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 has expanded its pipeline by acquiring EVT801, a small molecule inhibitor targeting VEGFR3, from Evotec for €1m upfront plus potential milestones of €308m and tiered single-digit royalties. EVT801, developed in collaboration with Sanofi, is currently in preclinical development, with a Phase I study expected to launch by the end of CY21. The company increased its valuation to US$247m or US$19.14 per basic ADR, up from US$215m. This expansion also raises Kazia's financing requirement to US$36m from US$7m, reflecting increased R&D spending.
Kazia Therapeutics has entered a worldwide exclusive licensing agreement with Evotec SE for EVT801, a first-in-class oncology drug candidate. Kazia will pay €1 million upfront and up to €308 million in contingent milestones. EVT801, a small-molecule VEGFR3 inhibitor, targets lymphangiogenesis to combat tumor growth and may enhance immuno-oncology therapies. The phase I clinical trial is expected to launch in 2021, focusing on cancers such as renal cell carcinoma and hepatocellular carcinoma. This collaboration aims to expedite EVT801's development.
Kazia (NASDAQ:KZIA) has secured an agreement with Simcere Pharmaceuticals for the Greater China rights to paxalisib. The deal entails an upfront payment of US$11 million, comprising US$7 million in cash and US$4 million in equity. Additionally, the agreement includes up to US$281 million in milestone payments and mid-teen royalties. This strategic move reduces Kazia's expected financing needs from US$14 million to US$7 million and increases the company's valuation to US$215 million, or US$16.60 per basic ADR.
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) has announced a licensing agreement with Simcere Pharmaceutical Group to develop and commercialize its investigational drug, paxalisib, in Greater China. Kazia will receive an upfront payment of US$11 million, including US$7 million in cash and US$4 million in equity. The deal allows Kazia to retain rights outside Greater China and continue its GBM AGILE study. The licensing deal could yield up to US$281 million in milestone payments and royalties from commercial sales, directly funding further development of paxalisib.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) has entered into an exclusive worldwide license agreement with Oasmia Pharmaceutical AB for Cantrixil, a clinical-stage drug candidate for ovarian cancer. Oasmia will provide an upfront payment of US$ 4 million, with additional milestone payments of up to US$ 42 million, plus royalties on sales. The deal follows positive Phase I study results for Cantrixil, which targets chemotherapy-resistant cancer cells. Oasmia plans to initiate a Phase II trial in 2022.
The Global Coalition for Adaptive Research has activated Kazia's paxalisib and Kintara's VAL-083 in the GBM AGILE trial, aimed at treating glioblastoma, the most aggressive brain cancer. This adaptive platform trial, which began screening patients in 2019, allows simultaneous evaluation of multiple therapies. Paxalisib targets the PI3K/AKT/mTOR pathway, while VAL-083 addresses MGMT resistance. The trial is set to expand to over 30 U.S. sites, enhancing access to cutting-edge therapies for GBM patients.
Kazia Therapeutics Limited (NASDAQ: KZIA) announced a partnership with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) to initiate a clinical trial, PNOC022, focusing on therapies for diffuse midline gliomas, including DIPG. The trial will evaluate multiple therapies, including Kazia's paxalisib, using an adaptive design to streamline assessment. Commencement is expected in early 2021, pending regulatory approvals. This study builds on promising data from previous research and is fully funded by PNOC, showcasing a collaborative effort to advance treatment options for pediatric brain cancer.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) announces positive top-line results from its phase I study of Cantrixil in patients with advanced ovarian cancer. The study involved 25 patients across the US and Australia, achieving the primary goal of determining a maximum tolerated dose (MTD) of 5 mg/kg. Among 16 evaluable patients, the overall response rate was 19%, with one complete response and two partial responses. Cantrixil was generally well-tolerated, with gastrointestinal side effects reported. Full data is expected to be published in early 2021.
Kazia's latest interim data analysis from its Phase IIa study of paxalisib in glioblastoma multiforme (GBM) shows promising results. The study reports progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months. The safety data at the full 60mg dose indicates a favorable profile. Additionally, Kazia increased its valuation to US$184 million or US$14.55 per ADR, reflecting higher success probability for paxalisib. This adjustment follows an October US$18 million capital raise, enhancing investor outlook.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) shared new data on its drug paxalisib at the Society for Neuro-Oncology (SNO) Annual Meeting. The interim analysis of the phase II glioblastoma study indicated a median progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months, significantly outperforming the standard treatment, temozolomide (PFS: 5.3 months, OS: 12.7 months). The safety profile at a 60mg dose is also consistent with earlier findings. A separate study on pediatric patients showed promising tolerability and pharmacokinetics.
FAQ
What is the current stock price of Kazia Therapeuti (KZIA)?
What is the market cap of Kazia Therapeuti (KZIA)?
What is Kazia Therapeutics' primary focus?
What are Kazia’s key drug candidates?
What regulatory designations has paxalisib received?
What differentiates Kazia Therapeutics from competitors?
What is EVT801’s mechanism of action?
What challenges does Kazia face in its market?
What collaborations has Kazia engaged in?
What is paxalisib being developed for?
What are EVT801’s clinical trial results so far?
How does Kazia generate revenue?
