Tag: PDSB

Release – PDS Biotech Completes Successful Meeting with FDA for Triple Combination of PDS0101, PDS0301 and a Commercial Immune Checkpoint Inhibitor

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Research, News, and Market Data PDSB

Received guidance on registrational path for combination in recurrent/metastatic, immune checkpoint inhibitor refractory head and neck cancer

FLORHAM PARK, N.J., Feb. 27, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced the successful completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) for a combination therapy of PDS0101, PDS0301 and an FDA-approved immune checkpoint inhibitor (ICI) for the treatment of recurrent/metastatic human papilloma virus (HPV)-positive, ICI refractory head and neck cancer. Head and neck cancers are the most common of all HPV-positive cancers and the number of cases is growing rapidly, according to the National Cancer Institute (NCI), one of the National Institutes of Health (NIH).   There remains a critical unmet medical need to develop new treatment options for patients who have failed treatment with ICIs.

In recent interactions with the FDA, PDS Biotech has confirmed the required contents of the study design for a potential registrational trial of the combination of PDS0101, PDS0301 and a commercial immune checkpoint inhibitor. PDS0101, PDS Biotech’s lead candidate, is a Versamune® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. PDS0301 is a novel, proprietary investigational tumor-targeting fusion protein of Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment, and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors. The combination of Versamune® and IL-12 is patented by PDS Biotech. In a National Cancer Institute (NCI)-led clinical trial in advanced HPV-positive ICI refractory patients, the combination of PDS0101 and PDS0301 administered with an investigational bi-functional ICI resulted in a median overall survival of 21 months, which compares favorably to the historical median survival of 3-4 months.

“We are pleased with the guidance from the FDA on key elements of a study design to progress the development of our assets, PDS0101 and PDS0301, in combination with a commercial immune checkpoint inhibitor,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “This concurrence to substitute an FDA-approved commercially available ICI for the investigational agent studied in the NCI trial simplifies the regulatory pathway for this triple combination.”

Dr. Bedu-Addo continued, “Versamune® based investigational immunotherapies in combination with PDS0301 represent a potentially transformative treatment approach for recurrent/metastatic, ICI refractory cancer patients with poor survival prognosis. We remain committed to addressing unmet needs in cancer with more effective immunotherapy.”

About PDS0101 PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS

Release – PDS Biotech Announces Preclinical Publication in Peer Reviewed Viruses Journal Showing Superior CD4 T Cell Induction by Infectimune™

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB


Infectimune™ (R-DOTAP) nanoparticles significantly enhance cytokine-inducing, CD4 T cell responses compared to leading commercial adjuvants being used in approved vaccines

FLORHAM PARK, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that new research performed in the laboratory of preeminent CD4 T cell researcher, Andrea Sant, PhD at the University of Rochester Center for Vaccine Biology and Immunology, was published in the peer-reviewed journal, Viruses. The preclinical research studied Infectimune™, PDS Biotech’s novel investigational infectious disease immune activating platform, and demonstrated the technology’s potency in eliciting CD4 T cells. The studies focused on comparing Infectimune™ induced immune responses following primary vaccination against influenza with immune responses induced by leading vaccine adjuvants. This publication follows a recent article in Viruses highlighting the ability of Infectimune™ to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.

The paper, titled, “R-DOTAP cationic lipid nanoparticles outperform squalene-based adjuvant systems in elicitation of CD4 T cells after recombinant influenza hemagglutinin vaccination,” reported findings from a preclinical study investigating the ability of Infectimune™ (R-DOTAP) to promote CD4 T cell responses to vaccination with recombinant influenza protein. Infectimune™ was compared to AddaVax™, which is analogous to commercial adjuvant MF59®, and AddaVax™ combined with CpG, a commercial adjuvant, using HA-B as the influenza vaccine antigen. Results from the study concluded that Infectimune™ dramatically enhanced CD4 T cell responses to recombinant HA-B proteins relative to AddaVax™ and AddaVax™ plus CpG. Further, the Infectimune™ elicited CD4 T cells displayed abundant Interferon (IFN)-gamma and Interleukin (IL)-2 production that are critical for protective immunity. CD4 T cells are documented to present multiple functions including CD8 T cell expansion and antibody responses as well as direct anti-viral effects and potentiation of antigen presenting function to enhance protection against viral infection.

“Influenza remains challenging due to low immune responses, especially in the elderly. Thus, there is a significant opportunity to develop a flu vaccine that induces broadly protective responses to influenza,” stated Dr. Gregory Conn, Chief Scientific Officer of PDS Biotech.

Dr. Sant, the senior author on the paper stated, “These results showing the potency of R-DOTAP to promote epitope-specific, cytokine-inducing CD4 T cells against a recombinant influenza antigen are exceptionally promising.”

The preclinical research published in Viruses demonstrates the ability of Infectimune™ to significantly boost CD4 T cell activity, suggesting that Infectimune™ based vaccines could provide durable protection against seasonal flu and potentially emerging pandemic flu.

The research was supported by grants from the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program and funded in part by the National Institute of Allergy and Infectious Diseases.

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.

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®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates 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 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. 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 our 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 success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.
AddaVax™ is a trademark of InvivoGen.
MF59® is a registered trademark of Novartis AG.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

Release – PDS Biotech Announces Publication of Preclinical Infectimune™ Based Vaccine Studies Demonstrating Effective Protection Against Viral Infection in Peer-Reviewed Journal, Viruses

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Infectimune™ induced neutralizing antibody and robust T cell responses completely protecting animals against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses

FLORHAM PARK, N.J., Feb. 08, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that preclinical studies involving Infectimune™, PDS Biotech’s novel investigational immune activating platform, were published in the peer-reviewed journal, Viruses, demonstrating the technology’s ability to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.

The paper, titled, “Recombinant Protein Vaccines Formulated with Enantio-Specific Cationic Lipid R-DOTAP Induce Protective Cellular and Antibody-Mediated Immune Responses in Mice,” highlighted results from preclinical studies. It was found that Infectimune™ (R-DOTAP) promoted strong T cell and antibody immune responses in both single- and multi-viral antigen (protein) containing vaccines. The vaccines induced antigen-specific and multi-cytokine-inducing CD8 and CD4 T cells associated with antigen-specific killing and immune memory, respectively.

Infectimune™ was tested in separate animal models of SARS-CoV-2 and influenza. Data suggest that Infectimune™ promotes robust neutralizing antibody and T cell responses to all three recombinant SARS‐CoV-2 spike protein variants tested in the studies. The investigational universal flu vaccine, containing two computationally optimized broadly reactive antigen (COBRA) influenza proteins, demonstrated induction of T cell and neutralizing antibodies against multiple strains of influenza. Robust T cell responses were also generated to influenza nucleoprotein, a protein contained in non-mutating regions of the virus. Importantly, these Infectimune™ induced neutralizing antibody and T cell responses completely protected animals from lethal challenges with live SARS-CoV-2 and influenza viruses. The Infectimune™ based vaccines also facilitated significant dose sparing of the viral protein antigens.

“We are encouraged by the data reported in Viruses which suggest that Infectimune™ is a promising platform for the effective delivery of recombinant protein antigens to the immune system and activation of the immune system for the development of next‐generation universal vaccines against respiratory viruses, including influenza and SARS-CoV-2,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech and one of the co-authors of the study. “PDS Biotech is advancing our Infectimune™ based programs, and these studies highlight the potential of Infectimune™ to induce memory T cell responses against viral antigens that can provide the immune system with long-term memory and sustained protection against infectious pathogens over an extended period of time.”

The research was funded in part by the National Institute of Allergy and Infectious Diseases, the University of Kentucky Flow Cytometry & Immune Monitoring and PDS Biotech.

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.

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®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates 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 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. 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 our 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

Release – PDS Biotech Announces Abstract Accepted for Presentation at ESMO Targeted Anticancer Therapies Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

Abstract, titled “HPV16-specific CD4 and CD8 T cell activation and functionality in patients receiving combination PDS0101 immunotherapy,” highlights data generated from VERSATILE-002 Phase 2 study

FLORHAM PARK, N.J., Feb. 06, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that an abstract investigating the ability of PDS0101 in combination with KEYTRUDA® (pembrolizumab) to induce HPV16-specific CD4 and CD8 T cell activation and functionality has been accepted for presentation at the ESMO Targeted Anticancer Therapies Congress 2023 (ESMO TAT) in Paris, March 6-8, 2023.  

PDS Biotech’s HPV-targeted immunotherapy, PDS0101, is being studied in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in the Phase 2, VERSATILE-002 clinical trial (NCT04260126) in patients with advanced recurrent or metastatic HPV16-positive head and neck cancer. Measurement of antigen-specific activation of endogenous T cells is critical to understanding drug-induced, T cell based immunity and its association with observed clinical outcomes.

Abstract Number: 246
Abstract Title: HPV16-specific CD4 and CD8 T-cell activation and functionality in patients receiving combination PDS0101 immunotherapy
Authors: Dr. Lauren V. Wood, Dr. David Schaaf, Nathalie Riebel, and Sally Jones from PDS Biotech and Stephen McCarthy, Dr. Adam Cotty and Dr. Julie Bick from FlowMetric

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®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates 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 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. 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 our 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

Release – PDS Biotech Announces Participation in the Channelchek Takeaway Series

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., Jan. 26, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced its participation in the Channelchek Takeaway Series from the J.P. Morgan Healthcare Conference to be broadcast Thursday, January 26, starting at 10:00 a.m., EST. The event will include an overview of PDS Biotech’s business and clinical development strategy from Frank K. Bedu-Addo, Ph.D., President and CEO, followed by a question and answer session with Noble Capital Markets’ Senior Analyst Robert LeBoyer.

Details regarding the event are as follows:

Event:Channelchek Takeaway Series
Date:January 26, 2023
Time:10:00 a.m., EST
Registration:https://us02web.zoom.us/webinar/register/WN_8AW1yjzKSIeqE1satmhSrQ

The J.P. Morgan Healthcare Conference is considered to be the most important healthcare investment symposium in the industry, connecting global industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. Noble Capital Markets’ equity analysts and investment bankers attended the conference and sat down with various c-suite executives. For the Channelchek Takeaway Series, Noble’s analysts are unpacking what they learned at the conference and talking to a selection of c-suite executives in the healthcare space.

The event will be broadcast starting at 10:00 a.m., EST on Thursday, January 26. Investors can attend the Channelchek Takeaway Series virtually at no cost. Registration details are available on Channelchek.

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®, PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune® and PDS0301 based candidates 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 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. 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 our 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden 
Phone: +1 (732) 910-1620
bborden@tiberend.com

Release – PDS Biotech to Participate at the B. Riley Securities 3rd Annual Oncology Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., Jan. 13, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that its management will participate in a fireside chat at the B. Riley Securities 3rd Annual Oncology Conference being held virtually on January 18-19, 2023.

B. Riley Securities 3rd Annual Oncology Conference
Fireside Chat: Thursday, January 19, 2023
Time: 1:00 PM EST
Virtual viewers: Livestream

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital  

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

PDS Biotechnology Corp. (PDSB) – PDS Licenses Merck’s IL-12 Used In Its Combination Studies

Posted on by cpereira@noblefcm.com


Wednesday, January 04, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

License Gives Exclusive Rights To M9241. PDS Bio announced a licensing agreement with Merck KGaA covering M9241, the proprietary IL-12 tumor-targeting cytokine used in its Phase 2 Triple Therapy combination study. As discussed in our Research Note on December 29, most recent results have shown significant improvement in outcomes for these patients. Since PDS did not have commercial rights to M9241 before the licensing agreement, we believe this is a highly positive development.

Licensing Terms Are Favorable For Both Companies. The license agreement gives PDS exclusive worldwide rights to M9241. PDS will take over all development, manufacturing, and commercialization, while Merck continues to supply the drug during the transition. PDS will pay Merck a licensing fee of $5 million in cash and $5 million in its common stock, consisting of 378,787 shares or about 1.3% of the shares outstanding. Merck will receive development and regulatory milestones of up to $11 million for the first two indications, as well as commercial milestones of up to $105 million plus 10% royalties on initial sales.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – PDS Biotech Announces Exclusive Global License Agreement for Investigational IL-12 Tumor-Targeted Cytokine from Merck KGaA, Darmstadt, Germany

Posted on by cpatches

Research News and Market Data on PDSB

PDS Biotech bolsters immuno-oncology portfolio with a clinical-stage product synergistic with its Versamune® platform

PDS Biotech to host conference call and webcast on Tuesday, January 3, 2023, at 8:00 AM EST

FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune® and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

“We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune® platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options.”

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune® based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

  • Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • 63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.
  • 79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

  • 88% (7/8) of CPI naïve patients had an objective response.
  • 38% (3/8) of responders had a complete response.
  • In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, “M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune®-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune®-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products.”

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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 PDS0301
PDS0301 is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. Together with Versamune® based immunotherapies, PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression. Clinical data suggest this combination may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis. A National Cancer Institute-supported Phase 2 clinical study of PDS0301 in a triple combination therapy is being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers.

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 our 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 success of the Company’s license agreements, including the potential for the clinical and nonclinical data available under the Company’s exclusive license agreement with Merck KGaA to aid in the development of the Versamune® platform; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: bborden@tiberend.com

Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325
Email: dschemelia@tiberend.com

PDS Biotechnology Corp (PDSB) – Triple Therapy Data Shows Large Improvements Over Standard of Care

Posted on by cpatches


Thursday, December 29, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Data From The Phase 2 Triple Therapy Trial Shows Better Response And Survival Data. PDS Bio announced new data from its Phase 2 trial testing PDS0101 in combination with two immunomodulating drugs. Patients with HPV16-positive cancer received the “Triple Therapy” consisting of PDS0101, an IL-12 fusion protein, and a bivalent checkpoint inhibitor. One of two arms in the trial reached its median objective survival (OS) of 21 months, an improvement over the last interim update and the historical survival of 3 to 4 months.

New Overall Survival Data Shows Improvement Over Last Interim Update. Patients enrolled in the trial had HPV16-positive cancer with progressive disease after standard therapies. Patients who received previous checkpoint inhibitor therapy  but no longer responded (checkpoint inhibitor refractory) reached a medial Overall Survival (OS) of 21 months. This compares to the last interim update of 16 months OS with 66% remaining alive. Expected survival for patients at this stage is 3 to 4 months. In the group that was naïve to checkpoint inhibitors, 75% remained alive at a median follow-up of 27 months, so the median OS has not been reached. Expected survival for similar patients is 7 to 11 months.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – PDS Biotech Reports Median Overall Survival (OS) of 21 Months in Advanced, Refractory Cancer Patients Having Few Remaining Treatment Options and with Reported Historical Survival of 3-4 months

Posted on by cpatches

Research News and Market Data on PDSB

Median OS of 21 months in 29 checkpoint inhibitor (CPI) refractory HPV16-positive cancer patients in National Cancer Institute-led Phase 2 clinical trial of PDS0101 triple combination

FLORHAM PARK, N.J., Dec. 28, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced expanded interim data in a Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers. The triple combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β), is being studied in CPI-naïve and CPI-refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.

The triple combination Phase 2 trial (NCT04287868) is being conducted at the Center for Cancer Research (CCR) at the National Cancer Institute (NCI), one of the Institutes of the National Institutes of Health.

All patients in the study had failed prior treatment with chemotherapy and 90% had failed radiation treatment. The interim efficacy data (n=50) involves 37 HPV16-positive evaluable patients, including 29 patients who have, in addition, failed treatment with CPIs (CPI refractory). Highlights of the expanded interim data are as follows and are consistent with the results presented at American Society of Clinical Oncology (ASCO) Annual Meeting 2022 and prior interim data announced in October:

  • Median OS is 21 months in 29 checkpoint inhibitor refractory patients who received the triple combination. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
  • In CPI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.
  • Objective response rate (ORR) in CPI refractory patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches ORR is reported to be less than 10%.
  • ORR in CPI naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved CPIs in HPV-associated cancers.
  • Safety data have not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) of patients experienced Grade 4 (severe) AEs, compared with approximately 70% of patients receiving the combination of CPIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

“The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, an extremely challenging population of refractory and previously untreatable HPV-positive patients,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We are pleased to see the continued consistency in the data with each update and we look forward to meeting with the FDA to discuss the registrational pathway.”

Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany, and its affiliates.

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. 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

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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 our 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital

Media
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com

Bill Borden
Phone: +1 (732) 910-1620
bborden@tiberend.com 

PDS Biotechnology Corp (PDSB) – Raising Price Target to $19 Based On Clinical Progress

Posted on by cpereira@noblefcm.com


Monday, November 28, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Raising Our Price Target to $19 Per Share. Data presentations from clinical trials for PDS0101 have driven PDSB within 10% of our previous price target. We continue to see PDS0101 as a highly promising treatment for HPV-positive cancers and see several important milestones to drive the stock higher in the coming year.

Price Target Is Based On PDS010 Sales Potential.  Our new price target is based on discounted sales estimates for PDS010 sales in HPV-positive cancer. Following an End-of-Phase 2 meeting with the FDA following the June 2022 VERSATILE-002 data presentation, the company announced that it was accelerating its timetable for the pivotal trial for PDS0101. We expect this trial to begin in 2023 and project product launch in 2026.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – PDS Biotech Executives to Present an Overview of Oncology and Infectious Disease Programs at the World Vaccine & Immunotherapy Congress

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on PDSB

Chief Medical Officer, Dr. Lauren V. Wood, to present on the development of targeted immunotherapies for solid tumors based on the Versamune® platform

Dr. Siva Gandhapudi, Director of Immunology Product Development, to present on development of a universal flu vaccine based on the Infectimune™ platform

FLORHAM PARK, N.J., Nov. 21, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced two executives will be giving presentations at the World Vaccine & Immunotherapy Congress, which will take place from November 28 through December 1, 2022, in San Diego.

PDS Biotech speakers at the conference include:

SpeakerTimeSubject
Dr. Lauren V. Wood,
Chief Medical Officer		Tuesday, Nov. 29, 4:50 p.m. Pacific TimeDevelopment of targeted immunotherapies for solid tumors based on the Versamune® platform
Dr. Siva Gandhapudi, Director of Immunology Product DevelopmentWednesday, Nov. 30, 2:30 p.m. Pacific TimeDevelopment of a universal flu vaccine based on the InfectimuneTM platform

More than 800 attendees are expected to attend the World Vaccine & Immunotherapy Congress to examine challenges around scientific, commercial, public health and policy issues in manufacturing, clinical trials, regulation, immune profiling, biomarkers, platform technologies, and additional topics.

“We welcome the opportunity to highlight the Versamune® and Infectimune™ platforms and their potential to address significant unmet medical needs to the biotechnology and scientific community,” said Dr. Frank Bedu-Addo, PDS Biotech President and CEO. “We are looking forward to advancing our product development in both oncology and infectious disease, ultimately to improve patient care.”

About Versamune®

Current immunotherapies have demonstrated an ability to treat certain cancers, but limitations with their effectiveness persist. Versamune® is a novel investigational T cell activating platform designed to stimulate a precise immune system response to cancer-specific proteins. PDS Biotech is advancing multiple Versamune® based clinical and pre-clinical programs with its lead clinical candidate – PDS0101 – targeting HPV-positive cancers.

About InfectimuneTM

Infectimune™ is a novel proprietary investigational T cell immune activating platform technology designed to train the immune system to better protect against disease. The Infectimune™ platform stimulates the immune system to recognize the pathogen and induce potent killer T cell and memory T cell response for long-term protection safely with no clinically relevant toxicities.

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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. 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, PDS0202 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, PDS0202 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 our 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, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Company’s annual and periodic reports filed with the SEC. 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 and Infectimune™ is a trademark of PDS Biotechnology. 

Investor Contacts: 
Deanne Randolph 
PDS Biotech 
Phone: +1 (908) 517-3613 
Email: drandolph@pdsbiotech.com 

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital

Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors, Inc.
Phone: +1 (609) 468-9325 
Email: dschemelia@tiberend.com 

Bill Borden 
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620 
Email: bborden@tiberend.com 

PDS Biotechnology Corp. (PDSB) – PDS Bio Reports 3Q22 and Reviews Full SITC Data

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financial Results Reported With Full Data. PDS Biotech reported a 3Q22 loss of $7.4 million or $(0.26) per share, with cash on September 30 of $71.6 million. PDS Management reviewed two presentations at last week’s Society for Immunotherapy of Cancer (SITC) meeting, providing additional information to the data published in the abstracts. These data continue to show improved efficacy for PDS0101 over current treatments.

Data From Two Studies Was Presented At SITC. As discussed in our Research Note on November 8, the response rate and patient survival for the Phase 2 IMMUNOCERV trial in cervical cancer exceeded the standard of care.  Data presented from the Phase 2 Triple Therapy trial showed anti-tumor action by PDS0101, with increases in immune response markers against the tumors and decreases in markers of immune suppression.


Get the Full Report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.