INOVIQ is advancing its CAR-NK-EVs to in vivo studies to assess anti-tumour efficacy in a TNBC mouse model, with initial results expected to be reported in Q4 CY2025. Following successful initial in vivo results, INOVIQ plans to conduct Investigational New Drug (IND) enabling studies with a US-based Contract Research Organization (CRO) to progress to human clinical studies. SUBB2M PROGRAM FOR CANCER MONITORING neuCA15-3 is a simple, accurate and affordable blood test in development for monitoring breast cancer in women. The assay uses a CA15-3 monoclonal antibody combined with INOVIQ’s SubB2M detection reagent to specifically identify CA15-3 produced by cancer cells. This enhances cancer detection and may reduce false positives. The test has been analytically and clinically validated to detect breast cancer across all stages (81% sensitivity and 93% specificity), key breast cancer types and subtypes and is also effective for monitoring breast cancer following treatment. During the year, INOVIQ completed disease specificity testing for its neuCA15-3 test, progressed the transfer program of its current research-grade ELISA to a beadbased assay, advanced discussions for an in-clinic study of the test for breast cancer monitoring and published data in an international peer reviewed journal. › On 5 December 2024, INOVIQ completed disease specificity testing for breast cancer. The neuCA15-3 test showed high specificity for breast cancer, with low false positives for non-cancer diseases. CA15-3 concentrations were measured in healthy individuals and patients with breast cancer or other conditions, including endometriosis, rheumatoid arthritis, Crohn’s disease, and type II diabetes. The test detected breast cancer with CA15-3 concentrations five times higher than in healthy individuals and was negative for 97.4% of non-breast cancer samples. An independent lab confirmed these results, showing the INOVIQ test’s superiority over the FDA-approved Roche Elecsys CA15-3 II test. › On 1 April 2025, INOVIQ announced its scientific paper titled ‘Improved breast cancer diagnosis using a CA15-3 capture antibody-lectin sandwich assay’ has been accepted for publication in the international peer reviewed journal Breast Cancer Research and Treatment. The published article is linked here. The paper describes the methods and results from case: control studies showing that INOVIQ’s neuCA15-3 test delivered superior diagnostic performance for breast cancer detection compared to the existing FDA-approved Roche Elecsys CA15-3 II test. The overall accuracy of the neuCA15-3 test was 81% compared to 55% for the comparator test. Additionally, the test had a sensitivity of 69% at 95% specificity for Stage I & II breast cancers, which compares favourably to mammography. The next steps to commercialise the neuCA15-3 test include completing transfer to a high-throughput instrument platform, additional in-clinic breast cancer monitoring study and securing a partner for commercialisation. Review of Operations continued The real-time xCELLigence assay demonstrated that CAR-NK-EVs exerted a significant cytotoxic effect on triple-negative breast cancer cells (Hs578T) compared to control treatments. Data from three independent experiments showed that treatment with 2.5 million CAR-NK-EVs/cell (orange line) resulted in 87.8% cell death in Hs578T cells within 96 hours. In contrast, EVs derived from HEK-293 cell (green line) conditioned medium did not induce cell death, confirming the specific cytolytic and antitumour activity of CAR-NK-EVs. 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 0 20 40 60 80 100 120 140 Cell Viability time (h) Breast Cancer Cells (Hs578T) Untreated control 2.5M CAR-NK-Exosomes 2.5M HEK-Exosomes 12 INOVIQ Limited
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