PDS Biotech Supports Oral, Head & Neck Cancer Awareness Month During April and Oral, Head & Neck Cancer Awareness Week from April 16-22, 2023

Rhea-AI Summary

PDS Biotech announced plans to advance PDS0101 into a Phase 3 clinical trial named VERSATILE-003, targeting HPV16-positive recurrent and/or metastatic head and neck cancer in 2023. This initiative aligns with Oral, Head & Neck Cancer Awareness Month in April. The Phase 3 trial follows positive results from a Phase 2 study, which indicated a 41% objective response rate and an 87% overall survival rate at nine months. The combination therapy of PDS0101 with KEYTRUDA received Fast Track designation from the FDA, underscoring its potential in addressing a significant unmet medical need.

Positive

• PDS0101 enters Phase 3 trial, VERSATILE-003, targeting HPV16-positive head and neck cancer.
• Positive results from Phase 2 trial showed 41% objective response rate.
• 87% overall survival rate at nine months in prior clinical studies.
• FDA Fast Track designation for PDS0101 and KEYTRUDA combination.

Negative

• None.

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: 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 

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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/

FAQ

What is the focus of PDS Biotech's VERSATILE-003 trial?

The VERSATILE-003 trial focuses on HPV16-positive recurrent or metastatic head and neck cancer.

What positive results did PDS0101 achieve in clinical trials?

PDS0101 achieved a 41% objective response rate and an 87% overall survival rate at nine months in Phase 2 trials.

When is the VERSATILE-003 trial expected to commence?

The VERSATILE-003 trial is planned to begin in 2023.

What designation has the FDA given to the PDS0101 and KEYTRUDA combination?

The FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA.

What is the significance of Oral, Head & Neck Cancer Awareness Month for PDS Biotech?

PDS Biotech recognizes the importance of awareness initiatives during Oral, Head & Neck Cancer Awareness Month, supporting increased screening and education.