XenImmune and GBI Bio to Assess SmartScale for AGF Production to Target Tumors

SmartScale platform aligns with the FDA's Operation TrialBlazer initiative

Plantation, Fla, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Xenimmune Therapeutics of Cambridge, Mass. and GBI Biomanufacturing have agreed to assess GBI’s SmartScale system for production of XenImmune’s Antibody Glycosyl Fusion (AGF) protein molecules. XenImmune is developing a new class of fusion protein molecules designed to target tumors and selectively "paint" cancer cell surfaces with foreign blood group sugars or antigens.

“We decided to assess GBI Biomanufacturing SmartScale™ GMP platform for production of Xenimmune’s AGFs, because the technology, manufacturing flexibility, and cost structure align with our development needs,” said Chris Moore, Ph.D., Chief Scientific Officer, XenImmune.

XenImmune said it wanted to explore new manufacturing approaches that could support the molecule’s specific requirements with a disciplined use of capital. SmartScale offers XenImmune an innovative way to potentially streamline CMC development and focus investment on reaching the next milestones for its cancer drug program,” Moore said.

For an emerging biotechnology company, making the CMC budget go further can create meaningful opportunities. It can preserve resources for studies that inform development decisions and strengthen the evidence supporting continued investment. “GBI’s SmartScale is a novel approach to connecting scientific progress with financial discipline, giving XenImmune potentially greater flexibility as we plan for the next stages of the program,” said Moore.

“We are excited to partner with GBI and explore if SmartScale can be a good fit for our early manufacturing needs. We believe this approach could open new avenues for XenImmune,” he said.

“SmartScale™ is a stable pool-based manufacturing platform that can deliver GMP material for customers,” Jesse McCool, Ph.D., and GBI Biomanufacturing CEO said. “Our goal is to help customers reach the critical milestone of generating human clinical data that supports future regulatory and commercial decisions.”

"We are pleased to support XenImmune as it advances this innovative oncology program," said McCool. "Our teams share a commitment to scientific excellence, efficient development, and ultimately bringing new therapies to patients who need them."

GBI noted that the platform aligns with the FDA's Operation TrialBlazer initiative, which seeks to accelerate the development of innovative therapies and modernize drug development pathways.

The platform’s combination of stable cell pools, deferred cloning, and single-use manufacturing is attractive to early-stage drug developers. Production options in shake flasks or bioreactors allow manufacturing scale to be matched to the material quantities a program needs. For XenImmune, this creates an opportunity to manage upfront CMC costs while establishing a practical manufacturing strategy and consider its future development requirements.

 XenImmune Therapeutics is a pioneering immuno-oncology biotechnology company that harnesses the biology of organ transplant hyperacute rejection to fight cancer.

GBI Biomanufacturing: GBI Biomanufacturing, ATUM, and Thomson Instrument Company have combined their technologies to create an integrated SmartScale solution designed specifically for first-in-human development programs.

Michael Smith
GBI Bio
7036233834
mike@greensmithpr.com