Japan PPI inflation slips to 11-mth low in July
Investing.com -- Kairos Pharma Ltd (NYSE:KAPA) stock surged 165% after the clinical-stage biopharmaceutical company reported positive safety results from its ongoing Phase 2 clinical trial of ENV-105 in patients with metastatic castration-resistant prostate cancer.
The interim safety analysis demonstrated that ENV-105 (carotuximab), a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide. The company reported no dose-limiting toxicities or unexpected adverse events from the first ten enrolled patients, with treatment-related side effects being manageable with standard supportive care. Importantly, no Grade 3 or 4 toxicities were observed.
"The favorable safety profile observed in this Phase 2 study is encouraging, as it validates our belief in ENV-105’s clinical potential and supports continued development in a patient population with limited effective treatment options," said John Yu, MD, Kairos Pharma CEO.
The randomized Phase 2 trial aims to enroll 100 patients in total and is currently recruiting at three medical centers: Cedars-Sinai Medical (TASE:BLWV) Center, City of Hope, and Huntsman (NYSE:HUN) Cancer Center. The study evaluates ENV-105 in men whose disease has progressed following standard hormone-based therapies.
Kairos Pharma noted that prostate cancer affects approximately one million men annually in the U.S. alone, with many developing resistance to current hormone therapies. The company expects to report interim efficacy data from the trial in September 2025.
The company also indicated plans to engage with regulatory agencies regarding the design of a potential pivotal Phase 3 study based on emerging data.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.