On 3 June 2024 INOVIQ announced that it had successfully produced and isolated engineered exosomes (EEVs) that target and kill breast cancer cells in vitro. A proof-of-concept study demonstrated that a breast cancer targeting protein (CAR) was expressed in exosomes released by immune cells. The engineered exosomes were isolated and concentrated from immune cell-conditioned media using INOVIQ’s proprietary EXOACE™ technology (for isolating exosomes at scale for therapeutic use). EXO-ACE recovered more than 80% of exosomes from cell-conditioned media with over 95% purity. When treated with these exosomes, 75% of breast cancer cells underwent cell death within 72 hours. Based on these excellent results, INOVIQ is progressing its exosome therapeutics program, initially focusing on immune-cell derived exosome therapeutics for breast and ovarian cancers. The next milestones are to complete further in vitro efficacy testing in NK-cell lines by end of CY24, followed by in vivo testing in animal models in CY25. INOVIQ is engaging with key opinion leaders in the immunotherapy field and expanding collaborations with leading research groups to fast-track this program. SUBB2M PROGRAM SubB2M is an engineered protein that specifically detects the pan-cancer biomarker neu5Gc that is found in multiple human cancers. INOVIQ is developing simple, accurate and affordable SubB2M-based blood tests for cancer detection and monitoring. SubB2M-based immunoassays have been designed using a protein specific monoclonal capture antibody combined with INOVIQ’s proprietary detection reagent to monitor the biomarker produced by cancer cells, resulting in improved specificity for cancer and potentially less false positives. Test for Breast Cancer Monitoring (neu-CA15-3) The neu-CA15-3 test is a blood test in development for monitoring breast cancer in women diagnosed with the disease. The test has been clinically validated to detect breast cancer across all stages with 81% sensitivity and 93% specificity. On 22 February 2024, INOVIQ announced the successful completion of a monitoring study showing that INOVIQ’s test detected key breast cancer subtypes (HR+, HER2+ and TNBC), correctly identified 19% more breast cancers than a leading approved CA15-3 test and is effective for monitoring breast cancer. The neuCA15-3 test has now been clinically validated to detect breast cancer across all stages, key breast cancer types and subtypes, and is effective for breast cancer monitoring. INOVIQ has initiated discussions with potential partners and key opinion leaders to secure a laboratory partner in the US for commercialisation of the test. A key scientific paper on neuCA15-3 for breast cancer detection and monitoring has been prepared for submission to an international peer-reviewed scientific journal. The Company also initiated a feasibility program to transfer the current ELISA to a bead-based assay that can be used on high-throughput automated laboratory equipment. Plans for an in-clinic study of the test for monitoring treatment response were also progressed to support commercialisation of the test. Test for Ovarian Cancer Monitoring (neu-CA125) The neu-CA125 test is a blood test in development for monitoring ovarian cancer in women diagnosed with the disease. On 19 April 2024, INOVIQ announced the successful completion of an analytical validation study for its neu-CA125 blood test for ovarian cancer. Overall, the test correctly identified 85% of all samples tested including 76% of the cancer samples and 94% of the cancer free samples. Analytical validation confirmed that the test is working properly and can reliably detect women with ovarian cancer. Further development of neu-CA125 test will include evaluation of new fit-forpurpose CA125 antibodies currently in production by a contract manufacturer. Surface Plasmon Resonance (SPR) test for cancer risk-assessment (neu-SPR test) INOVIQ completed a feasibility study with Nicoya Lifesciences Inc to evaluate a SubB2M-based SPR test on the Alto™ Digital SPR instrument (ASX: 13 October 2022). In December 2023, the study was finalised with results demonstrating that the SPR test could discriminate between cancer and healthy control samples. These initial results hold promise for developing a SPR-based multi-cancer risk assessment test, pending medical device approval of the ALTO platform. Review of Operations continued 12 INOVIQ Limited
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