What is Silvacx?
Silvacx is a vaccination platform currently under development at the Life Science Inkubator GmbH in Bonn (Germany). The platform is based on silica (=amorphous silicon dioxide) nanoparticles.
The nanoparticles perform in a dual mode of action:
- They are the carrier for antigens (peptides or proteins)
- They have an intrinsic strong adjuvant effect
The main R&D focus is therapeutic vaccination, but the platform is suitable for prophylactic vaccinations too.
Innovation & Business Idea
Our mission is to deliver the power of silica nanoparticles-based vaccines to patients. Our innovation introduces significant advantages,
embodied by the power of highly immunogenic silica nanoparticles and the speed of vaccine production, taking the immunotherapeutic technologies to the next level. The power of our proprietary platform is highlighted by a therapeutic vaccine program addressing HPV-related cancers. This program is a collaboration between Silvacx and the German Cancer Research Center. The generated know-how is the basis for a technology platform dedicated for neoepitope-based personalized antitumor vaccines. In addition, we are exploring the fields of animal health care to further validate the power of our technology.
Size Matters – Where Nano is Great
Virus-sized particles with a virus-like morphology enable the transport of antigens to lymph nodes via lymphatic vessels after subcutaneous administration. The target cells are immature dendritic cells residing in lymph nodes. They are specialized in the uptake of virus-sized particles. The nano size improves the cellular uptake by antigen presenting cells. Due to this targeting effect there are less systemic side effects. The particles also protect their cargo against enzymatic degradation. Nanoparticles have an own intrinsic adjuvant effect (NAMP = nanoparticle-associated molecular pattern). The nanoparticles and their cargo can pass sterile filters easily enabling a sterile filtration e.g. at the point of filling. They form a stable clear suspension without any tendency to sediment. Therefor there is no need for shaking or mixing prior administration.
Customers / Target Market
Cancer is, in general, the second leading cause of death world wide, and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. Human papillomavirus (HPV) is likely to be the number two human carcinogen after tobacco. Each year, HPV causes 530,000 new cancer cases, including cervical, anogenital, and head & neck HPV-related cancers. However, the available preventative vaccines have protective effects, they are not effective once HPV infection is established. Moreover, the overall low vaccination rate will not reduce cancer cases sufficiently. The Silvacx’s target market is focused also on personalized immunotherapy based on neoepitopes, which could outperform any medical application field. This is an extremely attractive and huge market.
Silvacx’s competitors in the fields of immunotherapy against HPV-related cancers and neoepitope-based vaccines, are e.g. ISA Pharmaceuticals, Advaxis Inc., Neon Therapeutics, BioNTech AG, CureVac AG, Moderna. Silvacx's technology platform, in contrast to the competitors, is dedicated for the rapid production of personalized vaccines based on neoepitopes conjugated with highly immunogenic silica nanoparticles. Using the carefully selected epitopes in vaccine design, post translational modifications of mutated proteins can be realized too. The peptide synthesis, the proprietary Silvacx’s spacer+linker technology as well as the conjugation with silica nanoparticles can be performed within hours.
Intellectual Property Status
Silvacx has an exclusive licence based on the patent application WO2010/006753 from Merck KGaA. Several already granted patents are derived from this application. Moreover, three new patent applications were filed in Spring 2020.
Development Status & Future Steps
Various in vitro studies have shown a strong adjuvant effect generated by silica nanoparticles. Epitopes, which are conjugated to nanoparticles, are presented by dendritic cells and based on indicative head-to-head in vivo studies confirm the strong potential of this platform. Together with the German Cancer Research Center, we are evaluating our front runner for proof of concept – a novel therapeutic vaccine against HPV-related cancers. Currently, several "deep dive" in vivo studies are ongoing respectively planned for 2020.
For our lead candidate, a novel therapeutic HPV vaccine, we had an advisory meeting with Paul-Ehrlich-Institut (regulatory institution in Germany). The first-in-human study is planned for 2021.