TIDMNSCI
NetScientific PLC
02 October 2023
Reach: For immediate release
NetScientific plc
PDS Biotechnology PDS Biotech Announces PDS0101 Combined with
Chemoradiotherapy Associated with Rapid Decline in Circulating
Tumor DNA (ctDNA/cfDNA)
Study evaluated levels of circulating cell-free HPV DNA (cfDNA)
in patients with locally advanced cervical cancer in the IMMUNOCERV
Phase 2 clinical trial and patients receiving standard of care
(SOC) treatment
Patients treated with PDS0101 had greater clearance of cfDNA as
compared to those treated with SOC (at week 5, 91.7% vs. 53.1%,
P=0.0179)
Data presented during oral presentation at ASTRO 2023 Annual
Meeting
NetScientific Plc (AIM: NSCI), the deep tech and life sciences
VC investment group, reports that its portfolio company, PDS
Biotechnology Corporation (Nasdaq: PDSB), 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, has announced
data demonstrating lead candidate PDS0101 in combination with
standard-of-care (SOC) chemoradiotherapy (CRT) was associated with
a rapid decline in human papillomavirus (HPV) circulating cell-free
DNA (cfHPV-DNA), a potential predictive biomarker of treatment
response. The data from the IMMUNOCERV Phase 2 clinical trial were
featured in an oral presentation by Aaron Seo, MD, PhD, of The
University of Texas MD Anderson Cancer Center, at the American
Society for Radiation Oncology ( ASTRO 2023 ) Annual Meeting in San
Diego, CA.
The IMMUNOCERV Phase 2 trial is investigating PDS0101 in
combination with SOC CRT in the treatment of cervical cancer
patients with large tumours over 5 cm in size and/or cancer that
has spread to the lymph nodes. HPV is the primary cause of cervical
cancer with over 99% caused by HPV infection, and cfHPV-DNA can be
detected in the blood of patients with cervical cancer. HPV type 16
(HPV16) is the most prominent subtype associated with cervical
cancer. The study presented at ASTRO 2023 evaluated the
relationship between the levels of circulating cfHPV-DNA and the
extent of disease, clinical staging, and treatment response in
patients with HPV-positive cervical cancer .
Dr Lauren V. Wood, PDS Biotech's Chief Medical Officer,
said:
" We are encouraged by this data from the IMMUNOCERV trial,
which highlight the potential of PDS0101 to positively impact
cfDNA, an emerging biomarker of clinical response in cervical and
other HPV-related cancers. The findings complement previously
presented IMMUNOCERV data which suggested PDS0101 promotes the
induction of multifunctional CD8 killer T cells that were
associated with declines in circulating tumour DNA and a clinical
response with greater than 60% tumour shrinkage at mid-point
evaluation in 100% of high-risk cervical cancer patients on the
trial. We look forward to continuing to address the unmet needs of
patients suffering from HPV-positive cancers such as cervical
cancer."
Sixty-one patients with cervical cancer were included in the
analysis either as part of a SOC treatment banking protocol (n=44)
or as part of the IMMUNOCERV Phase 2 clinical trial combining
PDS0101 with SOC (n=17). Longitudinal plasma samples were collected
from each patient at baseline, during weeks 1, 3, and 5, and at 3-4
months after CRT.
In the study, HPV16 was detected in 59% of tumours and 70% of
cfDNA. The median cfDNA at baseline was 28.15 copies/mL, with a
range of 0 to 206,030 copies/mL.
The presentation at ASTRO 2023 highlighted the following
data:
-- Earlier and greater proportion of cfDNA clearance with
PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3%
clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of
clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)
-- Baseline cfDNA levels correlated with the International
Federation of Gynecology and Obstetrics (FIGO) stage and lymph node
involvement; 100% of patients treated with PDS0101 had cancer that
had spread to the lymph nodes
Ann Klopp, MD, PhD, Professor of Radiation Oncology at MD
Anderson said:
"HPV16 cfDNA represents a novel biomarker with the potential to
help oncologists make more informed treatment decisions for their
patients with HPV16-positive cancers. This early data are
encouraging, and we will continue to evaluate patients to determine
any potential correlations between cfDNA clearance and clinical
outcomes. Further analysis of cfDNA kinetics could provide valuable
information on the relationship between cfDNA levels, treatment
response, and ongoing clinical outcomes. I look forward to the
continued evaluation of PDS0101 in combination with
standard-of-care chemoradiotherapy."
A full version of PDS Biotech's announcement can be accessed
here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/877-iotechnnounces0101ombinedwithhemoradiothera20231002
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: 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
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(R) ,
Versamune(R) plus PDS0301, and Infectimune(R) 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(R) clinical
candidate, PDS0101, has demonstrated the ability to reduce and
shrink tumors 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(R) for the treatment of recurrent/metastatic
HPV16-positive head and neck cancer in 2023. Our Infectimune(R)
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 or follow us on Twitter at
@PDSBiotech.
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