TIDMNSCI
NetScientific PLC
11 October 2022
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Update
PDS Biotech Announces Expanded Interim Data in PDS0101 Triple
Combination Phase 2 Trial Targeting Advanced HPV-Positive
Cancers
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 expanded interim data in the
Phase 2 clinical trial investigating the PDS0101-based triple
combination therapy in advanced human papillomavirus (HPV)-positive
cancers.
This Phase 2 study is being conducted at the Center for Cancer
Research (CCR) at the National Cancer Institute (NCI), one of the
Institutes of the National Institutes of Health. The interim
efficacy data from 37 HPV16-positive evaluable patients, including
29 patients in the checkpoint inhibitor (CPI) refractory arm, are
consistent with the results presented at ASCO 2022 and affirm the
selection of CPI refractory patients as the initial patient
population for ongoing clinical development of the triple
combination.
The NCI-led Phase 2 clinical trial (NCT04287868) is
investigating PDS0101 in combination with two investigational
immune-modulating agents - M9241, a tumor-targeting IL-12
(immunocytokine), and bintrafusp alfa, a bifunctional checkpoint
inhibitor (PD-L1/ TGF-<BETA>) - in recurrent or metastatic
HPV-positive cancers in patients who have failed prior therapy. The
triple combination is being studied in CPI-naïve and -refractory
patients with advanced HPV-positive anal, cervical, head and neck,
vaginal, and vulvar cancers. Both M9241 and bintrafusp alfa are
owned by Merck KGaA, Darmstadt, Germany.
Highlights of the expanded interim data are as follows:
-- Survival data : 66% (19/29) of HPV 16-positive CPI refractory
patients in the cohort were alive at a median follow up of 16
months. Historically, this group has a median overall survival of
only 3-4 months. (i)
-- Safety profile: 48% (24/50) of patients experienced Grade 3
treatment-related adverse events (AEs), and 4% (2/50) patients
experienced Grade 4 AEs. There were no grade 5 treatment-related
AEs
Results for HPV 16-positive checkpoint inhibitor naïve patients
also continue to appear to be encouraging: 75% (6/8) of CPI naïve
patients were alive at a median of 25 months of follow up. 38%
(3/8) of responders had a complete response.
Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech
commented: "The expanded interim data investigating the
PDS0101-based triple combination therapy in advanced HPV-positive
cancers continue to appear to show clinical signs of efficacy,
durability and safety in an extremely challenging patient
population with very few available treatment options.
"Importantly, these results affirm the decision to explore this
novel combination for the treatment of CPI refractory patients, who
have no approved standard of care, and support development of a
combination therapy to address the significant unmet need."
Dr. Ilian Iliev, CEO of NetScientific, commented: "In a really
challenging biotech public market, PDS stands out for its
consistent and steady delivery on its objectives. We are delighted
with the results and continue to monitor progress."
The full text of the announcement from PDS Biotechnology is
available online here: PDS Biotech - PDS Biotech - PDS Biotech
Announces Expanded Interim Data in PDS0101 Triple Combination Phase
2 Trial Targeting Advanced HPV-Positive Cancers
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 / Tom Cooper 07748 325 236 / 07971 221 972
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, EU and
USA.
With the acquisition of EMV Capital in August 2020 and further
investment activities, the Group more than doubled its portfolio
from 8 to 22 companies. These are held as direct subsidiary and
minority stakes, through 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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