TIDMSCLP
RNS Number : 8275G
Scancell Holdings Plc
29 July 2021
29 July 2021
Scancell Holdings plc
("Scancell" or the "Company")
COVIDITY Phase 1 clinical trial application in South Africa
approved
COVIDITY clinical trial expected to initiate in H2 2021
Scancell's COVID-19 vaccine candidates aim to protect against
all COVID-19 Variants of Concern
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces that the South African Health Products Regulatory
Authority (SAHPRA) has approved the clinical trial application
(CTA) for the Phase 1 clinical study of COVIDITY (COVIDITY-001) in
South Africa.
The COVIDITY programme, focused on the Company's novel COVID-19
vaccine candidates SCOV1 and SCOV2, 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. The programme has received funding from Innovate
UK.
SCOV1 and SCOV2, targeting the original and variant SARS-CoV-2
viruses, respectively, 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. Targeting the receptor-binding domain
(RBD) of the S antigen, the vaccines also elicit high titre
virus-neutralising antibodies (VNAbs) that cross-react against a
range of Variants of Concern (VoC), including the new Delta
variant.
Professor Lindy Durrant, Chief Executive Officer, Scancell,
commented: "We are very pleased that this CTA was approved so
rapidly, reflecting the importance of the study in South Africa,
and it is a testament to the dedication and professionalism of the
Scancell team and our colleagues in Cape Town. Our approach of
targeting the conserved N protein in addition to generating potent,
cross-reactive VNAbs has the potential to provide a significant
clinical advantage by eliciting potent T cells that can destroy
cells infected with any SARS-CoV-2 variants and other SARS-CoV
viruses that may emerge in the future."
COVIDITY-001 Part 1 (South Africa)
The regulatory application to initiate a Phase 1 clinical trial
of COVIDITY has been approved by the South African Health Products
Regulatory Authority (SAHPRA) and it is anticipated that the study
will start in H2 2021. This part of the study will be conducted at
the University of Cape Town Lung Institute, South Africa, in
unvaccinated, healthy adult volunteers. UK sites could not be
included in this part of the study due to the rapid rollout of the
UK vaccination programme and resulting lack of vaccine-naïve
subjects required for the initial safety evaluation.
The objectives will be to assess the safety and immunogenicity
of the two vaccine candidates, SCOV1 and SCOV2, evaluating
different vaccine doses delivered by two alterative injection
routes using needle-free systems. In addition to evaluating the
VNAbs, the Company will also analyse the T cell responses to the N
protein, which will provide additional information and data on the
potential utility of both SCOV1 and SCOV2 against future SARS-CoV-2
variants.
COVIDITY-001 Part 2 (UK & South Africa)
After demonstration of safety in Part 1 of the study in South
Africa, Scancell will 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 immune responses from this part of the COVIDITY study
will allow the Company to assess the ability of SCOV2 to boost the
immune response against current and potential future strains of
COVID-19 in pre-vaccinated individuals.
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
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.
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