PDS Announces Achievement of Efficacy Threshold
14/06/2023 15:31
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230614:nRSN7448Ca&default-theme=true
RNS Number : 7448C 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® 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
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=8f01752b77&e=735607fbc5)
) Phase 2 clinical trial investigating PDS0101 in combination with Merck's
anti-PD-1 therapy, KEYTRUDA® (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
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=c2152f5739&e=735607fbc5)
. 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
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=176e54f55d&e=735607fbc5)
, 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
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=acf078408d&e=735607fbc5)
observed in multiple types of HPV cancer
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=3ff6871b52&e=735607fbc5)
and at different stages
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=0c0f29d248&e=735607fbc5)
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
(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 (mailto: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 (http://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(®), Versamune(®) plus PDS0301, and Infectimune™
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(®) 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® for the
treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023.
Our Infectimune™ 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
(https://www.globenewswire.com/Tracker?data=jRAUZ9vVihowpdAsEMPXLvawVyf6cWn4jSBNSs1Qxd4OH4pOFi1DwEgzyPG3jtm6swg3LuMFHyYXSSsbu8L9zLgSpPa8kdMkxXgrpy1QyLQ=)
or follow us on Twitter at @PDSBiotech.
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END NRAFLFFSRDISLIV