On March 10, 2026 Piston Bio LLC, a clinical-stage biotechnology company developing therapeutics targeting neuroimmune mechanisms in cancer, reported the completion of a Type B Pre-IND meeting with the Division of Psychiatry and the Division of Oncology of the U.S. Food and Drug Administration (FDA) to discuss the clinical development program for PST-101 in the treatment of cancer-related apathy, a potential first-in-class therapy for this emerging indication.
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At the meeting, Piston Bio aligned with the FDA on key elements of the proposed Phase 2 study design, including endpoints, patient population, treatment duration, and dose selection. The agreed Phase 2 outcome measures include the Apathy Evaluation Scale – Clinician Version, clinician and patient global ratings of disease severity and improvement, and the EORTC QLQ-C30 Role Functioning subscale.
Cancer-related apathy is an underrecognized neuropsychiatric syndrome in patients with cancer characterized by diminished motivation, reduced goal-directed behavior, and impaired engagement in daily activities. Reduced motivation among patients with advanced cancer has been associated with poorer survival. Emerging evidence suggests inflammatory signaling may disrupt dopaminergic motivation circuits in the brain, contributing to apathy. No therapies are approved for cancer-related apathy, representing a significant unmet medical need in oncology.
PST-101 is an adenosine A2A receptor antagonist that modulates dopaminergic signaling in the central nervous system and may restore motivational function in patients with cancer-related apathy.
"We are encouraged by the open and constructive tone of our meeting with FDA," said Walter Hong, MD, Founder and Chief Executive Officer of Piston Bio. "This clarity from FDA de-risks our development strategy, confirms alignment with regulatory expectations, and strengthens our position as we advance PST-101 toward IND submission."
Based on FDA feedback from the meeting, Piston Bio plans to submit an IND for PST-101 in 2026.
(Press release, Piston Bio, MAR 10, 2026, View Source [SID1234663431])