TIDMNSCI
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(R)
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
###
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(R) 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-<BETA> "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-<BETA> (TGF-<BETA> "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(R) 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 NCIMO_Referrals@mail.nih.gov
, 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(R) T-cell
activating technology platform. Versamune(R) 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(R) 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(R) platform with targeted antigens in HPV-expressing
cancers. In partnership with Merck and Co., PDS Biotech is
advancing a combination of PDS0101 and KEYTRUDA(R) 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.
###
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 +44 (0)20 7220 1666
Walbrook PR
Anna Dunphy/ Nick Rome/ Paul McManus/ 07876 741 001 or 07748 325 236
Nicholas Johnson or 07980 541 893
or 07884 664 686
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END
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