PharmaJet and Scancell Sign Strategic Partnership Agreement for Development and Commercialization of a Needle-free DNA Vaccine for Advanced Melanoma

  • The PharmaJet Needle-free Delivery System has shown effective uptake of the SCIB1 DNA vaccine in addition to offering speed, convenience, and enhanced patient experience.
  • PharmaJet is eligible to receive development and regulatory milestone payments, as well as royalties on commercial sales of the combined Stratis and SCIB1+ Immunobody® vaccine for advanced melanoma.
  • Agreement builds on PharmaJet’s strategy to be the best-in-class delivery system for novel DNA and RNA cancer immunotherapies.
GOLDEN, Colo. — September 17, 2024 — PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling technology, today announced that it has entered into a long-term license and supply agreement with Scancell Holdings plc (LSE – SCLP.L) to use the US FDA 510(k)-cleared / CE-marked PharmaJet Stratis® Intramuscular (IM) Needle-free System for the delivery of its advanced melanoma DNA vaccine (Immunobody®, SCIB1/iSCIB1+). Under the terms of the agreement, Scancell will use Stratis for the clinical development and commercialization of their advanced melanoma DNA vaccine. PharmaJet will receive development and regulatory milestone payments, and upon commercialization, will also receive royalties on net sales. Scancell will be responsible for the clinical and regulatory development as well as commercialization of the combined product. PharmaJet has commercially scaled their needle-free delivery technology that enhances the performance of nucleic acid vaccines and therapeutics. Stratis delivery has shown to enable an effective uptake of the Scancell DNA melanoma vaccine by native cellular machinery to express the target antigen and induce a potent anti-tumor response. To date, 60 patients across 15 clinical sites have successfully received a total of 171 doses of SCIB1/iSCIB1+ via Stratis. The combination of SCIB1/iSCIB1+ vaccine with Stratis offers patients the convenience of an off-the-shelf therapeutic cancer vaccine with the speed and enhanced patient experience of needle-free delivery. “Securing long term supply for the PharmaJet Stratis Needle-free Injection System is important to allow clinical and commercial development of iSCIB1+. We are pleased that PharmaJet delivery works effectively with the SCIB1/iSCIB1+ therapeutic cancer vaccines and offers a well-received immunization for patients,” commented Professor Lindy Durrant, Chief Executive Officer, Scancell. “Our ultimate goal for Scancell has been 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.” A review article1 recently published in Vaccines Journal (MDPI) identified that PharmaJet needle-free delivery provides improved tissue distribution and cellular uptake of vaccines. DNA vaccines delivered needle-free also tend to elicit improved immunogenicity compared with needles. “The Scancell strategic partnership further solidifies PharmaJet’s commercial delivery platform as a leader in the delivery of nucleic acid vaccines and immunotherapies,” said Nathalie Landry, Chief Scientific Officer at PharmaJet. “We look forward to working with Scancell to advance their innovation further in clinical development and commercialization for the ultimate benefit of melanoma patients worldwide.” For more information about PharmaJet visit https://pharmajet.com.

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1 Ledesma-Feliciano, C et al, Improved DNA Vaccine Delivery with Needle-free Injection Systems, Vaccines 2023, 11(2), 280 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. 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 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/