REG - Scancell Hlds - Scancell initiates new arm in SCOPE Phase 2 study

Scancell HoldingsAnnouncement

Wed 07:00

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RNS Number : 2491O  Scancell Holdings Plc  25 June 2025

25 June 2025

 

Scancell Holdings plc

 

Scancell initiates new arm (Cohort 4) in SCOPE Phase 2 study to evaluate
intradermal administration and an accelerated dosing regimen for iSCIB1+

Cohort 4 evaluates iSCIB1+ immunotherapy for the treatment of advanced
melanoma

No significant adverse events observed in initial 8 patients dosed
intradermally with SCIB1+

 

Additional data from Cohorts 1-3 expected in July 2025

 

Interim data from Cohort 4 expected around the year end

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy
products for the treatment of multiple cancers, announces today that dosing of
patients has commenced in Cohort 4 of its Phase 2 clinical SCOPE study. This
cohort will evaluate iSCIB1+ Immunobody® through intradermal administration
and accelerated dosing in patients with advanced unresectable melanoma.

The initial 8 patients have now been safely dosed in the fourth cohort with
iSCIB1+, including patients recruited through the NHS Cancer Vaccine Launch
Pad. No significant adverse events have been observed with intradermal dosing.
The trial remains on track, with data from Cohorts 1 through 3 expected in
July 2025. With ongoing strong recruitment continuing in the iSCIB1+ Cohort 4,
initial data in this cohort is expected around the end of 2025.

Dr Nermeen Varawalla, Chief Medical Officer of Scancell, said: "The SCOPE data
reported so far are highly encouraging, with SCIB1 immunotherapy showing
excellent efficacy and long-term survival benefits that signal a meaningful
improvement over standard of care. Initiation of Cohort 4 is an important
milestone for our iSCIB1+ programme to evaluate intradermal administration on
our path to towards randomised studies."

SCOPE (NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?cond=Melanoma%20Metastatic&term=SCOPE&rank=1)
) is a Phase 2, multi-centre open-label study, investigating SCIB1/iSCIB1+,
with checkpoint inhibitors (CPIs) in late-stage melanoma and will enroll 140+
patients across four cohorts.  Initial data from 25 patients in Cohort 1,
receiving first-generation SCIB1 ImmunoBody® in combination with checkpoint
inhibitors, ipilimumab and nivolumab, showed 84% disease control rate, 80%
progression free survival (PFS), with a 20% complete response (CR) rate, and
72% ORR, demonstrating a significant improvement over standard of care
treatment.

Cohort 3, receiving next generation iSCIB1+ in combination with ipilimumab and
nivolumab, has now been completely enrolled. Cohort 4 will evaluate
intradermal administration of Scancell's iSCIB1+ Immunobody®, a potent and
targeted "off-the-shelf" active immunotherapy, with accelerated dosing of the
priming immunizations in patients with advanced unresectable melanoma.

Phil L'Huillier, Chief Executive Officer of Scancell, said: "We are making
strong clinical and strategic progress across our portfolio. The continued
momentum in the SCOPE study highlights the clinical potential of SCIB1, and
the next generation iSCIB1+, to address the unmet needs in melanoma. Modi-1
continues on track for further data readouts in the year. We are also
progressing plans on our commitment to unlock the full potential of our
innovative GlyMab® platform by establishing Glymab Therapeutics Ltd. We are
looking to bring focus to our product development execution across the
portfolio while positioning ourselves to deliver future value through creating
strategic optionality in a time of market headwinds."

Management will host a webcast on 25(th) June at 11.00 BST to outline further
the design of clinical development path for SCIB1 and iSCIB1+ and provide a
corporate update. There will be an opportunity to ask questions following the
presentation. Please click here
(https://www.investormeetcompany.com/scancell-holdings-plc/register-investor)
to register for the webcast.

 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

 

SCIB1 is the lead product from the Company's ImmunoBody® platform, which uses
the body's immune system to identify, attack and destroy tumours. iSCIB1+ is a
modified version of SCIB1 developed using Scancell's AvidiMab® platform to
enhance its potency compared to SCIB1. iSCIB1+ also includes additional
melanoma-specific epitopes so it has the potential to be effective in a broad
patient population.

 

The SCOPE study (NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?term=scib1&rank=2) ) 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 10 doses of either SCIB1 or
iSCIB1+ using the PharmaJet Stratis® or Tropis needle-free injection devices.
More information at clinicaltrials.gov
(https://clinicaltrials.gov/study/NCT04079166?term=scib1&rank=2) .

Scancell (LSE:SCLP; www.scancell.co.uk (http://www.scancell.co.uk) ) is a
clinical stage biotechnology company developing targeted off-the-shelf
immunotherapies which enhance long-lasting tumour specific immunity for a
cancer-free future. Scancell's lead product, iSCIB1+ immunotherapy, has shown
strong promise, showing clinically meaningful additional benefit when combined
with checkpoint therapies. The second immunotherapy, Modi-1, is being
investigated in a phase 2 study in a broad range of solid tumours. Scancell
also has an exciting early-stage pipeline of high affinity GlyMab® antibodies
targeting tumour specific glycans. Two GlyMab® antibodies are being developed
by Genmab under license from Scancell.

 

 

 

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