RE: SCIB1 Combo.......Proactive Latest28 Dec 2018 05:18
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®, 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® 2.0 electroporation delivery system and its use in combination with SCIB1.
Ichor’s TriGrid® 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® 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® 2.0 electroporation device. Working closely with Scancell, we aim to be trial ready
in H1 2019.
Sounds very positive to me, and just could be a very good example of giving a very realistic timeline, to avoid further delays.