DEVELOPING POWERFUL, SAFE, VERSATILE IMMUNOTHERAPIES

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that data from preclinical studies in ferrets of PDS0202, the company’s universal influenza vaccine utilizing proprietary COBRA (computationally optimized broadly reactive antigen) hemagglutinin (HA) flu proteins, will be featured in an oral lecture at the European Scientific Working Group on Influenza (ESWI) Conference. ESWI is being held September 17-20, 2023, in Valencia, Spain.

Abstract Title: Influenza pre-immune ferrets vaccinated with computationally optimized recombinant HA proteins generate sero-protective antibody responses against H1N1 and H3N2 viruses from the last decade.
Presenting Author: James Allen, PhD, Cleveland Clinic, United States of America
Session Title: Future vaccination strategies SCS09
Lecture: Tuesday 19 September; Time 14:10-15:45 (CET)

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Infectimune^®
Infectimune^® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune^® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune^® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; 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. 

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech, will participate and present an overview of the company and its programs at the H.C. Wainwright 25th Annual Global Investment Conference.

H.C. Wainwright 25th Annual Global Investment Conference
Date: September 11, 2023
Event: On-Demand Presentation
Time: 7:00 AM EDT
Investors can register for the webcast here

Following the presentation, a webcast replay will be available on the Investor section of the company’s website.

For more information about the conference or to schedule one-on-one meetings, please contact your H.C. Wainwright representative directly.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; 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. 

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Company to provide updated VERSATILE-002 data on combination of PDS0101 and KEYTRUDA®

PRINCETON, N.J., Sept. 13, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced it will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including an update from the Phase 2 VERSATILE-002 trial, for analysts, investors and the scientific community from 8:00 – 9:00 AM EDT on Wednesday, September 27, 2023.

The Company-sponsored event will focus on current and potential treatments for HPV16-positive head and neck cancer, including the emerging use of circulating tumor DNA (ctDNA), and unmet needs of this growing patient population. The event will also include a presentation on updated data from the VERSATILE-002 study of the combination of KEYTRUDA^® (pembrolizumab) and PDS0101, PDS Biotech’s novel investigational HPV-targeted immunotherapy, as well as the design for the planned VERSATILE-003 Phase 3 clinical trial due to be initiated in the fourth quarter of 2023. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration of PDS Biotech’s KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-003

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) compared with KEYTRUDA^® monotherapy as the control arm. The primary end point for the study is patient overall survival (OS). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contacts:
Dave Schemelia
Tiberend Strategic Advisors
Phone: +1 (609) 468-9325
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Eric Reiss
Tiberend Strategic Advisors
Phone: +1 (802) 249-1136
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

PDS0202 (Infectimune^® + COBRA influenza antigens) vaccination also prevented illness/weight loss
Vaccine protected against replication of the virus in the lungs of ferrets after challenge with the H1N1 virus
Data from Cleveland Clinic’s Ted Ross Lab presented at the 9^th ESWI Influenza Conference

PRINCETON, N.J., Sept. 20, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced its investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. The vaccine also provided protection against infection after challenged with high doses of the H1N1 virus in ferrets not previously exposed to flu. The data were presented in an oral lecture at the 9^th European Scientific Working Group on Influenza (ESWI) Conference in Valencia, Spain by James Allen, PhD, from the Cleveland Clinic laboratory of renowned influenza expert, Ted Ross, PhD.

“We are encouraged that PDS0202 has demonstrated activity in generating protective hemagglutination inhibition assay (HAI) antibody responses in pre-immune ferret studies, which are the gold standard in influenza vaccine testing. In addition to active neutralization of various influenza strains, the data demonstrated that PDS0202 prevented illness, weight loss and importantly protected the lungs of vaccinated animals from H1N1,” said Dr. Ross. “In humans, we expect PDS0202 to elicit a similar or more broadly reactive antibody profile due to humans having broader exposure to influenza and thus the recall of a more diverse population of memory B cells than the animals evaluated in our preclinical studies.”

H3N2 HAI Response

^{Vaccination with PDS0202 Provides broadly effective HAI antibody responses (minimum 1:40 ratio) across multiple strains of the H3N2 virus including Swtiz/13 and Kan/17 demonstrating the broad reactivity of the novel COBRA proteins. Similar results were demonstrated against multiple strains of the H1N1 virus.}

H1N1 Infection Results: D3 Nasal Wash Viral Titers

^{PDS0202 (Y2 + NG2 COBRA proteins) prevents viral replication in the lungs of ferrets after vaccination followed by viral challenge with A/Victoria/2570/2019 H1N1 flu strain (1e6 PFU/mL). The quantity of H1N1 virus stays below the detection limits. The vaccine based on the wild type HA (Mich/15 + Sing/16) and the control (Mock) do not effectively prevent replication and expansion of the H1N1 virus in the lungs of the ferrets.}

PDS0202 combines PDS Biotech’s Infectimune^® novel investigational immune activating platform with proprietary Computationally Optimized Broadly Reactive Antigens (COBRA) influenza antigens. The COBRA antigens developed in the laboratory of Dr. Ted Ross were designed using an in-silico layered consensus building approach, which utilizes HA sequence data from influenza surveillance databases. PDS0202’s ability to generate broad, robust antibody and T cell responses position the vaccine to potentially provide durable protection against seasonal and pandemic strains of influenza. PDS0202 is administered through intramuscular injection in a single dose.

“We are pleased that the PDS0202 data presented at the ESWI Influenza Conference are consistent with our previously reported preclinical studies in murine models, marking encouraging progress toward a potential universal influenza vaccine,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “We look forward to our continued discussions with the National Institute of Allergy and Infectious Diseases to advance PDS0202 into clinical trials with the goal of creating a universal vaccine that provides broad protection against multiple strains of influenza.”

In previous preclinical studies, PDS0202 demonstrated the ability to promote robust induction of broadly neutralizing influenza-specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T cells, as well as long-lasting memory T cells. This robust immune response to the COBRA antigens suggests strong potential for PDS0202 as a broad and long-term protecting universal influenza vaccine.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; 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. 

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/322b8fdb-bf6b-4c74-96c9-81b581f74513

https://www.globenewswire.com/NewsRoom/AttachmentNg/f7fe4fb9-3936-4f2b-9673-f571604ed431

2023 Cantor Fitzgerald Global Healthcare Conference
Date: Tuesday, September 26, 2023
Event: Panel presentation
Time: 2:45 PM EDT
Investors can register for the webcast here.

Following the panel presentation, a webcast replay will be available on the Investor section of the company’s website. For more information about the conference or to schedule one-on-one meetings, please contact your Cantor Fitzgerald representative directly.

About PDS Biotechnology

Forward Looking Statements

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Event to be held on Tuesday, October 3 from 8:00 to 9:00 AM EDT

PRINCETON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that its Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101 will now take place on Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, due to a scheduling conflict. The event was originally scheduled for Wednesday, September 27, 2023.

The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren V. Wood, and will feature presentations from the following head and neck cancer KOLs:

Dr. Glenn Hanna, Assistant Professor, Harvard University and Medical Oncologist, Dana-Farber Cancer Institute
Dr. John Kaczmar, Associate Professor, Medical University of South Carolina
Dr. Ricard Mesía, Head of Medical Oncology, Catalan Institute of Oncology
Dr. Katharine Price, Associate Professor, Oncology Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center

Registration for the event is open. A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; 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. 

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

PRINCETON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech, will present at the LD Micro Main Event XVI being held on October 3-5, 2023, in Los Angeles, CA. Details for the event are as follows:

LD Micro Main Event XVI
Date: Wednesday, October 4, 2023
Event: Presentation
Time: 11:00 AM PDT
Investors can register for the livestream here.

For more information about the conference or to schedule one-on-one meetings, please contact your LD Micro representative.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^®for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^®based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Versamune^® and Infectimune^® are registered trademarks of PDS Biotechnology. KEYTRUDA^®is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Relations:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Study evaluated levels of circulating cell-free HPV DNA (cfDNA) in patients with locally advanced cervical cancer in the IMMUNOCERV Phase 2 clinical trial and patients receiving standard of care (SOC) treatment
Patients treated with PDS0101 had greater clearance of cfDNA as compared to those treated with SOC (at week 5, 91.7% vs. 53.1%, P=0.0179)
Data presented during oral presentation at ASTRO 2023 Annual Meeting

PRINCETON, N.J., Oct. 02, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced data demonstrating lead candidate PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) was associated with a rapid decline in human papillomavirus (HPV) circulating cell-free DNA (cfHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation by Aaron Seo, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting in San Diego, CA.

The IMMUNOCERV Phase 2 trial is investigating PDS0101 in combination with SOC CRT in the treatment of cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes. HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer. HPV type 16 (HPV16) is the most prominent subtype associated with cervical cancer. The study presented at ASTRO 2023 evaluated the relationship between the levels of circulating cfHPV-DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer.

“We are encouraged by this data from the IMMUNOCERV trial, which highlight the potential of PDS0101 to positively impact cfDNA, an emerging biomarker of clinical response in cervical and other HPV-related cancers,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The findings complement previously presented IMMUNOCERV data which suggested PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and a clinical response with greater than 60% tumor shrinkage at mid-point evaluation in 100% of high-risk cervical cancer patients on the trial. We look forward to continuing to address the unmet needs of patients suffering from HPV-positive cancers such as cervical cancer.”

Sixty-one patients with cervical cancer were included in the analysis either as part of a SOC treatment banking protocol (n=44) or as part of the IMMUNOCERV Phase 2 clinical trial combining PDS0101 with SOC (n=17). Longitudinal plasma samples were collected from each patient at baseline, during weeks 1, 3, and 5, and at 3-4 months after CRT.

In the study, HPV16 was detected in 59% of tumors and 70% of cfDNA. The median cfDNA at baseline was 28.15 copies/mL, with a range of 0 to 206,030 copies/mL.

The presentation at ASTRO 2023 highlighted the following data:

Earlier and greater proportion of cfDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)
Baseline cfDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes

“HPV16 cfDNA represents a novel biomarker with the potential to help oncologists make more informed treatment decisions for their patients with HPV16-positive cancers. This early data are encouraging, and we will continue to evaluate patients to determine any potential correlations between cfDNA clearance and clinical outcomes. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and ongoing clinical outcomes,” said study principal investigator Ann Klopp, MD, PhD, Professor of Radiation Oncology at MD Anderson. “I look forward to the continued evaluation of PDS0101 in combination with standard-of-care chemoradiotherapy.”

About Versamune^®
Versamune^® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune^® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune^® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune^® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune^® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Interim VERSATILE-002 data for the first-line treatment of recurrent or metastatic head and neck cancer patients who were immune checkpoint inhibitor (ICI) naïve; published 24-month survival rate of less than 30% for approved ICI¹.
Received feedback from US Food and Drug Administration (FDA) on the Company’s amended Investigational New Drug (IND) application allowing initiation of VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.
12-month overall survival (OS) rate of 56% in ICI refractory patients; published median 12-month OS rate of 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)²^*.
Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events.
Interim VERSATILE-002 data and VERSATILE-003 Phase 3 trial design to be discussed during Key Opinion Leader (KOL) Roundtable today at 8:00 a.m. EDT.

PRINCETON, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced updated interim data based on an August 2^nd cut off from the VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations whose cancer has returned or spread – ICI naïve and ICI refractory. The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI refractory group included patients who had not responded to multiple prior treatments, including ICI therapy. Data presented at ASCO was based on a January 13th cut off.

“The updated interim data from our VERSATILE-002 clinical trial further validates the potential of PDS0101 when combined with KEYTRUDA^® to address the urgent need for more effective therapies that are well tolerated and allow advanced recurrent and metastatic HPV16-positive head and neck cancer patients to live significantly longer lives than current approaches,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Following feedback from the FDA, we look forward to evaluating this promising combination treatment in the VERSATILE-003 Phase 3 clinical trial, which we expect to initiate in the fourth quarter of 2023. VERSATILE-003 will investigate the efficacy and safety of PDS0101 combined with KEYTRUDA^® compared to KEYTRUDA^®monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary endpoint for the study will be overall survival.”

VERSATILE-002: ICI Naïve

Highlights of the interim data from the ICI naïve cohort include:

24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI¹.
12-month OS rate is 80%; published results of 30-50% with approved ICIs¹.
Tumor shrinkage seen in 60% (31/52) of patients.
Confirmed overall response rate (ORR) is 27% (14/52) to date.
Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs¹.
13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy¹.
60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to KEYTRUDA^®), and 40% (22/55) have CPS score >20 (who generally have a higher response to KEYTRUDA^®).

VERSATILE-002: ICI Refractory

The goal of this ICI refractory cohort was to confirm and to better understand the role of PDS0101 in prolonging the survival of advanced HPV16-positive head and neck cancer patients who received PDS0101 in combination with KEYTRUDA^®. This analysis is also intended to provide insight to the contribution of PDS0101 to overall survival in the National Cancer Institute-led study evaluating the combination of PDS0101, PDS0301 (antibody conjugated IL12), and an ICI.

Highlights of the interim data from the ICI refractory cohort include:

The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)²^*.
0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.
4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

“We are pleased with the OS results and knowledge gained from the ICI refractory cohort of VERSATILE-002. In agreement with our Data Monitoring Committee (DMC), we will not progress to stage 2 of this cohort in VERSATILE-002. As previously announced, we have no plans to further develop this combination for ICI refractory patients,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “PDS0101 appears to immunologically alter the patient’s tumor microenvironment to promote survival. This important data will help inform our development plans for PDS0101.”

Key Opinion Leader Roundtable
Today, Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, the Company will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including a discussion of the interim data from the VERSATILE-002 trial.

A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

^1*Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101.
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
²Bila M, Van Dessel J, Smeets M, Vander Poorten V, Nuyts S, Meulemans J, Clement PM. A Retrospective Analysis of a Cohort of Patients Treated With Immune Checkpoint Blockade in Recurrent/Metastatic Head and Neck Cancer. Front Oncol. 2022 Jan 27;12:761428. doi: 10.3389/fonc.2022.761428. PMID: 35155226; PMCID: PMC8828639. *No controlled or comparative studies have been conducted between PDS0101 and no salvage chemotherapy.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune^® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab).The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

About VERSATILE-003
The VERSATILE-003 Phase 3 clinical trial is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA^® compared to KEYTRUDA^® monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003 is overall survival. The Phase 3 study is expected to involve approximately 90-100 clinical sites globally.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS0301, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune^® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to 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; 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. 

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

First study of patients with metastatic prostate cancer to evaluate standard-of-care chemotherapy (docetaxel) combined with an antibody drug conjugate (PDS01ADC).
Decrease in prostate specific antigen (PSA) levels was seen in all patients at all three tested doses of PDS01ADC.
The combination was well-tolerated at all tested dose levels.
Data to be presented by National Cancer Institute as an oral presentation at Cytokines 2023.

PRINCETON, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced interim safety and immune response data for the first-in-human Phase 1/2 clinical trial evaluating PDS01ADC, a novel investigational tumor-targeting, antibody-conjugated Interleukin 12, in combination with current standard-of-care (SOC) chemotherapy, docetaxel, to treat metastatic castration sensitive (mCSPC) and castration resistant (mCRPC) prostate cancer. The data will be featured in an oral presentation by Ravi A. Madan, MD, Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research of the National Cancer Institute, an Institute of the National Institutes of Health, at the 11^th Annual Meeting of the International Cytokine & Interferon Society (Cytokines 2023) in Athens, Greece.

“We are encouraged by the preliminary data from the Phase 1/2 clinical trial evaluating PDS01ADC in combination with docetaxel for patients with metastatic prostate cancer which has the potential to improve treatment outcomes for patients with advanced and refractory prostate cancers that have spread to other parts of the body,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech.

Eighteen patients (11 with mCSPC and 7 with mCRPC) with a median age of 69 years (range 39-82) were evaluated for clinical activity and toxicity. Three dose levels of PDS01ADC (8.0 mcg/kg, 12.0 mcg/kg, and 16.8 mcg/kg) in combination with docetaxel (75 mg/m²) were administered every three weeks beginning with the second cycle of treatment. The dose-limiting toxicity (DLT) window spanned the 6 weeks after initiating docetaxel. While all doses of PDS01ADC were well-tolerated, the 12.0 mcg/kg dose of PDS01ADC with chemotherapy provided the best combination of immune response and tolerability.

Interim data highlights to be presented at Cytokines 2023 include:

Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and ranged from -4% to -100%.
All doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia.
Administration of the combination was associated with decreases in T reg cells and increases in activated natural killer (NK) cells, memory CD8 T cells, proliferating CD4 and CD8 T cells and cytokines INF-γ and Interleukin 10 (IL-10).
The changes in immune responses with the combination were independent of the PDS01ADC dose.

“The interim data show that adding PDS01ADC to docetaxel was associated with increases in peripheral activated natural killer cells, central memory CD8, proliferating CD4 and CD8 cells in addition to cytokines interferon-gamma and Interleukin 10 as well as decreases in T regulatory cells,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “As the first clinical study to evaluate docetaxel and an immunocytokine, we were pleased to see that the combination can be administered every 3 weeks and look forward to its continued evaluation and impact on clinical outcomes for the treatment of metastatic prostate cancer.”

For patients interested in enrolling in this clinical trial, please contact NCI’s toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email This email address is being protected from spambots. You need JavaScript enabled to view it., or visit https://trials.cancer.gov using the identifier NCT04633252.

About PDS01ADC
PDS01ADC is a novel investigational tumor-targeting antibody drug conjugate of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells and natural killer (NK) cells in the tumor microenvironment. PDS01ADC is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^®, Versamune^® plus PDS01ADC, and Infectimune^® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA^® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune^® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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PDS0202 Universal Influenza Preclinical Ferret Data to be Presented in Oral Lecture at 9th ESWI Conference

PDS Biotech to Participate at the H.C. Wainwright 25th Annual Global Investment Conference

PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023

PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

PDS Biotech to Participate in the 2023 Cantor Fitzgerald Global Healthcare Conference

PDS Biotech Reschedules Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101

PDS Biotech to Present at the LD Micro Main Event XVI

PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

PDS Biotech Announces Interim 24-Month Survival Rate of 74% in Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients Treated with PDS0101 in Combination with KEYTRUDA® (pembrolizumab)

PDS Biotech Announces Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial Evaluating Novel Antibody Drug Conjugate PDS01ADC Combined with Docetaxel to Treat Metastatic Prostate Cancer

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PDS0202 Universal Influenza Preclinical Ferret Data to be Presented in Oral Lecture at 9th ESWI Conference

PDS Biotech to Participate at the H.C. Wainwright 25th Annual Global Investment Conference

PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023

PDS Biotech Announces PDS0202 Elicits Active Neutralization of Multiple Influenza Strains in Preclinical Studies

PDS Biotech to Participate in the 2023 Cantor Fitzgerald Global Healthcare Conference

PDS Biotech Reschedules Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101

PDS Biotech to Present at the LD Micro Main Event XVI

PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

PDS Biotech Announces Interim 24-Month Survival Rate of 74% in Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients Treated with PDS0101 in Combination with KEYTRUDA® (pembrolizumab)

PDS Biotech Announces Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial Evaluating Novel Antibody Drug Conjugate PDS01ADC Combined with Docetaxel to Treat Metastatic Prostate Cancer

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