NCI to study PDS0103, in addition to planned Phase 2 clinical evaluation of PDS0101 in combination with other therapeutic agents
PRINCETON, N.J., April 29, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced an expansion of its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to include studies of PDS0103, a Versamune®-based product incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. This expansion adds to the NCI’s ongoing evaluation of PDS0101 in combination with two separate immune-modulating agents, NHS-IL12 and M7824, which will be evaluated in a phase 2 clinical trial in advanced HPV-associated cancers (NCT04287868).
Under the expanded CRADA, PDS Biotech will collaborate with the NCI Center for Cancer Research’s Genitourinary Malignancies Branch (GMB) and the Laboratory of Tumor Immunology and Biology (LTIB) to conduct preclinical studies of PDS0103, and potentially human clinical studies in combination with other therapeutic agents. PDS0103 combines Versamune® with novel highly immunogenic agonist epitopes of the mucin-1 (MUC1) oncogenic C-terminal region, designed and developed by the LTIB. PDS0103 is targeting ovarian, breast, colorectal and lung cancers where over-expression of MUC1 is associated with a high degree of unmet need.
“We are excited to further our collaboration with Dr. Schlom, Dr. Gulley, and their teams at the NCI to progress the development of PDS0103 and expand the CRADA beyond the previously announced collaboration involving PDS0101. PDS0103 monotherapy has demonstrated encouraging results in ongoing preclinical studies,” commented Dr. Bedu-Addo, Chief Executive Officer of PDS Biotechnology. “Based on the strong T-cell activation potential of the Versamune®-based products, we believe that PDS0101 and PDS0103 present an opportunity to improve immunotherapeutic treatment outcomes across multiple cancer indications. We look forward to working with the NCI as we jointly advance the development of PDS0101 and PDS0103.”
Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI will serve as principal investigators for the NCI for both the PDS0101 and PDS0103 programs, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Medical Officer, will serve as the Company’s investigators.
Dr. Julius Strauss, Staff Clinician, LTIB, will serve as the principal investigator of the phase 2 clinical trial of PDS0101 in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck, PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first line treatment of recurrent or metastatic head and neck cancer. In partnership with the National Cancer Institute (NCI), PDS Biotech is advancing a combination of PDS0101, M7824 and NHS-IL12 to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study in advanced localized cervical cancer combines PDS0101 with standard of care chemoradiotherapy.
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,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. 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 timing for the Company or its partners to initiate the planned clinical trials for its lead asset, PDS0101; the Company’s interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or 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 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 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.
Media & Investor Relations Contact:
Phone: +1 (908) 517-3613