News
Center

National Cancer Institute (NCI)-led research of PDS01ADC, a novel investigational tumor-targeting IL-12 fusion protein, shows dose-dependent, immune responses and association with improved clinical outcomes

FLORHAM PARK, N.J., March 01, 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 clinical research conducted by the NCI, one of the Institutes of the National Institutes of Health, was published in the peer-reviewed journal, International Immunopharmacology. The clinical study assessed immune changes in relation to the dose level and dosing schedule of PDS01ADC (NHS-IL12), a novel investigational fusion protein consisting of a tumor-targeting antibody conjugated to Interleukin 12 (IL-12). The study also evaluated the correlation of several treatment-related immunological changes with clinical responses.

As described in the paper, titled, “Immune correlates with response in patients with metastatic solid tumors treated with a tumor-targeting immunocytokine NHS-IL12,” the researchers at the NCI evaluated a subset of 23 patients with advanced cancers who participated in a Phase 1 clinical trial of PDS01ADC. Patients were dosed every 2 weeks with PDS01ADC at one of two levels – 12.0 mcg/kg and 16.8 mcg/kg – or every 4 weeks at 16.8 mcg/kg to identify dosing amounts and regimens of PDS01ADC that correlate with higher levels of immune activation, including quantities of CD8 T cells, immune suppressive T regulatory cells, natural killer cells (NK) and natural killer T cells (NKT).  

Patients receiving the higher dose of PDS01ADC generated “a more robust immune activation compared to a lower dose,” including a greater expansion of NK, NKT, and CD8 T cells. Additionally, patients treated with the higher dose at two-week intervals had a greater response than patients receiving treatment every four weeks in the study. Importantly, greater increases were seen at the higher dose level in the serum pro-inflammatory cytokines IFNγ and TNFα, and soluble PD-1 (sPD-1). Studies found that increases in sPD-1 post-therapy have been associated with improved survival in various cancers and may indicate re-activation of CD8 T cells.

The ability to limit exposure of IL-12 in the circulating blood, and to increase its presence within the tumors constitutes a significant advancement in the development of cytokine-based immunotherapy. “The research published by the NCI demonstrates the potential of PDS01ADC as a tumor-targeting IL-12 and its ability to stimulate immune activation and increase the frequency of CD8 T cells and certain NK cell subsets to potentially overcome the immunosuppressive tumor microenvironment,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Importantly, this study appears to demonstrate the safety and tolerability of biologically active doses of PDS01ADC and reports increases in specific immune cells that were associated with PDS01ADC administration and improved clinical outcomes."

The publication also summarizes clinical results from a study combining PDS01ADC, with a checkpoint inhibitor and PDS0101, PDS Biotech’s HPV-targeted immunotherapy that has been shown to promote induction of multifunctional, tumor-infiltrating killer T-cells. In this study in advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers patients with checkpoint inhibitor refractory disease, 63% of patients who received the 16.8 mcg/kg dose had an objective response.

About PDS01ADC

PDS01ADC is a novel investigational tumor-targeting Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune^® based immunotherapies PDS01ADC works synergistically to promote a targeted T cell attack against cancers. PDS01ADC is given by a simple subcutaneous injection. Clinical data suggest the addition of PDS01ADC to Versamune^® based immunotherapies may demonstrate significant disease control by shrinking tumors and/or prolonging survival in recurrent/metastatic cancers with poor survival prognosis.

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^®, PDS01ADC, and Infectimune™ T cell-activating platforms. We believe our targeted Versamune^® and PDS01ADC 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.  

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

Bill Borden 
Phone: +1 (732) 910-1620 
This email address is being protected from spambots. You need JavaScript enabled to view it.

FLORHAM PARK, N.J., March 07, 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 Dr. Frank Bedu-Addo, President and Chief Executive Officer, will present at the 33rd Annual Oppenheimer Healthcare Conference being held virtually on March 13-15, 2023.

Oppenheimer Conference 
Presentation Date: Tuesday, March 14, 2023
Time: 8:00 AM ET
Investors can register for the webcast here

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

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.

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

Bill Borden 
Phone: +1 (732) 910-1620 
This email address is being protected from spambots. You need JavaScript enabled to view it.

FLORHAM PARK, N.J., March 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, today announced that the Company will release financial results for the fourth quarter of 2022 on Tuesday, March 28, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

Tuesday, March 28, 2023, 8:00 AM EDT
Domestic: 877-407-3088
International: 201-389-0927
Conference ID: 13736455
Webcast: PDS Biotech Earnings Webcast

After the live webcast, the event will be archived on 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^®, 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 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. 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 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 Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
This email address is being protected from spambots. You need JavaScript enabled to view it.   

Bill Borden
Phone: +1 (732) 910-1620
This email address is being protected from spambots. You need JavaScript enabled to view it.

• Successful meeting with FDA to discuss registrational pathway for triple combination of PDS0101, PDS0301, and a commercial immune checkpoint inhibitor
• 100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation) in IMMUNOCERV trial for high-risk cervical cancer patients with tumors >5 cm in PDS0101 + CRT based on preliminary data
• Company to host conference call and webcast today, March 28, 2023, at 8:00 AM ET
  

FLORHAM PARK, N.J., March 28, 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 provided a business update and announced its financial results for the year ended December 31, 2022.

Fourth Quarter 2022 and Recent Business Highlights:

• PDS0101 Lead Drug Candidate
  • VERSATILE-002 Phase 2 combination trial with Merck & Co. Inc.’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.
    • Completed first stage of enrollment in checkpoint inhibitor refractory arm
    • Presented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA^® (pembrolizumab) with respect to T cell activation and functionality at the ESMO Targeted Anticancer Therapies Congress 2023
  • National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers.
    • Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)
    • Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options
  • IMMUNOCERV Phase 2 clinical trial of PDS0101 with chemoradiotherapy (CRT) in patients with locally advanced cervical cancer.
    • 100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation), and 89% (8/9) complete response based on preliminary data
    • Study demonstrated strong infiltration of T cells into the tumors, elimination of circulating tumor DNA
• PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
  • Signed exclusive global license agreement for PDS0301, a novel, investigational, proprietary investigational tumor targeting, antibody-conjugated IL-12, developed by Merck KGaA, Darmstadt, Germany
  • Publication of PDS0301 monotherapy study linking PDS0301-induced immune responses with clinical outcomes in International Immunopharmacology
    
• Infectimune™ Platform
  • Publication of preclinical Infectimune™ study in the peer-reviewed journal Viruses showing complete protection in animal studies with PDS0202, a novel investigational recombinant protein-based Universal flu vaccine
  • A second preclinical Infectimune™ publication in the peer-reviewed journal Viruses showing unique induction of higher levels of multifunctional CD4 T cells compared to leading commercial vaccine technologies

“This past quarter and year have been exciting for PDS Biotech as we have made significant progress on our strategic initiatives and substantial advances in the clinic, including key data and development milestones involving our lead oncology candidate, PDS0101,” stated Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. “We received FDA guidance on the regulatory pathway for the VERSATILE-002 Phase 2 trial and, most recently, the triple combination Phase 2 trial. We look forward to progressing PDS0101 into a registrational trial in 2023.”

Dr. Bedu-Addo continued, “Additionally, we were pleased to have signed an exclusive global agreement with Merck KGaA, Darmstadt, Germany to advance the development of PDS0301, a novel, investigational, proprietary antibody-conjugated IL-12. We also continued progressing our Infectimune™ platform as well as our preclinical oncology candidates.”

Full-Year 2022 Financial Results
Net loss for the year ended December 31, 2022, was approximately $40.9 million, or $1.43 per basic share and diluted share, compared to a net loss of approximately $16.9 million, or $0.66 per basic share and diluted share for the year ended December 31, 2021. The higher net loss was primarily the result of investment in research and development, including the clinical programs and the acquisition of PDS0301.

Research and development expenses for the year ended December 31, 2022, increased to approximately $29.4 million compared to approximately $11.3 million for the year ended December 31, 2021. The increase of $18.2 million was primarily attributable to an increase in personnel costs of $2.3 million, clinical costs of $2.3 million, quality and manufacturing costs of $3.6 million, and $10 million for the rights to PDS0301 from Merck KGaA, Darmstadt Germany. Of the $10 million paid to Merck KGaA, Darmstadt Germany, $5 million was in cash and the balance in shares of the Company’s common stock.

General and administrative expenses for the year ended December 31, 2022, increased to approximately $12.2 million compared to approximately $10.2 million for the year ended December 31, 2021. The $2.0 million increase was primarily attributable to an increase in personnel costs of $1.3 million and an increase in professional fees of $0.7 million.

Total operating expenses for the year ended December 31, 2022, were approximately $41.7 million, an increase of approximately 94% compared to total operating expenses of approximately $21.4 million for the year ended December 31, 2021.

The Company’s cash balance as of December 31, 2022, was $73.8 million. Based on the Company’s available cash resources and cash flow projections, the Company believes that with the anticipated initiation of one registrational trial in 2023, this balance is sufficient to fund Company operations and research and development programs into the third quarter of 2024.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 28, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13736455. 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^®, 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 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. 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. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients with HPV16-positive head and neck cancer is being conducted at the Mayo Clinic.

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.

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 risk factors included in the Company’s annual, quarterly 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.

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 Contacts:
Bill Borden
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Balance Sheets

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Consolidated Statements of Operations and Comprehensive Loss

FLORHAM PARK, N.J., March 29, 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 Dr. Frank Bedu-Addo, President and Chief Executive Officer, will participate in Cantor’s Future of Oncology Virtual Symposium being held on April 3-5, 2023.

Cantor Symposium
Presentation Date: Tuesday, April 4, 2023
Time: 3:00 PM ET

For more information about the conference, please contact your Cantor representative directly.

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

Bill Borden
Phone: +1 (732) 910-1620
This email address is being protected from spambots. You need JavaScript enabled to view it.

Company has completed Phase 3 manufacturing of PDS0101 for randomized, controlled, registrational trial in recurrent/metastatic HPV16-positive head and neck cancer

FLORHAM PARK, N.J., March 30, 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 it has completed key tech transfer, scale up and manufacturing activities required to initiate a global, multicenter Phase 3 registrational trial investigating the combination of PDS0101 and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in the fourth quarter of 2023. The Phase 3 trial, named VERSATILE-003, will investigate the combination compared to KEYTRUDA® monotherapy for the treatment of unresectable, recurrent/metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).

In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally.

PDS Biotech’s plan to initiate the VERSATILE-003 trial follows the successful completion of an End-of-Phase 2 meeting in the third quarter of last year with the FDA, during which PDS Biotech received guidance from the FDA on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). Data reported at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting indicated the combination of PDS0101 and KEYTRUDA® achieved an objective response rate of 41% and an overall survival rate of 87% at nine months in 17 evaluable patients with HPV16 and PD-L1 positive recurrent or metastatic HNSCC. Safety data reported on the first 43 patients enrolled in the trial suggested that the combination was well tolerated with no treatment-related Grade 3 or 4 Adverse Events. Based on these data, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.

“With the maturing data from VERSATILE-002, we are pleased to now have visibility into the progression free survival and potential overall survival, and we are excited to move into the final stage of development for our lead asset, PDS0101. The initiation of a randomized, controlled Phase 3 registrational trial of PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma is a significant milestone for the Company,” stated said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Head and neck cancer remains a devastating diagnosis with a significant unmet medical need. Our goal is to advance this Phase 3 trial as expeditiously as possible to provide additional treatment options for these patients. We are proud to have achieved this milestone on the eve of Oral, Head and Neck Cancer Awareness Month.”

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 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 papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by 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, 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) compared to KEYTRUDA® monotherapy. 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; 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. 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, quarterly 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, N.J., USA.

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 Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
This email address is being protected from spambots. You need JavaScript enabled to view it.  
Bill Borden 
Phone: +1 (732) 910-1620 
This email address is being protected from spambots. You need JavaScript enabled to view it.

PDS Biotech prepares to advance PDS0101 into a Phase 3 registrational clinical trial – VERSATILE-003 – in HPV16-positive recurrent and/or metastatic head and neck cancer in 2023

FLORHAM PARK, N.J., April 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, announced its support for Oral, Head & Neck Cancer Awareness Month in April and Oral, Head & Neck Cancer Awareness Week, April 16-22, both of which are organized by the Head & Neck Cancer Alliance (HCNA). PDS Biotech recognizes the important role and dedication of patient organizations, such as the HCNA and the U.K.-based Swallows Head & Neck Cancer Support Group (The Swallows) in not only raising awareness of oral, head and neck cancer, but also in providing advice, information and education to those impacted by the disease.

PDS Biotech recently announced it is planning to initiate a randomized, controlled Phase 3 trial of the company’s lead clinical candidate, PDS0101, in combination with KEYTRUDA^® (pembrolizumab) for the potential treatment of human papillomavirus (HPV)16-positive head and neck cancer. A growing number of head and neck cancers are caused by HPV^1,2 and 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine.³

“Head and neck cancer is among the most difficult-to-treat cancers, often leading to severe disfigurement and, in the worst cases, death,” said Dr. Frank Bedu-Addo, PDS Biotech CEO. “The tireless efforts of HCNA and The Swallows have been instrumental in increasing awareness of this devastating disease, including greater patient screening, access, and information about its association with HPV. We are proud to join these organizations during the month of April to celebrate the progress made while acknowledging that more is needed. To address this unmet need, PDS Biotech is advancing PDS0101 to a Phase 3 clinical trial for HPV16-positive recurrent and/or metastatic head and neck cancer, with the hope that we may soon be able to improve the lives of patients and their caregivers.”

“The mission of the Head and Neck Cancer Alliance is to advance the prevention, detection, treatment and rehabilitation of oral, head and neck cancer through public awareness, research, advocacy and survivorship,” said Amanda Hollinger, MPA, Executive Director of the Head and Neck Cancer Alliance. “In pursuit of this goal, we have helped to organize April as Oral, Head & Neck Cancer Awareness Month and April 16-22 as Oral, Head & Neck Cancer Awareness Week, during which time we are partnering with patients, medical professionals, advocates, and companies, such as PDS Biotech, to focus attention on this growing subset of cancer and the need for improved treatment opportunities.”

PDS Biotech is currently running – VERSATILE-002 – a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 in combination with KEYTRUDA^® in adults with HPV16 recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Data reported at the American Society for Clinical Oncology (ASCO) Annual Meeting in 2022 indicated the combination therapy achieved an objective response rate of 41%, a clinical benefit rate of 77%, and an overall survival rate of 87% at nine months in 17 evaluable patients. Following the release of these data, the U.S. Food and Drug Administration (FDA) granted the combination of PDS0101 and KEYTRUDA^® Fast Track designation.

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 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 papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by 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, 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) compared to KEYTRUDA^® monotherapy. 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; 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. 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, quarterly 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, N.J., USA.

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

Bill Borden 
Phone: +1 (732) 910-1620 
This email address is being protected from spambots. You need JavaScript enabled to view it. 

____________________
¹ Chaturvedi AK, Engels EA, Pfeiffer RM, et al. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. Journal of Clinical Oncology 2011; 29(32)4294–4301
² “Head and Neck Cancers” National Cancer Institute https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet
³ Kobayashi, Kazuhiro; Kenji Hisamatsu, et al. “A Review of HPV-Related Head and Neck Cancer,” Journal of Clinical Medicine, published online Aug. 27, 2018. Doi: 10.3390/jcm7090241 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6162868/

FLORHAM PARK, N.J., April 12, 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 it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.

This PDS Biotech-sponsored event will focus on the potential of an IL-12 immunocytokine in oncology and the clinical results and promise demonstrated to date with PDS0301, the company’s novel investigational tumor-targeting IL-12 fusion protein. The novel investigational antibody targeted IL-12 enhances the proliferation, potency and longevity of T cells in the tumor microenvironment while also limiting its presence in the blood, which appears to promote tolerability and safety. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren Wood, and will feature presentations from the following cancer research experts:

• James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology, Deputy Director of the Center for Cancer Research, and Acting Clinical Director of the National Cancer Institute
• Jeffrey Schlom, Ph.D., Co-Director of the Center for Immuno-Oncology at the Center for Cancer Research of the National Cancer Institute

Registration for PDS Biotech’s IL-12 Focused 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 PDS Biotech - Investor Relations. A replay will be available on the company website 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 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 PDS0301 

PDS0301 is a novel investigational fusion protein of a tumor-targeting antibody and Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune^® based immunotherapies PDS0301 may work synergistically to promote a targeted T cell attack against cancers. PDS0301 is given by a simple subcutaneous injection. Clinical data suggest the addition of PDS0301 to Versamune^® based immunotherapies, such as PDS0101, can demonstrate significant disease control by shrinking tumors and/or prolonging survival in patients with recurrent/metastatic cancers with poor survival prognosis.  

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

Bill Borden 
Phone: +1 (732) 910-1620 
This email address is being protected from spambots. You need JavaScript enabled to view it.

Study evaluates the effect of combining PDS0101 with standard of care on levels of circulating HPV viral DNA in cervical cancer patients and impact on disease status and clearance

PRINCETON, N.J., Aug. 16, 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 the IMMUNOCERV Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the treatment of locally advanced cervical cancer will be featured in an oral presentation at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting. ASTRO 2023 is being held October 1-4, 2023, in San Diego, CA.

The abstract, titled “HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation,” will report on the levels of circulating HPV-positive cell-free DNA (HPV-cfDNA) in the blood of 47 cervical cancer patients during and after CRT treatment, including subjects in the IMMUNOCERV study who received PDS0101 in addition to CRT. The research is designed to evaluate the relationship between the levels of circulating HPV viral DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. The findings will be presented by Dr. Aaron Seo, MD, Ph.D., The University of Texas MD Anderson Cancer Center.

“We are pleased that PDS0101 is being evaluated in this cutting-edge approach to better understand the patients’ prognosis and the mechanism by which PDS0101 may impact clinical outcomes in cervical cancer, and we look forward to Dr. Seo’s presentation at ASTRO 2023,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Examination of HPV-cfDNA in this larger cohort of patients will also provide additional insights to the IMMUNOCERV data presented at SITC 2022, which suggested that PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and 100% (9/9) clinical response with greater than 60% tumor shrinkage at mid-point evaluation in high-risk cervical cancer patients.”

The IMMUNOCERV Phase 2 study is investigating PDS0101 in combination with standard-of-care CRT in the treatment of patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
Presentation Details:
Abstract #: 55593 
Abstract Title: HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation 
Presenter: Aaron Seo 
Author Block: Aaron Seo, Weihong Xiao, Olsi Gjyshi, Kyoko Court, Tatiana Cisneros Napravnik, Aradhana Venkatesan, Erica Lynn, Julie Sammouri, Lauren Colbert, Anuja Jhingran, Melissa Joyner, Lilie Lin, Maura Gillison, Ann Klopp 
Scientific Session Number: SS 02  
Scientific Session Title: GYN 1: Integrating the Next Wave of Biomarkers for Future Gynecologic Clinical Trials 
Session Date/Time: October 1, 8:00AM-9:00AM

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 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 effective 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.

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

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 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.