On November 5, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported a major scientific breakthrough: its next-generation immune cell therapy led to complete regression of both primary and metastatic pancreatic tumors in humanized mouse models.
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The study was published in a new Brief Report in Vaccines on November 2, 2025. The peer-reviewed Brief Report details the development of a second-generation, clinical-grade DC construct that achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models. Pancreatic cancer is one of the deadliest cancers, often diagnosed late and resistant to conventional treatments. Lunai’s therapy uses engineered dendritic cells — specialized immune cells created from stem cells — that are genetically enhanced to activate the body’s immune system against cancer. This publication details a second-generation, clinical-compliant version of this platform, with the provided evidence critical in advancing ongoing partnering conversations for the therapy.
This new publication builds on Lunai’s earlier study (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749), which first demonstrated potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived DCs engineered to overexpress CD40L, CD93, and CXCL13 in humanized mouse models of pancreatic cancer. While the initial study utilized a research-grade lentiviral vector, the latest report describes an optimized, clinically compliant construct that preserves equivalent efficacy while improving design and manufacturing attributes to support future clinical translation.
The second-generation construct features a strong mammalian promoter and enhanced genetic elements to drive expression of key immune-modulating molecules. In preclinical humanized models, Lunai’s next-generation DC therapy triggered robust activation of cytotoxic T cells and NK cells and led to complete regression of both primary and metastatic pancreatic tumors. These findings mirrored the outcomes achieved with the original research-grade product. While the allogeneic DC product has been evaluated in pancreatic cancer models, its therapeutic potential extends to a broad range of solid tumors.
"These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold of IND-enabling studies," said David Weinstein, CEO of Lunai Bioworks. "This represents an important inflection point as we move from research innovation to clinical translation—positioning Lunai at the forefront of next-generation cell-based immunotherapies."
The full article, titled "Modified Hematopoietic Stem Cell-Derived Dendritic Cell Therapy Retained Tumor-Inhibitory Function and Led to Regression of Primary and Metastatic Pancreatic Tumors in Humanized Mouse Models," is available in Vaccines (View Source).
(Press release, Lunai Bioworks, NOV 5, 2025, View Source [SID1234659491])