TIDMNSCI
RNS Number : 5672O
NetScientific PLC
03 October 2023
RNS: For immediate release
NetScientific plc
PDS Biotechnology Interim 24-Month Survival Rate of 74% in
Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients
Treated with PDS0101 in Combination with KEYTRUDA(R)
(pembrolizumab)
Interim VERSATILE-002 data for the first-line treatment of
recurrent or metastatic head and neck cancer patients who were
immune checkpoint inhibitor (ICI) naïve; published 24-month
survival rate of less than 30% for approved ICI(1) .
Received feedback from US Food and Drug Administration (FDA) on
the Company's amended Investigational New Drug (IND) application
allowing initiation of VERSATILE-003 Phase 3 trial in the fourth
quarter of 2023.
12-month overall survival (OS) rate of 56% in ICI refractory
patients; published median 12-month OS rate of 17% with no salvage
chemotherapy following tumor progression on ICI (ICI
Refractory)(2*) .
Well tolerated with no patients having Grade 4 or 5 combination
treatment-related adverse events.
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
updated interim data based on an August 2(nd) cut off from the
VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in
combination with Merck's anti-PD-1 therapy, KEYTRUDA(R)
(pembrolizumab), in patients with unresectable, recurrent, or
metastatic HPV16-positive head and neck squamous cell carcinoma
(HNSCC). VERSATILE-002 is investigating two patient populations
whose cancer has returned or spread - ICI naïve and ICI refractory.
The ICI naïve group had not responded to standard-of-care
treatments but had not yet been treated with an ICI. The ICI
refractory group included patients who had not responded to
multiple prior treatments, including ICI therapy. Data presented at
ASCO was based on a January 13th cut off.
Frank Bedu-Addo, PhD, President and Chief Executive Officer of
PDS Biotech said:
" The updated interim data from our VERSATILE-002 clinical trial
further validates the potential of PDS0101 when combined with
KEYTRUDA(R) to address the urgent need for more effective therapies
that are well tolerated and allow advanced recurrent and metastatic
HPV16-positive head and neck cancer patients to live significantly
longer lives than current approaches. Following feedback from the
FDA, we look forward to evaluating this promising combination
treatment in the VERSATILE-003 Phase 3 clinical trial, which we
expect to initiate in the fourth quarter of 2023. VERSATILE-003
will investigate the efficacy and safety of PDS0101 combined with
KEYTRUDA(R) compared to KEYTRUDA(R) monotherapy in ICI-naïve
patients with recurrent or metastatic HPV16-positive HNSCC. The
primary endpoint for the study will be overall survival."
VERSATILE-002: ICI Naïve
Highlights of the interim data from the ICI naïve cohort
include:
-- 24-month overall survival (OS) rate is 74%; published
24-month survival rate of less than 30% for approved ICI1.
-- 12-month OS rate is 80%; published results of 30-50% with approved ICIs1.
-- Tumour shrinkage seen in 60% (31/52) of patients.
-- Confirmed overall response rate (ORR) is 27% (14/52) to date.
-- Median progression-free survival (PFS) is 8.1 months to date;
published results of 2-3 months PFS with approved ICIs1.
-- 13% (8/62) of patients experienced Grade 3 treatment-related
adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE;
published results report 13-17% Grade 3-5 TRAE with approved ICI
monotherapy1.
-- 60% (33/55) of patients have CPS score of 1-19 (who generally
have a weaker response to KEYTRUDA(R)), and 40% (22/55) have CPS
score >20 (who generally have a higher response to
KEYTRUDA(R)).
VERSATILE-002: ICI Refractory
The goal of this ICI refractory cohort was to confirm and to
better understand the role of PDS0101 in prolonging the survival of
advanced HPV16-positive head and neck cancer patients who received
PDS0101 in combination with KEYTRUDA(R). This analysis is also
intended to provide insight to the contribution of PDS0101 to
overall survival in the National Cancer Institute-led study
evaluating the combination of PDS0101, PDS0301 (antibody conjugated
IL12), and an ICI.
Highlights of the interim data from the ICI refractory cohort
include:
-- The 12-month OS rate is 56%. The published median 12-month OS
rate is 17% with no salvage chemotherapy following tumor
progression on ICI (ICI Refractory)2*.
-- 0% (0/21) confirmed ORR suggests that PDS0101's impact on
survival does not appear to be dependent on tumor shrinkage.
-- 4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21)
patients experienced Grade 4 and 5 TRAE.
Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech
said:
"We are pleased with the OS results and knowledge gained from
the ICI refractory cohort of VERSATILE-002. In agreement with our
Data Monitoring Committee (DMC), we will not progress to stage 2 of
this cohort in VERSATILE-002. As previously announced, we have no
plans to further develop this combination for ICI refractory
patients. PDS0101 appears to immunologically alter the patient's
tumour microenvironment to promote survival. This important data
will help inform our development plans for PDS0101."
(1*) 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/
(2) Bila M, Van Dessel J, Smeets M, Vander Poorten V, Nuyts S,
Meulemans J, Clement PM. A Retrospective Analysis of a Cohort of
Patients Treated With Immune Checkpoint Blockade in
Recurrent/Metastatic Head and Neck Cancer. Front Oncol. 2022 Jan
27;12:761428. doi: 10.3389/fonc.2022.761428. PMID: 35155226; PMCID:
PMC8828639. *No controlled or comparative studies have been
conducted between PDS0101 and no salvage chemotherapy.
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/878-iotechnnouncesnterim24onthurvivalateof7420231003
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +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 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 PDS0301, 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 tumors 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(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. To learn more, please
visit www.pdsbiotech.com or follow us on Twitter at
@PDSBiotech.
, the news service of the London Stock Exchange. RNS is approved by
the Financial Conduct Authority to act as a Primary Information
Provider in the United Kingdom. Terms and conditions relating to
the use and distribution of this information may apply. For further
information, please contact rns@lseg.com or visit 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.
END
UPDMZMGGDFNGFZM
(END) Dow Jones Newswires
October 03, 2023 10:21 ET (14:21 GMT)
Netscientific (LSE:NSCI)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Netscientific (LSE:NSCI)
Historical Stock Chart
Von Jun 2023 bis Jun 2024