LAST WEEK TODAY!

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

Hi fellow warriors! We’re right on track! This week there’s a lot to talk about…and ASCO GU 2026 hasn’t even started yet. 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 Trial: Magnetic Nanoparticle Hyperthermia for Solid Tumors
  ​The Mayo Clinic has introduced a novel magnetic nanoparticle hyperthermia system, marking a significant advancement in the use of heat to treat deep-seated tumors. This approach utilizes intravenous iron-oxide nanoparticles that act as microscopic “heaters” within the tumor after accumulating through leaky blood vessels. When the patient is placed inside an electromagnetic induction device, these particles convert energy into heat, raising the tumor’s temperature to 40–50 °C. This localized heating is designed to directly damage cancer cells and increase their sensitivity to radiation and chemotherapy without harming surrounding healthy tissue. The trial is currently enrolling patients with metastatic solid tumors in the torso who have exhausted other treatment options.​
  ​
• Phase 1 Trial: BG-C0979 Targeting ADAM9 in Advanced Solid Tumors
  ​This first-in-human clinical trial evaluates BG-C0979, an antibody-drug conjugate (ADC) designed to target the disintegrin and metalloproteinase enzyme ADAM9. ADAM9 is a significant target in prostate cancer because it is consistently overexpressed in malignant tissues and correlates with aggressive disease and resistance to hormone therapy. The drug functions by delivering a topoisomerase I (TOPO1) inhibitor payload directly to tumor cells to maximize potency while minimizing off-target effects. Preclinical studies have shown that knocking down ADAM9 can suppress tumor growth and inhibit bone metastasis, and this specific ADC design aims to overcome toxicity issues, such as ocular side effects, seen in earlier ADAM9-targeted therapies.​
  ​
• Phase 1/2 Trial: ACRES Study of 225Ac-rhPSMA-10.1 for mCRPC
  ​The ACRES trial investigates a promising targeted alpha therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after Lutetium-177 PSMA treatment. The therapeutic agent, 225Ac-rhPSMA-10.1, utilizes a “radiohybrid” design that allows the same molecule to be used for both PET imaging and therapeutic delivery. Unlike the beta particles used in Lutetium therapy, Actinium-225 emits high-energy alpha particles over a very short range, which can effectively kill cancer cells and potentially overcome resistance in PSMA-expressing lesions. This study aims to provide a new option for patients whose advanced prostate cancer has become resistant to existing radioligand therapies.​
  ​
• Phase 1/2 Trial: SHR-4394 CDK4/6 Inhibition in Combination Therapies
  ​This clinical trial explores the efficacy of SHR-4394, a selective CDK4/6 inhibitor, in combination with other anti-tumor therapies for men with metastatic prostate cancer. The CDK4/6 pathway is a key driver of uncontrolled growth in cancer cells; by blocking this axis, SHR-4394 can stop cell division and force cancer cells into a dormant state. Lab studies indicate that this inhibitor works synergistically with PARP or AKT inhibitors to kill cancer cells more effectively. Because genetic alterations in the CDK4/6 axis are common in aggressive, hormone-resistant prostate tumors, this trial could redefine combination strategies.​
  ​
• Phase 1/2 Trial: EBNK-001 Off-the-Shelf NK Cell Therapy​
  EBNK-001 is an “off-the-shelf” allogeneic natural killer (NK) cell therapy derived from healthy donors, designed for patients with advanced solid tumors. Unlike personalized therapies that require harvesting a patient’s own cells, this allogeneic approach allows for immediate availability and improved scalability. NK cells are uniquely capable of recognizing and destroying tumor cells without prior sensitization by targeting specific stress ligands overexpressed on cancer. The trial utilizes lymphodepleting chemotherapy and low-dose interleukin-15 (IL-15) to enhance the survival and expansion of the infused NK cells, and some study arms combine the therapy with pembrolizumab to further overcome immune evasion.​
  ​
• Phase 3 Trial: EvoPAR-PR01 Evaluating Saruparib in Prostate Cancer
  ​The Phase 3 EvoPAR-PR01 trial is testing saruparib (AZD5305), a next-generation PARP1-selective inhibitor, in approximately 1,800 men with metastatic castration-sensitive prostate cancer (mCSPC). Unlike older PARP inhibitors that target both PARP1 and PARP2, saruparib specifically inhibits PARP1, which may result in stronger antitumor effects with fewer hematologic toxicities. This selectivity could allow patients to remain on optimal doses longer and potentially extends the drug’s benefits to those without homologous recombination repair (HRR) mutations. Preclinical data have demonstrated that saruparib achieves significantly higher response rates and longer progression-free survival compared to first-generation inhibitors like olaparib.
  ​​

Preclinical Research & Reviews

• FDA Policy Shift: The Move to a Single-Trial Approval Standard
  ​In February 2026, the FDA announced a major policy shift, moving away from the traditional requirement of two pivotal clinical trials for drug approval in favor of a single-trial default standard. The agency argued that the “two-trial dogma” is often obsolete due to modern advances in biology, statistical inference, and the strength of confirmatory evidence from earlier phases. While this flexibility has already been applied to roughly 60% of recent first-of-a-kind drugs, particularly in oncology, the formalization of this policy aims to accelerate access to innovative treatments. Additionally, the use of artificial intelligence is expected to further compress drug development timelines by significantly shortening the preclinical phase.​
  ​
• Prognostic Impact of Genomic Alterations on LuPSMA Therapy
  ​A recent retrospective study published in the Journal of Nuclear Medicine found that patients with mCRPC harboring TP53, PTEN, and RB1 mutations have significantly inferior overall survival when treated with 177Lu-PSMA-617 (Pluvicto). These mutations, often referred to as tumor suppressor gene (TSG) alterations, are associated with aggressive, neuroendocrine-like phenotypes that appear more resistant to long-term survival benefits from radioligand therapy. Interestingly, the study found that these mutations did not negatively impact progression-free survival or initial PSA declines, suggesting a dissociation between short-term tumor control and long-term lethality. These results highlight the critical need for pre-treatment genomic profiling to better stratify patient risk and identify candidates who might benefit from intensified combination regimens.​
  ​
• Ultrasound-Activated Nanobubbles to Dismantle Tumor Barriers
  ​Researchers have developed tiny, ultrasound-activated nanobubbles designed to break through the dense collagen walls that protect solid tumors from treatment. These “fortresses” of stiff collagen often block immune cells and drugs from reaching the center of a tumor, particularly in aggressive cancers like prostate cancer. When targeted to a tumor and triggered by an ultrasound pulse, the nanobubbles jiggle and soften the tumor matrix by 60% without harming healthy tissue. This effect lasts for over five days and has been shown in lab models to activate immune cells and allow T cells to penetrate the tumor core, turning resistant “cold” tumors into “hot” ones that are more responsive to immunotherapy.​
  ​

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.

If this newsletter was delivered to your SPAM folder, make sure to let your email system know that it is not spam.
​
​
Have a great weekend!

Max