Plus Therapeutics Receives FDA Clearance for REYOBIQ Pediatric Brain Cancer Trial

June 25, 2025

DENVER, Colo., Jun 25, 2025 (247marketnews.com)- Plus Therapeutics (NASDAQ:PSTV) reported that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQ (Rhenium Re186 Obisbemeda) in pediatric patients with recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma.

The newly approved trial, ReSPECT-PBC (Pediatric Brain Cancer), will be funded by a $3 million research grant from the U.S. Department of Defense and will assess the safety and potential efficacy of REYOBIQ in children and young adults.

Marc Hedrick, M.D., Plus Therapeutics President and CEO of Plus Therapeutics, stated, “This pediatric FDA clearance builds on our successful track record in the safe administration and promising efficacy signals observed in adult patients with more common central nervous cancers. We expect REYOBIQ will offer much needed hope to children with aggressive and difficult-to-treat brain cancers and their families.”

About the ReSPECT-PBC Trial

The Phase 1/2a clinical study will be a two-part, single-arm, open-label trial designed to determine the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of REYOBIQ in pediatric patients aged 6 to 21 (with consideration up to age 25 in select cases).

Key Trial Components:

  • Phase 1a/b (Dose Escalation):
    • Will enroll approximately 24 patients
    • Uses a modified 3+3 dose-escalation design
    • Aims to establish MTD and the recommended Phase 2 dose (RP2D)
    • Includes safety assessments and FDA alignment at defined intervals
  • Phase 2a (Efficacy Assessment):
    • Will enroll around 32 patients: 20 with HGG and 12 with ependymoma
    • Focuses on early signals of efficacy at the RP2D

Addressing a Critical Need

High-grade gliomas and ependymomas in children are rare but highly aggressive tumors, with recurrence common and treatment options limited. Standard therapies, such as surgery and radiation, often fail to prevent progression. Survival rates for pediatric HGG can be as low as 22% at five years, depending on tumor type and treatment success.

Why REYOBIQ Matters

REYOBIQ is a novel, targeted beta-emitting radiotherapeutic that delivers high radiation doses directly to the tumor using convection-enhanced delivery (CED), bypassing the blood-brain barrier and sparing healthy brain tissue. This precision delivery method represents a potentially transformative approach for children with these difficult-to-treat brain cancers.

The ReSPECT-PBC study builds on the company’s ongoing ReSPECT-GBM trial in adults with recurrent glioblastoma, where REYOBIQ demonstrated favorable safety and clinical benefit. Results published in Nature Communications showed that patients who received a therapeutic radiation dose (>100 Gy) experienced a doubling of overall survival.

Additional information is available at @plustherapeutics.com or www.clinicaltrials.gov (identifier to be assigned upon registration).

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