On 12 June 2024, INOVIQ announced that its NEURONET™ technology could isolate brain-derived exosomes in Alzheimer’s Disease. Exosomes provide a “fingerprint” of the health or disease status of the parent cell and can cross the “blood-brain barrier”, making them promising candidates as diagnostics for neurological diseases. Initial analytical and clinical validation of NEURO-NET™ showed that exosomes isolated from blood contained proteins known to be expressed by brain cells including the identification of known Alzheimer’s biomarkers that could not be detected by other methods. Analysis of NEURO-NET-captured exosomes identified more than 200 proteins that were differentially expressed in Alzheimer’s Disease (AD) patients when compared with healthy individuals. These results were further validated by a larger study (48 cases and 44 controls) conducted by the Walter & Elisa Hall Institute, confirming the presence of previously identified biomarkers of AD. Importantly, 47 proteins were uniquely expressed in exosomes isolated from AD blood samples and provided robust discrimination between cases and controls. INOVIQ has presented these data to diagnostic and biopharma companies interested in using NEURO-NET™ to develop blood-based neurodegenerative disease tests and companion diagnostics for neuro-therapeutics. The next milestones for NEURO-NET™ include additional clinical validation data and collaborations with academia and industry in neurological diseases. Discussions with interested parties are progressing and multiple feasibility studies are underway. Exosome diagnostics INOVIQ is harnessing the power of exosomes to develop its own and partnered next-generation diagnostics for early detection, therapeutic selection and treatment monitoring in cancer and neurodegenerative diseases. The EXO-Ovarian Cancer Screening test (EXO-OC) is an exosome multi-marker blood test in development for early detection of ovarian cancer in asymptomatic high-risk women. On 9 August 2023, positive results were released from an equivalence study performed by INOVIQ’s collaborator, the University of Queensland (UQ), to evaluate exosome-based biomarkers and performance of the EXO-OC test algorithm in 250 paired plasma and serum samples. The study confirmed that EXO-NET can be used to isolate exosomes from biobanked plasma and serum samples. This enables large ovarian cancer serum biobanks to be used for further development of the EXO-OC test. During the year, UQ sourced over 500 samples of ovarian cancer and matched healthy controls from Westmead Hospital for a biomarker validation study of targeted proteins and miRNAs in the EXO-OC Test. The study to evaluate the performance of the EXO-OC test to discriminate ovarian cancer across all stages has commenced and is expected to complete by December 2024. INOVIQ has an Option to license the development and commercialisation of the EXO-OC test upon successful test validation (ASX: 1 April 2022). The next milestones include analytical and clinical validation studies in CY25, followed by submission of an Investigational Device Exemption (IDE) to undertake a clinical study in asymptomatic, high-risk ovarian cancer individuals in CY26. INOVIQ expects to expand its exosome diagnostic program in FY25 through collaborations with academic, diagnostic and therapeutic companies for liquid biopsies and companion diagnostics. Exosome therapeutics INOVIQ is developing exosomes therapeutics engineered to target and kill cancer. The exosome therapeutics program is a very exciting extension of our exosome diagnostic work. INOVIQ has leveraged its proprietary exosome platform, in-house capabilities and expertise in exosome science to commence its first in-house exosome therapeutics program. INOVIQ’s exosome therapeutics program uses chimeric antigen receptor (CAR)-exosomes that are released from genetically engineered CAR-T (T-lymphocytes) and CAR-NK (Natural-Killer) cells. These CAR-exosomes have enormous potential as cell-free therapeutics, with manufacturing, safety and efficacy advantages over autologous cell therapies for treating solid tumours. CAR-exosomes inherit the tumour-targeting and cytotoxic capabilities of their parent CAR-T/NK cells, specifically targeting and killing cancer cells. During the year, multiple in-house studies were performed including evaluation of various immune cell lines (T-cells and Natural Killer (NK)-cells) that release exosomes, establishment of a Master Cell Bank of NK cells, design and testing of proprietary cancer antigens to target solid tumours (i.e., chimeric antigen receptors, CAR), evaluation of the purity and yield of exosomes isolated using INOVIQ’s EXO-ACE technology and initial in vitro proof-of-concept studies for CAR-exosomes in breast cancer. 11 Annual Report 2024 Review of Operations
RkJQdWJsaXNoZXIy MjE2NDg3