REG - Scancell Hlds - Positive data from Phase 2 SCOPE trial with SCIB1

Scancell HoldingsAnnouncement

18/11/2024 07:00

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RNS Number : 5202M  Scancell Holdings Plc  18 November 2024

18 November 2024

 

Scancell Holdings plc

("Scancell" or the "Company")

 

Scancell announces further positive data from the ongoing SCOPE trial of SCIB1
with double CPIs for Advanced Melanoma

 

80% Progression Free Survival in 25 patients at 6 months

20% (5) patients have shown a complete response following treatment

Disease Control Rate of 84% and an Objective Response Rate of 72%

 

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for
the treatment of cancer, announces today that 25 patients in cohort 1,
receiving SCIB1 in combination with ipilimumab and nivolumab, have reached the
25-week landmark point of the SCOPE trial. These patients are showing
progression free survival (PFS) of 80% at 6 months, with 5 (20%) complete
responders (CR). 21 of 25 patients (84%) have shown disease control (stable
disease or tumour regression, DCR). 18 out of 25 patients have shown a
clinical response which is an objective response rate (ORR) of 72%, with many
patients continuing to show tumour shrinkage over time. These responses have
been verified in all patients with further scans at 19 and 25 weeks.

 

These results compare favourably with reported outcomes from the double
checkpoints alone, namely PFS of 65%, CR of 16%, DCR of 58% and ORR of 48%,
respectively. The PFS and accumulating number of complete responders indicates
that the combination of SCIB1 with double checkpoints gives sustained and
durable responses which are improved when compared to double checkpoints
alone. To date, cohort 1 of the SCOPE trial has recruited 42/43 patients, and
it is anticipated that all of these patients will reach week 25 during H1
2025.

 

Dr Heather Shaw, Medical Oncologist, University College Hospital, London, UK
commented: "Based upon the emergent striking PFS, DCR and ORR results from
cohort 1 so far and the lack of toxicity relating to the agent itself, SCIB1
is a promising product that would be a significant addition to ipilimumab and
nivolumab and would be an important step forward in improving first line
therapy for advanced melanoma patients. "

 

Cohort 2, investigating SCIB1 in combination with pembrolizumab, has recruited
9/43 patients and cohort 3, investigating the next generation, iSCIB1+ in
combination with ipilimumab and nivolumab has recruited 33/43 patients. The
iSCIB1+ cohort has predominantly recruited the non-HLA.A2 matched patients as
these patients are being enrolled in cohort 1. Once recruitment in cohort 1 is
complete, HLA.A2 patients will be recruited to complete cohort 3 to give a
representative sample of the advanced melanoma patient population. It is
anticipated that all cohort 3 patients will reach week 25 during H2 2025. This
will allow us to select the best vaccine for our planned phase 2/3 randomised,
adapted registration trial.

 

Prof Lindy Durrant, Chief Scientific Officer, Scancell, commented: "The SCOPE
study continues to yield excellent results with a PFS of 80% and five patients
now achieving a complete response. We are particularly impressed with the
progression free survival data as this will be the primary endpoint of the
next trial, a phase 2/3 randomised, adapted trial, and the key outcome for
product registration. We look forward to providing further updates on our
progress given the extremely positive results to date."

 

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

 

-ENDS-

 

 

 For further information, please contact:

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

 Dr Jean-Michel Cosséry, Non-Executive Chairman

 Panmure Liberum Limited (Nominated Advisor and Joint Broker)             +44 (0) 20 7886 2500
 Emma Earl/ Freddy Crossley/ Will Goode/ Mark Rogers (Corporate Finance)
 Rupert Dearden (Corporate Broking)

 WG Partners LLP (Joint Broker)                                           +44 (0) 20 3705 9330
 David Wilson/ Claes Spang/ Satheesh Nadarajah/ Erland Sternby

 ICR Healthcare
 Mary-Jane Elliott/ Angela Gray/ Lindsey Neville                          +44 (0) 20 37095700

                                                                          scancell@icrhealthcare.com (mailto:scancell@icrhealthcare.com)

 
 

About Scancell

 

Scancell is a clinical stage immunotherapy company that is leveraging its
proprietary research, built up over many years of studying the human adaptive
immune system, to generate novel medicines to treat significant unmet needs in
cancer. The Company is building a pipeline of innovative products by utilising
its four technology platforms: Moditope(®) and ImmunoBody(®) for vaccines
and GlyMab(®) and AvidiMab(®) for antibodies. Adaptive immune responses
include antibodies and T cells (CD4 and CD8), both of which can recognise
damaged or infected cells. In order to destroy such cancerous or infected
cells, Scancell uses either vaccines to induce immune responses or monoclonal
antibodies (mAbs) to redirect immune cells or drugs. The Company's approaches
are that vaccines (ImmunoBody(®) and Moditope(®)) use unique receptors to
target antigens to activated antigen presenting cells whereas its mAb
portfolio targets glycans or sugars that are added onto proteins and / or
lipids (GlyMab(®)) or enhances the potency of antibodies and their ability to
directly kill tumour cells (AvidiMab(®)).

Scancell is headquartered in Oxford, United Kingdom and is listed on AIM
(LSE.SCLP.L). For further information about Scancell, please visit:
https://www.scancell.co.uk. (https://www.scancell.co.uk.)

 

About SCIB1/iSCIB1+

SCIB1 is the lead product from the Company's ImmunoBody® DNA Vaccine
platform, which uses the body's immune system to identify, attack and destroy
tumours. SCIB1 is restricted to HLA.A2 matched patients. 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 broader patient
population beyond the 30% of HLA.A2 matched patients with the tissue type
treatable with SCIB1, where treatment is human leukocyte antigen (HLA)
dependent.

 

About the SCOPE Study

The SCOPE Study (NCT04079166
(https://clinicaltrials.gov/study/NCT04079166?term=scib1&rank=2) ) is a
Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in
Patients With Advanced Unresectable Melanoma Receiving Nivolumab With
Ipilimumab or SCIB1 With Pembrolizumab to determine the response rate and
safety and tolerability of intramuscular SCIB1 or iSCIB1+ when added to
nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab
(Keytruda). Conducted across approximately 16 participating sites in the
United Kingdom, this multi-site trial aims to demonstrate durable and potent
anti-tumour activity and ORR of SCIB1/Iscib1+ in addition to standard of care
checkpoint inhibitors. Additional endpoints include duration of response
(DOR), progression free survival (PFS), overall survival (OS), safety, and
tolerability. Participants receive up to 10 doses of either SCIB1 or iSCIB1+
using PharmaJet Stratis® Intramuscular Needle-free Injection System in the
upper arm or upper leg, up to 85 weeks, in combination with nivolumab with
ipilimumab or SCIB1 with pembrolizumab. More information on this trial can
be found at clinicaltrials.gov
(https://www.globenewswire.com/Tracker?data=kFdkwwLSgbD6z3fn9vUCka0Qz0AJKqFORBMc75T9h3-ujhX_zVQAo_xfzHMq1VSVaSwzYC-I4BJQN091N6PmYaksDhJ1Zxmuq5mzXzNqNFmb1OF68oHsNmON1xEoQHNN)
 or www.clinicaltrialsregister.eu
(https://www.globenewswire.com/Tracker?data=xr5c6tg-TO35E29FgLlaybp84b5tzMcxFBAWSK6wNjjVV9lFuc0E-ved76qXQ6iE3li1AgSKKhIzCZ7ZVeGWf0BwH1imiXxE1qEd6o-HwfgHdY4-D7q9cstA7wq7LA7s)
.

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