NetScientific PLC PDS prioritise PDS0101 in high risk HPV to Phase 2 (3764O)
01 Octubre 2019 - 08:10AM
UK Regulatory
TIDMNSCI
RNS Number : 3764O
NetScientific PLC
01 October 2019
NetScientific plc
("NetScientific" or the "Company")
Portfolio Company PDS Biotechnology to prioritise lead
immunotherapy treatment in high-risk human papillomavirus (HPV)
into Phase 2 studies
London, UK - 1 October 2019 - NetScientific plc (AIM: NSCI), the
transatlantic healthcare IP commercialisation Group, is pleased to
note today's announcement by portfolio company, PDS Biotechnology
("PDS") (Nasdaq: PDSB) to prioritise clinical development of
PDS0101 in combination therapies targeting advanced cancers. This
follows PDS' recent reporting of promising PDS0101 Phase 1 clinical
trial outcome data, in which regression of lesions was demonstrated
in 60% of patients.
Ian Postlethwaite, CEO of NetScientific, said:
"It is great to see the growing momentum at PDS following the
positive Phase I data for their lead immunotherapy treatment for
high-risk HPV. They are set to advance their combination studies
with PDS0101 in various advanced HPV-associated cancers into Phase
2 clinical studies which are partnered with top leaders in the
field. As a shareholder in PDS, we continue to provide our support
and look forward to hearing updates on the progress of PDS0101 in
the future."
# # #
Below is the full announcement made today by PDS
Biotechnology:
PDS Biotechnology Prioritizes Development of PDS0101 in Advanced
Cancers Following Promising Phase 1 Clinical Outcome Data
Data demonstrated regression of lesions in 60% of patients
Berkeley Heights, NJ, October 1, 2019 - PDS Biotechnology
Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage
immuno-oncology company pioneering the development of
multi-functional immunotherapeutic products, today announced it
will prioritize clinical development of PDS0101 in advanced cancers
following its recent reporting of promising PDS0101 Phase 1
clinical trial outcome data.
On September 19, 2019, PDS reported clinical outcome data from a
Phase 1 clinical trial of PDS0101 in patients with cervical
intraepithelial neoplasia (CIN) infected with multiple high-risk,
cancer-causing types of human papillomavirus (HPV). The study
demonstrated robust treatment-induced HPV16-specific killer T-cell
(CD8+) responses as well as clearance of the disease and regression
of lesions in 60% of patients. These in-vivo PDS0101-induced
T-cells were demonstrated to induce granzyme-b thus confirming
their cytolytic/killing potency. This clinical data supports the
superior CD8+ T-cell induction and anti-tumor efficacy of the
Company's Versamune(R) platform, as published based on the results
of preceding preclinical studies in the June 2019 Issue of the
Journal of Immunology.
"Our intent is to continue to advance our previously announced
combination studies with PDS0101 in various advanced HPV-associated
cancers. These phase 2 clinical studies are partnered with top
leaders in the field. We also intend to rapidly progress PDS0102
(targeting prostate and breast cancers), PDS0103 (targeting colon,
lung, ovarian cancers) and PDS0104 (targeting melanoma) into human
clinical trials in combination with checkpoint inhibitors. This
approach has been recently supported by promising Phase 1 clinical
outcome data," said Dr. Frank Bedu-Addo, CEO of PDS. "The unique
ability of PDS0101 to promote in-vivo induction of high levels of
CD8+ T-cells overcomes a significant limitation of many current
immunotherapy approaches such as checkpoint inhibitors. Checkpoint
inhibitors have a proven ability to induce effective anti-tumor
responses in approximately 20% of patients by "releasing the
brakes" of the immune system that have been activated by cancer. It
has been reported that there is a strong correlation between the
presence of tumor-targeting CD8+ T-cells and the efficacy of
checkpoint inhibitors. We believe that the Versamune(R) platform,
by promoting induction of these tumor-specific cytolytic CD8+
killer T cells, could be critical to substantially expanding
clinical efficacy of checkpoint inhibitors into a larger percentage
of the population, which could address unmet patient needs for
improved treatment options across a range of advanced cancer
indications."
As a result of the recent data showing strong CD8+ T-cell
induction and the subsequent decision to prioritize the platform's
application in combination therapies addressing advanced cancer,
the Company no longer anticipates starting a Phase 2 study to
evaluate PDS0101 monotherapy in CIN2/3 as previously reported.
About the Versamune(R) Platform Technology Versamune(R) is a
proprietary, synthetic lipid-based T-cell activating platform. PDS
Biotechnology's pipeline of Versamune(R)-based products, which are
administered by subcutaneous injection, provides strong activation
of type I interferon genes. The Versamune(R) mechanism of action
also involves effective presentation of tumor antigens via the MHC
Class I and Class II pathways. These mechanisms together promote
strong in-vivo induction of polyfunctional tumor-targeting CD8+
T-cells. Versamune(R)-based immunotherapies have been demonstrated
to alter the tumor micro-environment in preclinical mechanism of
action studies, thus further enhancing the ability of
Versamune(R)-induced T-cells to effectively kill tumor cells.
Preclinical data demonstrating the novel multi-functional mechanism
of action of the Versamune(R) platform technology and the resulting
superior T-cell induction and unique regression of advanced tumors
were published in the Journal of Immunology (Journal of Immunology,
Vol. 202, Issue 1215 June 2019).
About PDS Biotechnology and PDS0101 PDS Biotechnology is a
clinical stage immuno-oncology company with a growing pipeline of
clinical-stage immunotherapies to treat various HPV-associated
cancers, including head and neck cancer, cervical and anal cancers.
PDS0101 includes the Versamune(R) immune-activating platform and a
mixture of HPV16 E6 and E7 peptide antigens designed to induce
cytolytic T-cell responses against HPV expressed in patients with
HPV-associated cancers. Clinical outcome findings from the PDS0101
Phase 1 clinical study demonstrated unique in-vivo systemic
induction of high levels of granzyme-b inducing HPV-specific killer
T-cells associated with observed clinical responses (regression and
elimination of pre-cancerous lesions) in the majority of evaluable
patients treated with PDS0101 monotherapy, and a lack of dose
limiting toxicities at all tested doses. Versamune(R) is a
registered trademark of PDS Biotechnology Corporation, Berkeley
Heights, NJ, USA.
For full release and additional information about PDS, please
visit www.pdsbiotech.com.
# # #
This announcement contains inside information for the purposes
of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.
For more information, please contact:
NetScientific Tel: +44 (0)20 3514 1800
Ian Postlethwaite, CEO / CFO
WHIreland (NOMAD, Financial Adviser Tel: +44 (0)20 7220 1666
and Broker)
Chris Fielding / Darshan Patel
MO PR ADVISORY (Press Contact) Tel: +44 (0)78 7644 4977
Mo Noonan
About NetScientific
NetScientific PLC is a transatlantic healthcare IP
commercialisation Group focused on technologies and companies that
have the potential to treat chronic disease and significantly
improve the health and well-being of people.
For more information, please visit the website at
www.NetScientific.net
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END
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