Scancell Ltd.

GOLDEN, Colo.--( BUSINESS WIRE )-- 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 article 1 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 . Refer to Instructions for Use to ensure safe injections and to review risks. 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/

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. GOLDEN, Colo.--(BUSINESS WIRE)-- 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 . Refer to Instructions for Use to ensure safe injections and to review risks. 1 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 . 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:

Patients received the cancer vaccine, dubbed SCIB1, via a needle-free device. It’s been a good week for Scancell’s shareholders, as investors seized on early data from the biotech's phase 2 cancer vaccine trial to send its stock up 20%. Preliminary data from the first stage of the study showed that the DNA vaccine, dubbed SCIB1, produced an 82% response rate across 11 patients with advanced melanoma when given in combination with checkpoint inhibitors. This exceeded the 70% milestone for objective response rate (ORR) set by the Oxford, U.K.-based company for the trial, according to a release (PDF). The aim of the study was to see whether the vaccine could either induce new, or boost existing, immune responses. These responses could then be protected in the tumor environment by checkpoint inhibitors—in this case Bristol Myers Squibb’s Opdivo and Yervoy. Patients received SCIB1 via a needle-free device. Of the nine patients who have shown a response with radiological imaging at a 13-week evaluation, the reduction in tumor volume ranged from 31%-94%, the biotech said. The company is aiming to beat the 50% ORR of the Opdivo-Yervoy combo alone. “Previous studies indicated that a response rate of 50% was the best that could be achieved in the real world setting for patients with unresectable metastatic melanoma, as no other combination had improved on the response rates for doublet CPI alone,” Scancell CEO Lindy Durrant said in the release. “Confirmation of this data in a larger cohort could make a significant impact on melanoma patient survival, especially as melanoma is now one of the most common cancers in young women.” While it’s still early days for the study, the results appeared to be enough to get investors excited, sending the biotech’s stock up 20%. But even coming after a similar stock bump on Monday, the company’s share price is still only sitting at 15 pence as of 2:15 p.m. U.K. time on the London Stock Exchange’s AIM submarket. In total, the SCOPE trial is expected to recruit 87 participants. Around three-quarters of participants had been recruited as of July, with Scancell suggesting at the time that initial top-line data are likely to read out in the final quarter (PDF) of the year. The company has another cancer vaccine, dubbed Modi-1, in a phase 2 dose-expansion trial as a monotherapy and in combination with checkpoint inhibitors. The study in ovarian, triple negative breast, renal, and head and neck cancers is due to read out next year.