RESEARCH&DEVELOPMENT PROGRESS Our technologies have the potential to deliver significant commercial and clinical benefits to patients, the healthcare system and our shareholders. R&D activities during FY22 focused on progressing and transferring the SubB2M immunoassays to a contract diagnostics organisation for optimisation and validation, securing GMPmanufacture of SubB2M, expanding the EXO-NET data package, evaluating new EXO-NET prototypes and progressing the UQ collaboration for development of an exosome-based ovarian cancer test. SubB2M program SubB2M is an engineered protein that specifically binds the pan-cancer biomarker Neu5Gc that is found at elevated levels in multiple human cancers. INOVIQ is developing SubB2M-based tests for multiple uses including monitoring of breast and ovarian cancers, and for a general health panel. INOVIQ’s SubB2M/CA15.3 and SubB2M/CA125 immunoassays are being developed to improve the sensitivity and specificity of existing standard of care cancer biomarker tests for monitoring of breast and ovarian cancer, respectively. During the year, the SubB2Mprogram focused on completing feasibility studies to design, build and test prototype SubB2M immunoassays for breast and ovarian cancer at Griffith University, followed by technology transfer to a US-based contract diagnostics organisation for further optimisation and validation. Contract manufacture of the SubB2Mprotein under GMP conditions was also established for use in the commercial SuB2M tests. On 17 August 2021, INOVIQ announced that proof-ofconcept (POC) had been achieved for its SubB2M/CA125 immunoassay for ovarian cancer. INOVIQ’s collaborator, the Institute for Glycomics at Griffith University (Griffith), demonstrated that an initial SubB2M/CA125 assay could detect CA125-Neu5Gc in serum from stages I-IV ovarian cancer (OC) patients compared to healthy controls at biologically relevant levels. On 6 April 2022, INOVIQ announced that a paper, entitled, “N glycolylneuraminic acid serum biomarker levels are elevated in breast cancer patients at all stages of disease”, was published in the international peer reviewed journal, BMCCancer, by researchers fromGriffith University’s Institute for Glycomics and the University of Adelaide. The paper discussed the full data, methods and results underlying the previously announced (15 February 2021) poster presentation showing that a SubB2M-SPR test can be used to distinguish all stages of breast cancer (n=96) from cancer-free control (n=22) blood samples with over 95% sensitivity and 100% specificity, in the samples tested. 13 Annual Report 2022
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