PDS Announces Initiation of Phase 2 Trial PDS0101

RNS Number : 0019Q

NetScientific PLC

15 June 2020

 

NetScientific plc

("NetScientific" or the "Company")

PDS Biotech Announces Initiation of Phase 2 Trial of PDS0101 Led by the National Cancer Institute

NetScientific plc (AIM:NSCI), the transatlantic healthcare IP commercialisation group, announces that its portfolio company PDS Biotechnology Corporation ("PDS") (Nasdaq: PDSB) today announced that the first patient has been dosed in the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.

  NetScientific holds 7.18% of PDS' undiluted share capital.

The full details of the announcement are set out below and can be found here:  https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/394-iotechnnouncesnitiationofhase2rialof01020200615

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FLORHAM PARK, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- 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 that the first patient has been dosed in the National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.

The NCI Center for Cancer Research's Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB) are jointly leading this Phase 2 trial evaluating PDS0101, which combines the Versamune® platform with targeted antigens in HPV-expressing cancers, in combination with Bintrafusp alfa (M7824) and NHS-IL12.

The trial will evaluate the objective response rate of this novel triple combination in approximately 35 patients with advanced HPV-associated cancers. The first eight patients will be evaluated for safety and objective response before the trial progresses to full enrollment.

"We are excited to have the first patient dosed in this NCI-led Phase 2 clinical trial, which is an important next step in further demonstrating the power of our novel Versamune® platform to induce high levels of tumor-specific CD8 killer T-cells," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "We believe that PDS0101's demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced HPV-associated cancers."

Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech's Chief Executive Officer and Chief Medical Officer respectively, will serve as PDS Biotech's investigators. The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI.

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the principal investigator of this 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 [e-mail], 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.

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 & Co., 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 also advancing a combination of PDS0101 and two clinical stage immunotherapies to a Phase 2 study in advanced HPV-associated cancers. A third phase 2 study is to be performed in advanced localized cervical cancer combining PDS0101 with standard of care chemoradiotherapy.

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The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Following the publication of this announcement, this inside information is now considered to be in the public domain.

For more information, please contact:

NetScientific 

Ilian Iliev, CEO  Tel: [phone]

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About NetScientific

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

 

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