Scancell Holdings Plc Update on the SCIB1 Phase 2 clinical trial (4101J)
August 19 2019 - 1:00AM
UK Regulatory
TIDMSCLP
RNS Number : 4101J
Scancell Holdings Plc
19 August 2019
19 August 2019
Scancell Holdings plc
("Scancell" or the "Company")
Update on the SCIB1 Phase 2 clinical trial in patients with
advanced melanoma
Initiation of patient enrolment into UK sites
Scancell, the developer of novel immunotherapies for the
treatment of cancer, today announces the initiation of and further
updates on the SCIB1 Phase 2 trial in patients with metastatic
melanoma also receiving the checkpoint inhibitor pembrolizumab
(Keytruda).
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 in the UK have now been completed. In the US, the Food
and Drug Administration ("FDA" or the "Agency") requested
additional information from Ichor Medical Systems ("Ichor") on the
TriGrid(R) 2.0 electroporation delivery system. Whilst there has
been extensive dialogue between Ichor and the Agency, a timely
resolution to the device-specific questions has yet to be
agreed.
In order to initiate patient recruitment in the UK under the
Investigational New Drug (IND) application submitted to the Agency,
prior approval of the IND is required. Having considered the
ethical issues related to patients awaiting enrolment into the UK
sites, Scancell has decided to withdraw its IND application in the
US to allow the UK arm of the trial to proceed.
Scancell will resubmit the IND at a later date with the intent
to initiate clinical sites in the US, following further
clarification from the Agency regarding Ichor's TriGrid(R) 2.0
delivery device.
The Phase 2 study is designed to assess whether the addition of
SCIB1 to pembrolizumab will result in an improvement in the tumour
response rate, progression-free survival and overall survival in 25
patients with advanced melanoma, who are also eligible for
treatment with pembrolizumab. Professor Poulam Patel, Chief
Investigator for the SCIB1 Phase 1/2 clinical trial and Professor
of Clinical Oncology at the University of Nottingham, will now be
the Chief Investigator for the Phase 2 study. Patient enrolment
into the UK arm of the study will commence immediately.
Dr Cliff Holloway, Chief Executive Officer, Scancell,
commented:
"We are pleased to be able to advance our SCIB1 Phase 2 trial in
the UK as we believe that SCIB1 administration with an immune
checkpoint inhibitor such as pembrolizumab has the potential to
offer greater efficacy than when either agent is used alone. Whilst
it is disappointing that discussions in the US have taken longer
than anticipated, we will continue our dialogue with both Ichor and
the Agency, and plan to resubmit the IND as soon as possible."
Professor Poulam Patel, Chief Investigator, commented:
"There remains an urgent need for improved therapies in
melanoma. Based upon our previous successful trial with SCIB1 alone
we are excited to see if the addition of SCIB1 to current, standard
treatment with pembrolizumab increases our anti-cancer response
rate."
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
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
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END
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