REG - Scancell Holdings - FDA Fast Track Designation for iSCIB1+

Scancell HoldingsAnnouncement

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RNS Number : 1041C  Scancell Holdings Plc  28 April 2026

 

28th April 2026

 

Scancell Holdings plc

Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma
and provides data update from its SCOPE Phase 2 study

Potent and durable efficacy with iSCIB1+ of 77% progression free survival
(PFS) at 20 months, in combination with ipilimumab and nivolumab, demonstrated
in the Phase 2 SCOPE trial; more PFS and additional early overall survival
(OS) data expected in H1 2027

Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced
melanoma anticipated in H2 2026

Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to
treat cancer, announces that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for its lead ImmunoBody® iSCIB1+ for the
treatment of advanced melanoma.

Dr Phil L'Huillier, CEO of Scancell, said: "This designation is a major
achievement for Scancell and important recognition not only of the potential
of iSCIB1+, but also of the significant need for new and improved treatment
options for patients with advanced melanoma. We are very pleased with how the
Phase 2 SCOPE data is maturing and are advancing plans for a global
registrational Phase 3 trial, which we expect to initiate in the second half
of 2026."

Progression free survival (PFS) has matured positively, reaching 77% at 20
months in the target population(1). This widens the lead of iSCIB1+ over PFS
reported with ipilimumab plus nivolumab alone of 43% at 20 months, now
representing a 30+ percentage point improvement over standard of care
(SoC). 2  (#_ftn1)

The Fast Track Designation is granted for investigational therapies that show
advantage over available treatments, such as superior effectiveness, and
provides the process to expedite review of drugs for serious conditions, with
the aim of getting effective therapies to patients faster.  The designation
enables frequent engagement to ensure alignment on development plans, enhance
development predictability and support a more efficient path through clinical
development. Moreover, Fast Track Designation brings eligibility for
Accelerated Approval, Priority Review and Rolling Review.

Additional PFS data and early OS data from the Phase 2 SCOPE study are
expected in H1 2027.

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014 (MAR).

-ENDS-

 

About the SCOPE Phase 2 study

The SCOPE study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Study in
Advanced Unresectable Melanoma. Patients receiving either Nivolumab plus
Ipilimumab or Pembrolizumab as standard of care (SoC) will also be treated
with SCIB1 or iSCB1+. The study aims to determine the efficacy and safety of
SCIB1 or iSCIB1+ when added to these SoC therapies. Additional endpoints
include disease control rate (DCR), duration of response (DOR), progression
free survival (PFS), overall survival (OS). Participants receive up to 11
doses of either SCIB1 or iSCIB1+ using the PharmaJet needle-free injection
devices. More information at clinicaltrials.gov.

 

Scancell (LSE:SCLP; www.scancell.co.uk) is a clinical stage biotechnology
company developing targeted off-the-shelf active immunotherapies, to generate
safe and long-lasting tumour-specific immunity for a cancer-free future.
iSCIB1+, the lead product from their DNA ImmunoBody® platform has
demonstrated safe, durable and clinically meaningful benefit as a monotherapy
as well as additional benefit when combined with checkpoint therapies in a
Phase 2 trial in melanoma. Modi-1, the lead peptide immunotherapy from their
Moditope® platform, is being investigated in a Phase 2 study in a broad range
of solid tumours. In addition, Scancell's wholly owned subsidiary, GlyMab
Therapeutics Ltd., has been established with the intention to hold and develop
an exciting early-stage pipeline of high affinity GlyMab® antibodies
targeting tumour specific glycans, two of which already have been licensed and
are being developed by Genmab A/S, an international biotechnology company and
global leader in the antibody therapeutics space.

 

For more information please contact:

 Scancell Holdings plc                                   +44 (0) 20 3709 5700
 Phil L'Huillier, CEO

 Panmure Liberum (Nominated Adviser and Joint Broker)    +44 (0) 20 7886 2500
 Emma Earl, Will Goode, Mark Rogers (Corporate Finance)

 Rupert Dearden (Corporate Broking)

 WG Partners LLP (Joint Broker)                          +44 (0) 20 3705 9330

 David Wilson, Claes Spang

 Investor and media relations                            +44 (0) 20 7483 284853

 Mary-Ann Chang                                          MaryAnnChang@scancell.co.uk

 

(#_ftnref1) 1The target population represents patients with human leukocyte
antigen (HLA) alleles present in approximately 80% of melanoma patients in the
SCOPE trial's third cohort, which also represents the population to be
selected in the Company's upcoming Phase 3 trial.

 

2 SoC represents the combination of ipilimumab and nivolumab measured using
the results of the pivotal Checkmate 067 trial

 

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