Sementis is currently working with process development company APC & VLE Therapeutics to drive the technical strategy for the clinical products and manufacturing processes of Sementis’ proprietary viral vector-based vaccines. This relationship leverages the APC’s substantial experience in process and analytical development and GMP clinical supply for vaccinia-based vaccines.
Sementis’ research and development activities were established within the Experimental Therapeutics Laboratory headed by Professor John Hayball as part of UniSA’s Clinical and Health Sciences Unit. UniSA is a long-standing collaborative partner, providing research and development expertise and resources.
Sementis has partnered with Certara USA, Inc, a globally recognised drug development consultancy, to obtain a due diligence evaluation of Sementis’ proprietary vaccine platform and a clinical development plan to advance Sementis’ technology to Phase I clinical trials. With Certara’s wealth of knowledge and expertise in translational solutions, they are also Sementis’s partner for product and platform development and regulatory compliance.
Sementis has been awarded $3 million from the Federal Government’s CRC-P to harness the global potential of the SCV vaccine platform through the capability to enable manufacture of vaccines in Australia, at call, at scale, and for rapid deployment. This project is an ongoing collaboration between Sementis Ltd, DMTC Ltd, Global Life Sciences Solutions Australia Pty Ltd (Cytiva), and University of South Australia.
Health Security Systems Australia (HSSA), a division of DMTC Ltd, has invested in the development of Sementis’ SCV vaccine platform and has facilitated a collaboration between Sementis Ltd, UniSA, Monash University, and the Australian National University to develop protocols to accelerate vaccine development and methodology guidelines to optimise the functionality of the platform. This collaboration aims to produce a contemporary and agile system that represents the most advanced viral vector vaccine platform in Australia. HSSA is also currently collaborating with Sementis under the CRC-P grant to develop the SCV vaccine platform and enable manufacture of vaccines in Australia.
Sementis has partnered with CSIRO’s National Biologics Facility (NBF) to bridge the gap between basic research and the bioprocesses required to produce quality materials under cGMP-like conditions. CSIRO has provided support to produce clinical grade master and working virus seed stocks, and scale-up production of vaccines.
An NHMRC Ideas Grant will support the research to be undertaken by the Sementis R&D team, led by chief investigator for the project Dr Preethi Eldi. The funding will be used to better understand the immune signatures critical to modulating immune responses to peanut allergens. Uncovering these immune mechanisms will help develop a vaccine that can induce a shift to peanut tolerance or allergy remission, especially in children.
Sementis’ CSO Professor John Hayball has been awarded $3 million from the Federal Government’s MRFF to fast-track the development and human clinical trials of COVID-19 vaccines based on Sementis’ SCV technology. The Sementis COVID-19 vaccine development program is intended to complement the existing vaccines being rolled out and is anticipated to be effective against emerging mutation strains of SARS-CoV-2.
The National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health evaluated the effectiveness of SCV Zika/Chikungunya single vectored vaccine in a fully-funded non-human primate vaccination and challenge study.
Sementis, in partnership with InProTher is undertaking a research program for the development of a therapeutic vaccine against cancer caused by human endogenous retroviruses. The vaccine is a combination of InProTher’s proprietary novel antigens and the SCV vaccine delivery platform.
Sementis and Enesi Pharma are collaborating to develop and evaluate solid dose formulations of Sementis’ single vectored chikungunya/Zika vaccine and lead peanut hypoallergy vaccine for administration via Enesi Pharma’s needle-free ImplaVax® technology. ImplaVax®-enabled Sementis vaccines offer the potential to provide long-lasting immunity and retain potency across a wide range of storage conditions for prolonged periods.
QIMR Berghofer Medical Research Institute provided the expertise and PC3 infrastructure to test candidate vaccines for protection against the mosquito-borne Zika and chikungunya viruses. These vaccines, one of which is a single-vectored vaccine designed to produce immunity against both viruses after a single vaccination, showed efficacy against both Zika and chikungunya viral infection and prevented associated clinical complications.