On August 19, 2026 NTx Bio, a leader in next-generation biomanufacturing technologies, reported that its NTxscribe CORE platform is being used by researchers at Baylor College of Medicine to manufacture mRNA for a personalized dendritic cell vaccine (DCV) now in clinical use in an industry-sponsored Phase 1 trial for refractory melanoma, marking one of the first publicly disclosed clinical translations of NTx’s continuous-flow manufacturing platform.
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At Baylor, researchers use NTxscribe to amplify tumor mRNA derived from very small surgical biopsies, a foundational step in the double-loaded dendritic cell vaccine platform underlying Diakonos Oncology’s DOC1021 (dubodencel) platform. The mRNA produced by NTxscribe faithfully maintains the full-length range of the patient’s tumor transcriptome, preserving the integrity of longer sequences so that the material carried into the vaccine reflects a full representation of tumor antigens.
"Manufacturing consistency is one of the biggest hidden challenges in personalized cell and gene therapies, because manufacturing processes for these therapies are largely highly manual," said Joan Haab, Ph.D., CEO of NTx Bio. "Seeing NTxscribe support a program like DOC1021, from a patient’s own tumor DNA all the way to a dosed patient, is exactly the kind of real-world validation we set out to deliver when we built this platform."
The refractory melanoma trial is evaluating DOC1021 in patients whose disease no longer responds to standard treatments such as immune checkpoint inhibitors, a population with limited remaining options. DOC1021 is designed to reprogram a patient’s own immune cells to mount a targeted response against tumor.
"Working with patient-derived material means we don’t get the luxury of a standardized starting point," said William Decker, Ph.D., Professor of Pathology & Immunology at Baylor College of Medicine and inventor of the DOC1021 technology. "Automating the mRNA generation step with NTxscribe is solving the most challenging, time intensive, and variable step in the manufacturing process so we can focus our attention on delivering a high-quality product to more patients."
"NTxscribe has really improved reproducibility while virtually eliminating batch to batch variability," agreed Vanaja Konduri, Ph.D., Assistant Professor of Immunology and inventor of the mRNA amplification procedure.
NTxscribe’s role in the Baylor/Diakonos workflow reflects the same continuous-flow, hollow fiber bioreactor (HFBR) architecture behind NTx’s recently launched NTxscribe FLEX system, and highlights the platform’s benefits for translational and clinical programs, including:
Automating a hands-on process: Generate purified mRNA with minimal manual intervention, eliminating the need for skilled labor and multiple pieces of equipment.
Supporting reproducible output: Automation drives reproducibility. By eliminating certain manual steps and individual unit operations, FLEX ensures a reproducible and quality output every time.
Simplifying change-over and scale: Single-use, fully closed cassettes allow straightforward change-over between patient samples and a clear path to higher throughput.
Shortening translational timelines: The benchtop platform and scalable output makes FLEX suitable for early phase clinical programs while also supporting higher volumes required at later stages.
(Press release, Baylor College of Medicine, AUG 19, 2026, View Source [SID1234670239])