TIDMNSCI
NetScientific PLC
14 June 2023
Reach: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotechnology Announces Achievement of Efficacy Threshold in
Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and
KEYTRUDA(R) in Head and Neck Cancer
14 patients in the immune checkpoint inhibitor naïve arm of
VERSATILE-002 have experienced either a complete response or
partial response on two consecutive scans, thus constituting a
confirmed objective response
Efficacy and safety continue to be monitored as additional
patients have yet to undergo imaging evaluation
NetScientific Plc (AIM: NSCI), the investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology companies,
reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB), a clinical-stage immunotherapy company developing a
growing pipeline of targeted immunotherapies for cancer and
infectious disease, has today announced the achievement of an
important efficacy threshold .
PDS Biotechnology has achieved the threshold for efficacy as per
investigator assessment in Stage 2 of the VERSATILE-002 (
NCT04260126 ) Phase 2 clinical trial investigating PDS0101 in
combination with Merck's anti-PD-1 therapy, KEYTRUDA(R)
(pembrolizumab), for the treatment of unresectable, recurrent or
metastatic human papillomavirus (HPV)16-positive head and neck
cancer. The achievement of full recruitment of 54 patients in the
ICI naïve arm was announced in May 2023 . The threshold for
efficacy, as defined in the clinical protocol, was achieved when 14
out of the 54 immune checkpoint inhibitor (ICI) naïve patients
enrolled achieved a confirmed objective response. Additional
patients in the trial have yet to undergo imaging evaluation.
Per RECIST 1.1, the standard to classify oncologic imaging
outcomes in clinical trials, patients are considered to have
achieved an objective response when imaging studies document tumor
shrinkage of 30% or more. In VERSATILE-002, the primary endpoint
requires two consecutive scans 9 to 12 weeks apart, rather than
one, to be considered a confirmed objective response. Confirmation
with two consecutive scans is not required to achieve an objective
response in every clinical trial per RECIST 1.1.
At the recent 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting , PDS Biotechnology presented data showing 9
confirmed responses among 34 evaluable patients. Median
progression-free survival (PFS) of 10.4 months was also presented
at the 2023 ASCO Annual Meeting along with a 12-month overall
survival (OS) rate of 87.1% for patients with a CPS>=1.
Additional patients have been assessed since data was presented at
the 2023 ASCO Annual Meeting. With these additional data, a total
of 14 patients have now achieved a confirmed response to date. The
achievement of this endpoint suggests an additive effect of PDS0101
over published results with ICI monotherapy and is based on
statistical calculations using the appropriate power and alpha.
The primary endpoint in the VERSATILE-002 study is the best
overall response (BOR) of confirmed complete response (CR) or
confirmed partial response (PR) per RECIST 1.1. The key secondary
endpoints are progression-free survival (PFS), OS at 12 and 24
months, safety, and tolerability. The study utilizes a Simon's
2-stage optimum design.
Dr. Frank Bedu-Addo, President and Chief Executive Officer of
PDS Biotechnology said:
"We are highly encouraged by the growing set of PDS0101 efficacy
and safety data being generated in multiple independent trials by
leading experts in the field. The consistency in PDS0101 induced
HPV16-specific immune responses, the response rates and survival
benefit observed in multiple types of HPV cancer and at different
stages of disease, aligns with both the preclinical and Phase 1
monotherapy results. Multiple studies have demonstrated the
induction of high levels of active and potent, HPV16-specific CD4
and CD8 T cells, as well as long-lasting memory CD8 T cells by
PDS0101."
Lauren V. Wood, M.D., PDS Biotechnology's Chief Medical Officer
said:
" Achieving the efficacy threshold in VERSATILE-002 is an
important milestone for us, especially as it has been achieved
ahead of the full efficacy evaluation for this cohort. With our
Phase 2 trial near completion, and our planned global Phase 3
confirmatory randomized, controlled trial, VERSATILE-003, actively
advancing, we believe we are closer to our goal of providing a
well-tolerated, safe and effective therapy for those who suffer
from head and neck cancer, a critical unmet medical need ."
Dr. Ilian Iliev, CEO of NetScientific, added:
" Congratulations to Frank and his team for reaching this
important milestone as they continue their important work in the
battle against head and neck cancer ."
PDS Biotech plans to initiate the VERSATILE-003 as a result of
the successful completion of an End-of-Phase 2 meeting in the third
quarter of 2022 with the FDA, during which PDS Biotech received
guidance on key elements of the Phase 3 program that will support
the submission of a Biologics License Application (BLA). The
planned primary endpoints for VERSATILE-003 are OS and PFS. In
preparation for the VERSATILE-003 trial, PDS Biotech plans to
submit an amended Investigational New Drug (IND) application to the
FDA in the third quarter of 2023.
A full version of PDS Biotech's announcement can be accessed
here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/840-iotechnologynnounceschievementoffficacyhresho20230614
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
About NetScientific
NetScientific plc (AIM: NSCI) is an investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology
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(TM) 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
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(TM)
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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