LAST WEEK TODAY!

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

Hi fellow warriors! This week too, there are only a few articles, but they’re very interesting. To fill the space, I wrote longer summaries! But they’re worth reading—new approaches and new clinical trials are on the horizon. 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

• ENV105 in Combination with Apalutamide​
  Promising progress has been made in the clinical evaluation of ENV105, an experimental therapy being tested alongside apalutamide, a standard treatment for prostate cancer. This combination is under investigation in a Phase 2 trial focused on patients with metastatic castration-resistant prostate cancer (mCRPC) who have developed resistance to existing therapies. The safety lead-in phase of the trial has already been completed successfully, demonstrating initial tolerability of the combination. The trial includes a biomarker validation component to help identify which patients are most likely to respond to treatment. Preliminary data on both safety and efficacy are expected in the first half of 2025, and patient enrollment for the randomized portion of the trial is ongoing. This study represents a collaborative effort between public and private sectors, including the National Cancer Institute, highlighting the importance of multi-institutional partnerships in advancing treatment for difficult-to-treat prostate cancer.
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• TTX-MC138: RNA Therapy Targeting Metastasis​
  TTX-MC138 is a novel RNA-based therapy designed to inhibit microRNA-10b (miR-10b), a molecule identified as a key driver of metastasis in various solid tumors, including prostate cancer. The therapy uses antagomirs—synthetic RNA molecules that block the activity of miR-10b—delivered via a specialized nanoparticle platform to disrupt cancer spread. A Phase 1 clinical trial is underway, with dosing now taking place in the fourth patient cohort. So far, no significant safety issues have emerged across the first four cohorts. In parallel, early pharmacokinetic and pharmacodynamic data have been consistent with prior Phase 0 and preclinical results, suggesting good target engagement and biological activity. In the earlier Phase 0 trial, a radiolabeled version of TTX-MC138 demonstrated successful accumulation in metastatic lesions and produced a 66% inhibition of miR-10b within 24 hours of a single microdose, with a 20-hour circulation half-life. The favorable safety and efficacy signals from both early-phase trials support continued clinical development and point to a potentially powerful new tool in combating metastatic prostate cancer.
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• IDOV-Immune: Oncolytic Viral Immunotherapy​
  IDOV-Immune is a next-generation oncolytic virus therapy being developed to treat a range of solid tumors, including metastatic prostate cancer. It uses a genetically modified vaccinia virus—originally used in smallpox vaccines—engineered to selectively infect and replicate within cancer cells, leading to direct tumor cell death via a process known as oncolysis. As tumor cells rupture, they release tumor-specific antigens that act as signals to the immune system, effectively turning the tumor into a personalized cancer vaccine. This dual mechanism—direct cell destruction and immune activation—is particularly attractive for tumors that are resistant to conventional therapies. IDOV-Immune is also being explored for its ability to convert “cold” tumors (with low immune activity) into “hot” tumors, making them more responsive to immunotherapies such as PD-1 and CTLA-4 inhibitors. Its selectivity minimizes harm to normal tissues, and the viral vector can be further enhanced by inserting immune-stimulatory genes. The therapy is still in clinical development, but early findings suggest it may offer a powerful and flexible platform for tackling hard-to-treat cancers. A Phase 1 trial is starting the recruitment soon!

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Preclinical Research

• Zotatifin: Shutting Down Cancer’s Protein Factory​
  Zotatifin is an investigational therapy that operates at the translation level, shutting down the production of key cancer-driving proteins. It targets eIF4A, a protein that helps cancer cells translate RNA into proteins critical for their survival and proliferation. This mechanism is especially relevant for castration-resistant prostate cancer (CRPC), where tumors often rely on transcription factors like MYC and Cyclin D1—proteins that are notoriously difficult to target directly with drugs. Zotatifin avoids this problem by preventing the production of these proteins altogether. Preclinical studies in breast and lung cancer have shown zotatifin’s synergy with existing therapies, and researchers are hopeful that similar effects will be observed in prostate cancer, particularly in enhancing the efficacy of androgen receptor blockers and immune-based treatments. The drug’s precision lies in its ability to selectively interfere with structured mRNAs that cancer cells depend on. Animal model studies are ongoing to evaluate its safety, stability, and overall anti-tumor activity, and the results will inform the design of future clinical trials specific to prostate cancer.

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