PDS Biotech Initiates VERSATILE-002 Phase 2 Trial

RNS Number : 8655E

NetScientific PLC

10 November 2020

 

NetScientific plc

("NetScientific" or the "Company")

  PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer in Collaboration with Merck

 VERSATILE-002 Trial for First Line Treatment of Recurrent/Metastatic Head and Neck Cancer with Combination PDS0101-KEYTRUDA® is Now Open and Recruiting Patients

London, UK - 10 November 2020 - NetScientific plc (AIM: NSCI), the life sciences, technology investment and commercialisation company, announces that its portfolio company PDS Biotechnology Corporation ("PDS") (Nasdaq: PDSB) today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread, is now open. The trial is being conducted in collaboration with Merck.

The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomised trial that plans to enroll approximately 100 patients across 25 sites in the United States of America. The University of Tennessee Medical Center is the first site to open. The studies performed at the UT Medical Center will be led by Principal Investigator Dr. Timothy Panella, M.D. The clinical study will evaluate the efficacy and safety of PDS0101, PDS Biotech's lead Versamune®-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, in combination with KEYTRUDA® (pembrolizumab), Merck's checkpoint inhibitor, in the first-line treatment of patients with HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA® was approved by the FDA in June 2019 as first-line treatment for recurrent or metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. The main efficacy endpoint in this study is shrinkage of the tumor referred to as the objective response rate (ORR) at nine months following the initiation of treatment with the combination.

"The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients."

Dr. Ilian Iliev, Chief Executive Office of the Company and Director of PDS Biotechnology said: "We are pleased at the continued and accelerating progress of PDS in reaching this key milestone with the start of this Phase 2 combination trial. The collaboration with Merck for this trial is another significant step forward for the company. The trial will determine if the combination provides improved treatment benefit to patients when compared with administration of Merck's KEYTRUDA® first-line treatment only. This further progress follows the development plans presented earlier this year by PDS to NetScientific."

NetScientific holds approximately 5.75% of PDS' undiluted share capital.

The full details of the announcement are set out below and can be found here: https://pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/451-iotechnitiates002hase2ombinationri20201109  

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PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer in Collaboration with Merck

VERSATILE-002 Trial for First Line Treatment of Recurrent/Metastatic Head and Neck Cancer with Combination PDS0101-KEYTRUDA® is Now Open and Recruiting Patients

Florham Park, NJ, November 9, 2020 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company developing novel cancer therapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology, today announced that its VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 and KEYTRUDA® (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread is now open. The trial is being conducted in collaboration with Merck.

The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S.. The University of Tennessee Medical Center is the first site to open. The studies to be performed at the UT Medical Center will be led by Principal Investigator Dr. Timothy Panella, M.D. The clinical study will evaluate the efficacy and safety of PDS0101, PDS Biotech's lead Versamune®-based immunotherapy targeting human papillomavirus (HPV)-associated cancers, in combination with KEYTRUDA® (pembrolizumab), Merck's checkpoint inhibitor, in the first-line treatment of patients with HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA® was approved by the FDA in June 2019 as first-line treatment for recurrent or metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. The main efficacy endpoint in this study is shrinkage of the tumor referred to as the objective response rate (ORR) at nine months following the initiation of treatment with the combination.

"The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients."

Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech added, "Initial studies suggest that Versamune®-based immunotherapies administered in combination with checkpoint inhibitors, such as KEYTRUDA®, have the potential to enhance the immune system's ability to induce a more powerful and targeted anti-tumor response. We look forward to sharing updates as this study progresses."

"We are thrilled to offer our patients with recurrent or metastatic head and neck cancer such an exciting and potentially safe treatment option," commented Dr. Timothy Panella, who is the VERSATILE-002 Principal Investigator at the UT Medical Center, "this type of combination approach is attractive to patients and offers a novel targeted therapy in the fight against this very challenging disease."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [e-mail] or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

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 and 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 separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

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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]

WH Ireland (NOMAD, Financial Adviser and Broker)

Chris Fielding / Darshan Patel  Tel: [phone]

About NetScientific

NetScientific is a life sciences, technology investment and commercialisation Group, leveraging trans-Atlantic relationships and global opportunities to deliver shareholder value.

For more information, please visit the website at    www.NetScientific.net

 

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