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Kazia Therapeutics Limited (NASDAQ: KZIA) is an innovative biotechnology company focused on oncology, based in Sydney, Australia. The company is dedicated to developing cutting-edge anti-cancer drugs, with a robust pipeline aimed at addressing various forms of cancer.
The lead program for Kazia is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway. Paxalisib is primarily developed for treating glioblastoma multiforme, a highly aggressive brain cancer. Licensed from Genentech in late 2016, paxalisib has been the subject of numerous clinical trials. A Phase II study reported promising clinical activity, and the drug is currently undergoing pivotal trials, with additional studies targeting brain metastases and other central nervous system (CNS) cancers.
Besides paxalisib, Kazia is advancing EVT801, a small-molecule VEGFR3 inhibitor, licensed from Evotec SE in April 2021. EVT801 has shown preclinical efficacy across a range of tumor types and synergy with immuno-oncology agents. It's currently in Phase I clinical trials for advanced solid tumors.
Another notable drug in Kazia’s pipeline is Cantrixil (TRXE-002-1), under development for ovarian cancer and in Phase I clinical trials in Australia and the United States.
Kazia’s commitment to innovation and collaboration is evident through strategic partnerships and licensing agreements. For example, they recently signed a non-binding Letter of Intent with a biotechnology company to develop and commercialize paxalisib outside oncology, targeting epilepsy related to focal cortical dysplasia type 2 and tuberous sclerosis complex.
Financially, Kazia remains focused on securing funding to sustain its research and development endeavors. The company recently announced a direct offering expected to generate approximately $2 million.
Additionally, Kazia's forward-looking strategy includes addressing market listing requirements and ensuring compliance with Nasdaq’s Minimum Bid Price Requirement.
For more information, visit www.kaziatherapeutics.com or follow them on Twitter @KaziaTx.
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$18 million capital raise, enhancing investor outlook.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) shared new data on its drug paxalisib at the Society for Neuro-Oncology (SNO) Annual Meeting. The interim analysis of the phase II glioblastoma study indicated a median progression-free survival (PFS) of 8.4 months and overall survival (OS) of 17.5 months, significantly outperforming the standard treatment, temozolomide (PFS: 5.3 months, OS: 12.7 months). The safety profile at a 60mg dose is also consistent with earlier findings. A separate study on pediatric patients showed promising tolerability and pharmacokinetics.
Kazia Therapeutics (NASDAQ: KZIA) has entered a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to join the GBM AGILE pivotal study for glioblastoma. This collaboration will initiate the operational phase of the study, targeting the recruitment of patients for the paxalisib arm, expected to begin in Q1 CY2021. Kazia will pay an initial fee of US$ 5 million to GCAR, with additional milestone payments throughout the study. The GBM AGILE study aims to provide essential clinical evidence for the regulatory approval of paxalisib in key markets.