17 September 2024
Scancell Holdings
plc
("Scancell" or the "Company")
Scancell signs strategic
partnership with PharmaJet for use of the Stratis® IM Needle-free
delivery System in the development of SCIB1/iSCIB1+ cancer vaccine
for Advanced Melanoma
Scancell Holdings plc (AIM: SCLP),
the developer of novel immunotherapies for the treatment of cancer,
today announces that it has signed a strategic partnership with
PharmaJet for supply of the Stratis® Intramuscular (IM)
Needle-free Injection System for
delivery of Scancell's Immunobody® SCIB1/iSCIB1+ DNA vaccine for
both clinical development and commercial use.
Delivering SCIB1/iSCIB1+
intramuscularly via Stratis® has shown effective uptake of the DNA vaccine and
has the potential to provide clinical benefit to
patients with advanced/metastatic melanoma by allowing native cellular machinery to
express the target antigen and induce a potent anti-tumour
response. To date, 60 patients across 15 clinical sites have
successfully received a total of 171 doses of SCIB1/iSCIB1+
via Stratis®.
Stratis® has U.S. FDA 510(k) marketing clearance, CE Mark, and World
Health Organization Prequalification to deliver medications and
vaccines either intramuscularly or subcutaneously and has been
widely accepted and favoured by patients and clinicians throughout
the SCOPE Study.
The license agreement has been
completed in preparation for the Phase 2/3 adaptive registrational
trial planned for 2025, building on the previously announced
exceptional data from the first 13 patients receiving SCIB1 in the
ongoing SCOPE trial. Clinical data is expected from
SCIB1 and iSCIB1+ in Q4 2024 and Q1 2025,
respectively. The delivery of SCIB1/ iSCIB1+ vaccine
with Stratis® offers patients speed of treatment as an off the shelf
therapeutic cancer vaccine with the convenience of needle-free
delivery that enhances the patient experience.
Prof Lindy Durrant, Chief Executive Officer, Scancell,
commented: "Securing long term
supply for the PharmaJet Stratis® Intramuscular Needle-free Injection System is an important
step in allowing the clinical and commercial development of
SCIB1/iSCIB1+. We are pleased that PharmaJet's delivery system
works effectively with our SCIB1/iSCIB1+ therapeutic cancer
vaccines and offers a well-received immunisation for patients. Our
ultimate goal for Scancell is to deliver an off the shelf, safe,
tolerable, effective therapy that can provide potent and durable
anti-tumour responses for unresectable stage IV melanoma which
currently has a 5-year survival of 35%, according to the SEER
database, and we believe this agreement
will bring us another step closer to achieving this
goal."
Dr
Heather Shaw, Consultant Medical Oncologist, Mount Vernon Cancer
Centre and the UCLH, commented: "The
convenience of an off-the-shelf vaccine for patients, clinicians
and the healthcare system is further optimised with the ease of
delivery of SCIB1/iSCIB1+ with the Stratis® Needle-free Injection System. Our
patients on the SCOPE study are very comfortable with the delivery
system and our research team benefit from the convenience of
delivering the SCIB1/iSCIB1+ via Stratis®."
Nathalie Landry, Chief Scientific Officer at PharmaJet,
commented: "We are excited to
partner with Scancell to develop and commercialise their
SCIB1/iSCIB1+ DNA vaccine for advanced melanoma. This partnership
aligns with PharmaJet's strategy to enable improved delivery of
nucleic acid-based vaccines and therapies for oncology."
-ENDS-
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For
further information, please contact:
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Scancell Holdings plc
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+44 (0) 20 3709 5700
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Professor Lindy Durrant,
CEO
Dr Jean-Michel Cosséry,
Non-Executive Chairman
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Panmure Liberum Limited (Nominated Advisor and Joint Broker)
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+44 (0) 20 7886 2500
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Emma Earl/ Freddy Crossley/ Will
Goode/ Mark Rogers (Corporate Finance)
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Rupert Dearden (Corporate
Broking)
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WG
Partners LLP (Joint Broker)
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+44 (0) 20 3705 9330
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David Wilson/ Claes Spang/ Satheesh
Nadarajah/ Erland Sternby
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ICR
Consilium
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Mary-Jane Elliott/ Angela Gray/
Lindsey Neville
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+44 (0) 20 37095700
scancell@consilium-comms.com
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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. 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 40% of patients with the tissue type treatable with SCIB1,
where treatment is human leukocyte antigen (HLA)
dependent.
About the SCOPE Study
The SCOPE Study
(NCT04079166)
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 15
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 or www.clinicaltrialsregister.eu.
About Scancell
Scancell is a clinical stage
biopharmaceutical 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®).
For further information about
Scancell, please visit: https://www.scancell.co.uk/
About PharmaJet
The PharmaJet mission is to improve
the performance and outcomes of injectables with our enabling
technology that better activates the immune system. We are
committed to helping our partners realize their research and
commercialization goals while making an impact on public health.
PharmaJet Precision Delivery Systems™ can improve increased vaccine
effectiveness, allow for a preferred patient and caregiver
experience, and offer a proven path to commercialization. They are
also safe, fast, and easy-to-use. The Stratis® System
has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS
certification to deliver medications and vaccines either
intramuscularly or subcutaneously. The Tropis System has CE Mark
and WHO PQS certification for intradermal injections. They are both
commercially available for global immunization programs. For more
information or if you are interested in partnering with PharmaJet
to improve the impact of your novel development program,
visit https://pharmajet.com
or contact PharmaJet here. Follow us on LinkedIn.
