NetScientific PLC PDS completes End-of-Phase 2 meeting with FDA
October 03 2022 - 8:56AM
RNS Non-Regulatory
TIDMNSCI
NetScientific PLC
03 October 2022
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS completes End-of-Phase 2 meeting with FDA
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 it has successfully
completed an End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) for PDS0101 in combination with Merck's
anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab) for the treatment of
unresectable, recurrent/metastatic human papilloma virus (HPV)
16-positive head and neck squamous cell carcinoma (HNSCC).
Earlier this year, the FDA granted Fast Track designation to the
combination of PDS0101 and KEYTRUDA(R) (pembrolizumab) for the
treatment of HPV16-positive HNSCC. The FDA's Fast Track designation
program is designed to aid in the development and to expedite the
review of drug candidate applications that could potentially treat
serious or life-threatening conditions. Treatments granted this
designation are given the opportunity to have more frequent
meetings and interactions with the FDA throughout the entire drug
development and review process, with the goal of moving promising
new drugs more rapidly through the process.
Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech
commented: "We are very pleased with the guidance received from FDA
on key elements of the clinical program that will support the
submission of a Biologics License Application (BLA) for our lead
asset PDS0101. The interim safety and efficacy data we presented to
the FDA has allowed us to move into a registrational trial ahead of
our projected schedule. This, along with the recent capital raise,
allows us to efficiently advance our clinical programs.
"PDS0101 represents a potentially transformative treatment
approach for HPV16-positive HNSCC patients. We are committed to
providing physicians and patients a possibly more effective and
safer treatment option to address this debilitating and deadly
disease."
Dr. Ilian Iliev, CEO of NetScientific, commented: "We are
pleased with PDS' continued and systematic progress on its business
objectives, despite unfavourable capital markets conditions.
Building on momentum from the FDA Fast Track designation in June
2022, and the subsequent $35m venture debt facility in August 2022,
PDS is now well positioned for further progress in its PDS101
clinical programme."
The full text of the announcement from PDS Biotechnology is
available online here: PDS Biotech - PDS Biotech - PDS Biotech
Announces Successful End-of-Phase 2 Meeting With the FDA and
Preparation for the Registrational Trial of PDS0101 in Combination
With KEYTRUDA(R)
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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