REG - Scancell Hlds - Strategic Partnership with PharmaJet

Scancell HoldingsAnnouncement

17/09/2024 07:00

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RNS Number : 4159E  Scancell Holdings Plc  17 September 2024

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 (https://pharmajet.com/stratis-imsc/)
(https://pharmajet.com/stratis-imsc/) 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-

 

 For further information, please contact:
 Scancell Holdings plc                                                    +44 (0) 20 3709 5700
 Professor Lindy Durrant, CEO

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

                                                                          scancell@consilium-comms.com

 

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
(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 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
(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)
.

 

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/ (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 (https://pharmajet.com) or contact
PharmaJet here (mailto:sales@pharmajet.com) . Follow us on LinkedIn
(https://www.linkedin.com/company/pharmajet-inc/) .

 

 

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