Scancell Ltd.

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.

GUILDFORD, England, April 05, 2023 (GLOBE NEWSWIRE) -- RNA delivery and therapeutics company SiSaf Ltd today announced that it has appointed Dr. Richard Goodfellow to its Board of Directors. Richard draws on four decades of international experience across the biotechnology and pharmaceutical sectors, including leadership roles in business development and Chief Executive of Scancell, an AIM listed clinical stage immuno-oncology biopharmaceutical company. He has acted as a consultant to SiSaf since 2021. SiSaf’s founder and CEO Dr. Suzanne Saffie-Siebert said, “I’m delighted to welcome Richard to our Board. As we are building and expanding our commercial partnerships and in-house pipeline of RNA therapeutics, Richard’s vast range of experience in the life science industry will be a valuable addition to SiSaf’s board and will support the company’s further growth.” Dr Richard Goodfellow commented on his appointment as Non-Executive Director, “I welcome the opportunity to join SiSaf’s Board. Having worked with Suzanne and her team in an advisory capacity for the past two years, I believe the potential of SiSaf’s next-generation delivery technology for life-changing RNA treatments is significant. I look forward to taking on a strategic role to help the company make the most of the opportunities this offers.” SiSaf’s proprietary Bio-Courier technology addresses the limitations of other RNA delivery technologies through the hybridization of organic materials with inorganic bioabsorbable silicon. Its lead product SIS-101-ADO, an siRNA therapeutic for patients with Autosomal Dominant Osteopetrosis Type 2 (ADO2), a rare genetic skeletal disorder, began the U.S. FDA Regulatory process to obtain an Orphan Drug Designation in October 2022. ABOUT SISAF SiSaf is an RNA delivery and therapeutics company. The company’s portfolio of patented delivery technologies includes silicon-stabilized hybrid lipid nanoparticles (sshLNP) that improve the stability, safety, and transfection efficiency of RNA. SiSaf uses sshLNP to develop a pipeline of RNA therapeutics, including siRNA treatments for autosomal dominant disorders. The company is also conducting preclinical research on RNA therapeutics for oncological applications and is maximizing the potential of its technology through research partnerships. Led by founder and leading biomaterials specialist Dr Suzanne Saffie-Siebert, SiSaf is a venture capital-backed private company. Headquartered in Guildford, UK, it has fully integrated research labs and bio-analytical facilities, a scalable technology to fast-track development, and a growing patent estate with extensive freedom to operate. To learn more, please visit sisaf.com Follow us on LinkedIn and Twitter. MEDIA ENQUIRIES Scius Communications Sue Charles – sue@sciuscommunications.com +44 7968726585 Katja Stout – katja@sciuscommunications.com +44 7789435990

Results provide rationale for combining modern needle-free administration and plasmid DNA vaccines and therapeutics. GOLDEN, Colo.--(BUSINESS WIRE)-- PharmaJet®, a company engineering precision delivery systems that may overcome the challenges of nucleic acid vaccine delivery, today announced that its partner, Scancell, a developer of novel immunotherapies for the treatment of cancer and infectious diseases, reported positive results from their Phase 1 COVIDITY clinical trial. The trial was conducted at the University of Cape Town Lung Institute in South Africa to assess the safety and immunogenicity of their COVID-19 DNA candidate vaccines, SCOV1 and SCOV2. The vaccines were exclusively administered using the PharmaJet Tropis® and Stratis® needle-free precision delivery systems. The results from the trial were highly encouraging, inducing neutralizing antibody and T cell responses with no safety concerns. Administration with PharmaJet’s devices was well received by study participants. This new set of human data adds to the growing evidence indicating that this modern needle-free administration technology is an increasingly viable option to enhance plasmid DNA vaccine immune response. Professor Lindy Durrant, Chief Executive Officer, Scancell, commented, “We are encouraged by these results. The trial validates that AvidiMab®-modified immunotherapies boost immune responses and PharmaJet’s Needle-free Injection Systems are effective in delivering our ImmunoBody®-generated drug candidate. Our plans are to include PharmaJet Needle-free precision delivery systems in future trials with our immuno-oncology projects.’’ Chris Cappello, President and CEO, PharmaJet, said, “We are pleased by our collaboration with Scancell and we look forward to potentially contributing more as an advanced administration partner. Our precision delivery systems have demonstrated improved immune response for multiple DNA and RNA vaccines1 and our intradermal administration platform played a critical role in the commercialization of the world’s first plasmid DNA vaccine2. We operate at industrial scale, and we are able to rapidly deploy our systems for all stages of a clinical program as well as for the commercialization of vaccines developed in combination with our injection systems.” For more information about PharmaJet visit . Refer to Instructions for Use to ensure safe injections and to review risks. 1 Improved DNA Vaccine Delivery with Needle-Free Injection Systems 2 About PharmaJet PharmaJet’s 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 Needle-free 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 utilizing 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 recognize 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 tumor cells (AvidiMab®). For further information about Scancell, please visit: