REG - NetScientific PLC - PDS Biotech: Clinical trial meets study endpoints

NetscientificAnnouncement

10/05/2024 09:15

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RNS Number : 9747N  NetScientific PLC  10 May 2024

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
(https://pdsbiotech.com/index.php/investors/news-center/events/archive) .

 

·      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
(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)  +44 (0)20 7886 2500

 Rupert Dearden (Corporate Broking)

 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 (http://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
(https://www.globenewswire.com/Tracker?data=wp_KiU-Up2-vf_xfKSntdmde635Yz9-3wEWifc-H_fH-TMnJy8SK2XyfJS9nnnsiiJQQ-AzpSxON8d80hzL_UqOuIqv6n60NpThvUVMxBME=)
.

 

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