PDS Phase II Trial Update & Restoration of Trading

RNS Number : 9104N

NetScientific PLC

03 February 2021

 

NetScientific plc

("NetScientific" or the "Company")

PDS Biotech Announces Preliminary Efficacy Achievement in Phase II Combination Trial of PDS0101 Led by the National Cancer Institute

Restoration of Trading

· The National Cancer Institute's (NCI) Phase II clinical study of PDS Biotech's PDS0101 for HPV-associated cancers has achieved its preliminary objective response.

· Full enrollment for the Phase II trial is triggered by observation of 3 objective responses in continued evaluation of the initial group of 8 patients

· Milestone for treatment of HPV-associated cancers

NetScientific plc (AIM: NSCI), the life sciences, technology, investment and commercialisation company, announces   that its portfolio company PDS Biotechnology Corporation ("PDS") (Nasdaq: PDSB) has achieved its preliminary objective response for the National Cancer Institute's (NCI) Phase II clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment.

The trial, which studies PDS0101 in combination with two promising immune-modulating agents M7824 and NHS-IL12, will now progress to full enrollment of approximately 20 patients who are checkpoint inhibitor naïve, and approximately 20 who have failed prior therapy with checkpoint inhibitors (CPI refractory).

Dr. Ilian Iliev, CEO of NetScientific and Director of PDS Biotechnology commented : "PDS' progress is consistent with our investment and management strategy, which is focused on promising cutting edge companies who can deliver on their ambitious plans. We look forward to sharing further positive news of PDS and our other portfolio companies".

Prof. Stephen Smith, Non-Executive Director of NetScientific commented:

"Over the last year PDS has made significant progress in developing its pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. These preliminary results show the promise of PDS' approach in the personalised cancer care space."

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

Restoration of Trading

On 2 February 2021, the Company requested a suspension of trading in its shares on AIM pending the release of a notification from one of its portfolio companies.

Following the issue of this announcement and its publication to the market, it is expected that trading in the Company's ordinary shares on AIM will be restored at 2.45 p.m. today.

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-releases1/113-2021-news/477-iotechnnouncesreliminaryfficacychievementin20210203

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PDS Biotech Announces Preliminary Efficacy Achievement in Phase II Combination Trial of PDS0101 Led by the National Cancer Institute

Full enrollment triggered by observation of 3 objective responses in continued evaluation of the initial group of 8 patients

FLORHAM PARK, N.J., Feb. 03, 2021 (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 National Cancer Institute's (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response. The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β "trap"/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients.  As a result of achieving this milestone, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

The NCI Center for Cancer Research's Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial. The trial is evaluating the treatment combination in two patient groups: one in patients who failed prior treatment, but are naïve to checkpoint inhibitor treatment; and the second in patients who have failed treatment with checkpoint inhibitors. As prespecified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 or iRECIST among at least three of the first eight patients allows the trial to progress to full enrollment.

Pooled data from phase 1 and 2 trials reported in the October 2020 issue of the Journal for Immunotherapy of Cancer (J ImmunoTher Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a first-in-class bifunctional fusion protein composed of the extracellular domain of human TGF-β (TGF-β "trap") fused to an IgG1 antibody blocking PD-L1 (anti-PD-L1) protein, demonstrated efficacy in checkpoint inhibitor-naïve patients with HPV-associated malignancies. The observed response rate was 30.5%. M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells. In preclinical studies performed at the NCI comparing each drug alone versus all three agents used in combination, the triple combination achieved the highest induction of tumor-specific CD8+ killer T-cells and superior antitumor effect (J ImmunoTher Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612).

"The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune®platform's potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief 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 and currently untreatable HPV-associated cancers."

The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI. 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, are serving as PDS Biotech's investigators.

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial 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), email  [e-mail] , 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 and Co., PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to a Phase II 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 II studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.

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Further details and the information required in accordance with the requirements of Article 19(3) of the EU Market Abuse Regulation No 596/2014 are set out at the end of this announcement.

For more information, please contact:

NetScientific	Via Walbrook PR
Ilian Iliev, CEO
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel	[phone]
Walbrook PR
Anna Dunphy/ Nick Rome/ Paul McManus/ Nicholas Johnson	07876 741 001 or 07748 325 236 or 07980 541 893 or 07884 664 686

 

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