Kairos Pharma Announces Positive Interim Efficacy Analysis of Phase 2 Trial of ENV105 in Advanced Prostate Cancer with Median Progression Free Survival of Over One Year

About this update from Kairos Pharma, Ltd.

[{"type":"text","content":"Interim efficacy analysis highlights potential value of combination therapy of apalutamide and ENV105 following positive safety data","length":132,"tagName":"p","attribs":{}},{"type":"text","content":"Company to host virtual KOL discussion today to provide additional perspective on data and the Company’s lead program","length":117,"tagName":"p","attribs":{}},{"type":"text","content":"LOS ANGELES, September 18, 2025--(BUSINESS WIRE)--Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Kairos Pharma is hosting a virtual KOL (key opinion leader) event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT today. Interested participants can sign-up to receive the webcast link here.","length":560,"tagName":"p"},{"type":"text","content":"All patients enrolled in the trial had already failed at least one other hormone therapy modality. This predetermined interim analysis covers the same 10 patients from the safety-arm of the trial, with all patients having failed at least one androgen receptor inhibitor hormone therapy prior to acceptance. Two of the ten patients withdrew from the trial for unrelated events. Of the eight remaining patients, the median progression-free survival was more than 13 months, with five of the eight patients continuing treatment without progression. Seven of nine patients demonstrated a decrease of their prostate-specific antigen (or PSA) from baseline.","length":651,"tagName":"p"},{"type":"text","content":"The interim efficacy analysis of the trial demonstrated that ENV105, a first-in-class CD105 antagonist, in combination with standard of care hormone therapy apalutamide demonstrated a progression-free survival (PFS) of 13 months. Notably, the trial is powered to show a 45% improvement in the PFS. This translates to an increase in PFS from 3.7 to 6.7 months. This mark was far exceeded by the ENV105/ Apalutamide combination. The four-month timeframe is significant as 2nd or 3rd line standard of care hormone therapy has a 3.7-month median efficacy, as reported by the CARD trial (New Eng J. Med [2019] 381:2506). The same study also showed the use of chemot...

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