TIDMSCLP
Scancell Holdings Plc
01 July 2019
01 July 2019
Scancell Holdings plc
("Scancell" or the "Company")
H1 2019 Business Update
Scancell, the developer of novel immunotherapies for the
treatment of cancer, today announces a business update following
the progress made in H1 2019.
SCIB1 Phase 2 trial
As reported in April, the Company has received the necessary
regulatory and ethical approvals to initiate the UK arm of the
SCIB1 clinical trial. Operational activities for clinical centre
initiation have been completed and active patient recruitment is
anticipated in the coming weeks. The Company continues its dialogue
with both Ichor and the FDA with respect to the TriGrid(R) v2.0
device specific questions and awaits further feedback from the
agency with regards to the IND approval which is required to
initiate the US arm of the study. The Company will update the
market as soon as additional information is available.
Modi-1 manufacturing and preclinical programme
In May, the Company provided an update on progress towards
initiating the Modi-1 Phase 1/2 clinical trial, with initiation of
Good Manufacturing Practice (GMP) synthesis of the Modi-1 peptide
conjugates at the PolyPeptide Group's facilities in The
Netherlands. This has been progressed further with formulation work
well underway to produce the final product for clinical testing and
initiation of the preclinical toxicity testing programme.
Cancer Research UK SCIB2 partnership
Scancell and Cancer Research UK provided an update in May on
their clinical development partnership for the development of
Scancell's ImmunoBody(R) vaccine, SCIB2, as a potential treatment
for patients with solid tumours. Pre-clinical studies demonstrated
that administration of SCIB2 as a liposomal nanoparticle results in
potent immune responses and prolonged survival, therefore SCIB2
will be administered using this new nanoparticle formulation in the
planned Phase 1/2 clinical trial in patients with solid
tumours.
Strengthened team and Clinical Advisory Board established
In January, Scancell strengthened its team by appointing Dr
Samantha Paston as Head of Research and Dr Adrian Parry as Head of
Manufacturing. Their expertise will be invaluable as we expand our
R&D and manufacturing capabilities to further advance our
ImmunoBody(R) and Moditope(R) pipeline products through clinical
development. In May, Scancell appointed six world-leading
clinicians to establish its Clinical Advisory Board, chaired by
Professor Robert Coleman, to provide strategic guidance around the
Moditope(R) clinical development programme.
Strengthened IP portfolio
During this period, the Company was granted a US patent that
provides protection for Modi-1, the first clinical candidate from
Scancell's Moditope(R) platform, a patent that provides protection
for the Moditope(R) platform in Japan, and a European patent
relating to FG88, a monoclonal antibody directed to tumour
associated glycans.
Vulpes investment and Board position
In June, Scancell raised gross proceeds of GBP3,877,965.55 by
the issue of 77,559,311 new ordinary shares to Vulpes Life Sciences
Fund. Following this investment, Martin Diggle, Co-Founder and
Portfolio Manager of Vulpes Investment Management, has been
appointed to the Company's Board of Directors as a Non-Executive
Director.
Dr Cliff Holloway, Chief Executive Officer, Scancell,
commented:
"It has been a busy and productive six months for Scancell. We
were pleased to welcome Vulpes as a shareholder in June and their
investment not only strengthens our cash position, but provides a
ringing endorsement of Scancell's future potential. We look forward
to working with Martin Diggle, who will provide valuable insight as
a Non-Executive Director.
In addition to expanding our team and establishing a Clinical
Advisory Board of world class clinical oncologists, we further
advanced our ImmunoBody(R) and Moditope(R) pipeline and expanded
our intellectual property portfolio. In April, we received UK
regulatory approval to initiate the new SCIB1 Phase 2 clinical
trial and we look forward to updating the market on the US arm of
this trial and patient recruitment in due course."
For Further Information:
Scancell Holdings plc
Dr John Chiplin, Chairman +44 (0) 20 3727 1000
Dr Cliff Holloway, CEO
Panmure Gordon (UK) Limited
(Nominated Adviser and Corporate
broker)
Freddy Crossley/Emma Earl +44 (0) 20 7886 2500
FTI Consulting
Simon Conway/Natalie Garland-Collins +44 (0) 20 3727 1000
About Scancell
Scancell is developing novel immunotherapies for the treatment
of cancer based on its ImmunoBody(R) and Moditope(R) technology
platforms.
ImmunoBody(R) vaccines target dendritic cells and stimulate both
parts of the cellular immune system. They have the potential to be
used as monotherapy or in combination with checkpoint inhibitors
and other agents. This platform has the potential to enhance tumour
destruction, prevent disease recurrence and extend survival.
-- SCIB1, the lead programme, is being developed for the
treatment of melanoma. A phase 1/2 clinical trial has so far
successfully demonstrated survival data of more than five
years.
-- SCIB2 is being developed for the treatment of non-small cell
lung cancer and other solid tumours. Scancell has entered into a
clinical development partnership with Cancer Research UK (CRUK) for
SCIB2.
Moditope(R) represents a completely new class of potent and
selective immunotherapy agents based on stress-induced
post-translational modifications (siPTM). It stimulates the
production of killer CD4 T cells which overcome the immune
suppression induced by tumours, allowing activated T cells to seek
out and kill tumour cells that would otherwise be hidden from the
immune system. Moditope(R) alone, or in combination with other
agents, has the potential to treat a wide variety of cancers.
-- Modi-1 is being developed for the treatment of solid tumours
including triple negative breast cancer, ovarian cancer and head
and neck cancer.
For further details, please see our website:
www.scancell.co.uk
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRADGGDLUBXBGCG
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