Lunai Therapy Achieves Complete Regression of Pancreatic Tumors
Lunai Bioworks Announces Significant Advancement in Allogeneic Dendritic Cell Therapy Published in “Vaccines”
LOS ANGELES, Nov. 6, 2025 /PRNewswire/ – Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, has announced a major scientific accomplishment: its next-generation immune cell therapy has resulted in complete regression of both primary and metastatic pancreatic tumors in humanized mouse models. Images showcasing the contrast between treated and untreated mice, captured using an in vivo imaging system, demonstrate the observed tumor reduction at five weeks post-treatment. The study’s findings are detailed in a newly published Brief Report in Vaccines on November 2, 2025. This peer-reviewed report outlines the development of a second-generation, clinical-grade dendritic cell construct that achieved complete regression of both primary and metastatic pancreatic tumors within preclinical humanized models. Pancreatic cancer represents a significant challenge in oncology, frequently diagnosed at advanced stages and displaying resistance to conventional treatments. Lunai’s therapeutic approach utilizes engineered dendritic cells — specialized immune cells derived from stem cells — which are genetically enhanced to bolster the body’s immune response against cancer. This new publication details a second-generation, clinically compliant version of this platform, and the evidence presented is critical in advancing ongoing strategic discussions regarding potential partnerships for this therapy.
This latest publication builds upon Lunai’s earlier study, published in Vaccines in 2025 (July 12; 13(7): 749; doi:10.3390/vaccines13070749), which initially demonstrated the potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived dendritic cells 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 most recent report describes an optimized, clinically compliant construct that maintains equivalent efficacy while improving design and manufacturing attributes to facilitate future clinical translation. The second-generation construct incorporates a strong mammalian promoter and enhanced genetic elements to drive the expression of key immune-modulating molecules. Preclinical studies using humanized models revealed that Lunai’s next-generation DC therapy triggered robust activation of cytotoxic T cells and natural killer (NK) cells, ultimately resulting in complete regression of both primary and metastatic pancreatic tumors. These outcomes mirrored those achieved with the original research-grade product. Although allogeneic DC products have been evaluated in pancreatic cancer models, their therapeutic potential extends to a broader range of solid tumors.
“These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold for investigational New Drug (IND)-enabling studies,” stated David Weinstein, CEO of Lunai Bioworks. “This represents a crucial inflection point as we transition from innovative research 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 (https://www.mdpi.com/2076-393X/13/11/1131).
About Lunai Lunai Bioworks Inc. is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. Utilizing proprietary neurotoxicity datasets, advanced machine learning, and a focused approach to dual-use risk management, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more information, visit www.lunaibioworks.com.
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