UPDATE About ENV-105: Promising Phase 2 Interim Results for mCRPC

The investigational drug ENV-105 (carutoximab), a first-in-class CD105 antagonist, has shown promising interim efficacy results in a Phase 2 clinical trial involving patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after standard hormone therapies. This ongoing trial evaluated the combination of ENV-105 with apalutamide, a commonly used hormone therapy.

Among patients treated, 86% experienced clinical benefit, with all responders remaining progression-free for at least four months and half continuing progression-free beyond one year.

The median progression-free survival (PFS) observed was approximately 13 months, which notably surpasses the typical median PFS of about 3.7 months seen with second or third-line hormone therapies in this patient population. Additionally, seven of nine evaluable patients showed a reduction in prostate-specific antigen (PSA) levels, a marker commonly used to assess prostate cancer activity.

The safety profile of ENV-105 combined with apalutamide was favorable, with no dose-limiting toxicities or unexpected severe adverse events reported in the initial cohort. Treatment-related side effects were manageable with standard supportive measures, and no high-grade toxicities were observed, supporting the tolerability of this combination in patients often challenged by multiple prior treatments.

The mechanism underlying ENV-105’s clinical activity involves targeting CD105 (endoglin), a protein that contributes to resistance against cancer therapies through interactions in the tumor microenvironment. By antagonizing CD105, ENV-105 appears to restore sensitivity to hormone therapy, potentially overcoming resistance in advanced prostate cancer.

This randomized Phase 2 study is enrolling patients at several major centers and aims to further evaluate the safety, tolerability, and efficacy of ENV-105 combined with apalutamide in a broader patient population. Should these interim results be confirmed in the full study, ENV-105 could represent an important therapeutic option for men with hormone-resistant metastatic prostate cancer.

Clinical trial.

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