PharmaJet’s Needle-free Injection System Selected to Administer DNA Immunotherapy for Advanced Melanoma in Late-stage Clinical Development following Positive Phase 2 Data

• PharmaJet’s intramuscular (IM) Needle-free Injection System – Stratis^® – was used to deliver Scancell’s iSCIB1+ DNA immunotherapy in combination with immune checkpoint inhibitors in the SCOPE Phase 2 trial.
• The Scancell immunotherapy delivered using PharmaJet’s Stratis demonstrated a Progression-Free Survival rate of 74% at 16 months.¹

GOLDEN, Colo.–(BUSINESS WIRE)–PharmaJet^®, a company focused on improving the performance and outcomes of injectables through needle-free injection technology, announced that its partner Scancell has reported updated Phase 2 clinical data from the SCOPE study in unresectable advanced melanoma. In this study, Scancell’s iSCIB1+ immunotherapy was delivered intramuscularly using Stratis, PharmaJet’s Needle-free Injection System. Data was presented at the ESMO Immuno-Oncology Congress 2025 on December 11, 2025.

Advanced melanoma continues to represent a significant unmet medical need, with five-year survival rates of less than 23% for Stage IV patients, and an estimated 58,000 deaths annually.¹ While immune checkpoint inhibitors have improved outcomes for many patients, approximately half either fail to respond or experience non-durable benefits, underscoring the need for novel therapeutics that extend and deepen clinical responses.¹

Updated Phase 2 data of Scancell’s iSCIB1+ DNA immunotherapy delivered with PharmaJet’s Stratis demonstrated a Progression-Free Survival (PFS) rate of 74% at 16 months, compared to 50% PFS at 11.5 months for standard-of-care checkpoint inhibitor therapy alone.¹ Based on these results, Scancell has indicated plans to initiate a registrational Phase 3 study in the second half of 2026 with its immunotherapy delivered with Stratis, PharmaJet’s Needle-free Injection System.

“PharmaJet’s Needle-free Injection System is an effective delivery device for iSCIB1+ and we are delighted with the latest results in the Phase 2 study,” said Dr. Phil L’Huillier, CEO of Scancell. “Patients and providers alike prefer the needle-free system over conventional needle and syringe. We have significant experience with Stratis and its ability to consistently deliver our product in a more comfortable and convenient way.” Subject to regulatory outcomes and achievement of clinical endpoints, Scancell has outlined plans to advance iSCIB1+ towards potential commercialization by 2029.¹

“PharmaJet is pleased to support Scancell’s SCOPE Phase 2 program and preparations for the upcoming registrational trial,” said Wouter Latour, CEO of PharmaJet. “With U.S. FDA 510(k) clearance and CE mark in Europe, Stratis is designed to provide consistent, reproducible intramuscular delivery of DNA-based therapies, offering a needle-free alternative to traditional injections which can be inefficient for DNA delivery, and to electroporation, which is often uncomfortable for patients. We are encouraged by the clinical progress achieved with immunotherapy administered via Stratis and we look forward to making the technology available for the development of other next-generation vaccines and immunotherapies.”

For more information go to the PharmaJet website: https://www.pharmajet.com.

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

¹ Redefining Standard of Care in Advanced Melanoma SCOPE data update, Scancell presentation 11 December 2025, slide 4

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 vaccine and immunotherapy 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 globally for prophylactic and therapeutic applications. For more information or if you are interested in partnering with PharmaJet visit https://www.pharmajet.com or contact PharmaJet here. Follow us on LinkedIn.

About Scancell

Scancell is a clinical stage biotechnology company developing targeted off-the-shelf active immunotherapies, to generate safe and long-lasting tumour-specific immunity for a cancer-free future. iSCIB1+, the lead product from their DNA ImmunoBody® platform has demonstrated safe, durable and clinically meaningful benefit as a monotherapy as well as additional benefit when combined with checkpoint therapies in an ongoing Phase 2 trial in melanoma. Modi-1, the lead peptide immunotherapy from their Moditope® platform, is being investigated in a Phase 2 study in a broad range of solid tumours. In addition, Scancell’s wholly owned subsidiary, GlyMab Therapeutics Ltd., has been established with the intention to hold and develop an exciting early-stage pipeline of high affinity GlyMab® antibodies targeting tumour specific glycans, two of which already have been licensed and are being developed by Genmab A/S, an international biotechnology company and global leader in the antibody therapeutics space. For more information, visit www.scancell.co.uk

Contacts

Nancy Lillie

[e-mail]
1-888-900-4321 Option 3