TIDMSCLP
RNS Number : 8154I
Scancell Holdings Plc
17 August 2021
17 August 2021
Scancell Holdings plc
("Scancell" or the "Company")
Scancell selects PharmaJet's clinically proven Needle-free
Systems for COVID-19 vaccine trial
Preclinical studies confirm that PharmaJet delivery of COVIDITY
vaccines induces potent immune responses against both S and N
antigens
PharmaJet delivery improves both the patient and caregiver
experience, reducing vaccine hesitancy
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces that it has selected the PharmaJet Needle-free
Injection Systems to administer its two SARS-CoV-2 vaccine
candidates, SCOV1 and SCOV2, in its COVIDITY Phase 1 clinical trial
(COVIDITY-001). SCOV1 and SCOV2 will be administered either via an
intradermal injection using the PharmaJet Tropis(R) Needle-free
Injection System or via intramuscular delivery using the PharmaJet
Stratis(R) system. The Stratis(R) System has U.S. FDA 510(k)
marketing clearance, CE Mark, and World Health Organization (WHO)
Performance, Quality and Safety (PQS) certification to deliver
medications and vaccines either intramuscularly or subcutaneously.
The Tropis(R) System has CE Mark and WHO PQS certification for
intradermal injections. The PharmaJet Systems are the first and
only needle-free devices pre-qualified by the WHO.
As announced on 29 July 2021, the Company's COVIDITY-001 study,
including the use of the two PharmaJet injectors, has been approved
by the South African regulatory authority. The COVIDITY programme
is a collaboration between Scancell and scientists in the newly
established Centre for Research on Global Virus Infections and the
new Biodiscovery Institute at the University of Nottingham, and
Nottingham Trent University and the programme has received funding
from Innovate UK.
Needle-free injectors use a narrow stream of fluid to penetrate
the skin, delivering vaccines and other pharmaceuticals to the
required tissue depth. Both the PharmaJet systems have been
clinically proven with a wide range of vaccines, including the
delivery of DNA products. These injection systems are easy to use,
eliminate needlestick injuries and have the potential to expand
vaccine coverage to subjects with a fear of needles. Scancell's
preclinical studies have confirmed that PharmaJet delivery of its
COVIDITY vaccines induces potent immune responses against both S
and N antigens.
Prof Lindy Durrant, Chief Executive Officer, Scancell,
commented: "Our preclinical studies have shown that delivery of
SCOV1 and SCOV2 with the PharmaJet Needle-free Systems generate
excellent T cell and antibody responses. In addition, they are easy
to use and ideal for people who are needle phobic, an important
cause of vaccine hesitancy. We look forward to progressing our
COVIDITY-001 study in South Africa and updating the market in due
course."
Chris Cappello, President and CEO, PharmaJet, commented: "We are
pleased to be collaborating with Scancell as they start their
clinical trials with this innovative vaccine approach. Our
Needle-free Systems are proven to improve the immune response for
multiple DNA and RNA vaccines as well as being widely used to
deliver vaccines for diseases such as influenza, measles and
polio."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please contact:
Scancell Holdings plc +44 (0) 20 3727 1000
Dr John Chiplin, Executive Chairman
Professor Lindy Durrant, CEO
Panmure Gordon (UK) Limited (Nominated Adviser
and Joint Broker) +44 (0) 20 7886 2500
Freddy Crossley/Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Stifel Nicolaus Europe Limited (Joint Broker) +44 (0) 20 7710 7600
Nicholas Moore/Ben Maddison (Healthcare Investment
Banking)
Nick Adams (Corporate Broking)
FTI Consulting +44 (0) 20 3727 1000
Simon Conway/Natalie Garland-Collins
About Scancell
Scancell is developing novel immunotherapies for the treatment
of cancer based on its technology platforms, ImmunoBody(R) ,
Moditope(R) and AvidiMab(TM) , with four products in multiple
cancer indications and development of a vaccine for COVID-19.
ImmunoBody(R) vaccines target dendritic cells and stimulate both
CD4 and CD8 T cells with the ability to identify, target and
eliminate cancer cells. These cancer vaccines have the potential to
be used as monotherapy or in combination with checkpoint inhibitors
and other agents. The Directors believe that this platform has the
potential to enhance tumour destruction, prevent disease recurrence
and extend survival.
-- SCIB1, Scancell's lead product, is being developed for the
treatment of metastatic melanoma. In a Phase 1/2 clinical trial,
survival with SCIB1 treatment appears superior to historical
survival rates, with 14 of 16 resected patients receiving 2-4 mg
doses of SCIB1 surviving for more than five years.
-- SCIB2 is being developed for the treatment of non-small cell
lung cancer and other solid tumours.
DNA vaccine against COVID-19: As research data emerges, it is
becoming increasingly clear that the induction of potent and
activated T cells may play a critical role in the development of
long-term immunity and clearance of virus-infected cells. Initial
research is underway and Scancell anticipates initiating a Phase 1
clinical trial known as COVIDITY during 2021.
Moditope(R) represents a completely new class of potent and
selective immunotherapy agents based on stress-induced
post-translational modifications (siPTM). Examples of such
modifications are citrullination, an enzyme-based conversion of
arginine to citrulline, and homocitrullination (or carbamylation),
in which lysine residues are converted to homocitrulline.
Expression of peptides containing these modifications have been
demonstrated to induce potent CD4 cytotoxic t cells to eliminate
cancer. Previous pre-clinical studies have demonstrated that
conjugation of these Moditope(R) peptides to Amplivant(R) enhances
anti-tumour immune responses 10-100 fold and resulted in highly
efficient tumour eradication, including protection against tumour
recurrence.
-- Modi-1 consists of two citrullinated vimentin peptides and
one citrullinated enolase peptide each conjugated to Amplivant(R) .
Vimentin and enolase peptides are highly expressed in triple
negative breast, ovarian, head and neck, and renal cancer, as well
as many other cancers.
AvidiMab(TM) has broad potential to increase the avidity or
potency of any therapeutic monoclonal antibody (mAb) including
those being developed for autoimmune diseases, as well as cancer.
Scancell's development pipeline includes mAbs against specific
tumour-associated glycans (TaGs) with superior affinity and
selectivity profiles, that have now been further engineered using
the Company's AvidiMab(TM) technology; this confers the Scancell
anti-TaG mAbs with the ability to directly kill tumour cells. The
Company has entered into three non-exclusive research agreements
with leading antibody technology companies to evaluate the
Company's anti-TaG mAbs including those enhanced with the
AvidiMab(TM) technology.
About PharmaJet
PharmaJet's mission is to improve people's lives through
needle-free technology. The PharmaJet Needle-free Systems are safe,
fast, and easy-to-use. They eliminate needlestick injuries, needle
reuse and cross contamination, and help reduce sharps waste
disposal.
For more information visit www.pharmajet.com .
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August 17, 2021 02:00 ET (06:00 GMT)
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