TIDMNSCI
RNS Number : 9991M
NetScientific PLC
19 September 2019
NetScientific plc
("NetScientific" or the "Company")
Portfolio Company PDS Biotechnology announces new positive data
for lead immunotherapy treatment in high-risk human papillomavirus
(HPV)
London, UK - 19 September 2019 - NetScientific plc (AIM: NSCI),
the transatlantic healthcare IP commercialisation Group, is pleased
to note the new data announced today by portfolio company, PDS
Biotechnology (Nasdaq: PDSB), following a post-hoc follow up of its
Phase 1 clinical study of novel immunotherapy PDS0101 for patients
with cervical intraepithelial neoplasia (CIN) infected with
multiple high-risk, cancer-causing types of HPV.
Ian Postlethwaite, CEO of NetScientific, said:
"We are delighted to see this additional data which further
validates the potential of this new treatment for patients
suffering with high-risk HPV. 2020 will be an important year for
PDS as PDS0101 enters three Phase 2 clinical studies to evaluate
PDS0101 as a monotherapy in CIN2/3; to evaluate PDS0101 in
combination with KEYTRUDA(R) in collaboration with Merck and Co for
the treatment of HPV16-positive head and neck cancer; and to
evaluate PDS0101 in combination with two other novel clinically
tested immunotherapies in advanced HPV-associated cancers to be
conducted by the National Cancer Institute (NCI). We believe that
the continued strong progress of the PDS immunotherapy portfolio
and NetScientific's shareholding within demonstrates the potential
of increasing value for our shareholders as we seek to realise full
value of our investments in the coming months."
# # #
Below is the full announcement made today by PDS
Biotechnology:
PDS Biotechnology Reports Clinical Data for Its Novel
Immunotherapy PDS0101 in Follow up to Phase 1 Human Trial
60% of evaluable patients demonstrated a clinical response
Clinical activity observed at all dose levels
Data support previously reported in-vivo induction of active
HPV-specific (granzyme B-inducing) CD8+ (killer) T-Cells in
patients
Plan to initiate three Phase 2 studies for PDS0101 starting in
1Q 2020
Berkeley Heights, NJ, September 18, 2019 - PDS Biotechnology
Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology
company pioneering the development of novel immunotherapies, today
announced that it has reviewed limited available patient clinical
outcome data from its previously reported Phase 1 study. In the
study, 60% of evaluable patients had a clinical response (as
defined below). The primary focus of the study was safety and
evaluation of immune biomarkers resulting from administration of
Versamune(R)-based PDS0101 in patients with cervical
intraepithelial neoplasia (CIN) infected with multiple high-risk,
cancer-causing types of human papillomavirus (HPV). These
newly-available clinical data are the result of a post-hoc follow
up which was not part of the protocol design. The novel
Versamune(R) mechanisms of action and the resulting unique
regression of advanced preclinical tumors were recently published
(Journal of Immunology, Vol. 202, Issue 1215 June 2019).
The Phase 1 clinical trial was an open-label, dose-escalating
study that included 12 patients; 3 receiving a 1mg dose, 3
receiving a 3 mg dose, and 6 receiving a 10mg dose. All 12 patients
completed three doses of PDS0101. As previously reported, no
dose-limiting toxicities or long-term safety concerns were
observed.
PDS0101 was immunologically active at all three doses and
resulted in a strong increase (5 to 73-fold) in circulating HPV
disease-attacking T-cells in 10/12 subjects, quantified by either
INF-<GAMMA> or granzyme-b ELISPOT studies of blood drawn
approximately 14 days after subcutaneous injection. The potentially
unique ability of PDS0101 to safely generate high levels of
circulating, granzyme-b inducing (cytolytically active) CD8+
(killer) T-cells prompted a retrospective evaluation of clinical
outcomes.
PDS received limited follow-up clinical data from eleven out of
the twelve patients and was able to review the source data reported
for all but two of these patients (both in the 10mg dose group and
whose data were reported by correspondence from the investigator).
The clinical results were evaluated and reported by the respective
physicians/principal investigators outside the scope of the Phase 1
trial protocol and were not evaluated at specific predetermined
times after treatment. Clinical response (regression/ elimination
of CIN) was determined by cytology or colposcopy as available from
individual investigators.
Clinical responses were observed in 60% of evaluable patients
across the three tested doses. Of note, the timing of the
responses, seen as early as 1-3 months after treatment in some
patients, suggests a potential correlation of the immunologic and
clinical responses with the administration of PDS0101. Consistent
with the preclinical data, these data suggest that PDS0101's potent
induction of type I interferons with antigen cross-presentation may
lead to broad and effective CD8+ T cell activity, and suggests the
potential for a rare combination of clinical potency and safety
among immune-oncology therapeutics.
Dose Cohort Evaluable Patients* Clinical Response 12 Months Post
Treatment**
N = N = % of Evaluable
1mg 3 of 3 2 67%
3mg 2 of 3 1 50%
10mg 5 of 6 3 60%
Total 10 6 60%
*Two of twelve patients were not evaluable: one patient, who
demonstrated a strong immune response, was lost to follow up
and another received LEEP excision therapy (standard of care)
**Two of ten evaluable patients who had clearance of CIN by cytology
were not considered as clinical responders: one patient regressed
from CIN to atypical squamous cells of undetermined significance
(ASCUS) with detectable virus, and the other showed consistent
disease elimination by cytology, but showed residual disease
by colposcopy
"The exciting translation of the Versamune(R)-induced
immunological mechanisms from animal to human studies support the
planned Phase 2 trials to be initiated in the first quarter of 2020
in cancer and CIN2/3 patients with well-defined HPV type
infections," said Dr. Lauren V. Wood, M.D., PDS' Chief Medical
Officer.
Starting in the first quarter of 2020, PDS anticipates
initiating three studies:
-- A Phase 2 study to evaluate PDS0101 monotherapy in CIN2/3. --
A Phase 2 study in collaboration with Merck and Co. to evaluate
PDS0101 in combination with KEYTRUDA(R) in the treatment of
HPV16-positive head and neck cancer.
-- A Phase 2 study to evaluate PDS0101 in combination with two
other novel clinically tested immunotherapies in advanced
HPV-associated cancers to be conducted by the National Cancer
Institute (NCI) as a result of the NCI's independent preclinical
testing of the combination.
In addition, PDS is continuing to advance a pipeline of similar
Verasmune(R)-based antigen-specific immunotherapies targeting
prostate, colon, lung, breast and ovarian cancers and melanoma.
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.
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, anal, prostate, breast and other 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 pre-cancers and cancers.
Dose Cohort Evaluable Patients* Clinical Response 12 Months Post
Treatment** N = N = % of Evaluable 1mg 3 of 3 2 67% 3mg 2 of 3 1
50% 10mg 5 of 6 3 60% Total 10 6 60% *Two of twelve patients were
not evaluable: one patient, who demonstrated a strong immune
response, was lost to follow up and another received LEEP excision
therapy (standard of care) **Two of ten evaluable patients who had
clearance of CIN by cytology were not considered as clinical
responders: one patient regressed from CIN to atypical squamous
cells of undetermined significance (ASCUS) with detectable virus,
and the other showed consistent disease elimination by cytology,
but showed residual disease by colposcopy
About HPV-related Cancer and CIN1
Human papillomavirus (HPV) infection is responsible for over 99%
of cervical cancers, and the majority of head and neck cancers and
anal cancers. HPV is also the most common viral sexually
transmitted disease in the United States. HPV is unequivocally
linked with cervical preneoplastic lesions, categorized as cervical
intraepithelial neoplasia (CIN) of various degrees, with the low
grade disease being categorized as CIN1. It is reported that
spontaneous regression of CIN1 occurs in about 44% of patients
within 2 years (Stefani C. et al, 2014, European Review for Medical
and Pharmacological Sciences, 18: 728-733).
For full release and additional information about PDS, please
visit www.pdsbiotech.com.
Ends
# # #
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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