TIDMNSCI
NetScientific PLC
15 February 2022
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Clinical Trial with Mayo Clinic
PDS Biotech Announces Clinical Trial with Mayo Clinic to Study
PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head and Neck
Cancer
The study evaluates PDS0101 with and without KEYTRUDA(R) prior
to surgery for HPV-associated oropharyngeal cancer
London, UK - 15 February 2022 - NetScientific plc (AIM: NSCI),
the international life sciences and sustainability technology
investment and commercialisation Group, announces that its
portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB),
announced the initiation of an Investigator-Initiated Trial (ITT),
MC200710, for PDS0101 alone or in combination with the checkpoint
inhibitor, KEYTRUDA(R) , in patients with HPV-associated
oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The
trial is being led by Drs. David Routman, Katharine Price, Kathryn
Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally
and internationally recognized center of excellence for the
treatment of head and neck cancers.
HPV(+)OPSCC is now the most common type of head and neck cancer
and has been increasing significantly in recent years.
Oropharyngeal cancer is a disease in which cancer cells form in the
tonsil tissues of the back (base of tongue) and side (palatine
tonsils) of the throat. According to the National Cancer Institute,
smoking or being infected with the human papillomavirus (HPV),
especially HPV16, can increase the risk of oropharyngeal cancer.
The American Cancer Society estimates there are over 54,000 new
cases of oral and oropharyngeal cancer and over 11,000 related
deaths in the United States, annually.
Dr. Lauren Wood, Chief Medical Officer of PDS Biotech commented:
"We are excited to have a team of doctors at Mayo Clinic conducting
a trial to study our novel Versamune(R)-based T cell immunotherapy
platform and lead asset, PDS0101 in earlier-stage disease.
"This upcoming trial not only broadens our addressable patient
population of those affected by the increasing incidence of
HPV(+)OPSCC, but also allows us to better understand the activity
of PDS0101."
Dr. Ilian Iliev, CEO of NetScientific, commented: "The
initiation of this trial with the world famous Mayo Clinic is in
addition to the Phase 2 clinical partnerships PDS has with Merck,
the National Cancer Institute and MD Anderson. We believe that PDS'
focus on high-quality clinical partnerships provides the company
with a strong differentiator in a time of volatility in the biotech
sector."
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-releases1/118-2022-news/591-iotechnnounceslinicalrialwithayolinictot20220215
###
FLORHAM PARK, N.J., Feb. 15, 2022 (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) and Infectimune(TM) T-cell activating technologies,
today announced the initiation of an Investigator-Initiated Trial
(ITT), MC200710, for PDS0101 alone or in combination with the
checkpoint inhibitor, KEYTRUDA(R) , in patients with HPV-associated
oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The
trial is being led by Drs. David Routman, Katharine Price, Kathryn
Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally
and internationally recognized center of excellence for the
treatment of head and neck cancers.
HPV(+)OPSCC is now the most common type of head and neck cancer
and has been increasing significantly in recent years.
Oropharyngeal cancer is a disease in which cancer cells form in the
tonsil tissues of the back (base of tongue) and side (palatine
tonsils) of the throat. According to the National Cancer Institute,
smoking or being infected with the human papillomavirus (HPV),
especially HPV16, can increase the risk of oropharyngeal cancer.
The American Cancer Society estimates there are over 54,000 new
cases of oral and oropharyngeal cancer and over 11,000 related
deaths in the United States, annually.
"We are excited to have a team of doctors at Mayo Clinic
conducting a trial to study our novel Versamune(R) -based T cell
immunotherapy platform and lead asset, PDS0101 in earlier-stage
disease," commented Dr. Lauren Wood, Chief Medical Officer of PDS
Biotech. "This upcoming trial not only broadens our addressable
patient population of those affected by the increasing incidence of
HPV(+)OPSCC, but also allows us to better understand the activity
of PDS0101 alone or in combination with KEYTRUDA(R) in earlier
stages of disease."
The study treatment will be administered before patients proceed
to transoral robotic surgery (TORS) with curative intent. Treatment
in this setting is referred to as neoadjuvant treatment. PDS0101
has been shown to induce killer T-cells that target and kill
HPV-positive cancers, either alone or in combination with
checkpoint inhibitors in preclinical studies, and in combination in
clinical studies of patients with advanced recurrent/metastatic
HPV-associated cancers. This study will explore whether PDS0101
with or without checkpoint inhibition may increase HPV-specific
anti-tumor responses, potentially resulting in tumor shrinkage,
pathologic regression, and decreases in circulating tumor DNA
(ctDNA).
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of cancer and infectious disease immunotherapies
based on the Company's proprietary Versamune(R) and Infectimune(TM)
T-cell activating technology platforms.
Our Versamune(R) -based products have demonstrated the potential
to overcome the limitations of current immunotherapy by inducing in
vivo , large quantities of high-quality, highly potent
polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells.
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. The Company's pipeline
products address various cancers including HPV16-associated cancers
(anal, cervical, head and neck, penile, vaginal, vulvar) and
breast, colon, lung, prostate, and ovarian cancers.
Our Infectimune(TM)-based vaccines have demonstrated the
potential to induce not only robust and durable neutralizing
antibody responses, but also powerful T-cell responses including
long-lasting memory T-cell responses. To learn more, please visit
www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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 (including, without limitation, any preclinical
results or data),
which are not necessarily indicative of the final results of the
Company's ongoing clinical trials; any Company statements about its
understanding of product candidates mechanisms of action and
interpretation of preclinical and early clinical results from its
clinical development programs and any collaboration studies; 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 (AIM: NSCI) is a holding company, that invests
in, develops, commercialises and realises shareholder value in life
sciences/healthcare, sustainability and technology companies, which
offer significant growth potential predominately in the UK and USA,
as well as globally.
With the acquisition of EMV Capital in August 2020, the Group
doubled its portfolio from 8 to 17 companies, either through direct
subsidiary, balance sheet investment or capital under advisory,
varying from start-up private companies to publicly listed
equities.
NetScientific delivers shareholder returns through a proactive
and hands-on management approach to their portfolio companies;
identifying, investing in, and helping to build game-changing
companies. The Group targets value inflection points and the
release of value through partial or full exits from trade sales,
public listings, or equity sales. The Company has a strong
transatlantic and growing international presence, providing
attractive expansion prospects.
NSCI can deploy a capital-light investment structure; utilising
the power of the PLC Brand, and the NetScientific balance sheet to
anchor future investments and achieve a multiplier effect by
attracting 3rd party investment for the portfolio companies.
NetScientific is headquartered in London, United Kingdom, and
was admitted to trading on AIM, a market operated by the London
Stock Exchange, in 2013 (website: netscientific.net ).
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