A PSMA-targeted radioligand built on a compound called NYM032 is heading into the pivotal phase 3 trial that will decide whether its early data hold up. The molecule can be labeled with gallium-68 for PET imaging or lutetium-177 for therapy, giving a matched diagnose-and-treat pair. In mouse tumor models, escalating the dose from 18.5 to […]
FDA has cleared the way for an early clinical trial of a new, off‑the‑shelf cell therapy designed to tackle metastatic castration‑resistant prostate cancer, a late and difficult stage of the disease. The investigational product, referred to in regulatory filings as ADI‑212, is a gene‑edited, “armored” gamma delta CAR T cell therapy that targets prostate‑specific membrane […]
A new phase 2 trial is evaluating MRT-2359 in combination with apalutamide for patients with androgen receptor (AR) mutation-positive metastatic castration-resistant prostate cancer, an advanced disease that may become resistant to standard hormone-directed treatments. The first patient has been dosed in the MODeFIRe-1 study, which plans to enroll up to 25 patients. Participants must have […]
The investigational B7‑H3–targeting antibody–drug conjugate AK157D1, recently cleared for a Phase I trial in advanced solid tumors, is especially compelling from a prostate cancer perspective because B7‑H3 (CD276) is one of the most uniformly expressed and biologically aggressive surface targets across the full disease continuum, from hormone‑sensitive to castration‑resistant and neuroendocrine phenotypes. Unlike PSMA, which […]
Long-term follow-up from a randomized phase 2 trial suggests that the DNA vaccine pTVG-HP (MVI-816) may significantly extend overall survival in men with PSA-recurrent, non-metastatic, castration-sensitive prostate cancer. The findings are particularly notable because the vaccine did not improve the study’s original primary endpoint of 2-year metastasis-free survival. The trial enrolled 99 men whose prostate […]
Mount Sinai is testing a personalized vaccine designed to help the immune system recognize and attack residual prostate-cancer cells. The phase 1 trial is evaluating PGV001, a multi-peptide vaccine created from each patient’s own tumor mutations, in combination with CDX-301, a cytokine intended to strengthen the immune response. Unlike a preventive vaccine, this is a […]
CRG-150 is entering first-in-human testing as an unconventional immunotherapy for patients with relapsed or refra9ctory metastatic prostate cancer and other solid tumors. The autologous, CRISPR-edited cell therapy targets steroid receptor coactivator 3, or SRC-3, in regulatory T cells. Tregs help maintain immune tolerance but can suppress antitumor immunity in prostate cancer. By disrupting SRC-3, CRG-150 […]
Fifteen years after sipuleucel‑T became the first cellular immunotherapy to show an overall‑survival benefit in metastatic castration‑resistant prostate cancer (mCRPC), a new phase Ib trial at Washington University is testing whether adding the IL‑15 superagonist N‑803 (Anktiva) can turn that modest, durable survival signal into a stronger, more consistent immune attack on metastatic disease. The […]
Bria-PROS+ has received clearance from the U.S. Food and Drug Administration to enter clinical testing as an investigational personalized, off-the-shelf cellular immunotherapy for prostate cancer. The FDA completed its review of the Investigational New Drug application allowing a Phase 1/2a clinical study to move forward. The study is expected to evaluate the safety, tolerability, and […]
A small but encouraging clinical dataset suggests that 67Cu-SAR-bisPSMA may produce substantial anti-tumour activity in patients with metastatic castration-resistant prostate cancer (mCRPC) who have exhausted multiple treatment options. The findings come from the SECuRE clinical trial, in which 19 participants received treatment with 67Cu-SAR-bisPSMA at an 8 GBq dose. Despite the advanced disease setting, treatment […]
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