RCS - NetScientific PLC - PDS Phase 2 Trial Update

NetscientificAnnouncement

02/02/2022 15:00

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RNS Number : 5117A  NetScientific PLC  02 February 2022

NetScientific plc

("NetScientific", the "Group" or the "Company")

 

PDS Phase 2 Trial Update
 
PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA® (pembrolizumab) in Advanced Head and Neck Cancer

 

London, UK - 2 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 that its VERSATILE-002
Phase 2 study for the treatment of advanced human papillomavirus
(HPV)-associated head and neck cancer achieved its preliminary objective
response benchmarks.

The trial, which studies PDS0101 in combination with Merck's anti-PD-1 therapy
KEYTRUDA(®) (pembrolizumab), will now progress to full enrolment of 54
patients in this group of checkpoint inhibitor (CPI) naïve patients. As
pre-specified in the clinical trial design, the achievement of an objective
response as measured by radiographic tumour responses according to RECIST 1.1
(tumour reduction of 30% or more) confirmed by two separate measurements among
at least four or more of the first 17 patients in the CPI naïve arm allows
that arm to progress to full enrolment. We anticipate these data will be
presented in more detail at an upcoming medical conference.

VERSATILE-002, being conducted in collaboration with Merck (known as MSD
outside the US and Canada), is being studied in two groups of HPV16-positive
head and neck cancer patients whose cancer has returned or spread. The first
group have not been previously treated with a checkpoint inhibitor (CPI
naïve). An initial assessment of the combination in a second group of 21
patients who have failed prior therapy with checkpoint inhibitors (CPI
refractory) is ongoing.

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the
University of Carolina at Chapel Hill School of Medicine and Lineberger
Comprehensive Cancer Centre, is serving as the Lead Principal Investigator of
VERSATILE-002.

Dr. Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech said: "The
achievement of this important milestone in the VERSATILE-002 Phase 2 clinical
trial strengthens the evidence of our novel Versamune(®) platform's potential
ability to induce high levels of tumor-specific CD8+ killer T-cells that
attack the cancer to achieve tumor regression.

"The initial data solidifies our belief that PDS0101's demonstrated
preclinical efficacy when combined with KEYTRUDA(®) has the potential to
significantly improve clinical outcomes for patients with advanced
HPV16-positive head and neck cancers."

Dr. Ilian Iliev, CEO of NetScientific, commented: "The move to full patient
recruitment in this Phase 2 trial is a very meaningful step in PDS' Phase 2
trial. We look forward to the company's continued progress on its multiple
clinical programmes."

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-releases1/118-2022-news/590-iotechnnouncesreliminaryfficacychievementin20220202
(https://pdsbiotech.com/investors/news-center/press-releases/press-releases1/118-2022-news/590-iotechnnouncesreliminaryfficacychievementin20220202)

###

FLORHAM PARK, N.J., Feb. 02, 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(®) and Infectimune™ T-cell activating technologies,
today announced its VERSATILE-002 Phase 2 study for the treatment of advanced
human papillomavirus (HPV)-associated head and neck cancer achieved its
preliminary objective response benchmarks. The trial, which studies PDS0101 in
combination with Merck's anti-PD-1 therapy KEYTRUDA(®) (pembrolizumab), will
now progress to full enrollment of 54 patients in this group of checkpoint
inhibitor (CPI) naïve patients. As pre-specified in the clinical trial
design, the achievement of an objective response as measured by radiographic
tumor responses according to RECIST 1.1 (tumor reduction of 30% or more)
confirmed by two separate measurements among at least four or more of the
first 17 patients in the CPI naïve arm allows that arm to progress to full
enrollment. We anticipate these data will be presented in more detail at an
upcoming medical conference.

VERSATILE-002, being conducted in collaboration with Merck (known as MSD
outside the US and Canada), is being studied in two groups of HPV16-positive
head and neck cancer patients whose cancer has returned or spread. The first
group have not been previously treated with a checkpoint inhibitor (CPI
naïve). An initial assessment of the combination in a second group of 21
patients who have failed prior therapy with checkpoint inhibitors (CPI
refractory) is ongoing.

"The achievement of this important milestone in the VERSATILE-002 Phase 2
clinical trial strengthens the evidence of our novel Versamune(®) 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 V.
Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our
belief that PDS0101's demonstrated preclinical efficacy when combined with
KEYTRUDA(®) has the potential to significantly improve clinical outcomes for
patients with advanced HPV16-positive head and neck cancers."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the
University of Carolina at Chapel Hill School of Medicine and Lineberger
Comprehensive Cancer Center, is serving as the Lead Principal Investigator of
VERSATILE-002. Patients interested in enrolling in this clinical study should
email info@pdsbiotech.com or visit the website at
http://pdsbiotech.com/VERSATILE-002 (http://pdsbiotech.com/VERSATILE-002) to
learn more.

 

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(®) and Infectimune™ T-cell activating
technology platforms.

Our Versamune(®)-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(®) 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™-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
(https://urldefense.proofpoint.com/v2/url?u=https-3A__pdsbiotech.us4.list-2Dmanage.com_track_click-3Fu-3D407bd594246e0ad6fd93882af-26id-3De1bce4750c-26e-3D4eb4565683&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=lwwmT1lSfgELFLcwvlJQ2ZXDKcVbkQyitKwD17cChBQ&m=eIDokKI5WfXuhS876IjocGMmrjScz1X8OzeQ9hQBfq8&s=EDz6ED8rjsdh5uP5GDiOYJoufOof8Mpr8_TKxPvwrq0&e=)
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(®) 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(®) 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 McManus       07748 325 236 / 07884 664 686 / 07980 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 (https://netscientific.net/) ).

 

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