REG - NetScientific PLC - PDS Biotech Announces Updated Survival Data

NetscientificAnnouncement

09/11/2023 17:30

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RNS Number : 0055T  NetScientific PLC  09 November 2023

RNS: For immediate release

 

NetScientific plc

 

PDS Biotech Announces Updated Survival Data from NCI-Led Phase 2 Clinical
Trial of PDS0101-Based Triple Combination Therapy in Advanced HPV16-Positive
Cancer Patients which Show 75% Survival of ICI Naïve Patients at 36 Months

 

75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36
months; published median overall survival (OS) in similar patients is 7-11
months

 

12-month survival rate in ICI resistant patients is 72%

 

Median OS in ICI resistant patients is approximately 20 months; published
median OS is 3.4 months

 

NetScientific Plc (AIM: NSCI), the deep tech and life sciences VC investment
group, reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing
pipeline of targeted cancer immunotherapies and infectious disease vaccines
based on the Company's proprietary T cell activating platforms, has
announced updated survival data from the Phase 2 clinical trial investigating
the triple combination of PDS0101, PDS0301 (IL-12 antibody-drug conjugate) and
an investigational immune checkpoint inhibitor (ICI) in two groups of advanced
cancer patients with various types of human papillomavirus (HPV) 16-positive
cancers.

 

The ICI naïve group had not responded to standard-of-care treatments but had
not yet been treated with an ICI. The ICI resistant group included patients
who had not responded to multiple prior treatments, including ICI therapy.
Investigators at the National Cancer Institute (NCI), part of the National
Institutes of Health, have completed the primary endpoint analysis of the
Phase 2 trial.

 

In the ICI naïve group, final survival data from the trial indicated that 75%
(6/8) of these patients were still alive at 36 months, and the median overall
survival (OS) has not yet been reached. Published data on standard-of-care
ICIs report 30-50% of these patients typically remain alive at 12 months, and
less than 30% of the patients remain alive at 24 months.

 

In the ICI resistant group, the 12-month OS rate was 72% and the triple
combination achieved a median OS of approximately 20 months. In addition:

 

·      For PDS0101 plus high doses of ICI and PDS0301, the overall
response rate (ORR) was 63% (5/8).

·      For PDS0101 plus low doses of ICI and/or PDS0301, the ORR was 5%
(1/21).

·    The historical median survival for ICI therapy in HPV-positive
cancer ICI resistant patients is reported to be 3.4 months.

 

Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech said:

 

"We are encouraged by the survival rates for both ICI naïve and ICI resistant
patients with HPV16-positive cancers who were treated with the triple
combination therapy.  The ICI resistant data from the VERSATILE-002 trial
evaluating PDS0101 in combination with KEYTRUDA(®) (pembrolizumab) that were
reported 3 October 2023, further clarify the path forward for a potential
registrational clinical trial of PDS0101 and PDS0301 in combination with a
commercial ICI. With this exciting information, we will be finalising the
regulatory and clinical pathway for the triple combination with OS as the
primary endpoint."

 

PDS0101, PDS Biotech's lead candidate, is a Versamune(®) based
investigational immunotherapy designed to stimulate a potent targeted T cell
attack against HPV16-positive cancers. PDS0301 is a novel, proprietary
investigational tumour-targeting IL-12 antibody-drug conjugate that enhances
the proliferation, potency, and longevity of T cells in the tumour
microenvironment formulated to overcome tumour immune suppression utilizing a
different mechanism from checkpoint inhibitors. PDS Biotech has patented the
combination of Versamune(®) and IL-12.   The investigational ICI used in
the triple combination therapy is Bintrafusp alfa, a bifunctional fusion
protein targeting two independent immunosuppressive pathways (PD-L1 and
TGF-β).

 

About PDS0101

PDS0101, PDS Biotech's lead candidate, is a novel investigational human
papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted
T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous
injection alone or in combination with other immunotherapies and cancer
treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment
demonstrated the ability to generate multifunctional HPV16-targeted CD8 and
CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates
clinically active immune responses, and the combination of PDS0101 with other
treatments can demonstrate significant disease control by reducing or
shrinking tumours, delaying disease progression and/or prolonging survival.
The combination of PDS0101 with other treatments does not appear to compound
the toxicity of other agents.

 

About PDS0301

PDS0301 is a novel investigational tumour-targeting IL-12 antibody-drug
conjugate IL-12 that enhances the proliferation, potency and longevity of T
cells in the tumour microenvironment. PDS0301 is given by a subcutaneous
injection. PDS0301 is designed to improve the safety profile of IL-12 and to
enhance the anti-tumour response.

 

References:

Strauss J et al. Journal for Immuno Therapy of Cancer 2020;8:e001395

Burtness B et al., Lancet. 2019; 394:1915-1928

Ferris RL, et al. NEJM. 2016;375:1856-67

 

A full version of PDS Biotech's announcement can be accessed here:
https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/885-iotechnnouncespdatedurvivalatafromedh20231109
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/885-iotechnnouncespdatedurvivalatafromedh20231109)

 

-Ends-

For more information, please contact:

 

 NetScientific
 Ilian Iliev, CEO                                               Via Belvedere Communications

 Panmure Gordon (UK) Limited (NOMAD and Broker)
 Emma Earl / Freddy Crossley / 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-light 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 Biotech is a clinical-stage immunotherapy company developing a growing
pipeline of targeted cancer and infectious disease immunotherapies based on
our proprietary Versamune(®), Versamune(®) plus PDS0301, and Infectimune(®)
T cell-activating platforms. We believe our targeted immunotherapies have the
potential to overcome the limitations of current immunotherapy approaches
through the activation of the right type, quantity and potency of T cells. To
date, our lead Versamune(®) clinical candidate, PDS0101, has demonstrated the
ability to reduce and shrink tumors and stabilize disease in combination with
approved and investigational therapeutics in patients with a broad range of
HPV16-associated cancers in multiple Phase 2 clinical trials and will be
advancing into a Phase 3 clinical trial in combination with KEYTRUDA(®) for
the treatment of recurrent/metastatic HPV16-positive head and neck cancer in
2023.   Our Infectimune(®) based vaccines have also demonstrated the
potential to induce not only robust and durable neutralizing antibody
responses, but also powerful T cell responses, including long-lasting memory T
cell responses in pre-clinical studies to date.

 

To learn more, please visit www.pdsbiotech.com
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=7407d497e9&e=735607fbc5)
or follow us on Twitter at @PDSBiotech

 

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