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Last update 01 Oct 2025

Pexipepimut-S

Last update 01 Oct 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+ [10]

Inactive Indication

Cervical Intraepithelial Neoplasia

Originator Organization

PDS Biotechnology Corp.

Active Organization

PDS Biotechnology Corp.

National Cancer Institute

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

NCT07090174

/ Not yet recruitingPhase 2IIT

A Single-Arm, Open-Label Clinical Phase II Trial of the Safety and Immunogenicity of PDS0101 in People Living With HIV

This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enroll 27 adults between the ages of 25 and 65 who have been receiving antiretroviral therapy (ART) for at least 12 months, have a cluster of differentiation 4 (CD4) cell count of at least 200 cells/mm³, and have an HIV viral load below 200 copies/mL. All participants must have HPV 16 detected in the cervix, vagina, or anus. Some participants will have high-grade squamous intraepithelial lesions (HSIL), a condition that can lead to cancer. At least 10 participants will have cervical HSIL, and at least 10 will have anal HSIL. Participants with both cervical and anal HSIL will count in both groups. Others may have HPV 16 without HSIL.
This is a single-arm, open-label trial, which means that all participants will receive the same treatment, and both the investigators and the participants will know what the treatment is. Each participant will receive three doses of the PDS0101 vaccine. Participants who receive at least one dose will be included in the study's main safety analysis. If a participant does not receive all three doses and does not experience a serious side effect related to the vaccine (defined as a Grade 3 or higher toxicity), that participant may be replaced to make sure that 27 participants either complete the full vaccination schedule or experience a primary safety event. Participants who do have a qualifying safety event will not be replaced. Even if someone stops the study early, their data will still be included in the final analysis.
The main goals of this study are to evaluate the safety of PDS0101 and to measure the immune response it produces. The safety evaluation includes monitoring for serious or unexpected side effects, especially those that are Grade 3 or higher in severity. The immune response will be assessed by looking at how the body's T cells respond to HPV 16 after PDS0101 administration. The total time a participant is involved in the study includes the PDS0101 administration period and several follow-up visits, which may take place over the course of several months. This research may help inform future strategies for preventing or treating HPV-related disease in people living with HIV.

Start Date20 Oct 2025

Sponsor / Collaborator

Weill Medical College of Cornell University

[+8]

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 Date30 May 2025

Sponsor / Collaborator

PDS Biotechnology Corp.

NCT05232851

/ Active, not 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

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 ; Floudas, Charalampos S. ; Steinberg, Seth M. ; Kackley, Mary ; Francis, Deneise C. ; Pastor, Danielle M. ; Krauss, Elizabeth ; Manukyan, Manuk ; Redman, Jason M. ; Marté, Jennifer L. ; 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.

03 Oct 2015·Expert review of anticancer therapyQ3 · MEDICINE

Cancer therapy using nanoformulated substances: scientific, regulatory and financial aspects

Q3 · MEDICINE

Review

Author: Mandawala, Chalani ; Durand-Dubief, Mickael ; Lefèvre, Raphael ; Grand-Dewyse, Pierre ; Alphandéry, Edouard

Several nanoformulated anti-cancer substances are currently commercialized or under development. Pre-clinical and clinical results have revealed better properties, that is, larger efficacy and lower toxicity for these substances than for conventional anti-cancer treatments. Here, we review the development of several of these substances such as Marqibo, Myocet, Doxil, DaunoXome, MM398, MM302, Mepact, Versamune, Thermodox, Depocyt, Livatag, Abraxane, Eligard, Opaxio, Zinostatin Stimalamer (SMANCS), Pegasys and PegIntron, BIND-014, CRLX-101, Oncaspar, Neulasta, Aurimmune, Auroshell, AuNPs, Nanotherm, NanoXray, Magnetosome chains, Kadcyla (T-DM1), Ontak (DAB/IL2), Gendicine and Curcumin. We describe their specific properties, such as their stability, solubility, mean of administration or targeting, distribution, metabolism and toxicity. We discuss their categorization as medical devices or drugs, their fabrication process within a regulatory environment as well as intellectual property and financial aspects that are all essential to enable their industrial development.

158

News (Medical) associated with Pexipepimut-S

18 Sep 2025

·www.globenewswire.com

PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population

First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19* Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients PRINCETON, N.J., Sept. 18, 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 details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial. The VERSATILE-002 trial evaluated PDS0101 (Versamune® HPV) + Keytruda® in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”). “This is great news for these patients who may now have the possibility of a well-tolerated treatment without chemotherapy” stated Prof. Kevin Harrington, M.D., Head of the Division of Radiotherapy, The Institute of Cancer Research, London. “Patients with low levels of PD-L1 expression have typically shown poor response to immune checkpoint inhibitor therapy, leaving HNSCC patients in this sub-type with few viable treatment options and a poor prognosis,” said Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “This sub-analysis of survival data from the CPS 1-19 patient cohort appears to show that the multifunctional T cell immune response of PDS0101 treatment may overcome the documented limitations of immune checkpoint inhibitor therapy and significantly improve survival in one of the most difficult-to-treat patient populations. This is a very encouraging finding, pointing to the potential of PDS0101 to improve treatment outcomes in a patient group that has historically derived limited benefit from current standards of care.” Approximately 60% of the patients enrolled (n=53) in the VERSATILE-002 trial had low PD-L1 expression, a difficult to treat subset of the overall HNSCC patient population. The sub-analysis of this patient cohort shows: Median overall survival (mOS) for patients within the CPS 1-19 cohort (n=32) was 29.5 months.Published mOS in this CPS cohort was 10.8 months with Keytruda® monotherapy and 12.3 months with Keytruda® plus chemotherapy* The Company announced mOS results for the full study population of 39.3 months from the VERSATILE-002 trial on August 25, 2025, and the full data set for the trial is expected to be published later this year. *No head-to-head studies have been performed comparing Keytruda® (pembrolizumab) monotherapy and Keytruda® plus chemotherapy with PDS0101 * About the VERSATILE-002 TrialVERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors. 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 PDS0101 (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. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care. For more information, please visit www.pdsbiotech.com Forward Looking Statements This 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 PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (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 PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (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 or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, 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.Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:David SchullRusso PartnersPhone +1 (858) 717-2310Email: david.schull@russopartnersllc.com

ImmunotherapyClinical ResultPhase 2

02 Sep 2025

·www.globenewswire.com

PDS Biotech to Participate in the H.C. Wainwright 27th Annual Global Investment Conference

PRINCETON, N.J., Sept. 02, 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 the Company will participate in the 27th Annual H.C. Wainwright Global Investment Conference, to be held in New York, NY and virtually September 8-10, 2025. Frank Bedu-Addo, Ph.D., Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer, will be available to meet with investors in one-on-one meetings during the conference. Investors interested in speaking with management should contact their H.C. Wainwright representative. 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 PDS0101 (Versamune® HPV) is being developed in combination with standard-of-care immune checkpoint inhibitor pembrolizumab. 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 PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (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 PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (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 or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, 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:David SchullRusso PartnersPhone +1 (858) 717-2310Email: david.schull@russopartnersllc.com

ImmunotherapyClinical Study

26 Aug 2025

·www.globenewswire.com

PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer

Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months* VERSATILE-003 Phase 3 trial in progress Aug. 25, 2025 -- 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 final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”). 53 patients were enrolled in the 1L R/M HNSCC arm of the trial. PDS0101 was administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35. The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable. Durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 and was similar across patient demographics and clinical characteristics such as age, CPS status, and prior treatment. “We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers,” said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.” “With these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors. 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 PDS0101 (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. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical Result

100 Deals associated with Pexipepimut-S

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and neck cancer metastatic	Phase 3	United States	PDS Biotechnology Corp.	30 May 2025
HPV positive oropharyngeal squamous cell carcinoma	Phase 3	United States	PDS Biotechnology Corp.	30 May 2025
Recurrent Head and Neck Carcinoma	Phase 3	United States	PDS Biotechnology Corp.	30 May 2025
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	PDS Biotechnology Corp.	30 May 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	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
Oropharyngeal Neoplasms	Phase 2	United States	National Cancer Institute	09 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04260126 (VERSATILE-002, GlobeNewswire) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line HPV16-positive	53	PDS0101 + Keytruda	tkkekxzraa(pkirgduios) = hgkpdwgmrr kfzrahlswi (rwtftzjsfw, 23.9 - NE)	Positive	25 Aug 2025
NCT04260126 (VERSATILE-002, ASCO2025)	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck First line CPS ≥1 \| CPS ≥1-19 \| CPS ≥20	53	PDS0101 and pembrolizumab combination	yiluhvscla(wcwtcnlfwa) = uovejwgzxf jflximkgdo (tvwwuuaear, 23.9 - NE)	Positive	30 May 2025
				Pembrolizumab alone	yiluhvscla(wcwtcnlfwa) = jtoyikntxy jflximkgdo (tvwwuuaear, 15.3 - NE)
NCT04287868 (Company_Website \| Pubmed) Manual	Phase 1/2	HPV-related carcinoma HPV16-positive	50	PDS0101 + PDS01ADC + bintrafusp alfa (BA) (ICB naïve patients)	tawckpsknw(wmkvcmbsfd) = zclvmxcipe wvdntowdhl (fhrexqbswy, 8.3 - NE) View more	Positive	26 Feb 2025
				PDS0101 + PDS01ADC + bintrafusp alfa (BA) (ICB naïve patients + HPV16-positive)	tawckpsknw(wmkvcmbsfd) = zbwhipghfd wvdntowdhl (fhrexqbswy, 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)	snarprafet(follumakuq) = kyfwcmdtvg jhzyslkqcs (bmasyggfif ) View more	Positive	02 Oct 2024
				Versamune® HPV + Chemoradiation (five doses)	snarprafet(follumakuq) = qfmrduniaq jhzyslkqcs (bmasyggfif ) View more
NCT04580771 (IMMUNOCERV, ASTRO2024)	Phase 2	Locally Advanced Cervical Carcinoma	35	PDS0101	tlrsfxlvce(dstcuumrex) = jlodxthjqp fqhtzjylxe (oxcquzmqeo )	Positive	01 Oct 2024
NCT04260126 (VERSATILE-002, ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	-	PDS0101 anpembrolizumabab	jhbxfyrodm(emxtvjnqpp) = oyqtbtolle ypkjogygsm (gcejhsxbdu, 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)	xbzwicyqcz(ahhvgqnfps) = yyehifmeck jzgsbsvelv (qbebinoidp ) Met View more	Positive	09 May 2024
				Versamune® HPV + KEYTRUDA® (pembrolizumab) (CPS≥20)	xbzwicyqcz(ahhvgqnfps) = agtqqzqcam jzgsbsvelv (qbebinoidp ) Met View more
NCT04287868 (GlobeNewswire) Manual	Phase 2	Human Papillomavirus-16 Positive	-	PDS0101+PDS0301+Bintrafusp-alfa (ICI naïve group)	gmcneapepr(brgswjidrn) = hjgzifasqn kcfogajtvl (riyxkqzrwf ) View more	Positive	09 Nov 2023
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	gmcneapepr(yjalpoisxl) = bqvehtstan gcaivdevgg (jtlvkqpzof ) View more
NCT04260126 (VERSATILE-002 , Corporate Publications) Manual	Phase 2	Head and Neck Neoplasms	-	PDS0101+pembrolizumab (ICI naïve pts)	yeccuummps(eajfjfkmvk) = wzifjknjeg ieqytdcgsa (dnhjtunnjs ) View more	Positive	03 Oct 2023
				PDS0101+pembrolizumab (ICI Refractory pts)	yeccuummps(eajfjfkmvk) = akkrlzxuqd ieqytdcgsa (dnhjtunnjs ) View more
NCT04260126 (VERSATILE002, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Human Papillomavirus-Related Squamous Cell Carcinoma of Head and Neck HPV16 Positive	48	PDS0101+pembrolizumab	lpomfkhgyj(icjtfqvgxk) = uhynzjcnbk tqqihzbyny (svvinhenid ) View more	Positive	31 May 2023

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