Prostate cancer drug shows ‘promising’ mechanism of action

Prostate cancer cells

Pharmaceutical company Promontory Therapeutics has completed enrolment of its Phase II clinical trial of lead therapeutic candidate, PT-112, in patients with late-line metastatic castration-resistant prostate cancer (mCRPC).

The study is evaluating PT-112 in patients who have been treated with at least three prior life-prolonging therapies for mCRPC, and who exhibited radiographic evidence of disease progression at study entry.

Patients with bone-only metastatic disease are also included in the study. These requirements create a representative treatment population following standard of care of androgen receptor signalling inhibitors, taxane chemotherapies, and any other drug approved by FDA on the basis of overall survival.

“This clinical trial is the largest study to date of PT-112 and will establish the optimal dose in line with the FDA’s Project Optimus, as well as proof of concept in our late-line mCRPC patient population,” said Promontory Therapeutics Chief Medical Officer Johan Baeck. “Data from our earlier Phase I/II studies have shown that PT-112 is clinically safe and active, and promotes immunogenic cancer cell death induced by the inhibition of ribosomal biogenesis, which is a promising mechanism of action for late-stage patients with prostate cancer – an ‘immune-cold’ disease with no broadly approved and effective immunotherapy.”

In addition to safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, including on immune activation by PT-112 monotherapy as evaluated by the propagation of new T cell populations, as well as reductions in circulating tumor cells and ctDNA.

Promontory Therapeutics Chief Executive Officer Robert Fallon added: “We look forward to presenting topline safety, efficacy, and correlative data at relevant research and medical conferences later this year.”

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