LAST WEEK TODAY!

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

Hi fellow warriors! This week brings a solid batch of seven articles. From bold new strategies to cutting-edge trials, it seems that momentum is building. 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

• SVV-001 Oncolytic Virus Phase 1 Trial – Now Enrolling​
  The Sylvester Comprehensive Cancer Center has begun enrolling patients for a Phase 1 clinical trial targeting high-grade neuroendocrine tumors (NETs), including those affecting the lungs, gastrointestinal tract, gynecological tract, and prostate. This trial combines checkpoint inhibitors (nivolumab and ipilimumab) with SVV-001, an oncolytic virusadministered directly into tumors. SVV-001 selectively infects and destroys cancer cells, potentially converting “cold” tumors into ones more responsive to immunotherapy. The study will also evaluate the biomarker TEM8 to identify patients most likely to benefit, offering a promising form of targeted immunotherapy.
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• PGV001 Vaccine​
  Results from a completed Phase 1 clinical trial of PGV001—a personalized multi-peptide neoantigen cancer vaccine—showed robust immune activation across various tumor types. PGV001 is custom-designed to target neoantigens unique to each patient’s cancer. The vaccine was well tolerated, and five-year follow-up data revealed that six out of 13 patients recruited were still alive, with three remaining tumor-free. These results suggest PGV001 may offer long-term protection by reinforcing the immune system’s ability to recognize and eliminate cancer cells.
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• FC705 Radioligand Therapy Phase 2​
  FC705, a lutetium-177-labeled radioligand therapy, demonstrated superior efficacy compared to Pluvicto in a Phase 2 clinical trial for metastatic castration-resistant prostate cancer (mCRPC). FC705 achieved a 60% response rate in PSMA-PET imaging for both soft-tissue and bone metastases, significantly outperforming Pluvicto’s 29.8% soft-tissue response rate. The PSA50 response reached 73.3%, compared to 46% with Pluvicto. Although FC705 was associated with a slightly higher rate of serious adverse reactions (10% vs 9.3%), its safety profile remained comparable. An IND has been submitted for Phase 3 trials in South Korea, and Phase 2a trials in the U.S. are currently undergoing.
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• FPI-2265 + Olaparib Trial Phase 2 Now Enrolling​
  A multicenter Phase 2 trial is recruiting patients with mCRPC to investigate the combined use of FPI-2265 (²²⁵Ac-PSMA-I&T), a targeted alpha-emitting radioligand, and olaparib, a PARP inhibitor. The study includes two cohorts: one for patients previously treated with lutetium-177 (¹⁷⁷Lu)-based PSMA radioligand therapy, and another for those who have not. Participants will receive different doses and treatment schedules of FPI-2265 alongside twice-daily olaparib. The trial aims to assess safety, tolerability, and anti-tumor activity, and importantly, does not require the presence of homologous recombination repair (HRR) mutations for enrollment.
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• COSMYC Phase 2 Trial – Expected to Begin June 2025:​
  The COSMYC Trial, an open-label Phase 2 study, will evaluate a novel sequential treatment strategy for men with mCRPC who have progressed after second-generation androgen receptor (AR)-axis inhibitors. The trial explores the combination of ZEN-3694, a BET bromodomain inhibitor targeting MYC-driven resistance mechanisms, with Bipolar Androgen Therapy (BAT), followed by enzalutamide. The treatment arms —BATZEN (BAT + ZEN-3694) and ZENZA (ZEN-3694 + enzalutamide following BATZEN)— aim to improve both progression-free survival and PSA-progression-free survival. COSMYC represents an innovative approach to re-sensitizing tumors and overcoming AR-pathway resistance.

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Preclinical Research

• SABER – A Powerful New STING-Agonist Vaccine Enhancer​
  SABER (STING Agonist-Based ER-Targeting molecule) is a newly developed immune-modulating agent that dramatically amplifies vaccine-induced CD8+ T cell responses. It works by directing antigens into the endoplasmic reticulum (ER) of dendritic cells, accelerating antigen processing and boosting cytotoxic T cell activity. In preclinical models, SABER triggered CD8+ T cell responses up to 120 times stronger than antigen alone and led to complete tumor regression in cases of colorectal cancer. It also showed strong efficacy against melanoma in mouse models. SABER’s mechanism makes it a promising adjunct for cancer vaccines and infectious disease immunization strategies alike.
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• ENVLPE – A Next-Generation Gene Editing Delivery Platform​
  NVLPE (Engineered Nucleocytosolic Vehicles for Loading of Programmable Editors) is an advanced system designed to deliver gene-editing tools—such as CRISPR/Cas9—into living cells with exceptional efficiency and minimal immune activation. Unlike traditional delivery systems, ENVLPE uses engineered virus-like particles that bypass innate immune detection.In preclinical models of inherited blindness, ENVLPE corrected disease-causing mutations at over tenfold lower doses than existing methods, underscoring its potency. This platform holds promise for treating advanced prostate cancer by enabling precise targeting of cancer-driving mutations or reprogramming the tumor microenvironment. ENVLPE has also been successfully applied to modify T cells, potentially enabling the creation of “universal” T cell therapies, an innovation that could reduce manufacturing costs and improve access to immunotherapy.
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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