For immediate release
NetScientific
plc
PDS Biotech VERSATILE-002
Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line
Recurrent/Metastatic HPV16-Positive Head and Neck
Cancer
30 month median overall
survival (OS); median OS independent of patient CPS
score
ORR 34% (CPS≥1); 48%
(CPS≥20)
Phase 3 registrational trial
planned to initiate in 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 3.5% direct holding, hosted a Key Opinion Leader
event on May 8, 2024. PDS Biotech is a late-stage immunotherapy
company focused on transforming how the immune system targets and
kills cancers and the development of infectious disease vaccines.
During the event, prominent experts in head and neck squamous cell
cancer ("HNSCC") discussed positive, updated VERSATILE-002 data and
the unmet need in HPV16-positive HNSCC. A replay of the event can
be found
here.
· The
VERSATILE-002 trial is evaluating Versamune® HPV +
KEYTRUDA® (pembrolizumab) in patients with
HPV16-positive HNSCC.
· Median
overall survival ("mOS") is 30 months (n=53) in first line
recurrent metastatic HNSCC; Published results for immune checkpoint
inhibitors are 7-18 months.
· The
immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its
primary endpoint of best overall response (BOR).
o BOR
by investigator assessment is 34% (Combined Positive Score (CPS)
≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are
<20% (CPS>1) and <25% (CPS≥20).
o Progression free survival ("PFS") is 6.3 months (CPS≥1); 14.1
months (CPS≥20); Published results for immune checkpoint inhibitors
2-3 months.
o VERSATILE-002 data to date indicate a durable response in
first line recurrent and / or metastatic HNSCC patients with
CPS≥1.
o The
combination of Versamune® HPV + pembrolizumab was well
tolerated.
· The
Company announced an updated clinical strategy with a two-part
registrational trial focused on the triple combination of
Versamune® HPV + PDS01ADC + pembrolizumab as a first
line treatment in HPV16-positive recurrent/metastatic
HNSCC.
o PDS01ADC is the Company's novel, investigational
tumour-targeting IL-12-fused antibody-drug conjugate (ADC), which
has shown promise in a clinical trial of Versamune® HPV
+ PDS01ADC + an investigational ICI conducted by the National
Cancer Institute.
o Part
one of the clinical trial will focus on dose optimisation with a
data readout based on safety and objective response
rate.
o The
randomised second part of the trial will include an interim data
readout with OS as its primary endpoint.
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/918-iotech002hase2linicalrialeetsrim20240509
-Ends-
For
more information, please contact:
NetScientific
|
|
Ilian Iliev, CEO
|
Via Belvedere
Communications
|
|
|
Panmure Gordon (UK) Limited (NOMAD and
Broker)
|
|
Emma Earl / Freddy Crossley / Will
Goode / Mark Rogers (Corporate Finance)
Rupert Dearden (Corporate
Broking)
|
+44 (0)20 7886 2500
|
|
|
Belvedere Communications
John West / Llew 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 head and neck squamous cell cancers (HNSCC). PDS Biotech's
lead program is a proprietary dual-acting combination of IL-12
fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator
Versamune® HPV in regimen with a standard-of-care
immune checkpoint inhibitor. We believe that proof-of-concept
long-term data have shown positive survival results and tumour
shrinkage with this combination and indicate favourable
tolerability.
We believe that with a novel
investigational "inside-outside" mechanism, the PDS01ADC and
Versamune® HPV immunotherapy has shown compelling
results with potential to successfully disrupt a tumour inside
defences, while also generating potent, targeted killer T-cells to
attack the tumour from the outside. We believe that data from more
than 350 patients, as well as ongoing clinical trials across
multiple tumour types and standard treatment regimens, have
validated the potential for both platforms and point to potential
broad utility.
Our
Infectimune® based vaccines have demonstrated the
potential to induce not only robust and durable neutralising
antibody responses, but also powerful T-cell responses, including
long-lasting memory T-cell responses in pre-clinical studies to
date. For more information, please
visit www.pdsbiotech.com.