Needle-Free Tech Boosts Melanoma Drug, Paving Way for New Cancer Care

By Frank Reed

GOLDEN, CO – January 09, 2026 – A novel DNA immunotherapy for advanced melanoma has shown remarkable promise in a mid-stage clinical trial, a success attributed not only to the drug itself but also to the innovative needle-free technology used to deliver it. PharmaJet, a medical technology firm, announced that its Stratis® Needle-free Injection System was used to administer Scancell's iSCIB1+ immunotherapy, which demonstrated a significant improvement in patient outcomes compared to the current standard of care. The positive data has prompted Scancell to plan a pivotal late-stage trial, potentially heralding a new, more effective, and patient-friendly approach to fighting one of the deadliest forms of skin cancer.

A New Beacon of Hope in Melanoma Treatment

For patients with advanced, unresectable melanoma, the prognosis remains grim. Despite the revolutionary impact of immune checkpoint inhibitors (ICIs) over the past decade, a large portion of patients either do not respond to treatment or see their cancer return. For those with Stage IV disease, the five-year survival rate lingers below 23%, highlighting a critical unmet medical need for more durable and effective therapies.

New data from Scancell's Phase 2 SCOPE study, presented at the ESMO Immuno-Oncology Congress, offers a significant ray of hope. The study evaluated iSCIB1+, a DNA-based immunotherapy designed to stimulate a patient's immune system to target and destroy cancer cells, administered in combination with standard ICI therapy. When delivered with PharmaJet's needle-free system, the treatment achieved a 74% Progression-Free Survival (PFS) rate at 16 months. This figure stands in stark contrast to the historical 50% PFS rate at 11.5 months observed for patients receiving standard-of-care ICI therapy alone.

The overall response rate (ORR) was equally impressive, reaching 69% for patients with a specific genetic profile (HLA type) that represents about 80% of the melanoma patient population. This is substantially higher than the 48-50% ORR typically seen with the standard combination of ipilimumab and nivolumab. These results are not just an incremental improvement; they suggest a potentially synergistic effect between the DNA immunotherapy and the delivery method, setting a new benchmark for what may be possible in this challenging disease.

The Technology Behind the Breakthrough

The success of iSCIB1+ is inextricably linked to its delivery mechanism. Traditional needle-and-syringe injections can be inefficient for delivering DNA-based therapies, which must effectively penetrate muscle cells to trigger the desired immune response. Another alternative, electroporation, uses electrical pulses to increase cell permeability but is often painful and uncomfortable for patients.

PharmaJet's Stratis system offers a compelling alternative. It uses a high-velocity jet of fluid to deliver medication deep into the muscle tissue without a needle. This method is designed to ensure consistent, reproducible delivery, which is critical for the efficacy of advanced therapies. The technology has already received U.S. FDA 510(k) clearance and a CE Mark in Europe for delivering medications and vaccines.

“PharmaJet is pleased to support Scancell’s SCOPE Phase 2 program and preparations for the upcoming registrational trial,” said Wouter Latour, CEO of PharmaJet, in the company's recent press release. He noted that Stratis provides a needle-free alternative that avoids the discomfort of electroporation and the potential inefficiencies of traditional injections, adding, “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.”

The benefits extend beyond clinical efficacy. The global market for needle-free injection systems is growing rapidly, driven by a desire to reduce needle-stick injuries among healthcare workers and improve the patient experience. For cancer patients who often endure frequent injections and procedures, eliminating the pain and anxiety associated with needles—a condition known as needle phobia—can significantly improve quality of life and treatment adherence.

A Strategic Alliance Forging the Path to Market

The collaboration between Scancell, a clinical-stage biotechnology company, and PharmaJet, a medical device specialist, exemplifies a crucial trend in modern drug development. Bringing a complex therapy like a DNA immunotherapy to market requires not just a powerful therapeutic agent but also an optimized delivery system. This partnership ensures that the drug's full potential can be realized through effective and patient-centric administration.

Based on the strong Phase 2 results and positive discussions with regulatory bodies like the U.S. FDA, Scancell has outlined an ambitious timeline. The company plans to initiate a large-scale, registrational Phase 3 trial in the second half of 2026. This pivotal study will be the final step before seeking marketing approval. If the trial successfully replicates the promising results, Scancell aims for a potential commercial launch of iSCIB1+ by 2029.

“Patients and providers alike prefer the needle-free system over conventional needle and syringe,” stated Dr. Phil L’Huillier, CEO of Scancell. “We have significant experience with Stratis and its ability to consistently deliver our product in a more comfortable and convenient way.”

While the 2029 target is aggressive, it is not outside the realm of possibility. The strong clinical data in an area of high unmet need could qualify the therapy for accelerated regulatory review pathways. Furthermore, the ability to pre-select patients most likely to respond using HLA-type biomarkers could help streamline the Phase 3 trial design, increasing its probability of success and potentially shortening timelines. This strategic approach, combining a targeted therapy with an advanced delivery platform, represents a sophisticated model for accelerating oncological innovation from the lab to the clinic.