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Strategic partnership offers both organizations a way to share information about emerging treatment options with clinicians and patients battling HPV-attributed head and neck cancer

FLORHAM PARK, N.J., May 27, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a novel therapy for HPV-associated cancer based on the Company’s proprietary Versamune® T-cell activating technology, and the Head and Neck Cancer Alliance (HNCA) today announced a partnership. This collaboration seeks to raise awareness of new and developing treatment options, including available clinical trials, for patients with HPV-attributed head and neck cancer diagnoses.

Unlike many other cancers, the incidence of head and neck cancer is increasing in the United States, primarily due to rates of infection with human papillomavirus (HPV). Because head and neck cancer is often diagnosed at later stages, treatment is often more difficult and more invasive. PDS Biotech is working to change the landscape of HPV-attributed head and neck cancer treatment with their lead candidate, PDS0101, which uses Versamune® to activate the immune system to recognize HPV-associated cancer cells and respond by inducing T-cells to attack and destroy them.

Partnerships such as the one between PDS Biotech and HNCA are becoming more common in the patient advocacy and biotechnology spaces. By combining their efforts, partners can more efficiently spread the word about emerging treatments, clinical trials, and additional options for patients who may not have responded to traditional therapies.

“Raising awareness of treatment options for patients and their families who are dealing with head and neck cancer that has returned or spread is critical,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Treatment options for these patients can be limited and the search often expands to include investigational therapies being studied in clinical research. We’re excited to partner with the HNCA to raise awareness of these options for patients and physicians.”

“There are exciting things happening in clinical research for head and neck cancer therapies,” said Amanda Hollinger, Executive Director of HNCA. “Partnering with companies like PDS Biotech who are leading the way forward and working together to raise awareness of new and developing treatment options brings hope to patients, survivors, and families of those battling cancer, as well as offering new avenues of treatment for clinicians.”

Head and neck cancer refers to cancers that arise in the mouth, voice box, throat, sinuses, nasal cavity, or salivary glands. Worldwide in 2021, there will be more than 650,000 new cases of oral, head and neck cancer diagnosed and approximately 330,000 deaths from these cancers. Over the last few decades, there has been a 225% increase in HPV-attributed head and neck cancer diagnoses. In 2018, head and neck cancer surpassed cervical cancer as the most common HPV-attributed cancer in the United States.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products 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. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. 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-expressing cancers.  In partnership with Merck and 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. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

About Head and Neck Cancer Alliance
HNCA’s mission is to advance prevention, detection, treatment and rehabilitation of oral, head and neck cancer through public awareness, research, advocacy and survivorship. As the one-stop center for patients, survivors, and family members seeking information about head and neck cancer, HNCA provides support to head and neck cancer patients throughout the year and works in partnership with healthcare, corporate, and community partners to raise awareness of ongoing research in head and neck oncology and educate the public in the disease process, treatment and prevention of oral, head and neck cancers. Led by a Board of Directors with expertise in head and neck surgery, research, and survivorship, HNCA develops strategic priorities to tackle the challenges facing those impacted by this disease.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; 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® based products 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 our ability to fully fund our 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 results, 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 acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; 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.

PDS Biotech Media & Investor Relations Contact:

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.


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