• SCOPE trial surpasses its first milestone with an 82% response rate.
• Needle-free delivery is favored by patients.
• If confirmed in a larger cohort, these data could result in significantly improved care for melanoma patients.

PharmaJet^®, a company that engineers precision delivery systems that overcome the challenges of vaccines and pharmaceuticals delivery, today announced that its partner, Scancell, has received positive data from the first stage in its Phase 2 clinical study for treatment of patients with unresectable advanced melanoma. The vaccine is delivered by needle-free injection with the PharmaJet Stratis^® System, which patients prefer over needle and syringe delivery.

Historically, the prognosis of patients with unresectable stage III and IV melanoma, when surgery is not an option, has been poor: Median overall survival is only 6.2 months¹. Scancell’s immunotherapy platform aims to improve on this prognosis using the body’s immune system to identify, attack and destroy tumors. The first stage in the Phase 2 study trial investigated whether the combination of SCIB1 treatment and checkpoint inhibitors (nivolumab and ipilimumab) resulted in an improvement in patient objective response rate (ORR) to treatment. Initial data from 11 patients showed an 82% ORR, which is better than the 70% ORR that the trial was configured to show and significantly better than previous studies that indicated a maximum 50% response rate. The treatment was delivered needle-free using PharmaJet’s precision delivery system.

Prof Lindy Durrant, Chief Executive Officer of Scancell commented, “We are excited by these highly impressive results for SCIB1 combined with the doublet CPI therapy. PharmaJet has been a great partner and their Stratis system is easy to use. We chose the system because it initially worked well with our COVID vaccine and administration was well received by study participants. It is now efficiently delivering our SCIB1 vaccine, and the patients really appreciate a needle free delivery. The data from this study adds to the growing evidence of modern needle-free administration technology being an enabling delivery platform that can enhance plasmid DNA vaccine immune response.”

Recruitment is underway for the second stage of the trial, with expected results during the first half of 2024. Based upon the first 11 patients, there is a greater than 90% probability that the second stage will also be successful.

Chris Cappello, President and CEO, PharmaJet commented, “We are pleased to be partnering with Scancell as they move forward with the second phase of the Phase 2 trial. In addition to increasing patient acceptance, our partners have published data showing improved immunogenicity with DNA vaccines.”

For more information about PharmaJet visit www.pharmajet.com.

Refer to Instructions for Use to ensure safe injections and to review risks.

¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281176/

About PharmaJet

The PharmaJet vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ provide increased vaccine effectiveness, a preferred patient and caregiver experience, and 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 visit https://pharmajet.com. Follow us on LinkedIn.

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 and infectious disease. 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 unique approach is that its innovative products target modifications of proteins and lipids. For the vaccines (Moditope^® and ImmunoBody^®) this includes citrullination and homocitrullination of proteins, 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/

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