TIDMSCLP
RNS Number : 8147J
Scancell Holdings Plc
26 August 2021
26(th) August 2021
Scancell Holdings plc
("Scancell" or the "Company")
Modi-1 Phase I/II clinical trial application approved by
MHRA
First-in-human clinical trial in patients with triple negative
breast cancer, ovarian cancer, head and neck cancer, and renal
cancer
Modi-1 to be administered in combination with checkpoint
inhibitors in patients with head and neck or renal tumours
Patient enrolment expected to begin in H2 21
Scancell Holdings plc (AIM: SCLP), the developer of novel
immunotherapies for the treatment of cancer and infectious disease,
today announces that the UK's Medicines and Healthcare Products
Regulatory Authority (MRHA) has approved the clinical trial
application (CTA) to initiate the first-in-human Phase I/II
clinical study of Modi-1. The Company expects to enrol patients
into the study in H2 21, following ethics committee sign-off.
Initial safety/tolerability data from the initial open label
portion of the trial could be available from H1 22.
The Modi-1 clinical trial will be a first-in-human clinical
trial in patients with triple negative breast cancer, ovarian
cancer, head and neck cancer, and renal cancer. Modi-1 will be
administered in combination with checkpoint inhibitors in patients
with head and neck or renal tumours. The trial will initially focus
on the safety of two citrullinated vimentin peptides and, if there
are no significant side effects, a citrullinated enolase peptide
will be added.
The Modi-1 peptides are linked to AMPLIVANT(R) , a potent
adjuvant which enhanced the immune response 10-100 fold and
resulted in highly efficient tumour clearance, including protection
against tumour recurrence, in preclinical models. AMPLIVANT(R) is
the subject of a worldwide licensing and collaboration agreement
with ISA Pharmaceuticals for the manufacturing, development and
commercialisation of Modi-1.
The Modi-1 clinical trial will evaluate the first therapeutic
vaccine candidate from the Company's novel Moditope(R) platform,
which stimulates immune responses to stress induced
post-translational modifications (siPTMs). When cells become
stressed, they modify their proteins to alert the immune response
that there is a problem. One of these modifications is
citrullination which is the target for the Modi-1 vaccine. Fast
growing cancer cells need a lot of oxygen and nutrients and are
always highly stressed. Included in the Modi-1 vaccine are specific
T cell epitopes derived from citrullinated vimentin, which is
involved in tumour spread, and citrullinated enolase, which is an
enzyme that generates nutrients to drive tumour growth. Removal of
cells expressing these proteins by vaccine-specific T cells should
eradicate the tumour and prevent further spread.
Professor Lindy Durrant, Chief Executive Officer, Scancell,
commented: "The approval of the Modi-1 CTA is a significant
achievement for the Company. Targeting siPTMs generated dramatic
regression of large tumours in our preclinical models and we hope
to see similar results in cancer patients during this trial. This
is the first of several vaccines that we are developing from the
Moditope(R) platform and look forward to updating the market on our
progress in due course."
Professor Christian Ottensmeier at The Clatterbridge Cancer
Centre and University of Liverpool, commented: "I am very excited
to be the principal investigator for this first-in-human clinical
trial to determine if siPTMs and, in particular, citrullination
will be able to transform the prognosis for these patients with
hard to treat tumours."
Professor Kees Melief, Chief Scientific Officer, ISA
Pharmaceuticals, commented: "We are delighted to be collaborating
with Scancell on this innovative trial. We have shown that
AMPLIVANT(R) is an excellent adjuvant for therapeutic vaccines and
think that extending the scope of our technology to targeting
siPTMs could have enormous benefit for patients with a range of
solid tumours."
Julie Crane, Centre Manager of Liverpool Head and Neck Centre
(LHNC), commented: "On behalf of LHNC, I am delighted that this
exciting novel, first-in-human treatment will be available for our
head and neck patients."
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.
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 (siPTMs). 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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