Review of Operations SubB2M immunoassays 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. The CA15-3 test is a blood test commonly used to monitor breast cancer treatment response and disease recurrence. On 8 February 2023, INOVIQ announced positive results from an analytical validation study of its SubB2M/CA15-3 test for breast cancer. In a 94-serum sample, retrospective case-control study, INOVIQ’s SubB2M/CA15-3 test outperformed a leading commercially available CA15-3 tumour marker test for detection of breast cancer. INOVIQ’s SubB2M/CA15-3 test clearly discriminated between breast cancer and healthy controls across all cancer stages, correctly identifying 73% (69/94) of all samples tested, with AUC=0.81, overall sensitivity of 69% and specificity of 78%. Following further optimisation of the SubB2M/ CA15-3 test, on 27 June 2023, INOVIQ announced excellent results from a clinical validation study of its SubB2M/CA15-3 test for breast cancer detection. An independent, 483-sample case-control clinical validation study of the SubB2M test demonstrated high area under the curve (AUC) of 0.93, 81% sensitivity and 93% specificity for detection of breast cancer, significantly outperforming the comparator (AUC of 0.70, 37% sensitivity and 88% specificity). These positive results represent a major clinical validation milestone and support the commercial potential of the SubB2M program for detection and monitoring of cancer. The next step is to conduct a cross-sectional monitoring study to demonstrate the superior performance of the SubB2M/CA15.3 test for treatment response and/or disease recurrence over approved CA15-3 tests. This clinical study is expected to complete by the end of H2 CY23, with the test then expected to be market-ready for partnering. INOVIQ is also progressing its development plans for the SubB2M/CA125 test for ovarian cancer. Samples have been sourced and assay development and analytical validation studies are expected to commence in H2 CY23 and complete within 6 months. Clinical validation of this test is expected to complete in H1 CY24. SubB2M SPR test The SubB2M‐based SPR test measures Neu5Gc. Increased Neu5Gc concentrations in the blood may provide an early warning that an individual requires follow‐up investigation for the presence of cancer such as breast, ovarian, prostate, melanoma and others. A research-stage SubB2M multi-cancer test (MCT) is being evaluated on the Nicoya ALTO™ SPR instrument as a potential cancer risk assessment tool for inclusion in a general health panel. On 13 October 2022, INOVIQ announced it had signed a contract research agreement with Canadian biotechnology company, Nicoya Lifesciences Inc, to transfer, develop and evaluate a SubB2M-based Surface Plasmon Resonance (SPR) test on Nicoya’s Alto™ Digital SPR instrument. Alto is the world’s first digital, high‐ throughput, benchtop SPR instrument. It has revolutionised SPR sample analysis by using digital microfluidics and nanotechnology biosensors that are integrated into a disposable microwell plate, making it compatible for high throughput diagnostics in a clinical laboratory. The initial work program under the agreement to demonstrate effective discrimination between cancer and cancer ‐free blood samples on the Alto instrument progressed during the year, with data expected to report in H2 CY23. EXO-NET PROGRAM EXO-NET is an immunoaffinity magnetic-bead capture technology that uses a proprietary multiantibody matrix coated on nanobeads to isolate exosomes based on their surface markers. The DNA, RNA, protein and lipid biomolecules found in exosomes have important applications in the research, diagnosis and treatment of cancer, inflammatory, metabolic and neurodegenerative diseases. EXO-NET enables the rapid isolation of purified exosomes and development of more effective diagnostics. EXO-NET can be customized to capture specific types of EVs and can be fullyautomated for high throughput sample analysis for large scale clinical trials or routine pathology or CLIA laboratory applications. 14 INOVIQ Limited
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