On July 5, 2021 Prescient Therapeutics Limited (ASX: PTX), the clinical stage oncology company developing personalised medicine approaches to cancer, reported excellent results from in silico immunogenicity testing of OmniCAR’s key binding components, SpyTag and SpyCatcher (Press release, Prescient Therapeutics, JUL 5, 2021, file:///C:/Users/komal/Downloads/PTX_PTX_successful_immunogenicity_testing_of_OmniCAR%20(1).pdf [SID1234584601]). These results substantially de-risk the entire platform and are important for progressing Prescient’s in-house programs and external collaborations with OmniCAR.
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Immunogenicity testing evaluates the immune response against a new therapy, which can adversely affect safety and efficacy. In the case of CAR-T cell therapies, high levels of immunogenicity can adversely impact CAR-T cell expansion and persistence, which can impact the overall safety and clinical response of the treatment.1
The immunogenicity of OmniCAR’s binding system components – SpyTag and SpyCatcher were tested in silico by an independent US research provider to determine if either component has the potential to elicit unfavourable immune responses that could compromise the therapy.
The results demonstrated that both SpyTag and SpyCatcher have very low immunogenicity-lower than a panel of humanised therapeutic antibodies already approved for human use and on par with circulating human antibodies. It is worth noting that in silico immunogenicity testing is widely recognised as being over-predictive as contemporary algorithms are unable to account for cellular antigen processing. 1 Gorovits B, Koren E. Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics. BioDrugs. 2019 Jun;33(3):275-284. Figure 1: SpyCatcher and SpyTag linked to either a heavy (H) or light (L) chain human IgG, were of either lower or comparable immunogenicity when compared against human monoclonal antibodies approved for human use, and have comparable to immunogenicity to human antibodies.
Prescient’s CEO and Managing Director, Steven Yatomi-Clarke said, "This is another incremental but important milestone that significantly de-risks the entire OmniCAR platform. The immunogenicity results could not have been better. In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself. This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently."
"Prescient’s development plan is on schedule to deliver a number of important milestones. Together with our talented research team at Peter Mac, we are excited to progress our inhouse next generation cell therapies for cancer patients." The development follows the successful completion of manufacturing and delivery of critical components of the OmniCAR platform including cell binders for several cancer targets and lentiviral vectors used to produce CAR-T cells.
Prescient is developing OmniCAR programs for acute myeloid leukemia; Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (the most common form of brain cancer). In addition, Prescient has developed OmniCAR as a platform, allowing collaborations and partnerships under licence with third parties wishing to incorporate OmniCAR to enhance their respective cell therapies.
The OmniCAR platform is based on technologies developed at the University of Pennsylvania and University of Oxford. Prescient has a worldwide licence to commercialise the technologies.