RCS - NetScientific PLC - PDS Announces Preliminary Safety Data on PDS0101

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24/02/2022 17:00

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RNS Number : 7705C  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® (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(®) (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® (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® 200 mg intravenously every
three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA® 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® (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®
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® 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® 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
(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(®) and Infectimune™ 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(®) (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(®) 200 mg intravenously
every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA(® )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(®) (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(®) 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
(https://www.globenewswire.com/Tracker?data=A8udRuKUcEdvvOy4jaVDZ_2Q0XLvnbCgDc_CU9hz2XvJxgZ24X6sulyS7huyLpP8rgFXa_fdYruJFcBogbALPUHidFCmysrY2XppDoJbrpzvvoCJp4NLt62vMhXm-xFs21Sr1jBc64DsUnfWljs2rw==)
.

 

Receipt of preliminary results are not necessarily indicative of the
final-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.

"We are encouraged by the preliminary safety data of PDS0101 in combination
with KEYTRUDA(® )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(®) 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(®) prior to
surgery in locally advanced HPV-associated oropharyngeal cancer
(NCT05232851).

KEYTRUDA(®) 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(®) 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://www.globenewswire.com/Tracker?data=WyDdZOERmKL6j8V7EIvizj3S90pxEBhHn6iKcUwA7cmMN0pcUVQ1wi5Z3TbiUXkGLOsVNxZxmI3tRw92Pvz842aIHmj1gTCy49U7zlKnHH330qxO_hxiqgQazCVziTQ1ceZV-I6uDDccq6NJwjHZ95_GOBKeOikP88mLBmo4lEiRxie9ZOfknNYdVoA3YlXin7cRdaGtiUGJH0ZqmDEK2q-g324e4mx-UW3Srvgardo-7WrMejOki20wqYX-XUs3J30uFfYm1hNYfuuHlgSlZ3fciReMyiJH2tr54L1xZPokDapnHPZrSfefCFUeqqLwJffGwDLwiXjrU4AsjdlEBYZyCg6K1VtwmPFq-hD4QSsfnEJkX14m7oWKD6AAdMEci3LEigtYKIr6YDek2BL5T9WSjqBJanwfTNRRn7vRzSFljuWYUJCz-2Zzk71qm9nU2p9ReQMGJJZKTg_h2mSpI86eNIukC02JM0xpRfFoDL75emNA2hDBjU7FYsyoAQcuChzoNvOhV1Jz6TW_Ln1RJzt8vPXGRVcVZ4pjyqaqhY_UrXbWD4XHpAa9bqnJWgpYKi84q1W0wdmNGBZm7zSJBO2notBj1QI_xr5DGp0gsE4rk96nXzwqCAcAYTsBO9CskghCkHk0AG3R1Nc5P3eBXvDbbGHi23Fz7V5fZ-bpPfn9qqKw5Sj9i5dTzefZAjom4n4T0Mt_zr7tBH7rg2v1r5Zwi31BdcllbMgzkuLUNts=)
 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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