REG - Scancell Holdings - FDA clearance of IND application for iSCIB1+

Scancell HoldingsAnnouncement

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RNS Number : 2266Q  Scancell Holdings Plc  26 January 2026

 

26 January 2026

 

Scancell Holdings plc

Scancell announces FDA clearance of IND application for global Phase 3 trial
of iSCIB1+ in advanced melanoma

Unlocks path towards registrational Phase 3 trial planned to start in 2026

Data from Phase 2 SCOPE trial show iSCIB1+ has potential to redefine standard
of care (SoC)

iSCIB1+ shows an interim 24%-point improvement in progression free survival
(PFS) over real world SoC and historic controls

Scancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to
treat cancer, announces the U.S. Food and Drug Administration (FDA) has
cleared its Investigational New Drug (IND) application for a registrational
Phase 3 trial of its iSCIB1+ Immunobody® in advanced melanoma, with
progression free survival as the agreed surrogate endpoint.

Scancell has completed the 140-patient SCOPE Phase 2, open-label, multi-centre
study evaluating ImmunoBody® immunotherapies (SCIB1 and iSCIB1+) in
combination with nivolumab plus ipilimumab in previously untreated
unresectable stage IIIB/IV melanoma. In addition to demonstrating potentially
best-in-class efficacy and durability, from the data analysis we have
identified a selection marker to enrich the phase 3 trial for responders.

Dr Phil L'Huillier, CEO of Scancell, said: "This IND clearance creates a clear
pathway for late-stage registrational development of our iSCIB1+ Immunobody®.
Data from the Phase 2 SCOPE trial shows a significant improvement in
progression free survival as well as emerging overall survival with iSCIB1+
compared to historic benchmarks. I take this endorsement of our program as a
strong measure of the clinical benefit and safety of our very novel product as
well as the quality of our manufacturing and preclinical work. We are
continuing our dialogue with regulators broadly as we continue to evaluate all
financing options, including partnering discussions, for the Phase 3 trial."

Results from the SCOPE Phase 2 trial have enabled Scancell to select iSCIB1+,
administered needle-free intramuscularly, for further development in patients
with selected human leukocyte antigen (HLA) alleles, representing 80% of
melanoma patients. This profile is reflected within Cohort 3 of the SCOPE
trial.

Updated data in this cohort show PFS was 74% at 16 months in the target
population. This compares favourably to PFS reported with ipilimumab plus
nivolumab alone, the current standard of care, of 50% at 11.5 months 1 
(#_ftn1) . The favourable PFS remains consistent across key subgroups analysed
including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure,
who might be expected to have worse outcomes.

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

-ENDS-

SCOPE (ClinicalTrials.gov: NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?cond=Melanoma%20Metastatic&term=SCOPE&rank=1)
) is a Phase 2, UK multi-centre open-label study investigating SCIB1/iSCIB1+
in combination with checkpoint inhibitors in late-stage melanoma and enrolling
140 patients across four cohorts. Its aim is to evaluate the efficacy, safety
and durability of SCIB1 or iSCIB1+ DNA Immunobody® therapies when given to
patients in combination with SoC checkpoint inhibitors in stage IIIB/IV
unresectable metastatic melanoma, and to define the parameters to design a
Phase 3 randomised registration trial.

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
 Sath Nirmalananthan, CFO

 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

 

 1  (#_ftnref1) Ipilimumab and Nivolumab in Checkmate 06

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