Scancell Holdings Plc Update on SCIB1 Phase 2 Clinical Study (9581E)
October 24 2018 - 2:00AM
UK Regulatory
TIDMSCLP
RNS Number : 9581E
Scancell Holdings Plc
24 October 2018
24 October 2018
Scancell Holdings Plc
Scancell and Ichor provide update on SCIB1 Phase 2 clinical
study
in patients with advanced melanoma
Scancell Holdings plc ("Scancell"), the developer of novel
immunotherapies for the treatment of cancer, and Ichor Medical
Systems, Inc. ("Ichor"), today provide an update on the proposed
international Phase 2 clinical study of Scancell's lead
ImmunoBody(R), SCIB1, in combination with Keytruda (pembrolizumab),
in patients with advanced melanoma.
Following the submission of an Investigational New Drug (IND)
application for the clinical study to the US Food and Drug
Administration (FDA), the FDA has responded requesting additional
information, in particular with respect to Ichor's new TriGrid(R)
2.0 electroporation delivery system and its use in combination with
SCIB1.
Ichor's TriGrid(R) 2.0 is an electroporation delivery system
which is designed to support eventual commercial deployment and
will be used to deliver the SCIB1 vaccine to patients in the
proposed Phase 2 study. Scancell has previously used Ichor's
TriGrid(R) 1.0 delivery system in the SCIB1 Phase 1/2 clinical
study in patients with Stage III/IV malignant melanoma. In this
study SCIB1 was shown to have a favorable safety profile with no
dose-limiting toxicities and no serious adverse events related to
study drug or the delivery device.
Scancell and Ichor are working with the FDA to provide the
necessary information to enable initiation of the trial. In
parallel, Scancell is continuing to work on the operational
activities required to initiate clinical sites in the US and UK.
Scancell anticipates that patient enrolment into this trial will
commence in the first half of 2019, subject to the necessary
regulatory approvals.
Cliff Holloway, CEO of Scancell, said:
"We are working closely with Ichor and the FDA to address the
questions they have raised and we are confident we can respond to
these in timely manner. We continue to advance the operational
processes and procedures to ensure a rapid start to the study once
approval is obtained."
Robert Bernard, President & CEO of Ichor, added:
"We have taken on board the comments from the FDA and are
confident we can promptly respond to the questions on our
TriGrid(R) 2.0 electroporation device. Working closely with
Scancell, we aim to be trial ready in H1 2019."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
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
Mo Noonan/Simon Conway +44 (0) 20 3727 1000
Ichor Medical Systems, Inc. 1 858 550 2022
Bob Bernard, President, CEO
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 can be used as
monotherapy or in combination with checkpoint inhibitors. 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 for
SCIB2.
Moditope(R) represents a completely new class of potent and
selective immunotherapy agents. 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 triple
negative breast cancer, ovarian cancer and sarcomas.
For further details, please see our website:
www.scancell.co.uk
About Ichor Medical Systems, Inc.
Ichor Medical Systems' investigational TriGrid(R) Delivery
System (TriGrid) is the first integrated and fully automated device
for electroporation-mediated nucleic acid administration in humans.
Ichor, a privately-held biotech company based in San Diego, CA, is
collaborating with partners to provide its enabling TriGrid
platform as a means for delivery of nucleic acid-based drugs and
vaccines in disease indications such as cancer, hepatitis B virus
(HBV) infection, human papillomavirus (HPV) infection, and human
immunodeficiency virus (HIV) infection, as well as for multiple
biodefense agents. The TriGrid platform is also being developed for
nucleic acid-based antibody delivery as a rapid countermeasure in
the event of an infectious disease outbreak or biological weapons
attack. Visit http://www.ichorms.com.
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contact rns@lseg.com or visit www.rns.com.
END
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