RCS - NetScientific PLC - PDS Preliminary Biomarker Study Results

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23/10/2023 18:30

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RNS Number : 0241R  NetScientific PLC  23 October 2023

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NetScientific plc

Biotech Announces Preliminary Biomarker Study Results in Subset of Advanced
HPV-Positive Head and Neck Cancer Patients at ESMO

Combination of PDS0101 and KEYTRUDA(®) appears to lead to changes towards a
TH1 predominant cytokine profile reported to be associated with improved
killer T cell activity

Lowered CD8 T cells in peripheral blood after treatment align with previously
reported CD8 T cell targeting and accumulation in tumors(1)

NetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment
group, reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB) ("PDS Biotech" or "the Company"), a clinical-stage
immunotherapy company developing a growing pipeline of targeted cancer
immunotherapies and infectious disease vaccines based on the Company's
proprietary T cell activating platforms, announced immune response data from a
preliminary analysis of a subset of patients in VERSATILE-002, the Phase 2
clinical trial evaluating the safety and efficacy of PDS0101 in combination
with Merck's anti-PD-1 therapy KEYTRUDA(®) (pembrolizumab) in patients with
human papillomavirus (HPV)16-positive recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC). The data presented during the European
Society for Medical Oncology Congress 2023 (ESMO Congress 2023) provided
preliminary insight to the pre-existing immune responses in advanced
HPV-positive HNSCC patients and potential changes to the immune profile after
treatment.

Kevin Harrington, PhD, Professor of Biological Cancer Therapies, The Royal
Marsden

"Generation of multifunctional, anti-tumour T cells with the relevant cytokine
and chemokine profiles are necessary for effective long-term control of tumour
growth and clinical outcomes. This initial study focused on understanding the
immunological profile of advanced head and cancer patients in the blood. This
preliminary study suggests that PDS0101 may promote a TH1 predominant cytokine
profile as well as induction of important T cell activating chemokines. Such
studies could be helpful in providing further insight into how PDS0101 in
combination with KEYTRUDA® alters T cell cytokine and chemokine profiles to
promote improved clinical outcomes."

The data presented at ESMO 2023 included 18 patients with a median age of 63
years (range 46-83) and all had confirmed HPV16-positive tumours. The
immunological profiles were assessed at three timepoints: pre-treatment,12
(cycle 5), and 36 weeks (cycle 13) following four and five cycles of
combination therapy, respectively.

Highlights of the analysis include:

·     Combination of PDS0101 and KEYTRUDA® appears to lead to changes
towards a TH1 predominant cytokine profile reported to be associated with
improved killer T cell activity

·     Combination of PDS0101 and KEYTRUDA® resulted in increased
polyfunctionality reflected in T cells expressing 5 or more cytokines.
Increased polyfunctionality is typically associated with enhanced killing
function and anti-tumour activity

Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech said:

"This analysis provides preliminary insights into how PDS0101 in combination
with KEYTRUDA® may be impacting specific cytokines and chemokines in CD8 and
CD4 T cell populations. The investigational combination appears to be
promoting a predominant TH1 immunologic profile that is associated with
decreases in CD8 T cells in peripheral blood. We are encouraged that these
observations align with other Phase 2 studies reporting PDS0101-induced
polyfunctional CD8 T cells traffic to tumours and we look forward to continued
investigation in our VERSATILE-003 Phase 3 study."

 

1 Klopp A, et al. 2022. IMMUNOCERV, an ongoing Phase II trial combining
PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation
for treatment of locally advanced cervical cancers. Presented at: Society for
Immunotherapy of Cancer; November 8-12, 2022. Boston, MA. Abstract: 674.

A full version of PDS Biotech's announcement can be accessed here:

PDS Biotech - PDS Biotech Announces Preliminary Biomarker Study Results in
Subset of Advanced HPV-Positive Head and Neck Cancer Patients at ESMO
(https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/880-iotechnnouncesreliminaryiomarkertudyesultsi20231023)

-Ends-

For more information, please contact:

 

NetScientific

Ilian Iliev, CEO
 
Via Belvedere Communications

 

WH Ireland (NOMAD, Financial Adviser and Broker)

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                +44 (0)20 7220 1666

 

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Angus
+44 (0) 203 008 6867

Email: nsci@belvederepr.com (mailto:nsci@belvederepr.com)

 

About NetScientific

NetScientific plc (AIM: NSCI) is a deep tech and life sciences VC investment
group with an international portfolio of innovative companies.

NetScientific identifies, invests in, and builds high growth companies in the
UK and internationally. The company adds value through the proactive
management of its portfolio, progressing to key value inflection points, and
delivering investment returns through partial or full liquidity events.

NetScientific differentiates itself by employing a capital-light investment
approach, making judicial use of its balance sheet and syndicating investments
through its wholly owned VC subsidiary, EMV Capital. The group secures a
mixture of direct equity stakes and carried interest stakes in its portfolio
of companies, creating a lean structure that can support a large portfolio.

NetScientific is headquartered in London, United Kingdom, and is admitted to
trading on AIM, a market operated by the London Stock Exchange.

www.netscientific.net (http://www.netscientific.net)

 

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing
pipeline of targeted cancer and infectious disease immunotherapies based on
our proprietary Versamune(®), Versamune(®) plus PDS0301, and Infectimune(®)
T cell-activating platforms. We believe our targeted immunotherapies have the
potential to overcome the limitations of current immunotherapy approaches
through the activation of the right type, quantity and potency of T cells. To
date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the
ability to reduce and shrink tumours and stabilize disease in combination with
approved and investigational therapeutics in patients with a broad range of
HPV16-associated cancers in multiple Phase 2 clinical trials and will be
advancing into a Phase 3 clinical trial in combination with KEYTRUDA(®) for
the treatment of recurrent/metastatic HPV16-positive head and neck cancer in
2023. Our Infectimune(®) based vaccines have also 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
in pre-clinical studies to date. To learn more, please visit
www.pdsbiotech.com
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d57813ccb02%26e%3d27d88613f0&c=E,1,j_VgAE2py-bdHxISEfT30YqAoRwv72dTmqBKlkzNMeMOXbjGIlglSxjnN_kR7gXdV3Sf-nEuTGVcc-I9-VnHowaun2dCxGAH3Rf7QtJSpts7NgMxsRjJ9jc,&typo=1)
or follow us on Twitter at @PDSBiotech.

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