Enzastaurin Hydrochloride

SYDNEY, Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting. "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia. "We are highly encouraged with the preliminary overall survival data from the PNOC022 clinical study that we believe will provide an alternative to the current therapies considered as standard of care." Key paxalisib highlights from the meeting: Friday, November 17th Combining ONC201 and paxalisib for the treatment of diffuse midline glioma (DMG); the preclinical results underpinning the international Phase II clinical trial (NCT05009992). Presenter: Evangeline R. Jackson; University of Newcastle, NSW, Australia The mechanism of action of both paxalisib and ONC201 were reviewed as well as the synergistic effects of their combination in DMG preclinical models Specifically, the authors observed how ONC201 over activates the PI3K-AKT pathway, which is the target pathway for paxalisib Consistent and statistically significant improvements were observed with the combination of paxalisb and ONC201 in DMG preclinical mouse models Two patient case studies were discussed; each receiving the combination of paxalisib and ONC201 through compassionate access 16-year old female with advanced and relapsed diffuse intrinsic pontine glioma (DIPG) who demonstrated significant neurological improvements as well as rapid tumour regression after receiving the combination Six-year old female with DIPG who received the combination of paxalisib and ONC201 after upfront radiation therapy. Tumor regression has been maintained for more than two years on paxalisib and ONC201 Exploiting the genetic dependency on PI3K/mTOR signaling for the treatment of H3-altered Diffuse Midline Glioma Presenter: Ryan Duchatel, PhD; University of Newcastle, NSW, Australia PI3K pathway activation is observed in >80% of all DMGs and was shown to be required for DMG cell growth The authors stated that the success of a monotherapy in DMG is highly unlikely; therefore they explored several combinations [of other therapies] with paxalisib with the aim of optimizing tolerability and efficacy of such combinations in preclinical mouse studies Adding metformin to paxalisib was observed to improve hyperglycemia (elevated blood glucose) as well as extend the overall survival rate The combination of paxalisib and enzastaurin (PKC inhibitor) was observed to further extend the overall survival when combined to radiation treatment Authors concluded the triple combination of paxalisib, enzastaurin and metformin warranted further investigation in clinical trials Phase I study of paxalisib and radiotherapy for CNS disease harboring PI3K pathway mutations: pilot analysis of circulating tumor DNA for patient eligibility confirmation and post-treatment response Presenter: Brandon Imber, MD, Memorial Sloan Kettering Cancer Center, NYC, USA This is a multi-institutional, Phase I trial of concurrent paxalisib and radiation therapy in patients with brain metastases with documented PI3K pathway mutations Study has expanded after data from the initial stage identified the maximal tolerated dose (45mg once daily) along with observed signals of clinical activity (100% response rate) The authors observed that plasma circulating tumor DNA (ctDNA) was able to accurately confirm the tumor's genetic mutations at baseline and can potentially be used as a biomarker to assess patient treatment response The authors presented a representative case from the ongoing Phase I study: 70-year-old woman with metastatic breast cancer with tumor harboring PIK3CA mutation received radiation therapy in combination with paxalisib for brain metastases Her baseline plasma ctDNA test before starting treatment detected the same PIK3CA mutation as her tumor MRI scan three months after treatment demonstrated radiographic response. In addition, a 99% reduction in the amount of ctDNA with PIK3CA mutation compared to baseline was detected, indicating ctDNA can potentially be used as an accurate method to monitor response after radiation therapy in combination with paxalisib This is the first time in this patient population to demonstrate a link between MRI findings and a blood-based measure of tumor burden (ctDNA) Sunday, November 19 PNOC022: a combination therapy trial using an adaptive platform design for patients with diffuse midline gliomas (DMGs) at initial diagnosis, post-radiation therapy and at time of therapy Presenter: Sabine Mueller, MD, UCSF, San Francisco, USA 30 sites open to enrollment in North America, Europe and Australia Total enrollment to date: 137 patients Cohort 1 (newly diagnosed) = 37 patients Cohort 2 (post radiation therapy) = 69 patients (one patient was replaced due to physician preference) Cohort 3 (at the time of recurrence) = 31 patients Cohort 2 preliminary analyses (median follow-up time was approximately 9 months) Median Overall Survival rate was 16.5 months Median Progression Free Survival (PFS) was 9.9 months (central review is ongoing) Analysis of preliminary data from all cohorts is still ongoing and the protocol is subject to amendment to refine dosing with the aim of improving tolerability and efficacy at which time the enrollment of new patients will start Additional data includes ctDNA, microbiome and quality of life measures This announcement was authorized for release by Dr. John Friend, CEO. 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, a 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 II study in glioblastoma reported promising signals of clinical activity in 2021, and a pivotal study, GBM AGILE, is ongoing, with final data expected in CY2023. Other clinical trials are ongoing in brain metastases, DMGs, and primary CNS lymphoma, with several of these having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US Food and Drug Administration (US FDA) in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020, and for atypical teratoid / rhabdoid tumors 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 tumor types and has provided evidence of synergy with immuno-oncology agents. A Phase I study in advanced solid tumors commenced recruitment in November 2021. For more information, please visit or follow us on Twitter @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, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, as well as any potential future indications and timing for the release of interim or final data for such programs. 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, including the risk that preliminary or interim data may not reflect final results, 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 United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. 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. SOURCE Kazia Therapeutics Limited

Emerging technologies such as microarray are also expected to be integrated more into molecular oncology diagnostics soon, which is expected to further boost the market growth. FREMONT, Calif., Dec. 9, 2022 /PRNewswire/ -- BIS Research, the global leader in providing market intelligence on deep technologies, has released its latest study titled Molecular Oncology Diagnostics Market - A Global and Regional Analysis. According to this study, the market for global molecular oncology diagnostics was valued at $3.62 billion in 2021 and is projected to reach $12.13 billion by 2032. The following factors are responsible for the increase in demand for molecular oncology diagnostics: Rising incidence of cancer cases Launch of innovative products in the molecular oncology diagnostics ecosystem Growth in biomarker identification and transformations in molecular techniques The detailed study is a compilation of 3 market data tables and 206 figures spread through 264 pages. Check out the detailed table of content here Analyst's Take on the Market Projection According to Nitish Kumar, Principal Consultant, Healthcare, BIS Research, "Although there have been significant innovations for the enhancement of all the important areas of diagnostics, molecular diagnostics, particularly, has harbored phenomenal attention in recent years owing to the in-depth insights they bring to diagnosis and treatment. As the next frontier of precision medicine, the global molecular oncology diagnostics market is expected to showcase enormous potential to completely revolutionize patient care and overall wellness in general." Request a FREE sample of this report here Existing Competitive Landscape The companies that are profiled have been selected based on input gathered from primary experts and analyzing company coverage, product portfolio, and market penetration. Some of the established names in the market are Agilent Technologies, Inc., Abbott, Biocartis NV, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., QIAGEN N.V., Thermo Fisher Scientific, Inc., Danaher, Guardant Health, HTG Molecular Diagnostics, Inc., Illumina, Inc., Invivoscribe, Inc., Myriad Genetics, Inc., Sysmex Corporation, and more. Recent Developments in the Global Molecular Oncology Diagnostics Market In August 2022, Guardant Health expanded its Guardant Reveal usage, a liquid biopsy test for residual disease detection and recurrence monitoring, to include early-stage breast and lung cancers. It is the only tissue-free test used for colorectal cancer (CRC) and is now available for patients with breast and lung cancer. In December 2021, QIAGEN partnered with Denovo Biopharma to develop a companion diagnostic test for the treatment of diffuse large B-cell lymphoma. This test identified patients expressing Denovo genomic marker 1 (DGM1), which responded to Denovo's investigational cancer drug DB102. In September 2021, Illumina partnered with Merck to develop and commercialize research tests for use in identifying specific cancer genetic mutations used in the assessment of homologous recombination deficiency (HRD). In August 2021, Agilent Technologies, Inc. expanded its CE-IVD marked PD-L1 IHC 22C3 pharmDx assay usage in Europe. This assay was used as an aid in identifying esophageal cancer patients for treatments with KEYTRUDA using a combined positive score. Polymerase Chain Reaction Technology Type to Witness the Highest Market Growth The global market for molecular oncology diagnostics (by technology) has been divided into six categories, i.e., next-generation sequencing (NGS), polymerase chain reaction (PCR), fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), flow cytometry, and others. These rapidly evolving technologies have the potential to transform medical diagnoses and treatment for the better. Not only are developing diagnostic tools becoming more useful in a wider range of clinical scenarios, but they are also assisting in a more exploratory outlook in order to cater to a holistic approach to cancer treatment. According to this study from BIS Research, the PCR segment dominated the technology market in 2021 with a cumulative value of $1.20 billion, and the trend is expected to continue during the forecast period 2022-2032. Want to learn more about the latest trends in precision medicine? Speak to our analysts Exclusive DeepTechTM MAP Analysis for Healthcare by BIS Research: Molecular Diagnostics Market About BIS Research: BIS Research is a global B2B market intelligence and advisory firm focusing on deep technology and related emerging trends which can disrupt the market dynamics in the near future. We publish more than 200 market in telligence studies annually that focus on several deep technology verticals. Our strategic market analysis emphasizes on market estimations, technology analysis, emerging high-growth applications, deeply segmented granular country-level market data, and other important market parameters useful in the strategic decision-making for senior management. BIS Research offers syndicate as well as custom studies and expert consultations to firms, providing them with specific and actionable insights on novel technology markets, business models, and competitive landscapes. Contact: Bhavya Banga Email: [email protected] Ph no: 1-510-404-8135 BIS Research Inc. 39111 PASEO PADRE PKWY STE 313, FREMONT CA 94538-1686 Visit our Blog @ Get Expert Insights @ Connect with us on LinkedIn @ Connect with us on [email protected] Logo: SOURCE BIS Research