TIDMNSCI
RNS Number : 2062B
NetScientific PLC
08 June 2021
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Biotech Announces Release of Interim Data for PDS0101 in
NCI-Led Phase 2 Clinical Study in Oral Presentation at ASCO 2021
Annual Meeting
London, UK - 8 June 2021 - 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),
today announced the presentation of interim data from the Phase 2
trial led by the National Cancer Institute (NCI), of the National
Institutes of Health (NIH), at the American Society of Clinical
Oncology (ASCO) 2021 Annual Meeting.
The Phase 2 trial (NCT04287868) studies PDS0101 (Versamune(R)
-HPV16) 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 tumour-targeting immunocytokine. PDS0101 is an immunotherapy
candidate designed to treat cancers caused by infection with HPV16
(HPV16-positive cancers) by activating the immune system to produce
in vivo CD8+ (killer) T-cells to target and kill tumours that are
HPV16-positive. Analyses of immune responses and other immune
correlates are ongoing.
Dr. Lauren Wood, Chief Medical Officer of PDS Biotechnology,
commented: "The achievement of a 67% tumour reduction among all
HPV16-positive cancer patients including both CPI naïve and CPI
refractory patients continues to strengthen the evidence supporting
continuing clinical investigation of novel Versamune(R) platform's
potential ability to induce high levels of tumour-specific CD8+
killer T-cells that attack the cancer in which we believe results
in a strong synergy with bintrafusp alfa and NHS-IL12. The data
provide early evidence of notable clinical activity, and we saw
effective tumour regression in these patients"
"The interim data demonstrating that this response was limited
only to patients with HVP16-positive cancer, and also the fact that
all responding patients who have stayed on treatment continue to
show ongoing responses after a median duration of 8 months
solidifies our belief that PDS0101's ability to generate a robust,
targeted T-cell response may have the potential to significantly
improve clinical outcomes for patients with advanced, refractory
HPV16-associated cancers who have limited treatment options."
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://pdsbiotech.com/investors/news-center/press-releases/press-releases1/113-2021-news/532-iotechnnounceseleaseo20210608
###
FLORHAM PARK, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- PDS
Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies based on
the Company's proprietary Versamune(R) T-cell activating
technology, today announced the presentation of interim data from
the Phase 2 trial led by the National Cancer Institute (NCI), of
the National Institutes of Health (NIH), at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting.
The Phase 2 trial (NCT04287868) studies PDS0101 (Versamune(R)
-HPV16) 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. PDS0101 is an immunotherapy
candidate designed to treat cancers caused by infection with HPV16
(HPV16-positive cancers) by activating the immune system to produce
in vivo CD8+ (killer) T-cells to target and kill tumors that are
HPV16-positive. Analyses of immune responses and other immune
correlates are ongoing.
Highlights from the presentation include the following:
-- Data from a total of 25 patients with data available as of
the time of presentation submission:
o Update on the data previously reported for the original
fourteen (14) HPV16-positive patients who were in the subject of
the abstract published on May 19(th) .
o An additional seven (7) HPV16-negative patients (patients
whose cancer was NOT caused by HPV16 infection) who were not
discussed in the abstract.
o An additional four (4) HPV16-positive patients who are
checkpoint inhibitor refractory whose data became available after
the abstract submission.
-- 100% (25/25) of patients enrolled had failed chemotherapy treatment.
-- 96% (24/25) of patients enrolled had failed both chemotherapy and radiation treatment.
-- 56% (14/25) of patients enrolled had failed checkpoint
inhibitor therapy (checkpoint inhibitor refractory).
-- Most types of HPV-related cancers (anal, cervical, head and
neck, vaginal and vulvar cancers) were represented among the study
subjects.
-- The following update was provided on the initial six (6)
HPV16-positive patients who had NOT been treated with checkpoint
inhibitors (checkpoint inhibitor naïve):
o 83% (5/6) of the patients demonstrated an objective response
(tumor reduction >30%). The reported objective response rate
with current standard of care checkpoint inhibitor treatment is
12-24%.
o 100% (6/6) are still alive at 8 months - the historic average
(median) survival or life span for this patient population is 7-11
months.
o 80% (4/5) of patients who had an objective response still have
an ongoing response at 8 months.
o One (1) patient had a complete response (no evidence of
disease).
o No new patients had been added to this group by the time of
submission.
-- The following information was provided on the twelve (12)
HPV16-positive patients who have also failed treatment with
checkpoint inhibitors after failing chemotherapy and radiation
treatment (checkpoint inhibitor refractory):
o Four patients had recently been added since the abstract.
Tumor reduction was observed in 58% (7/12), with an overall
objective response rate of 42% (5/12) already achieved; the
objective response rate of the current standard of care is
5-12%
o One patient in this group had achieved a complete response by
the time of reporting
o 80% (4/5) of patients who had an objective response have an
ongoing response at 8 months
o 83% (10/12) of patients are still alive at 8 months; historic
average (median) survival or life span for this patient population
is only 3-4 months
-- PDS0101 is designed to treat patients whose cancer is caused
by infection with HPV16. Seven (7) patients had cancer that was not
caused by HPV16 (HPV16-negative patients). In this group
o 0% (0/7) experienced tumor reduction.
o 80% (4/5) checkpoint inhibitor naïve patients are still alive
at 8 months.
o 0% (0/2) checkpoint inhibitor refractory patients are still
alive at 8 months.
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. Bintrafusp alfa is
being jointly developed by Merck KGaA, Darmstadt, Germany, and
GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA,
Darmstadt, Germany.
The trial is evaluating the treatment combination in both
checkpoint inhibitor naïve and refractory patients with advanced
HPV-associated cancers that have progressed or returned after
treatment. The vast majority of these cancers are caused by HPV16
infection. Objective response is measured by radiographic tumor
responses according to RECIST 1.1. These reported data provide
additional insights following the preclinical studies published by
the NCI examining the potentially complementary mechanisms of
action of the three immunotherapies, understood to involve potent
in-vivo HPV16-specific killer and helper T-cell induction with
effective T-cell tumor infiltration (PDS0101), blocking of immune
checkpoints as well as targeting of TGF-<BETA> (Bintrafusp
alfa). The preclinical results suggested superior tumor
regression.
"The achievement of a 67% tumor reduction among all
HPV16-positive cancer patients including both CPI naïve and CPI
refractory patients continues to strengthen the evidence supporting
continuing clinical investigation of novel Versamune(R) platform's
potential ability to induce high levels of tumor-specific CD8+
killer T-cells that attack the cancer in which we believe results
in a strong synergy with bintrafusp alfa and NHS-IL12. The data
provide early evidence of notable clinical activity, and we saw
effective tumor regression in these patients," commented Dr. Lauren
Wood, Chief Medical Officer of PDS Biotech. "The interim data
demonstrating that this response was limited only to patients with
HVP16-positive cancer, and also the fact that all responding
patients who have stayed on treatment continue to show ongoing
responses after a median duration of 8 months solidifies our belief
that PDS0101's ability to generate a robust, targeted T-cell
response may have the potential to significantly improve clinical
outcomes for patients with advanced, refractory HPV16-associated
cancers who have limited treatment options."
There are more than 630,000 cases of HPV-associated malignancies
including cervical, oropharyngeal and anal cancer worldwide
annually. HPV-16 is responsible for most of these cases. About
15-20% of HPV-associated malignancies respond to PD-(L)1
inhibitors. However, for the overwhelming majority of patients who
progress on these immunotherapies there is no effective standard of
care therapy.
The company is hosting a conference call today at 8:00 am ET to
discuss the data presented at ASCO. Registration for the conference
call is now open and a live webcast of the event will be available
online in the investor relations section of the company's website
at https://pdsbiotech.com/investors/news-center/events. A replay
will be available on the company website for 90 days following the
webcast.
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 developing
a growing pipeline of cancer immunotherapies and infectious disease
vaccines based on the Company's proprietary Versamune(R) T-cell
activating technology platform. Our Versamune(R) -based products
may 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 investigational 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. Our immuno-oncology
product candidates are initially being studied in combination
therapy to potentially enhance efficacy without compounding
toxicity across a range of cancer types. The company's lead
investigational cancer immunotherapy product PDS0101 is currently
in Phase 2 clinical studies in HPV-associated cancers. 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 & 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 NCI and The University of Texas MD
Anderson Cancer Center, respectively. The current product targets
HPV16-positive cancers, and upon successful proof of concept will
be broadened to address cancers caused by other oncogenic
HPV-types.
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; 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.
###
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 +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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