TIDMNSCI
NetScientific PLC
24 February 2022
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Biotech Announces Preliminary Safety Data on PDS0101 in
Combination With Merck's anti PD-therapy KEYTRUDA(R)
(pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers
Symposium
Preliminary safety data has shown that PDS0101 in combination
with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab) for the
treatment of recurrent or metastatic HPV16-positive head and neck
cancer is likely safe and well tolerated without evidence of
enhanced or significant toxicity
London, UK - 24 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 presentation of preliminary safety data on PDS0101 in
combination with Merck's anti-PD-1 therapy, Keytruda. The data is
based on a total of 18 checkpoint inhibitor (CPI) naïve patients
from the Company's ongoing VERSATILE-002 Phase 2 study. The study
is being conducted in collaboration with Merck (known as MSD
outside the US and Canada) (NCT04260126). The data from the study
will be presented at the 2022 Multidisciplinary Head and Neck
Cancers Symposium.
The Phase 2 trial studies PDS0101 in combination with Merck's
anti-PD-1 therapy KEYTRUDA(R) (pembrolizumab) for the treatment of
recurrent or metastatic HPV16-positive head and neck cancer. The
trial is designed to treat both CPI naïve and refractory patients
and will assess the primary efficacy endpoint, as well as partial
response per RECIST 1.1. The Company previously announced that it
had achieved its preliminary efficacy milestone in the CPI naive
arm earlier this month.
Patients in the trial are treated with KEYTRUDA(R) 200 mg
intravenously every three weeks plus PDS0101 delivered
subcutaneously with KEYTRUDA(R) on cycles of 1-4 and again at cycle
12. An initial safety cohort was assessed during cycle 1 and 21
days following for dose-limiting toxicity, and thereafter for
safety and tolerability of the combination.
Highlights from the PDS Biotech's presentation at the 2022
Multidisciplinary Head and Neck Cancers Symposium regarding the
preliminary results of the Phase 2 trial studying PDS0101 in
combination with KEYTRUDA for the treatment of recurrent or
metastatic HPV16-positive head and neck cancer include the absence
of dose-limiting toxicities, drug discontinuation related to
toxicity, or immune-related adverse events. Subjects received a
median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of
KEYTRUDA(R) (range 1-13). In addition, no treatment-related grade 3
or higher toxicities were reported.
Preliminary safety data has shown that PDS0101 in combination
with KEYTRUDA(R) for the treatment of recurrent or metastatic
HPV16-positive head and neck cancer is likely safe and well
tolerated without evidence of enhanced or significant toxicity in
the first 18 patients evaluated on the study. Accrual in this study
has progressed to Stage 2 for the CPI naïve cohort and is ongoing
in Stage 1 for the CPI refractory cohort.
Dr. Lauren Wood, Chief Medical Officer of PDS Biotech commented:
"We are encouraged by the preliminary safety data of PDS0101 in
combination with KEYTRUDA(R) for patients with recurrent or
metastatic HPV16-positive head and neck cancer.
"These data and the preliminary efficacy data continue to
support the unique combination of safety and potency of our novel
Versamune(R) platform."
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/592-iotechnnouncesreliminaryafetyataon0101in20220224
###
FLORHAM PARK, N.J., Feb. 24, 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 technology,
today announced the presentation of preliminary safety data. The
data are based on a total of 18 checkpoint inhibitor (CPI) naïve
patients from the Company's ongoing VERSATILE-002 Phase 2 study.
The study is being conducted in collaboration with Merck (known as
MSD outside the US and Canada) (NCT04260126). The data from the
study will be presented at the 2022 Multidisciplinary Head and Neck
Cancers Symposium.
The Phase 2 trial studies PDS0101 in combination with Merck's
anti-PD-1 therapy KEYTRUDA(R) (pembrolizumab) for the treatment of
recurrent or metastatic HPV16-positive head and neck cancer. The
trial is designed to treat both CPI naïve and refractory patients
and will assess the primary efficacy endpoint, as well as partial
response per RECIST 1.1. The Company previously announced that it
had achieved its preliminary efficacy milestone in the CPI naive
arm earlier this month.
Patients in the trial are treated with KEYTRUDA(R) 200 mg
intravenously every three weeks plus PDS0101 delivered
subcutaneously with KEYTRUDA(R) on cycles of 1-4 and again at cycle
12. An initial safety cohort was assessed during cycle 1 and 21
days following for dose-limiting toxicity, and thereafter for
safety and tolerability of the combination.
Highlights from the PDS Biotech's presentation at the 2022
Multidisciplinary Head and Neck Cancers Symposium regarding the
preliminary results of the Phase 2 trial studying PDS0101 in
combination with KEYTRUDA for the treatment of recurrent or
metastatic HPV16-positive head and neck cancer include the absence
of dose-limiting toxicities, drug discontinuation related to
toxicity, or immune-related adverse events. Subjects received a
median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of
KEYTRUDA(R) (range 1-13). In addition, no treatment-related grade 3
or higher toxicities were reported.
Preliminary safety data has shown that PDS0101 in combination
with KEYTRUDA(R) for the treatment of recurrent or metastatic
HPV16-positive head and neck cancer is likely safe and well
tolerated without evidence of enhanced or significant toxicity in
the first 18 patients evaluated on the study. Accrual in this study
has progressed to Stage 2 for the CPI naïve cohort and is ongoing
in Stage 1 for the CPI refractory cohort. The full data set can be
found under abstract number 157 at the virtual poster library, here
.
Receipt of preliminary results are not necessarily indicative of
the final-results of the Phase 2 trial studying PDS0101 in
combination with KEYTRUDA(R) for the treatment of recurrent or
metastatic HPV16-positive head and neck cancer.
"We are encouraged by the preliminary safety data of PDS0101 in
combination with KEYTRUDA(R) for patients with recurrent or
metastatic HPV16-positive head and neck cancer," commented Dr.
Lauren V. Wood, Chief Medical Officer of PDS Biotech. "These data
and the preliminary efficacy data continue to support the unique
combination of safety and potency of our novel Versamune(R)
platform."
In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS
Biotech is conducting another Phase 2 clinical study in both
second-and third-line treatment for multiple advanced
HPV-associated cancers with the National Cancer Institute (NCI)
(NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV
(NCT04580771), in first-line treatment of locally advanced cervical
cancer is being performed with The University of Texas, MD Anderson
Cancer Center. In addition, the Company recently announced a fourth
Phase 2 trial with Mayo Clinic to study PDS0101 with and without
KEYTRUDA(R) prior to surgery in locally advanced HPV-associated
oropharyngeal cancer (NCT05232851).
KEYTRUDA(R) is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
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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