Newsletter 25/2025

LAST WEEK TODAY!

A summary of what was published on ProstateWarriors.com during the past week

Hi fellow warriors! This week we have pretty much only clinical trials. We’ll be fully focused on practical studies! Stay strong and fight on!

As usual, we also have a podcast if you prefer to listen to the newsletter, you can find it HERE.

Clinical Research

  • Phase 1 Clinical Trial: Switchable CAR T-Cell Therapy for Safer mCRPC Treatment
    A Phase 1 trial is evaluating BRL-302, a novel CAR T-cell therapy for metastatic castration-resistant prostate cancer (mCRPC). Unlike traditional CAR T therapies, BRL-302 features a “switchable” mechanism where the targeting module can be deactivated if severe side effects arise, such as cytokine storms or neurotoxicity. This allows for rapid control of immune activity, increasing safety in early patient cohorts.
  • Phase 1 Clinical Trial: ART-101 – A New PSMA-Targeting Radiopharmaceutical
    ART-101 is a small molecule radiopharmaceutical designed for both imaging and treating PSMA-positive mCRPC. Preclinical data showed improved tumor retention and reduced uptake in healthy tissues, including salivary glands. Compatible with several therapeutic isotopes, ART-101 has received FDA clearance for a Phase 1 trial expected to begin later in 2025.
  • Phase 1a/1b Clinical Trial: Dual-Target Immune Activation with DR-0202
    DR-0202 is a bispecific antibody in Phase 1a/1b trials for solid tumors including mCRPC. It recruits and activates myeloid immune cells by binding to CLEC7A and a tumor-specific antigen, leading to phagocytosis of cancer cells and stimulation of adaptive immunity. Its design reduces the risk of severe immune-related side effects, such as cytokine release syndrome.
  • Phase 1 Clinical Trial: Blocking Early Hormone Production with HSK46575
    HSK46575, now in Phase 1 trials in China, targets the enzyme CYP11A1 to suppress steroid hormone synthesis at an earlier stage than existing androgen deprivation therapies. In preclinical models, this once-daily oral drug outperformed abiraterone, reducing tumor size and PSA levels, with potential to overcome resistance in mCRPC.
  • Phase 1 Clinical Trial: Targeting MYC-Driven Cancers with PMR-116
    PMR-116 is the first therapy to indirectly disrupt MYC-driven cancer by blocking a downstream pathway essential for ribosomal RNA synthesis. MYC is involved in about 70% of cancers, including prostate cancer. Preclinical studies showed dramatic reductions in tumor burden (-85%) and cancer spread. The Phase 1 trial will launch in Australia in 2025.
  • Phase 1/2 Clinical Trial: PARP1 Inhibitor for Prostate Cancer with Brain Metastases
    EIK1004 (IMP1707), in Phase 1/2 trials, is a selective PARP1 inhibitor aimed at treating genetically vulnerable cancers, including prostate cancer with BRCA mutations. Its ability to cross the blood-brain barrier makes it a promising candidate for brain metastases, and selective targeting may reduce common side effects such as bone marrow suppression.
  • Phase 1/2 Clinical Trial: BRD4 Degradation Strategy with MT-4561
    MT-4561 is being tested in a Phase 1/2 trial for advanced prostate cancers, including neuroendocrine variants. It uses targeted protein degradation to eliminate BRD4, a regulator of cancer-driving genes like c-Myc and Bcl-2. Unlike older inhibitors, MT-4561 aims to completely dismantle BRD4’s function, with early data supporting its potential to trigger cancer cell death.
  • Phase 1/2 Clinical Trial: Heating Up “Cold” Tumors with SX-682 Combinations
    SX-682, a dual CXCR1/2 antagonist, is being tested in two Phase 1/2 trials in combination with apalutamide or enzalutamide for mCRPC. By blocking immunosuppressive signals from myeloid cells, it reactivates immune responses within the tumor microenvironment. The goal is to enhance treatment response and delay resistance to hormone therapy.
  • Phase 2 Clinical Trial: Trispecific T Cell Engager for Neuroendocrine Prostate Cancer
    ZG006, in a Phase 2 trial, is designed for patients with aggressive neuroendocrine prostate cancer who have no standard treatment options. It binds to DLL3 on tumor cells and CD3 on T cells, activating immune attacks while sparing healthy tissue. Preclinical and early human data suggest strong antitumor activity with a favorable safety profile.
  • Phase 3 Clinical Trial: Antibody-Drug Conjugate Targets B7-H3 in Resistant mCRPC
    Ifinatamab deruxtecan (MK-2400) is in a global Phase 3 trial for patients with mCRPC that progressed after hormone-based therapies. It delivers a chemotherapy payload directly to B7-H3–positive tumor cells, sparing normal tissue. Previous trial phases showed 25% response rates, and the ongoing trial will compare its performance to standard chemotherapy.
  • Real-World Study: Apalutamide Shows Survival Benefit in mCSPC
    Large-scale real-world studies involving nearly 4,000 patients suggest that apalutamide offers a survival advantage over abiraterone and enzalutamide in treating metastatic castration-sensitive prostate cancer (mCSPC). Patients taking apalutamide had a 23–26% reduced risk of death at 24 months. The analysis included diverse populations and used robust statistical controls, though further studies are needed to address long-term safety and comparisons with other emerging therapies.

Preclinical Research

  • Only very early stage preclinical research this week…we will see if there will be anything interesting next week!

And…that’s all folks! For today at least!
Please let me know if there is anything I can improve in my newsletters, and let me know if you have enjoyed the podcast.

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Have a great weekend!

Max

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