Immediate release
NetScientific
plc
Replacement RNS: PDS Biotech
Aligns with FDA on Phase 3 Trial in HPV16-Positive First-Line
Recurrent or Metastatic Head and Neck Cancer
The following amendment has been
made to the "PDS Biotech Aligns with FDA on Phase 3 Trial in
HPV16-Positive First-Line Recurrent or Metastatic Head and Neck
Cancer" released on 2 August at 07:00 under RNS number
8959Y.
The following two sub-headings have been
removed:
·
Aligns with FDA
on Phase 3 Trial in HPV16-Positive First-Line Recurrent or
Metastatic Head and Neck Cancer
·
Expanded Global
Intellectual Property Surrounding Versamune®
Platform
The following sub-heading has been added:
·
Company to
initiate Phase 3 VERSATILE-003 trial in Q4 2024
The full amened text is shown
below.
___________________________________
Company to initiate Phase 3
VERSATILE-003 trial in Q4 2024
NetScientific Plc (AIM: NSCI), the
deep tech and life sciences VC investment group, reports that its
portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), in
which it holds a 3% direct holding, has announced that it has
received the official minutes from its meeting with the U.S. Food
and Drug Administration ("FDA") regarding next steps in its planned
Phase 3 clinical trial of its Versamune® based
investigational immunotherapy designed to stimulate a targeted T
cell attack against HPV16-positive head and neck squamous cell
carcinoma ("HNSCC").
PDS Biotech presented the FDA with
recent data from both the VERSATILE-002 study of
Versamune® HPV + pembrolizumab, and the triple
combination of Versamune® HPV + PDS01ADC +
bintrafusp alfa. The Company also provided an updated design of the
Phase 3 VERSATILE-003 trial of Versamune® HPV +
pembrolizumab which included updated statistical endpoints based on
recent and more mature survival data. PDS Biotech proposed the
addition of a third arm to the study which would be a triple
combination of Versamune® HPV + PDS01ADC +
pembrolizumab. The first part of the study would therefore involve
a dose optimization of PDS01ADC in the novel
combination.
The FDA supported the strategy and
development of the double and triple combinations. Also, the FDA
requested additional safety analysis in the lead-in PDS01ADC dose
optimization part of the study. To avoid potential delays in
initiating the randomized trial, the FDA agreed that the dose
optimization should be done separately and the registrational trial
of the revised 2-arm double combination trial, VERSATILE-003,
should proceed. The Versamune® HPV + pembrolizumab
combination has received Fast Track designation.
Frank Bedu-Addo, PhD, President and Chief Executive Officer of
PDS Biotech said:
"We appreciate the FDA's support in the development of both
the double and triple Versamune® HPV-based combinations. We are
also pleased to have aligned on initiating the updated
VERSATILE-003 study. The VERSATILE-002 results have matured
significantly and positively over the last year, allowing us to
revise the statistical endpoints of the study to provide additional
robustness to the study design. We continue to believe that the
combination, based on encouraging survival, disease control
response rates and safety has the potential to significantly
advance the treatment of HPV16-positive HNSCC. Our goal now is to
investigate Versamune® HPV + pembrolizumab's potential as the first
targeted immunotherapy for HPV16-positive HNSCC. The addition of
PDS01ADC in the future has the potential to provide further
clinical benefit to an effective targeted
immunotherapy."
Kirk Shepard, MD, Chief Medical Officer,
continued:
"We have contracted with a clinical research organization and
the preparatory work is advancing to begin enrolment in the
VERSATILE-003 Phase 3 clinical trial in first-line treatment of
patients with recurrent or metastatic HPV16-positive HNSCC, with
overall survival as the study's primary endpoint. Our VERSATILE-003
trial has significant key opinion leader support, including from
the investigators involved in VERSATILE-002, and we have lined up a
significant number of the target sites that have indicated strong
interest in participating in the trial."
A
full version of PDS Biotech's announcement can be accessed
here:
https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/933-iotechlignswithonhase3rialin16osit20240801
-Ends-
For more information, please
contact:
|
NetScientific
|
|
|
Ilian Iliev, CEO
|
Via Belvedere
Communications
|
|
|
|
|
Panmure Liberum Limited (NOMAD and Broker)
|
|
|
Emma Earl / Will Goode / Freddy
Crossley / Mark Rogers (Corporate Finance)
Rupert Dearden (Corporate
Broking)
|
+44 (0)20 7886 2500
|
|
|
|
|
Belvedere Communications
John West / Llewellyn Angus / Lily
Pearce
|
+44 (0)20 7653 8702
|
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-efficient 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 Biotechnology is a
late-stage immunotherapy company focused on transforming how the
immune system targets and kills cancers and the development of
infectious disease vaccines. The Company plans to initiate a
pivotal clinical trial in 2024 to advance its lead program in
advanced HPV16-positive head and neck squamous cell cancers. PDS
Biotech's lead investigational targeted immunotherapy
Versamune® HPV is being developed in combination
with a standard-of-care immune checkpoint inhibitor, and also in a
triple combination including PDS01ADC, an IL-12 fused antibody drug
conjugate (ADC), and a standard-of-care immune checkpoint
inhibitor.
www.pdsbiotech.com.