(“NetScientific” or the “Company”)
PDS Biotechnology Expands CRADA with the National Cancer Institute
to Include Second Versamune®-Based Anti-Cancer Product
London, UK – 30 April 2020 – NetScientific plc (AIM: NSCI), the transatlantic healthcare IP commercialisation Group, today announces that its portfolio company PDS Biotechnology Corporation (“PDS”) (Nasdaq: PDSB) announced yesterday (29 April 2020) 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).
Below is the full announcement made yesterday (29 April 2020) by PDS Biotechnology.
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PDS Biotechnology Expands CRADA with the National Cancer Institute to Include Second Versamune®-Based Anti-Cancer Product
NCI to study PDS0103, in addition to planned Phase 2 clinical evaluation of PDS0101 in combination with other therapeutic agents
Princeton, NJ, April 29, 2020 – PDS Biotechnology Corporation (Nasdaq: 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.
For more information, please contact:
Ian Postlethwaite, CEO/CFO
|Tel: +44 (0)20 3514 1800|
|WHIreland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel
|Tel: +44 (0)20 7220 1666|
|MO PR ADVISORY (Press Contact)
|Tel: +44 (0)78 7644 4977|
NetScientific PLC is a transatlantic healthcare IP commercialisation Group focused on technologies and companies that have the potential to treat chronic disease and significantly improve the health and well-being of people.
For more information, please visit the website at www.NetScientific.net