Kairos Pharma Ltd (NYSE:KAPA) saw its stock jump 165% following the announcement of encouraging safety results from its ongoing Phase 2 clinical trial of ENV-105 in patients battling metastatic castration-resistant prostate cancer.
The interim safety review revealed that ENV-105 (carotuximab), a novel CD105 antagonist, was well tolerated when used alongside the standard hormone therapy, apalutamide. Among the first ten patients enrolled, the company reported no dose-limiting toxicities or unexpected adverse effects, and side effects related to treatment were manageable through standard supportive care. Notably, there were no Grade 3 or 4 toxicities observed.
John Yu, MD, CEO of Kairos Pharma, commented, “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.”
The ongoing randomized Phase 2 study plans to enroll a total of 100 participants and is currently active at Cedars-Sinai Medical Center, City of Hope, and Huntsman (NYSE:HUN) Cancer Center. This trial focuses on men whose prostate cancer has advanced despite prior hormone-based therapies.
Highlighting the medical need, Kairos Pharma pointed out that prostate cancer impacts roughly one million men annually in the U.S., many of whom develop resistance to existing hormone treatments. The company anticipates sharing interim efficacy results from this study in September 2025.
Kairos also mentioned intentions to consult with regulatory authorities about designing a possible pivotal Phase 3 trial informed by the emerging clinical data.
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