BlueWhale Bio Announces First Patient Dosed in Clinical Trial Using Synecta™ T1 Cell-Derived Nanoparticles (CDNPs)

PHILADELPHIA, Sept. 3, 2025 /PRNewswire/ -- BlueWhale Bio, a company dedicated to transforming immune cell therapy manufacturing, today announced that the first patient has been dosed in a clinical trial at the University of Pennsylvania (NCT04684563). The trial uses BlueWhale Bio's first-in-line product from the company's Synecta™ platform to streamline the manufacturing process for huCART19-IL18 cells in the treatment of hematologic cancers.

"BlueWhale Bio is developing a portfolio of critical materials that brings the full benefits of higher-performing cell therapies faster to more patients and at lower costs," said Peter Keller, Chief Executive Officer at BlueWhale Bio. "Our Synecta technology platform helps address the current limitations in the activation and expansion steps of cell manufacturing by mimicking the physiological stimulation of immune cells."

The inaugural product from the Synecta platform, Synecta™ T1 CDNPs (cell-derived nanoparticles), offers a scalable, qualified alternative to synthetic activators. Designed to mimic natural T-cell stimulation, this product composition contains membrane-bound signals, cytokines, and adhesion molecules to enhance T-cell receptor engagement during CAR-T cell manufacturing. BlueWhale Bio's Drug Master File for Synecta T1 CDNPs has been accepted by the U.S. Food and Drug Administration—representing the first regulatory clearance of CDNPs for T-cell activation.

"This pioneering trial of huCART19-IL18, manufactured in just 3 days, showed durable complete responses in patients with refractory lymphoma," said Jim Riley, PhD, Professor of Microbiology at the University of Pennsylvania and Scientific Co-founder of BlueWhale Bio. "With BlueWhale's cell-derived nanoparticle activation and expansion technology, we aim for more consistent and scalable manufacturing results to accelerate the growth and adoption of cell-based therapies."

In preclinical studies using both healthy donor and patient samples, Synecta T1 outperformed commercially available activation methods by reaching target dose levels faster and with greater consistency across diverse samples—including those derived from exhausted T cells—while generating a higher yield of proliferative CD19 CAR-T cells.

About BlueWhale Bio

BlueWhale Bio is dedicated to accelerating the growth and adoption of cell-based therapies by transforming the manufacturing process of immune cell therapy. The company is developing a portfolio of critical materials that bring the full benefits of higher-performing cell therapies to more patients faster and at lower costs. BlueWhale's innovations are based on cutting-edge discoveries in cell activation led by Dr. Carl June and Dr. Jim Riley at the University of Pennsylvania. For more information, visit www.bluewhale.bio and follow us on LinkedIn.

SOURCE BlueWhale Bio, Inc.