PDS Biotech announces that it has achieved an enrollment goal in a Phase 2 clinical trial of the PDS0101-based combination in advanced HPV-associated cancers led by the National Cancer Institute


PDS Biotechnology Corporation

NCI meets target enrollment of 30 patients in the refractory checkpoint inhibitor arm

FLORHAM PARK, NJ, March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly targeted cancer therapies and infectious disease vaccines based on the company’s Versamune® and Infectimune™ T-cell activation technologies announced today that the National Cancer Institute (NCI) has met its intended enrollment goal of 30 patients in the refractory checkpoint inhibitor (CPI) arm of the NCI-led Phase 2 clinical trial (NCT04287868). has PDS0101 (Versamune®+HPV16mix) in combination with two immunomodulating test substances in advanced HPV-associated cancer. Currently, the study has enrolled 45 patients and will continue to enroll both CPI-refractory and CPI-naïve patients until the total enrollment of 56 is reached.

The study evaluates the novel triple combination in two patient groups. First, in the second-line treatment of recurrent or metastatic HPV-positive cancers, including anal, cervical, head and neck, penile, vaginal, and vulvar cancer in patients not treated with CPIs (CPI-naïve) and at least one Standard of failed nursing therapy. Second, in the third-line treatment of the recurrent or metastatic HPV-positive cancers listed above in patients who have failed at least two standard therapies including CPI treatment (CPI-refractory).

The NCI, part of the National Institutes of Health, presented promising preliminary efficacy and safety data from the study at the American Society of Clinical Oncology (ASCO) conference in June 2021. The NCI plans to provide an update in the near future. Earlier this year it was reported that the median survival of these patients now exceeds 12 months.

“We are pleased that the NCI has achieved this important milestone, as CPI-refractory patients with various HPV-associated cancers have very few effective treatment options and study data have demonstrated the potential to prolong the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all their efforts in achieving this recruitment goal.”

Patients interested in participating in this clinical study should call NCI toll-free 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and send an email to [email protected] nih.gov and/or visit: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies for cancer and infectious diseases based on the company’s Versamune® and Infectimune™ T-cell activating technology platforms.

Our versamune®-based targeted products have shown the potential to overcome the limitations of current induction-based immunotherapy in vivo, large quantities of high-quality, highly potent polyfunctional tumor-specific CD4+ helper and CD8+ killer T cells. PDS Biotech has developed several therapies based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products treat multiple cancers, including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar), breast, colon, lung, prostate and cancer ovarian cancer.

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also potent T-cell responses, including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward-Looking Statements

This release 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) with respect to PDS Biotechnology Corporation (the “Companies “) and other matters. These statements may discuss goals, intentions and expectations regarding 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 and information currently available, administration. Forward-looking statements generally include statements that are forward-looking in nature and depend on or relate to future events or conditions and contain words such as “may”, “will”, “should”, “would”, “expects”, “anticipates” . ”, “plan”, “likely”, “believe”, “estimate”, “forecast”, “intend”, “forecast”, “guidance”, “outlook” and other similar expressions. 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 statements due to a number of 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 liquidity needs and the company’s current expectations regarding its plans for future equity financing; the Company’s dependence on additional financing to fund its operations and to complete the development and commercialization of its product candidates and the risks that raising such additional capital could limit the Company’s operations or require the Company to acquire rights to the technologies or product candidates of the give up company; 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 a business plan; the timing for the Company or its partners to initiate planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such attempts; the successful implementation of the Company’s research and development programs and collaborations, including all collaboration studies related to 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 costs 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 recruitment and completion of the trials (including our ability to maintain our disclosed fully fund clinical trials). , assuming no material changes from our current projected outputs), futility analyses, conference presentations and data reported in an abstract, and the receipt of interim results (including but not limited to any pre-clinical results or data) that are not necessarily the final results of the Company’s ongoing clinical trials indicate this; all statements by the Company regarding its understanding of the mechanisms of action of product candidates and the interpretation of pre-clinical and early clinical results from its clinical development programs and collaborative studies; the market acceptance of the Company’s product candidates, if approved; the Company’s timing and ability to obtain and maintain U.S. Food and Drug Administration or other regulatory agency approval or other actions with respect to the Company’s product candidates; and other factors, including legal, regulatory, political and economic developments beyond the Company’s control, including unforeseen circumstances or other disruptions to normal business operations, arising out of or related to COVID-19. The foregoing summary 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 contained herein and elsewhere, including the risk factors contained in The Company’s annual and interim reports filed with us include the S. The forward-looking statements are made only as of the date of this press release and, except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements or to endorse any other forward-looking statements whether as a result of new information, future events or any other reason.

Investor contact:
Rich Cockrell
CG capital
Telephone: +1 (404) 736-3838
[email protected]


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