TIDMNSCI
RNS Number : 4436T
NetScientific PLC
14 November 2023
RNS: For immediate release
NetScientific plc
PDS Biotech Reports Third Quarter 2023 Financial Results and
Provides Business Update
-- Announced 75% of ICI-naive patients alive at 36 months in the
NCI-led triple Phase 2 combination trial for advanced
HPV16-positive cancer patients; published median overall survival
of 7-11 months with FDA approved ICI1
-- Announced 2-year overall survival rate of 74% in
VERSATILE-002 Phase 2 trial of ICI-naïve HPV16-positive recurrent
or metastatic head and neck cancer patients; published 2-year
overall survival of less than 30% with FDA approved ICI1
-- Announced interim safety and immune response data for Phase
1/2 clinical trial evaluating docetaxel and PDS01ADC in metastatic
prostate cancer patients; PSA decline was seen in all 18 patients
and 61% of patients had at least a 60% decrease in PSA levels
-- Company to host conference call and webcast today at 8:00 AM EST
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
its financial results for the quarter ended September 30, 2023.
Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech
said:
"We are pleased with the outcome of the National Cancer
Institute (NCI)-led Phase 2 triple combination trial of PDS0101,
PDS01ADC (formerly known as PDS0301) and an investigational immune
checkpoint inhibitor (ICI). The data show that 75% of immune
checkpoint inhibitor (ICI)-naïve patients remain alive at three
years, and the 12-month overall survival (OS) rate in the
ICI-resistant patients is 72. Furthermore, the triple combination
continues to be well tolerated, with only 4% of patients reported
to have Grade 4 treatment-related adverse events."
He continued:
"As the development of our IL12 fused antibody-drug conjugate or
ADC, PDS01ADC, continues to progress, its potential to overcome key
safety and efficacy limitations associated with existing cytokine
therapy is reinforced. Data presented at Cytokines 2023 marked the
first-in-human clinical trial evaluating the combination of
docetaxel chemotherapy and PDS01ADC to treat advanced metastatic
castration sensitive (mCSPC) and castration resistant prostate
cancer (mCRPC). Decreases in prostate-specific antigen (PSA) levels
were reported in all patients. In addition, with our lead candidate
PDS0101, the interim Phase 2 VERSATILE-002 data presented during
our Key Opinion Leader (KOL) roundtable showed a 2-year overall
survival rate of 74% in ICI-naïve human papillomavirus (HPV)16-
recurrent/metastatic head and neck cancer patients. We are excited
about the strides we are making across our pipeline, fuelled by our
commitment to developing groundbreaking therapies that
revolutionize cancer treatments."
Recent Business Highlights:
PDS0101 Lead Drug Candidate
-- VERSATILE-003: Received feedback from the U.S. Food and Drug
Administration (FDA) regarding the Phase 3 clinical protocol for a
randomized, controlled multicentre trial of PDS0101 in combination
with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab) in
patients with HPV16-positive recurrent and/or metastatic head and
neck cancer. PDS Biotech anticipates initiation of VERSATILE-003 in
Q1 2024.
-- VERSATILE-002 : Phase 2 open-label, multicentre clinical
trial of PDS0101 in combination with KEYTRUDA(R) in patients with
HPV16-positive recurrent and/or metastatic head and neck
cancer.
o Hosted KOL roundtable on interim VERSATILE-002 data and
current and future treatments. Highlights from ICI-naïve
patients:
-- 24-month OS rate of 74%; published 24-month OS less than 30%
data with approved ICIs for head and neck cancer.(2)
-- Well tolerated with no patients having Grade 4 or 5
combination treatment-related adverse events. Thirteen percent with
Grade 3 combination treatment-related adverse events.
o Presented biomarker data at European Society for Medical
Oncology Congress 2023, highlighting that the combination of
PDS0101 and KEYTRUDA(R) has the potential to promote a TH1 immune
response which is known to promote a strong CD8 T cell response.
Biomarker data demonstrated that the combination promotes the
induction of HPV16-specific multifunctional CD8 T cells.
-- IMMUNOCERV: Phase 2 clinical trial investigating PDS0101 in
combination with standard-of-care (SOC) chemoradiotherapy (CRT) in
the treatment of locally advanced cervical cancer patients with
large tumours over 5 cm in size and/or cancer that has spread to
the lymph nodes.
o Data presented at American Society for Radiation Oncology 2023
Annual Meeting demonstrated PDS0101, in combination with SOC CRT,
was associated with a rapid decline in HPV circulating cell-free
DNA, a potential predictive biomarker of treatment response.
Ninety-two percent reduction in ctDNA with PDS0101 and SOC and 53%
reduction was seen with SOC at 5 weeks.
PDS01ADC (formerly known as PDS0301): IL12 Fused Antibody Drug
Conjugate
-- NCI-led Triple Combination: Phase 2 clinical trial for
combination therapy of PDS0101, PDS01ADC and an investigational ICI
for the treatment of recurrent/metastatic HPV-positive, ICI-naïve
and ICI-resistant HPV16-positive cancers including anal, cervical,
head and neck, vaginal and vulvar cancers.
o ICI-naïve group:
-- 75% of patients remain alive at 36 months; published median
OS data in similar patients is 7-11 months.(1) The median OS has
not yet been reached.
o ICI-resistant group:
-- 12-month OS rate of 72%.
-- Median OS approximately 20 months; published median OS in
HPV-positive ICI-resistant cancer is 3.4 months(3) .
o Responses were seen in all HPV-positive tumour types.
-- NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label,
single-arm trial of PDS01ADC in combination with docetaxel in
advanced mCSPC and mCRPC.
o Presented interim safety and immune response data of the
combination in the first clinical trial of an immunocytokine with
docetaxel in prostate cancer patients at Cytokines 2023.
o Decrease in PSA levels was seen in all patients at all three
tested doses of PDS01ADC and 61% of patients had at least a 60%
decrease in PSA levels.
-- All doses of the combination were well tolerated with one
patient experiencing Grade 4 neutropenia.
-- Presented data from the NCI-led preclinical study evaluating
PDS0101, PDS01ADC and an HDAC inhibitor at the Society for
Immunotherapy of Cancer's 38(th) Annual Meeting, demonstrating
anti-tumour activity against ICI-resistant cancers.
PDS0202 Universal Flu Candidate
-- Presented data from the preclinical universal flu vaccine
program at 9th European Scientific Working Group on Influenza,
demonstrating the potential ability of PDS0202 to neutralize
multiple influenza viruses. PDS0202 also demonstrated the ability
to prevent viral replication in the lungs of ferrets and provide
complete protection after challenge with lethal doses of the H1N1
influenza virus.
Third Quarter 2023 Financial Results
Net loss for the three months ended September 30, 2023 was
approximately $10.8 million, or $0.35 per basic share and diluted
share, compared to a net loss of approximately $7.4 million, or
$0.26 per basic and diluted share, for the three months ended
September 30, 2022. The higher net loss reported for the three
months ended September 30, 2023 is primarily due to the increase in
research and development expenses and general and administrative
expenses.
Research and development expenses increased to $6.4 million for
the three months ended September 30, 2023 from $4.4 million for the
three months ended September 30, 2022. The increase of $2.0 million
is primarily attributable to an increase of $1.3 million in
clinical trials, and $0.7 million in personnel costs, including
$0.3 million in non-cash stock-based compensation.
General and administrative expenses increased to $4.1 million
for the three months ended September 30, 2023 from $2.9 million for
the three months ended September 30, 2022. The increase of $1.2
million is primarily attributable to an increase of $0.7 million in
personnel costs, including $0.5 million in non-cash stock-based
compensation, and $0.5 million in investor relations costs.
PDS Biotech's cash balance as of September 30, 2023 was
approximately $54.3 million. PDS Biotech believes that, with
initiating the VERSATILE-003 Phase 3 clinical trial in the first
quarter of 2024, its available cash resources will sustain
operational and research and development endeavours into the third
quarter of 2024. PDS Biotech expects to execute its current
operational and research and development endeavours by obtaining
additional capital, principally through entering into
collaborations, strategic alliances or license agreements with
third parties and/or additional public or private debt and/or
equity financings. The Company has had and continues to provide,
what the Company believes to be favourable development milestones
to the market and has upcoming development milestones.
References:
(1) Baumi J, et al. J Clin Oncol 2017:1542-49 and Morris VK, et
al. Lancet Oncol 2017;18:446-53.
(2) Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma
of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B
et al., Pembrolizumab alone or with chemotherapy versus cetuximab
with chemotherapy for recurrent or metastatic squamous cell
carcinoma of the head and neck (KEYNOTE- 048): a randomized,
open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No
control or comparative studies have been conducted between immune
checkpoint inhibitors and PDS0101.
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
(3) Strauss J et al. Journal for ImmunoTherapyof Cancer
2020;8:e001395
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 PDS01ADC
PDS01ADC, formerly PDS0301, is a novel investigational
tumour-targeting antibody drug conjugate of Interleukin 12 (IL-12)
that enhances the proliferation, potency and longevity of T cells
and natural killer cells in the tumour microenvironment. PDS01ADC
is given by subcutaneous injection and is designed to improve the
safety profile of IL-12 and to enhance the anti-tumour
response.
The Condensed Consolidated Balance Sheets; The Condensed
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited) and the Condensed Consolidated Statements of Cash
Flows
(Unaudited) are available on the full version of PDS Biotech's
announcement.
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/886-iotecheportshirduarter2023inancialesultsan20231114
-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 PDS01ADC, 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 tumours 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
plan to advance into a Phase 3 clinical trial in combination with
KEYTRUDA(R) for the treatment of recurrent/metastatic
HPV16-positive head and neck cancer in the first quarter 2024. 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.
www.pdsbiotech.com
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