TIDMNSCI
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(R) (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(R) 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(R) 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-<BETA>).
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
-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)
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-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
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(R) ,
Versamune(R) plus PDS0301, and Infectimune(R) 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(R) 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(R) for the treatment of recurrent/metastatic
HPV16-positive head and neck cancer in 2023. Our Infectimune(R)
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 or follow us on
Twitter at @PDSBiotech
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