TIDMNSCI
NetScientific PLC
26 May 2023
Reach: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Announces Interim Data
Demonstrates 12-Month Survival Rate of 87% with PDS0101 in
Combination with KEYTRUDA(R) (pembrolizumab) for Head and Neck
Cancer Patients
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 announced promising interim data.
The interim data relates to the VERSATILE-002 (NCT04260126)
Phase 2 clinical trial investigating PDS0101 in combination with
Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients
with unresectable, recurrent, or metastatic human papillomavirus
(HPV)16-positive head and neck cancer.
The results will be featured in a poster presentation and in a
head and neck cancer expert panel discussion at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting being held from
2 - 6 June in Chicago.
The presentation, titled "Safety and Efficacy of Immune
Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and
Pembrolizumab in HPV16-positive Head and Neck Squamous Cell
Carcinoma (HNSCC)" (Abstract #6012), concluded that the combination
was well tolerated, and the results justify a global confirmatory
randomized, controlled study, VERSATILE-003, which PDS Biotech is
planning to initiate this year . The study's 48 ICI naïve
participants, 94% of whom were male with a median age of 62.5,
received at least one cycle of the combination arm, 56.3% received
four doses, and 22.9% received five doses.
In measuring the efficacy of PDS0101 in combination with
KEYTRUDA(R), the abstract highlights the following interim
data:
-- Estimated 12-month overall survival rate was 87.1%. Published
results are 36-50% with approved ICIs used alone*.
-- Median progression-free survival was 10.4 months (95% CI 4.2,
15.3). Published results are median PFS of 2-3 months for approved
ICIs when used as monotherapy in patients with similar PD-L1
levels*.
-- A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34).
-- Confirmed and unconfirmed objective response rate was 41.2%
(14/34 patients), which is identical to the preliminary response
rate data PDS Biotech previously reported at ASCO 2022 (7/17
patients). To date these responses have been confirmed in nine of
the 34 patients (26.5%), including one complete response.
-- 15/34 patients (44.1%) had stable disease.
-- 9/34 patients (26.5%) had progressive disease.
-- 4/48 (8.3%) of patients had a Grade 3 treatment-related
adverse event (TRAE). No Grade 4 or higher TRAEs were observed.
VERSATILE-002 is a Phase 2, open-label, multicenter study of the
efficacy and safety of PDS0101 administered in combination with
KEYTRUDA(R) in adults with HPV16-positive unresectable, recurrent,
or metastatic HNSCC. VERSATILE-002 is investigating two patient
populations of HPV16-positive head and neck cancer patients whose
cancer has returned or spread. Interim data from the first group,
which had not been previously treated with an ICI (ICI naïve), is
the focus of the ASCO poster presentation and follow-up discussion
among a panel of head and neck cancer experts. The second group of
patients had previously failed treatments including ICI therapy
(ICI refractory).
Katharine A. Price, MD, Associate Professor, Oncology Head and
Neck Disease Group, Mayo Clinic and presenting author of the study
said:
"We are pleased to present updated survival data from
VERSATILE-002, which suggest the addition of PDS0101 to KEYTRUDA(R)
may improve survival for the growing number of HPV16-positive head
and neck cancer patients."
Lauren V. Wood, M.D., PDS Biotech's Chief Medical Officer and a
co-author of the study said:
"The interim data showed an estimated 12-month survival rate of
87% and a progression-free survival of 10.4 months, which is very
encouraging given the poor prognosis these patients face.
Furthermore, we remain encouraged by the safety profile of PDS0101
in combination with KEYTRUDA(R), with only 8% of patients
experiencing a Grade 3 treatment-related adverse event without more
serious Grade 4 or 5 events. We believe these data are encouraging
for HNSCC patients and indicate that the addition of the
HPV16-targeted immunotherapy PDS0101 to KEYTRUDA(R) should be
further evaluated for its potential to enhance survival in
HPV16-positive head and neck cancer patients."
Dr Ilian Iliev, CEO of NetScientific, said:
"I am delighted with the interim data that will be presented by
PDS at the prestigious American Society of Clinical Oncology 2023
Annual Meeting, demonstrating median progression-free survival of
10.4 months from the PDS Phase 2 study focused on HPV16-positive
head and neck cancer patients whose cancer has returned or spread.
PDS' programme continues to progress well across its Phase 2
studies, and a planned Phase 3 programme. Congratulations to Lauren
and her team."
The research was authored by Katharine Price, M.D., Mayo Clinic;
John Michael Kaczmar, M.D., Medical University of South Carolina;
Francis Worden, M.D., University of Michigan Health; Marya Chaney,
Ph.D., Merck & Co. Inc.; Jared Weiss, M.D., University of North
Carolina, Chapel Hill; and PDS Biotech's Lauren V. Wood, M.D; David
Schaaf, M.D.; and Nathalie Riebel.
Details of the presentation are as follows:
Abstract Number: 6012
Abstract Title: Safety and Efficacy of Immune Checkpoint
Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and
Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell
Carcinoma (HNSCC)
Presenting Author: Katharine Price, M.D., Co-chair, Head and
Neck Disease Group, Mayo Clinic Comprehensive Cancer Center
Session Title: Head and Neck Cancer
Poster Presentation: Monday, June 5, 2023, 1:15 PM-4:15 PM
CDT
Head and Neck Cancer Poster Discussion Session: Monday, June 5,
2023, 4:30 PM-6:00 PM CDT
Conference call Information:
PDS Biotech will host a conference call on Tuesday, June 6, at
8:00 a.m. EDT to discuss the interim data being presented at the
ASCO 2023 Annual Meeting. A live webcast of the event will be
available online at PDS Biotech Post-ASCO Webcast . The event will
be archived in the investor relations section of PDS Biotech's
website for six months.
Additionally, interested participants and investors may access
the conference call by dialing either 877-407-3088 (US) or
201-389-0927 (International).
*No control or comparative studies have been conducted between
immune checkpoint inhibitors and PDS0101; 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
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
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/838-iotechnnouncesnterimataemonstrates12onthu20230525
-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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