TIDMNSCI
RNS Number : 1375X
NetScientific PLC
30 April 2021
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Biotech Announces Oral Presentation of PDS0101 Data
by the National Cancer Institute at 2021 American Society of
Clinical Oncology Annual Meeting
London, UK - 30 April 2021 - NetScientific plc (AIM: NSCI), the
life sciences and sustainability technology investment and
commercialisation Group, announces that its portfolio company PDS
Biotechnology Corporation (Nasdaq: PDSB) yesterday announced that
initial efficacy and safety data from 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 (NCT04287868) has
been accepted for oral presentation at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting taking place 4-8 June
2021.
NetScientific holds 5.75% of PDS on an undiluted basis.
The full text of the announcement from PDS Biotechnology is
reproduced below and is available online here:
https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/113-2021-news/516-iotechnnouncesralresentationof0101ataby20210429
# # #
FLORHAM PARK, N.J., April 29, 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
initial efficacy and safety data from 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 (NCT04287868) has
been accepted for oral presentation at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting taking place June
4-8.
The accepted abstract summarizes initial findings from the
ongoing trial, which studies PDS0101 in combination with two
investigational immune-modulating agents: bintrafusp alfa (M7824),
a bifunctional "trap" fusion protein targeting TGF-<BETA> and
PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine.
Earlier this year, it was announced that the trial had achieved its
preliminary efficacy threshold of an objective response in 3 or
more of the first 8 patients as measured by RECIST 1.1. The trial
subsequently expanded enrollment to both checkpoint inhibitor naïve
patients and patients who have failed prior therapy with checkpoint
inhibitors. "We are encouraged by the data and look forward to the
presentation of initial findings from the study," said Dr. Lauren
V. Wood, Chief Medical Officer of PDS Biotech. "ASCO provides an
important opportunity to share the potential of both PDS0101 and
the Versamune(R) platform with the research and medical
community."
Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of
PDS0101, M9241, and bintrafusp alfa in patients with HPV 16
positive malignancies.
Presenting Author: Julius Strauss, MD, National Cancer
Institute
Session: Developmental Therapeutics-Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT
The abstract will be available on Wednesday, May 19 at 5:00 PM
EDT on ASCO.org.
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(R) T-cell
activating technology platform. The company's lead investigational
cancer immunotherapy product PDS0101 is currently in Phase 2
clinical studies in multiple indications. 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 developed multiple therapies, based on combinations
of Versamune(R) and disease-specific antigens, designed to train
the immune system to better recognize diseased 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
evaluating a combination of PDS0101 and KEYTRUDA(R) in a Phase 2
study in first-line treatment of recurrent or metastatic head and
neck cancer. PDS Biotech is also conducting two additional Phase 2
studies in advanced HPV-associated cancers and advanced localized
cervical cancer with the National Cancer Institute (NCI) and The
University of Texas MD Anderson Cancer Center, respectively.
Forward Looking Statements
This communication contains forward-looking statements
(including within the meaning of Section 21E of the United States
Securities Exchange Act of 1934, as amended, and Section 27A of the
United States Securities Act of 1933, as amended) concerning PDS
Biotechnology Corporation (the "Company") and other matters. These
statements may discuss goals, intentions and expectations as to
future plans, trends, events, results of operations or financial
condition, or otherwise, based on current beliefs of the Company's
management, as well as assumptions made by, and information
currently available to, management. Forward-looking statements
generally include statements that are predictive in nature and
depend upon or refer to future events or conditions, and include
words such as "may," "will," "should," "would," "expect,"
"anticipate," "plan," "likely," "believe," "estimate," "project,"
"intend," "forecast," "guidance", "outlook" and other similar
expressions among others. Forward-looking statements are based on
current beliefs and assumptions that are subject to risks and
uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors,
including, without limitation: the Company's ability to protect its
intellectual property rights; the Company's anticipated capital
requirements, including the Company's anticipated cash runway and
the Company's current expectations regarding its plans for future
equity financings; the Company's dependence on additional financing
to fund its operations and complete the development and
commercialization of its product candidates, and the risks that
raising such additional capital may restrict the Company's
operations or require the Company to relinquish rights to the
Company's technologies or product candidates; the Company's limited
operating history in the Company's current line of business, which
makes it difficult to evaluate the Company's prospects, the
Company's business plan or the likelihood of the Company's
successful implementation of such business plan; the timing for the
Company or its partners to initiate the planned clinical trials for
PDS0101, PDS0203 and other Versamune(R) based products; the future
success of such trials; the successful implementation of the
Company's research and development programs and collaborations,
including any collaboration studies concerning PDS0101, PDS0203 and
other Versamune(R) based products and the Company's interpretation
of the results and findings of such programs and collaborations and
whether such results are sufficient to support the future success
of the Company's product candidates; the success, timing and cost
of the Company's ongoing clinical trials and anticipated clinical
trials for the Company's current product candidates, including
statements regarding the timing of initiation, pace of enrollment
and completion of the trials (including our ability to fully fund
our disclosed clinical trials, which assumes no material changes to
our currently projected expenses), futility analyses, presentations
at conferences and data reported in an abstract, and receipt of
interim results, which are not necessarily indicative of the final
results of the Company's ongoing clinical trials; the acceptance by
the market of the Company's product candidates, if approved; the
timing of and the Company's ability to obtain and maintain U.S.
Food and Drug Administration or other regulatory authority approval
of, or other action with respect to, the Company's product
candidates; and other factors, including legislative, regulatory,
political and economic developments not within the Company's
control, including unforeseen circumstances or other disruptions to
normal business operations arising from or related to COVID-19. The
foregoing review of important factors that could cause actual
events to differ from expectations should not be construed as
exhaustive and should be read in conjunction with statements that
are included herein and elsewhere, including the risk factors
included in the Company's annual and periodic reports filed with
the SEC. The forward-looking statements are made only as of the
date of this press release and, except as required by applicable
law, the Company undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
# # #
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 +44 (0)20 7933 8780 or netscientific@walbrookpr.com
Nick Rome / Nicholas Johnson / Paul 07748 325 236 / 07884 664 686 / 07980
McManus 541 893
About NetScientific
NetScientific Plc is a life sciences and sustainability
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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