS Biotech announced that, due to new U.S. National Institutes of Health policies regarding employee attendance at scientific conferences and meetings, the abstract “Alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapy,” submitted by the National Cancer Institute, will no longer be part of Poster Sessions at the American Association for Cancer Research Annual Meeting 2025. About PDS BiotechnologyPDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial 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 Versamune® HPV, PDS01ADC and other Versamune® 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 Versamune® HPV, PDS01ADC and other Versamune® 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.   Infectimune® and Versamune® 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

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Indication	Highest Phase	Country/Location	Organization	Date
Head and neck cancer metastatic	Phase 3	United States	PDS Biotechnology Corp.	01 Apr 2025
HPV positive oropharyngeal squamous cell carcinoma	Phase 3	United States	PDS Biotechnology Corp.	01 Apr 2025
Recurrent Head and Neck Carcinoma	Phase 3	United States	PDS Biotechnology Corp.	01 Apr 2025
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	PDS Biotechnology Corp.	01 Apr 2025
HPV16 Infection	Phase 2	United States	PDS Biotechnology Corp.	29 Mar 2021
HPV16 Infection	Phase 2	Ireland	PDS Biotechnology Corp.	29 Mar 2021
HPV16 Infection	Phase 2	Puerto Rico	PDS Biotechnology Corp.	29 Mar 2021
HPV16 Infection	Phase 2	United Kingdom	PDS Biotechnology Corp.	29 Mar 2021
Anus Neoplasms	Phase 2	United States	National Cancer Institute	09 Jun 2020
Human Papillomavirus Infection	Phase 2	United States	National Cancer Institute	09 Jun 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04287868 (Company_Website \| Pubmed) Manual	Phase 1/2	HPV-related carcinoma HPV16-positive	50	PDS0101 + PDS01ADC + bintrafusp alfa (BA) (ICB naïve patients)	gaozxzwhjs(krwcknqvgs) = zrfkwbmkqf jnqubillim (qjeolqpjne, 8.3 - NE) View more	Positive	26 Feb 2025
				PDS0101 + PDS01ADC + bintrafusp alfa (BA) (ICB naïve patients + HPV16-positive)	gaozxzwhjs(krwcknqvgs) = manilyhhcr jnqubillim (qjeolqpjne, 9.0 - 21.3) View more
NCT04580771 (IMMUNOCERV, GlobeNewswire) Manual	Phase 2	Locally Advanced Cervical Carcinoma HPV16-positive	17	Versamune® HPV + Chemoradiation (at least 2 doses)	xdmdhxchly(ecaymfnddj) = oyxlfwgoac usrtdyeyhp (momcumtbct ) View more	Positive	02 Oct 2024
				Versamune® HPV + Chemoradiation (five doses)	xdmdhxchly(ecaymfnddj) = ixlmobrygf usrtdyeyhp (momcumtbct ) View more
NCT04287868 (GlobeNewswire) Manual	Phase 2	Human Papillomavirus-16 Positive	-	PDS0101+PDS0301+Bintrafusp-alfa (ICI naïve group)	xreskhpbao(qswwnxnzqh) = vonuptdprk qbxdeadtou (wockytktdy ) View more	Positive	09 Nov 2023
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	xreskhpbao(uwoqgxazqb) = dkbgatwtpv hvjaxgwhpz (oasdqyuius ) View more
NCT04580771 (IMMUNOCERV, GlobeNewswire) Manual	Phase 2	Uterine Cervical Cancer	9	chemoradiotherapy+PDS-0101	nibecwpsgx(spatvkynmu) = low-grade local injection site reactions czrbranaji (ivsuarwxyw )	Positive	14 Nov 2022
NCT04580771 (IMMUNOCERV, SITC2022)	Phase 2	Locally Advanced Cervical Carcinoma HPV16	17	PDS0101	hqictsypee(jjktcgbxir) = mwnzhblozm rgsggojdme (hwykjcwbfp ) View more	Positive	07 Nov 2022
NCT04287868 (Biospace) Manual	Phase 2	Neoplasms HPV Positive	37	NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI refractory)	aatiovlgdi(xyowpzuaba) = xgcnxalkov fslslyvaey (kcsnmgdcdk )	Positive	11 Oct 2022
				NHS-IL-12+bintrafusp alfa+PDS 0101 (CPI naïve)	znwacgorey(xsslarxmkx) = apgfsckjnh wbxcxjomcx (nizirlpokc ) View more
NCT04287868 (ASCO2022) Manual	Phase 2	HPV-related carcinoma HPV Positive	30	M9241+bintrafusp alfa+PDS0101 (with checkpoint naïve disease)	svzxghgcnf(dtwgarrqhf) = gcgbarsemd xikyjjegbt (ygdahozuvr ) View more	Positive	02 Jun 2022
				M9241+bintrafusp alfa+PDS0101 (with checkpoint refractory disease)	svzxghgcnf(dtwgarrqhf) = aaesloaamh xikyjjegbt (ygdahozuvr ) View more
NCT04287868 (ASCO 12021 \| ASCO 22021) Manual	Phase 2	HPV-related carcinoma HPV Positive	14	M9241+bintrafusp alfa+PDS0101	jybidkugtm(ndtwsaysqd) = foblcxcbla wmaloekqnl (fvjbiilvij )	Positive	20 May 2021
				M9241+bintrafusp alfa+PDS0101 (checkpoint naïve disease)	jybidkugtm(ndtwsaysqd) = rcryameenu wmaloekqnl (fvjbiilvij )

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