RIO RANCHO, N.M. — NTx Bio said its NTxscribe CORE platform is being used by researchers at Baylor College of Medicine to manufacture mRNA for a personalized dendritic cell vaccine now being administered in a Phase 1 trial for refractory melanoma.
The company said the work represents one of the first publicly disclosed clinical uses of its continuous-flow manufacturing platform.
Researchers at Baylor are using NTxscribe to amplify tumor mRNA derived from small surgical biopsy samples as part of the manufacturing process for Diakonos Oncology’s DOC1021, or dubodencel, personalized cancer vaccine platform.
According to NTx Bio, the platform preserves the full-length range of each patient’s tumor transcriptome during mRNA amplification, helping ensure that the resulting vaccine reflects a broad 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,” Haab said.
The Phase 1 trial is evaluating DOC1021 in patients with refractory melanoma whose disease no longer responds to standard treatments such as immune checkpoint inhibitors. The vaccine is designed to use a patient’s own immune cells to generate a targeted response against the 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,” Decker added.
Vanaja Konduri, Ph.D., Assistant Professor of Immunology and inventor of the mRNA amplification procedure, said the platform has improved reproducibility while reducing batch-to-batch variability.
NTxscribe uses a continuous-flow, hollow fiber bioreactor architecture that is also used in NTx Bio’s recently launched NTxscribe FLEX system.
The company said the technology is designed to automate mRNA production with limited manual intervention, improve manufacturing reproducibility and simplify changeovers between patient samples through single-use, closed cassettes.
NTx Bio also said the benchtop platform is intended to support both early-stage clinical programs and higher-volume manufacturing as programs advance.
