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SYDNEY - Kazia Therapeutics Limited (NASDAQ:KZIA), a micro-cap biotech company with a market capitalization of $5.9 million, announced today the publication of preclinical research showing its lead drug paxalisib demonstrated potential effectiveness against triple-negative breast cancer when combined with immunotherapy. According to InvestingPro data, the company’s stock has shown significant volatility, with a beta of 2.48.
The study, published in Molecular Cancer Therapeutics, was conducted by researchers at QIMR Berghofer Medical Research Institute. Results indicated that paxalisib, which targets both PI3K and mTOR pathways, increased T cell infiltration in tumors and showed synergistic effects when combined with pembrolizumab (KEYTRUDA) in preclinical models.
According to the research, the combination resulted in tumor regression and prolonged survival in laboratory models of advanced breast cancer. The findings provide scientific rationale for ongoing clinical exploration of paxalisib with checkpoint inhibitors.
"This landmark study offers a mechanistic and translational foundation for our newly launched Phase 1b clinical trial of paxalisib in advanced breast cancer," said Dr. John Friend, CEO of Kazia, in the press release.
Kazia recently began dosing patients in a Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer.
Paxalisib has previously received multiple FDA designations, including Orphan Drug Designation for glioblastoma in 2018 and Fast Track Designation for glioblastoma in 2020. The company is also developing EVT801, a VEGFR3 inhibitor licensed from Evotec SE in 2021.
The Sydney-based clinical-stage biotechnology company focuses on developing oncology therapeutics, with paxalisib being studied in multiple forms of brain cancer in addition to this breast cancer research. With its next earnings report due on June 27, investors seeking deeper insights into Kazia’s financial health and growth prospects can access additional analysis through InvestingPro, which offers 8 more exclusive tips about the company’s performance and outlook.
In other recent news, Kazia Therapeutics Limited has sold the intellectual property and trademark assets for its oncology drug candidate, Cantrixil, to Vivesto for USD $1 million. This transaction provides Kazia with non-dilutive capital to support its clinical-stage pipeline, particularly its focus on paxalisib, a brain cancer drug candidate. Paxalisib has been involved in several clinical trials, including a Phase 2/3 study, and has received multiple designations from the U.S. Food and Drug Administration to expedite its development. Additionally, Kazia is advancing EVT801, a VEGFR3 inhibitor, with preliminary data presented recently.
Kazia also released its annual report for the fiscal year ending June 30, 2024, offering insights into its financial performance and operational progress. While specific financial figures were not disclosed in the press release, they are expected to be detailed in the full annual report filed under the SEC’s Form 20-F. The report includes updates on the development of Kazia’s drug pipeline, regulatory achievements, and potential market opportunities. It also provides information on the company’s governance and outlines the risks and challenges it faces in the competitive pharmaceutical industry. This routine disclosure is part of Kazia’s commitment to maintaining transparency with its shareholders and the broader investment community.
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