Drug intelligence / Profile preview

JNJ-64041809 + apalutamide

Development stage
Unknown
Lead developer
Janssen Research & Development
Modality
Small Molecules, Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Intravenous, Oral
01

Overview

JNJ-64041809 + apalutamide is a **combination therapy** under clinical investigation for metastatic castration-resistant prostate cancer (mCRPC). JNJ-64041809 (also JNJ-809) is a live-attenuated, double-deleted *Listeria monocytogenes* (LADD *Lm*)-based immunotherapy engineered to express four prostate cancer antigens. It is designed to induce a targeted antigen-specific T cell immune response against prostate cancer cells. Apalutamide is a next-generation, selective androgen receptor antagonist that binds to and inhibits androgen receptor (AR) signaling, a driver of prostate cancer progression. The combination aims to improve anti-tumor efficacy by engaging both immune-mediated and hormonal therapy mechanisms. JNJ-64041809 was developed by Janssen (Johnson & Johnson), and apalutamide is developed and marketed as Erleada by Janssen. Early phase studies have shown manageable safety and immunogenic effects for JNJ-64041809, with apalutamide known for its established antitumor efficacy in mCRPC[2][1][3].

Brand names
Erleada
Other names
apalutamideJNJ-809JNJ809JNJ 809JNJ-64041809JNJ64041809JNJ 64041809
02

Targets

PAP (Prostatic acid phosphatase)PSMA (Prostate-specific membrane antigen)SSX2 (Synovial sarcoma X breakpoint protein 2)AR (Adrenergic receptors)NKX3.1 (Homeobox protein NKX3.1)

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