Background:
Prostate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed.
Objective:
To test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment.
Eligibility:
People aged 18 years and older with prostate cancer that returned after treatment.
Design:
Participants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample.
Participants will be treated in 4-week cycles.
Enzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home.
PDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs.
All participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated.
All participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once.
Participants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated.
...

Start Date22 Apr 2024

Sponsor / Collaborator

National Cancer Institute

NCT05361798

/ RecruitingPhase 2IIT

A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy

Background:
Prostate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (M9241) can help the immune system to fight prostate cancer.
Objective:
To find what doses of M9241 are safe in people who are treated for prostate cancer. Also, to see what effects M9241 has on the immune system.
Eligibility:
People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body.
Design:
The study will last 7 months.
Participants will be screened. They will share their medical history. They will also have:
A physical exam
Routine blood and urine tests
Imaging scans of the chest, abdomen, and pelvis
A bone scan
A tumor biopsy
A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum.
All participants will be treated with radiation therapy and ADT.
Some participants will also receive M9241 as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit.
Participants who do not receive M9241 will also have screening tests during the treatment period.
Participants will return for follow-up about 1 month after the last treatment or set of tests.

Start Date12 Jun 2023

Sponsor / Collaborator

National Cancer Institute

NCT05286814

/ RecruitingPhase 2IIT

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Background:
One way to treat liver cancer is to deliver chemotherapy drugs only to the liver (and not to the whole body). Researchers want to see if adding the drug PDS01ADC can improve the treatment. The drug triggers the immune system to fight cancer.
Objective:
To see if treatment with HAIPs to deliver liver-directed chemotherapy in combination with PDS01ADC is effective for certain cancers.
Eligibility:
People aged 18 and older who have cancer of the bile ducts that is only in the liver, or colorectal cancer that has spread to the liver.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Pregnancy test (if needed)
Tumor biopsy (if needed)
Electrocardiogram
Computed tomography (CT) scans
Participants will have an abdominal operation. A catheter will be placed into an artery that feeds blood to the liver. The catheter will then be attached to the HAIP. The HAIP will lay under the skin on the left side of the abdomen.
Participants will have chemotherapy drugs or heparin with saline infused into the HAIP every 2 weeks. PDS01ADC will be injected under the skin every 4 weeks. They will get systemic chemotherapy through an IV or mediport every 2 weeks. They will receive this treatment until their cancer gets worse or they have bad side effects.
Participants will have 2 study visits each month. They will have CT scans every 8 weeks. At visits, they will repeat some screening tests.
Participants will have a follow-up visit 1 month after treatment ends. Then they will be contacted every 6 months for 5 years.

Start Date24 Oct 2022

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with NHS-IL-12

100 Translational Medicine associated with NHS-IL-12

100 Patents (Medical) associated with NHS-IL-12

Literatures (Medical) associated with NHS-IL-12

01 May 2025·Journal for ImmunoTherapy of Cancer

Combination of HDAC inhibition and cytokine enhances therapeutic HPV vaccine therapy

Article

Author: Medina-Enriquez, Miriam Marlene ; Lassoued, Wiem ; Khelifa, Asma S ; Jochems, Caroline ; Gulley, James L ; Gameiro, Sofia R ; Burnett, Daniel ; Lothstein, Katherine E ; Schlom, Jeffrey ; Roller, Nicholas ; Miyamoto, Masaya ; Poppe, Lisa K

Background:

Human papillomavirus (HPV)-associated malignancies continue to present a major health concern despite the development of prophylactic vaccines. Standard therapies offer limited benefit to patients with advanced-stage disease. Despite improved outcomes with programmed cell death protein-1 (PD-1) targeted therapies, treatment resistance and modest response rates highlight a significant unmet need to develop novel therapies for these patients. PDS0101 (designated HPV vaccine) is a liposomal nanoparticle HPV16-specific therapeutic vaccine that has been shown to generate strong HPV-specific responses in preclinical and clinical studies. Here we assess the efficacy of this HPV vaccine in combination with the tumor-targeting immunocytokine NHS-IL12 (PDS01ADC), plus either αPD-1 or the class I histone deacetylase inhibitor Entinostat.

Methods:

Mice bearing HPV16+, αPD-1 refractory TC-1 and mEER tumors were treated with HPV vaccine, NHS-IL12, and either αPD-1 or Entinostat to determine antitumor efficacy and survival benefits. A comprehensive analysis of the tumor microenvironment was performed using flow cytometry, multiplex immunofluorescence, chemokine and cytokine assessment, and single-cell RNA sequencing with T-cell receptor (TCR) enrichment.

Results:

Combination of HPV vaccine and NHS-IL12 with either Entinostat or αPD-1 yielded significant antitumor activity and prolonged survival in αPD-1 refractory models of HPV16+cancer, with superior activity employing Entinostat versus αPD-1 combination. Entinostat triple therapy increased overall and HPV16-specific tumor CD8+T-cell infiltration with heightened cytotoxicity. TCR sequencing revealed a CD8+T-cell clone unique to vaccine-treated cohorts, which displayed an enriched cytotoxic transcriptional profile with triple therapy. These effects were paralleled by strong differentiation of tumor-associated macrophages (TAMs) towards pro-inflammatory, antitumor M1-like cell states. Single-cell transcriptomic analysis indicated all three agents were required for highest modulation of both CD8+T cells and TAMs conducive to tumor control. A biomarker signature reflecting the preclinical findings was found to be associated with improved survival in patients with HPV-associated malignancies.

Conclusion:

Together, these findings provide a rationale for the combination of HPV vaccine, NHS-IL12, and Entinostat in the clinical setting for patients with HPV16-associated malignancies.

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 ; Redman, Jason M. ; Manukyan, Manuk ; 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

01 Jun 2024·Journal of Gastrointestinal Oncology

Hepatic artery infusion pump (HAIP) therapy in combination with targeted delivery of IL-12 for patients with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: a phase II trial protocol

Article

Author: Rainey, Ashley J ; Hannah, Cathleen E ; Eade, Alyssa V ; Smith, Kathleen M ; Pu, Tracey ; Blakely, Andrew M ; Hernandez, Jonathan M ; Smith, Emily C ; Davis, Jeremy L ; Luberice, Kenneth ; Xie, Changqing ; Friedman, Lindsay R ; Gulley, James L ; Greten, Tim F ; Monge, Cecilia ; Ramamoorthy, Bhavishya ; Victory, Jack H ; Lambdin, Jacob ; Larrain, Carolina ; Mabry, Donna ; Schlom, Jeffrey ; Sarvestani, Amber Leila ; Ryan, Carrie E

Background:

Treatment of advanced liver tumors remains challenging. Although immune checkpoint inhibition has revolutionized treatment for many cancers, responses in colorectal liver metastases and biliary tract cancers remain suboptimal. Investigation into additional immunomodulatory therapies for these cancers is needed. Interleukin-12 (IL-12) is a pro-inflammatory cytokine with robust anti-tumor activity, but systemic adverse effects largely terminated therapeutic development of recombinant human IL-12 (rhIL-12). PDS01ADC is a novel human monoclonal antibody (NHS76) conjugated to two IL-12 heterodimers with established safety in phase I trials. The NHS76 antibody specifically targets histone/DNA complexes which are accessible only in regions of cell death and this antibody has been shown to accumulate locally in tumors.

Methods:

Patients with unresectable metastatic colorectal cancer (mCRC) or unresectable intrahepatic cholangiocarcinoma (ICC) will receive synchronization of subcutaneous PDS01ADC with floxuridine delivered via a hepatic artery infusion pump (HAIP). The primary outcome measured in this study will be overall response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary outcomes measured in this study will include hepatic and non-hepatic progression-free survival (PFS), overall survival, and safety of PDS01ADC combination therapy with HAIP.

Discussion:

Poor clinical response of these liver tumors to immunotherapy is likely due to various factors, including poor immune infiltrate into the tumor and immunosuppression by the tumor microenvironment. By exploiting the tumor cell death induced by HAIP locoregional therapy in combination with systemic chemotherapy, PDS01ADC is poised to modulate the tumor immune microenvironment to improve outcomes for patients undergoing HAIP therapy.

Trial Registration:

ClinicalTrials.gov (ID NCT05286814 version 2023-10-18); https://clinicaltrials.gov/study/NCT05286814?term=NCT05286814&rank=1.

News (Medical) associated with NHS-IL-12

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

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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

ImmunotherapyAACRVaccineClinical Study

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Prostate Carcinoma	Phase 2	United States	National Cancer Institute	22 Apr 2024
Localized Prostate Carcinoma	Phase 2	United States	National Cancer Institute	12 Jun 2023
HPV-related carcinoma	Phase 2	North America	PDS Biotechnology Corp.	03 Jan 2023
Adrenocortical Carcinoma	Phase 2	United States	National Cancer Institute	24 Oct 2022
Intrahepatic Cholangiocarcinoma	Phase 2	United States	National Cancer Institute	24 Oct 2022
Metastatic Colorectal Carcinoma	Phase 2	United States	National Cancer Institute	24 Oct 2022
Advanced cancer	Phase 2	United States	National Cancer Institute	05 Oct 2021
Colonic Cancer	Phase 2	United States	National Cancer Institute	05 Oct 2021
Vagina Carcinoma	Phase 2	United States	National Cancer Institute	05 Oct 2021
Metastatic Pancreatic Cancer	Phase 2	United States	National Cancer Institute	15 Jun 2021

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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)	wwqtnakpjl(vfhnxxjluv) = fjwelpaqmn wytijpnomb (ogxekczkrz, 8.3 - NE) View more	Positive	26 Feb 2025
				PDS0101 + PDS01ADC + bintrafusp alfa (BA) (ICB naïve patients + HPV16-positive)	wwqtnakpjl(vfhnxxjluv) = xmfxgiqtty wytijpnomb (ogxekczkrz, 9.0 - 21.3) View more
NCT02994953 (COMBO \| JAVELIN IL-12, CTgov)	Phase 1	Locally Advanced Malignant Solid Neoplasm	52	Avelumab+M9241 (Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg)	rjdsfydupb = nhfutafaae hyukzssdkx (tkrvupnuii, wdhvyroujh - lvpjmysleq) View more	-	20 Sep 2024
				Avelumab+M9241 (Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg)	rjdsfydupb = mithefvupe hyukzssdkx (tkrvupnuii, ueuihjwaxu - elyergyvzg) View more
NCT04491955 (CTgov)	Phase 2	Colorectal Cancer \| Small intestine carcinoma	32	NHS-IL12 (M9241) (Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))	uxtzyohokv = ftsjoinbxh zioydklucv (pjixhlkjjh, pojlnhjiyn - maoultllte) View more	-	14 Nov 2023
				Fowlpox (FPV)-CV301+N-803+MVA-BN-CV301+M7824+NHS-IL12 (M9241) (Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)	uxtzyohokv = aavgbhiiaq xuaehhstju (goqhbkngky, xbnvyseiyx - wmehimkphs) View more
NCT04287868 (GlobeNewswire) Manual	Phase 2	Human Papillomavirus-16 Positive	-	PDS0101+PDS0301+Bintrafusp-alfa (ICI naïve group)	saigkmsfpp(qeganrdbcv) = acvlzgfkfy jopukszvai (orohfiribe ) View more	Positive	09 Nov 2023
				PDS0101+PDS0301+Bintrafusp-alfa (ICI resistant group)	saigkmsfpp(jsultpgqdb) = bfslwfoeqr xagupdsxjn (rkwcjjpvna ) View more
NCT04235777 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Urogenital Neoplasms	16	Bintrafusp alfa+M9241	rbyvmwaeiy(kcrzppkken) = The most frequent TRAEs were fatigue (grade 2, 38%), lipase increase (grade 2+3, 31%), and anemia (grade 2+3, 31%). Grade 3 hematuria occurred in 2 patients (13%); a grade 4 creatinine increase occurred in one (8%). nuayngghmj (bdooqqcdwz )	Positive	26 May 2023
				SBRT+Bintrafusp alfa+M9241 (bintrafusp alfa and M9241 with either sequential SBRT)
NCT04491955 (ASCO_GI2023) Manual	Phase 2	Advanced Colorectal Adenocarcinoma \| Small intestine carcinoma Second line	30	overall	nbnupgvrie(luyucnbpul) = kbezhofkil carwoqyjey (evmpwyfypn )	Positive	24 Jan 2023
				CV301+N-803+bintrafusp alfa (triple therapy)	iyjhqpifgm(mmljxgryli) = cktznyygqe bqudruytuc (hjqibawddd, 33.7 - 86.0) View more
NCT04287868 (ASCO2022) Manual	Phase 2	HPV-related carcinoma HPV Positive	30	M9241+bintrafusp alfa+PDS0101 (with checkpoint naïve disease)	ncfukvcijl(cjpdmzbksw) = zhvycpknok jlsnzxrfhw (yppfkcjjok ) View more	Positive	02 Jun 2022
				M9241+bintrafusp alfa+PDS0101 (with checkpoint refractory disease)	ncfukvcijl(cjpdmzbksw) = purabwzirc jlsnzxrfhw (yppfkcjjok ) View more
SITC2019	Not Applicable	-	-	Entinostat	wxtcjpqlnt(mkcxfxkhlu) = areas of tumor necrosis identified via H&E staining also displayed DNA fragmentation measured by the TUNEL assay cgiyahdeml (sshlusjzza ) View more	Positive	01 Nov 2019
NCT02994953 (JAVELIN IL-12, ESMO2019) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	-	Avelumab+M9241	xltbxbxaqd(iwbttepnyc) = 1 pt (DL3, grade 3 autoimmune hepatitis) tihcqdgnag (cfjfdepjvd ) View more	Negative	30 Sep 2019
NCT01417546 (Pubmed \| Clin Cancer Res) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	-	NHS-IL-12	jchuuvitas(ghyabcagze) = No observed lzikussufm (lhedchegdz ) View more	Positive	15 Jun 2019

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