Welcome to our dedicated page for Kazia Therapeuti news (Ticker: KZIA), a resource for investors and traders seeking the latest updates and insights on Kazia Therapeuti stock.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is a pioneering oncology-focused biotechnology company headquartered in Sydney, Australia. The company is dedicated to developing innovative, targeted therapies for some of the most aggressive and treatment-resistant cancers, with a primary focus on brain and solid tumors. Kazia’s drug development pipeline is centered around two key assets: paxalisib and EVT801, both of which are designed to target critical pathways involved in tumor growth and progression.
Core Drug Development Programs
Paxalisib is Kazia’s lead program and is an investigational brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway, a signaling cascade frequently implicated in cancer cell survival and proliferation. Licensed from Genentech in 2016, paxalisib is being developed as a potential treatment for multiple forms of brain cancer, including glioblastoma, brain metastases, diffuse midline gliomas, and primary CNS lymphoma. The drug has been the subject of ten clinical trials, with several reporting encouraging interim data. Notably, paxalisib has received multiple designations from the U.S. FDA, including Orphan Drug Designation and Fast Track Designation, underscoring its potential to address significant unmet medical needs in oncology.
EVT801, Kazia’s second major asset, is a small-molecule inhibitor of VEGFR3, a receptor that plays a crucial role in tumor angiogenesis. Licensed from Evotec SE in 2021, EVT801 has demonstrated preclinical activity across a broad range of tumor types and has shown synergy with immuno-oncology agents. A completed Phase I trial has confirmed its safety and tolerability, paving the way for further clinical development in advanced and metastatic solid tumors, including ovarian cancer.
Market Position and Strategic Focus
Kazia operates in the highly specialized field of oncology drug development, focusing on therapies for cancers with limited treatment options. Its strategic licensing agreements with globally recognized entities like Genentech and Evotec SE provide access to cutting-edge technologies and strengthen its competitive position. The company’s emphasis on brain-penetrant inhibitors and its robust clinical trial portfolio highlight its commitment to addressing critical gaps in cancer treatment.
Regulatory and Clinical Achievements
Paxalisib has received significant regulatory endorsements, including Orphan Drug Designation and Rare Pediatric Disease Designation for glioblastoma, diffuse intrinsic pontine glioma (DIPG), and atypical teratoid/rhabdoid tumors (AT/RT). These designations not only validate the drug’s potential but also position Kazia to benefit from expedited regulatory pathways. Similarly, EVT801’s promising Phase I results and its potential as a first-in-class VEGFR3 inhibitor further bolster Kazia’s standing in the oncology sector.
Collaborations and Research Initiatives
Kazia actively collaborates with leading academic institutions and research organizations to explore additional therapeutic applications for its drug candidates. Recent partnerships include preclinical studies funded by The Michael J. Fox Foundation to investigate paxalisib’s potential in treating Parkinson’s disease, showcasing the company’s versatility and commitment to scientific innovation.
Challenges and Opportunities
While Kazia faces challenges typical of the biotechnology sector, such as regulatory hurdles and the inherent risks of clinical trials, its focused strategy and strong pipeline position it for long-term success. The company’s ability to secure licensing agreements, achieve regulatory milestones, and expand its clinical programs into new indications underscores its growth potential.
Conclusion
Kazia Therapeutics Limited exemplifies innovation in oncology drug development, leveraging its expertise in targeted therapies to address some of the most pressing unmet needs in cancer treatment. With a robust pipeline, strategic collaborations, and a focus on high-impact therapeutic areas, Kazia is poised to make a meaningful contribution to the field of oncology.
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) announced the initiation of the PNOC022 study at the University of California, San Francisco, focusing on DIPG and diffuse midline gliomas, with the first patient successfully enrolled. This phase II study will investigate the efficacy of Kazia's investigational drug, paxalisib, in various treatment arms. DIPG is a highly aggressive childhood brain cancer with no FDA-approved treatments. The study aims to recruit several hundred patients and will utilize novel trial designs to explore combination therapies, making it a significant step in pediatric oncology.
Kazia Therapeutics Limited (KZIA) has commenced patient enrollment for a Phase I clinical trial of EVT801, an investigational cancer therapy. Licensed from Evotec SE in April 2021, EVT801 targets VEGFR3 to inhibit lymphangiogenesis, showing promising preclinical results. The trial aims to assess safety, tolerability, and pharmacokinetics while exploring preliminary efficacy signals through biomarker analyses. The study will recruit up to 60 patients at the IUCT-Oncopole in Toulouse, France, focusing on renal cell carcinoma and soft-tissue sarcoma. Kazia anticipates further updates as the trial progresses.
Kazia Therapeutics anticipates releasing critical data from its paxalisib program in Q4 2021, including results from a 30-patient Phase II trial for newly diagnosed glioblastoma multiforme and initial data for treating brain metastases. The company has raised its valuation to US$277 million or US$20.92 per basic ADR, which reflects a forward adjustment in its NPV, despite lower net cash of US$20.4 million as of June 30, 2021. Kazia's financing requirement has increased to US$44 million, driven by heightened R&D expenditure.
Kazia Therapeutics Limited (NASDAQ: KZIA) will present at the LD Micro Main Event from October 12-14, 2021. CEO Dr. James Garner will discuss significant developments in 2021, including three cross-border licensing deals and the start of an international pivotal study for its lead asset, paxalisib. The hybrid event will feature around 120 companies, with the Kazia presentation scheduled for 10 AM ET on October 12. Registration for the conference is complimentary and available through the conference website.
Kazia Therapeutics Limited (NASDAQ: KZIA) will present at the HC Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO Dr. James Garner will discuss the company's pivotal study on paxalisib, aimed at treating glioblastoma, which affects over 12,500 patients annually. The market potential for this treatment is valued at US$ 1.5 billion. Significant developments include an out-licensing deal for pazalisib in Greater China and in-licensing of another oncology asset, EVT801. Dr. Garner will also outline Kazia's objectives for FY2022.
Kazia Therapeutics Limited (NASDAQ: KZIA) highlights Glioblastoma (GBM) Awareness Day on July 21, 2021, urging increased research focus on this aggressive brain cancer, which affects around 13,000 Americans annually. Current GBM treatments yield limited benefits, with median survival at 16 months. CEO Dr. James Garner expresses confidence in future treatment advancements, particularly with the drug paxalisib, currently in phase II trials. Kazia calls for collaboration among stakeholders to improve GBM treatment prospects.
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) provided an update on its oncology pipeline, focusing on paxalisib and EVT801. The GBM AGILE study for paxalisib is recruiting nearly 25 sites ahead of schedule in the U.S., with over 650 patients screened to date. The phase II study of paxalisib has seen its final patient complete treatment, while the phase I study of EVT801 has submitted its protocol to French regulators. Kazia anticipates upcoming data releases from ongoing studies in 2021.
Kazia Therapeutics Limited (NASDAQ: KZIA) has initiated a collaboration with Weill Cornell Medical College for a Phase II clinical trial examining paxalisib combined with a ketogenic diet for glioblastoma treatment. This study aims to explore the potential of ketogenesis in enhancing paxalisib's effectiveness and reducing side effects like hyperglycemia. Led by Dr. Howard Fine, the trial will consist of two arms, with an initial cohort of 16 patients in each. Recruitment is expected to start by the end of 2021, pending regulatory approvals.
Kazia Therapeutics Limited (NASDAQ: KZIA) has initiated a phase II clinical study of its investigational drug, paxalisib, targeting primary CNS lymphoma at the Dana-Farber Cancer Institute. The study, which has enrolled its first patient, aims to recruit a total of 25 patients over the next two years. Paxalisib is the only PI3K inhibitor capable of penetrating the blood-brain barrier, addressing a significant treatment gap for patients with CNS lymphoma. Kazia is providing support for the trial, including the study drug and financial grant.
Kazia Therapeutics Limited (NASDAQ: KZIA) announced that its CEO, Dr. James Garner, will present virtually at the LD Micro Invitational XI on June 9, 2021, at 5 PM ET. The company is advancing its lead program, paxalisib, in a pivotal study for glioblastoma and expects to begin clinical trials for a new program, EVT801, in 2021. The LD Micro Invitational runs from June 8-10, showcasing around 180 companies. Investors can register for free at the event's website.
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