Scancell Holdings Plc First subject dosed in COVIDITY clinical trial (1072O)
05 Octubre 2021 - 10:22AM
UK Regulatory
TIDMSCLP
RNS Number : 1072O
Scancell Holdings Plc
05 October 2021
5(th) October 2021
Scancell Holdings plc
("Scancell" or the "Company")
First subject dosed in COVIDITY Phase 1 clinical trial in South
Africa
Novel bivalent COVID-19 vaccine based on ImmunoBody(R) DNA
vaccine technology
SCOV1 administered using clinically proven PharmaJet Needle-free
Injection System
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces that the first subject has been dosed in its
COVIDITY clinical trial being conducted at the University of Cape
Town (UCT) Lung Institute in South Africa. 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.
The objectives of Part 1 of the trial are to assess the safety
and immunogenicity of two vaccine candidates, SCOV1 and SCOV2,
which target the original and variant SAR-CoV-2 viruses,
respectively, in healthy, vaccine-naïve subjects. The study will
determine the immunological responses induced by the vaccines
administered by two alternative injection routes using two
PharmaJet needle-free delivery systems. In addition to measuring
virus neutralising antibodies (VNAbs) induced by the viral spike
(S) protein, the Company will also analyse the T cell responses to
the highly-conserved nucleocapsid (N) protein, which will provide
further information and data on the potential utility of both SCOV1
and SCOV2 against future SARS-CoV-2 variants, including the Delta
variant.
SCOV1 and SCOV2 are based on a modification of Scancell's
ImmunoBody(R) DNA vaccine technology and have a dual mechanism of
action to induce high avidity T-cell immune responses against both
the N and S viral antigens. After demonstration of safety in the
South African part of the study, the Company plans to seek approval
from the Medicines & Healthcare products Regulatory Agency
(MHRA) to initiate a UK extension of the study, in which COVIDITY
will be given to healthy volunteers who have already received two
doses of an approved vaccine. The results from this part of the
study will allow the Company to assess the strength and breadth of
the immune responses induced in pre-vaccinated individuals, with
the potential to provide durable protection against emerging
variants.
Honorary Prof Rod Dawson, Managing Director of the University of
Cape Town Lung Institute, commented: "Novel vaccine candidates are
required to increase the cover, strength and durability of the
global COVID-19 vaccination platform. The UCT Lung Institute is
excited to partner with Scancell to investigate these promising new
COVID-19 vaccine candidates."
Prof Lindy Durrant, Chief Executive Officer, Scancell,
commented: "We are delighted that we have been able to start this
trial so quickly following regulatory approval in South Africa. The
Scancell team and collaborators have worked diligently since the
start of the pandemic to design, characterise, manufacture and
deliver this second generation COVID-19 vaccine and we look forward
to evaluating its clinical potential with our colleagues in South
Africa."
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/Samira Essebiyea (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.
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. The Directors believe that this platform has the potential
to eradicate hard to treat solid tumours.
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
mAbs targeting TaGs can also be used to deliver cytotoxic payload
to cancer or to redirect T 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.
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