Kairos Pharma Ltd. (NYSE:KAPA) on Tuesday announced interim efficacy results from its ongoing Phase 2 clinical trial testing ENV-105 alongside apalutamide for patients with metastatic castration-resistant prostate cancer.
The interim evaluation demonstrated a statistically significant improvement in progression-free survival among patients receiving the ENV-105 combination compared to those receiving apalutamide alone.
Patients on the combination therapy achieved a median progression-free survival of 17.7 months, whereas patients receiving apalutamide alone recorded a median of 2 months.
Promising Drug Resistance Strategy
ENV-105 functions as a first-in-class antibody targeting CD105, a protein driving cancer drug resistance and disease relapse.
The trial evaluates this treatment in men resistant to standard hormone therapies, enrolling participants.
Strategic Protocol Modification
Following these interim findings, the biopharmaceutical firm modified its Phase 2 study protocol to recruit patients earlier during disease progression.
Under the updated framework, researchers will enroll patients who show prostate-specific antigen increases after initial treatment with androgen signaling inhibitors.
Trial participants will now undergo randomization to receive either enzalutamide alone or enzalutamide with ENV-105.
The company aims to broaden its eligible patient population, simplify trial recruitment, and finalize the Phase 2 study in or before the fourth quarter of 2027.
KAPA Price Action: Kairos Pharma shares were down 22.58% at $1.20 at the time of publication on Tuesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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