LAST WEEK TODAY!

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

Hi fellow warriors! Tired of this rain! Today’s update highlights three promising clinical trials alongside two intriguing preclinical 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 3 Trial Initiated for FC705 in mCRPC
  ​A Phase 3 clinical trial started in South Korea for FC705, a novel PSMA-targeted radiopharmaceutical therapy designed for metastatic castration-resistant prostate cancer (mCRPC). The trial aims to enroll 94 patients to evaluate FC705, which utilizes Lutetium-177 (177Lu) and is optimized for extended circulation. Earlier Phase 2 results indicated a ≥50% reduction in PSA levels in 60% of patients, with complete PSA elimination observed in three patients. Uniquely, this Phase 3 trial will leverage PSMA PET/CT imaging to assess therapeutic efficacy, with interim radiographic progression-free survival (rPFS) data expected soon.
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• Promising Results from Phase 1/2 Trial of 177Lu rhPSMA-10.1
  ​A Phase 1/2 clinical trial of the novel radiopharmaceutical therapy 177Lu rhPSMA-10.1 is showing encouraging results in patients with metastatic castration-resistant prostate cancer (mCRPC). Initial data from 13 patients demonstrated precise targeting of tumor sites and minimal radiation exposure to healthy tissues. Previously, four patients treated in Germany experienced promising outcomes, including notable progression-free survival (>24 months) and significant PSA reductions, with some achieving complete and sustained responses. Due to the favorable safety and efficacy profile, the trial will expand to further explore long-term outcomes and combination treatment strategies.
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• Personalized mRNA Cancer Vaccine EVM16 Enters Clinical Trials
  ​EVM16, a personalized mRNA cancer vaccine targeting advanced solid tumors, has begun a first-in-human Phase 1/2 clinical trial (EVM16CX01) in China. Leveraging the EVER-NEO-1 AI-based neoantigen prediction algorithm and lipid nanoparticle (LNP) delivery, EVM16 aims to activate patient-specific immune responses against tumor antigens. Preclinical findings demonstrated strong T-cell activation and effective tumor growth inhibition. This clinical study is evaluating the vaccine’s safety, immunogenicity, tolerability, and initial efficacy, both as monotherapy and in combination with the PD-1 antibody tislelizumab, specifically in patients with advanced or recurrent solid tumors who have no remaining standard treatment options.

Preclinical Research

• AI-Designed ATR Inhibitors Advance to Preclinical Testing
  ​AI-generated cancer therapies targeting the ATR protein have advanced into preclinical testing. These novel ATR inhibitors exploit synthetic lethality in tumors deficient in functional ATM genes, leading to targeted cancer cell death while preserving healthy cells. This approach holds promise for aggressive cancers including ovarian, breast, prostate, and CNS malignancies, with notable potential to cross the blood-brain barrier. Generative AI rapidly identified these drug candidates from millions of molecular structures, optimizing potency, selectivity, CNS penetration, and safety profiles. Preclinical studies will now evaluate pharmacokinetics and tumor suppression capabilities to select optimal candidates for upcoming clinical trials.
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• New Research Unlocks Potential for Immunotherapy Enhancement in Prostate Cancer
  ​Research indicates that inhibiting the PIM1 kinase protein can reprogram tumor-associated macrophages (TAMs) to support the immune system’s fight against prostate cancer, potentially making previously ineffective immunotherapies viable. Studies in laboratory and animal models showed that combining PIM1 kinase inhibition with checkpoint inhibitors significantly reduced tumor growth. Researchers hope this discovery will lead to clinical trials.
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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