REG - NetScientific PLC - PDS: Interim 24-month survival rate of 74% update

NetscientificAnnouncement

03/10/2023 15:30

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231003:nRSC5672Oa&default-theme=true

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® (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(®) (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(®) 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(®)
compared to KEYTRUDA(®) 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®), and 40% (22/55) have CPS score >20
(who generally have a higher response to KEYTRUDA®).

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®.
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://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3da8212ae7fa%26e%3d27d88613f0&c=E,1,YTy_mMeGZyvcChPgKTikWxr7MckC9TE2LBtne3d_O1Emod4vJl_lYSw_7S1RVyg9lrTP4zpFlySIiMFIV6EA2zEB8cxqXYdVNtGQyUSmn_FLJuTDMSE,&typo=1)

https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d305e788a58%26e%3d27d88613f0&c=E,1,aOWX4VyyOuhX-dNhGTmMNpFp2UmeRaaryRZh_Gpo_sPZug8jjYeuZ_pdx1IDlIGdbfveallG-Sr2VRcTUbPpNoHPzWKw3NyS06qGsF44Pwf38g,,&typo=1)

(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
(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 (mailto: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 (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 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(®) 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://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d57813ccb02%26e%3d27d88613f0&c=E,1,j_VgAE2py-bdHxISEfT30YqAoRwv72dTmqBKlkzNMeMOXbjGIlglSxjnN_kR7gXdV3Sf-nEuTGVcc-I9-VnHowaun2dCxGAH3Rf7QtJSpts7NgMxsRjJ9jc,&typo=1)
or follow us on Twitter at @PDSBiotech.

This information is provided by RNS, 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 (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  UPDMZMGGDFNGFZM