high grade serous adenocarcinoma of ovary

Publications describe foundational technology and the verification of the Mercy Halo™ ovarian cancer screening test WALTHAM, Mass., Sept. 30, 2024 /PRNewswire/ -- The Journal of Molecular Diagnostics has published two companion papers describing a novel technology platform and clinical verification of an ovarian cancer test based on the platform from Mercy BioAnalytics, Inc., a pioneer in blood-based detection of early-stage cancer. Only a handful of cancer screening tests have been broadly adopted because of the high performance bar that must be achieved. Tests must be sensitive enough to detect nearly all cancers but specific enough to protect against unnecessary anxiety and intervention. Additionally, test costs must be low enough to enable routine screening of the entire at-risk population. Mercy BioAnalytics has embraced these challenges, and these publications provide compelling preliminary evidence of significant progress toward the development of a safe and effective ovarian cancer screening test for postmenopausal women, the group most affected by the disease. The Mercy Halo Technology Platform The first publication, "Colocalization of cancer-associated biomarkers on single extracellular vesicles for early detection of cancer" details Mercy's groundbreaking technology platform. Mercy's key insight is that tumor-derived extracellular vesicles (EVs) are among the most abundant biomarkers in the blood, offering significant advantages for detecting early-stage cancers compared to lower-abundance markers like circulating tumor DNA. By measuring co-localized membrane proteins on the surface of these tumor-associated EVs, the platform enables a highly sensitive and specific determination of cancer presence or absence. The combination of a simple assay design and a qPCR readout also enables low-cost testing. This innovative combination of features allows the Mercy Halo platform to achieve the high performance and broad accessibility required for a population-wide cancer screening test. Mercy has used this foundational technology platform to generate promising clinical data for the early detection of ovarian cancer, reported in a second companion paper. Clinical Verification of The Mercy Halo Platform for Ovarian Cancer Screening Ovarian cancer is one of the leading causes of cancer-related death among women, with nearly 13,000 deaths expected in the U.S. this year. More than 80% of ovarian cancer cases are diagnosed in women 50 and older, and nearly 75% are detected at an advanced stage, where survival rates are poor. The majority of deaths are linked to high-grade serous carcinoma (HGSC), making early detection of this subtype especially critical. Given the low incidence and high mortality of ovarian cancer, any screening test must be both highly sensitive and highly specific to be effective. Despite decades of research, no test has demonstrated the necessary sensitivity and specificity to merit broad use in ovarian cancer screening. CA125 serum biomarker testing and transvaginal ultrasound imaging frequently miss early-stage ovarian cancers and often produce false positives, incorrectly classifying healthy women as potentially having cancer, leading to unnecessary and invasive diagnostic procedures. The second publication, titled "Improving specificity for ovarian cancer screening using a novel extracellular vesicle-based blood test – Performance in a training and verification cohort" demonstrates that the Mercy Halo technology can detect HGSC with both high sensitivity and specificity. Mercy's test offers the potential for significant improvement over existing approaches and may be suitable for ovarian cancer screening. A HGSC case-control training clinical sample set from 397 women obtained from the Ontario Tumor Bank (OTB) and the Ovarian Cancer Research Program (OVCARE) was used to lock down the test design, the data interpretation algorithm, and establish the cut-off between cancer and non-cancer in the Mercy Halo assay. Test performance was then verified in an independent blinded case-control study with 390 serum samples obtained at diagnosis from the MRC Clinical Trials Unit (CTU) at UCL UK Ovarian Cancer Population Study (UKOPS) biobank. In the verification study, the test showed 97.0% specificity, 97.0% HGSC sensitivity, and an AUC of 0.97. This included a sensitivity of 84.6% for stage I and 100% for stage II, with a specificity of 97%. Compared to CA125, this test produced fewer false positives in patients with benign ovarian tumors, non-ovarian cancers, and inflammatory conditions, suggesting it may be a promising tool for ovarian cancer screening. "These two seminal publications mark a significant step forward in our efforts to reduce suffering and save lives through the early detection of cancer." said Dawn Mattoon, Ph.D., Mercy's Chief Executive Officer. "They validate the incredible potential of our Mercy Halo technology platform and demonstrate our dedication to improving patient outcomes, starting with ovarian cancer." "The superior performance of the Mercy Halo test in comparison to serum CA125 is promising. We look forward to further evaluation of the test using samples prior to clinical diagnosis from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)," said Professor Usha Menon at MRC CTU at UCL, Chief Investigator of UKCTOCS. These articles are available online at the Journal of Molecular Diagnostics (paper 1 here and paper 2 here) and will be featured in an upcoming print issue. About Mercy BioAnalytics Mercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer. Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. The patented Mercy Halo™ liquid biopsy platform utilizes biomarker co-localization to interrogate highly abundant, blood-based extracellular vesicles that carry unique cancer signatures from their parent cells. The Mercy Halo platform is designed to detect early-stage cancer, when it is most treatable, and enhance the quality of life for cancer patients and their families. Mercy's initial focus is the early detection of ovarian and lung cancers. Ovarian cancer, the most lethal gynecological cancer, typically goes undetected until it is too late to cure. Lung cancer, the number one cancer killer, takes more lives than breast and prostate cancers combined. About Medical Research Council Clinical Trials Unit at University College London The MRC CTU at UCL is at the forefront of resolving internationally important questions in infectious diseases and cancer and delivering swifter and more effective translation of scientific research into patient benefits. It does this by carrying out challenging and innovative studies, and developing and implementing methodological advances in study design, conduct and analysis. SOURCE Mercy BioAnalytics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SYDNEY, Sept. 23, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce the presentation of data highlighting promising clinical activity of EVT801 in high grade serous (HGS) Ovarian Cancer at the 15th Biennial Ovarian Cancer Research Symposium, co-presented by American Association of Cancer Research (AACR) and the Rivkin Center for Ovarian Cancer Research on Saturday, September 21, 2024 in Seattle Washington. Dr. John Friend, CEO Kazia Therapeutics presented preliminary data from a Phase 1 first-in-human clinical trial evaluating the safety and tolerability of EVT801, a highly selective small molecule VEGFR3 inhibitor targeting tumour angiogenesis. The Phase 1 study met its primary objectives, with the maximal tolerated dose identified at 500mg twice a day (BID). The Phase 1 study also identified the recommended Phase 2 dose starting at 400mg BID. It was observed that EVT801 was tolerated across all doses, with the majority of toxicities being mild to moderate and transient in nature. Key points of the presentation included: A total of 26 patients were treated across 6 dosing cohorts ranging from 50mg once daily (QD) to 500mg twice daily (BID) Patients with eleven different cancer types (ex. colon, renal cell, pancreatic) were enrolled in the study, with heavily pretreated advanced ovarian cancer being the most prevalent indication (11 patients) Biomarkers have shown strong VEGFR3 expression in multiple indications, including ovarian cancer Encouraging clinical activity in High Grade Serous ovarian cancer patients with forty-six percent (46%) having stable disease or for at least three cycles, including two patients who received 9 cycles One patient had a partial response (-39% decrease) after 2 cycles of EVT801 therapy Dr John Friend, CEO of Kazia Therapeutics, commented: "I was honored to participate at the Ovarian Cancer Research Symposium and present our findings to fellow clinicians and ovarian cancer researchers from around the globe. Ovarian cancer is often diagnosed at late stages with poor patient prognosis, so the data from the Phase 1 study is extremely encouraging and gives us confidence that we could potentially have a first-in-class VEGFR-3 inhibitor with EVT801." Abstract: Phase I study of EVT801, a VEGFR-3 inhibitor, shows promising clinical activity in HGS ovarian cancer September 21, 2024 – 11:30am-1:30pm About Kazia Therapeutics Limited Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit or follow us on X @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the potential benefits of EVT801 as a VEGFR3 inhibitor and the potential market opportunity for EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. This announcement was authorized for release by Dr John Friend, CEO. SOURCE Kazia Therapeutics Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WEST CHESTER, Pa.--( BUSINESS WIRE )--Molecular Targeting Technologies, Inc. (MTTI) will update findings on its proprietary topical near-infrared fluorescent dye, CypH-11 (Cmetglo), at the World Molecular Imaging Conference (WMIC) meeting in Montreal from September 9-13 and at the Peritoneal Surface Oncology Group International (PSOGI) meeting in Lyon from September 26-28, 2024. This convenient fast-acting technology* shows promise as an effective real-time tool for oncologists in fluorescence-guided surgery (FGS). This will allow clinicians to see small tumor residue and achieve a more complete resection of cancer in the abdominal cavity. We expect that Cmetglo may improve patient outcomes by avoiding unnecessary damage to normal tissue and increase progression-free survival of patients with peritoneal surface malignancies (PM). Dr. Johnny Ong, MD, Associate Professor, Department of Sarcoma, Peritoneal and Rare Tumors, National Cancer Centre Singapore** commented: “One of the limitations of cytoreductive surgery (CRS) is the difficulty in distinguishing tumors from normal and scar tissues. Here, we performed ex vivo validation of patient tissues to evaluate the clinical utility of Cmetglo in detecting PM via topical administration. Preliminary analysis suggests that the best clinical utility of Cmetglo could be in patients with colorectal malignancy, with the possibility of expanding its use to other histological subtypes.” Dr. Brian D Gray, SVP Research and Development noted: “MTTI’s Cmetglo makes the invisible visible. Tumor margins and metastases glow under near-infrared light. It can be a valuable addition to the surgeon’s’ armamentarium to achieve maximal cytoreduction during FGS.” Dr. Seung Koo Lee, Assistant Professor of Cell Biology Research, in Radiology at Weill Cornell Medicine***, commented: “CypH-11 is a sprayable pH-responsive fluorogenic probe that exhibits minimal fluorescence at neutral pH; however, it fluoresces brightly in an acidic environment which is a universal signature of cancer cell proliferation. Its capability of detecting small-sized ovarian tumors was further demonstrated by the spray of CypH-11 in a disseminated high-grade serous ovarian cancer (HGSOC) model.” Chris Pak, President & CEO of MTTI commented: “This groundbreaking molecule builds on MTTI’s innovative legacy in targeted diagnostics and therapeutics. We’re pursuing its use in colorectal, ovarian, and brain cancers, adding value to patients, surgeons, and other stakeholders.” Molecular Targeting Technologies, Inc. (MTTI) . MTTI is a private, clinical stage biotech developing targeted radiotherapeutics for rare cancers. MTTI is committed to building value by translating innovative diagnostics and radiopharmaceuticals to improve human health. For more information: www.mtarget.com . *This research is supported by the National Cancer Institute (NCI) for a SBIR phase II grant # R44CA275434 to MTTI. **This research is also supported by the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd and administered by National Health Innovation Centre (NHIC) under its Innovation to Industry (I2I) grant (NHIC Ref No.: NHIC-I2I-2306016) to National Cancer Centre Singapore. Any opinions, findings and conclusions or recommendations expressed in this material are those of the authors and do not reflect the views of NHIC ***Weill Cornell Medicine and MTTI hold intellectual property and financial interests in Cmetglo technology under development by MTTI.