Lunai Bioworks announces publication of second-generation allogeneic dendritic cell therapy platform in Vaccines.
/PRNewswire/ — Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, has announced 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.
Images of control and 2nd Gen treatment condition mice using in vivo imaging system. Live imaging system was utilized to capture the tumor growth at various timepoints. The DC treated mouse showed absent signals of tumor at 5-week post dosing.
The study was conducted on November 2, 2025 in a new Short report in Vaccines published. The expert-reviewed short report describes the development of a Second-generation, clinical-grade DC constructwhich 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 unresponsive to conventional treatments. Lunai’s therapy uses engineered dendritic cells – special immune cells made from stem cells – that are genetically modified to activate the body’s immune system against cancer. This publication presents a clinically compliant, second-generation version of this platform, the findings of which are critical to advance ongoing partnership discussions for this therapy.
This new publication builds on a previous study by Lunai (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749) and has shown for the first time that CD34+ hematopoietic stem cell (HSC)-derived dendritic cells engineered to overproduce CD40L, CD93 and CXCL13 have potent anti-tumor effects in humanized mouse models of pancreatic cancer. While the first study used a lentiviral vector for research purposes, the latest report describes an optimized, clinically compliant construct that maintains equivalent efficacy while improving design and manufacturing characteristics to support future clinical translation.
The second-generation construct features a strong mammalian promoter and improved genetic elements to promote the expression of key immunomodulatory 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 primary and metastatic pancreatic tumors. These results reflect the results obtained with the original research-grade product. Although the allogeneic DC product has been studied in pancreatic cancer models, its therapeutic potential extends to a broad spectrum of solid tumors.
“These results demonstrate that our vector optimization strategy maintains therapeutic efficacy while advancing our allogeneic DC platform to the threshold of IND-ready trials,” said David Weinstein, CEO of Lunai Bioworks. “This represents an important turning point in the journey from research innovation to clinical translation and positions Lunai at the forefront of next-generation cell-based immunotherapies.”
The full article with the title „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).
Information about Lunai
Lunai Bioworks Inc. is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. With proprietary neurotoxicity data, advanced machine learning, and a focus on risk management for dual-use products, Lunai shows how artificial intelligence can accelerate therapeutic innovation while protecting society from new threats. For more information, see www.lunaibioworks.com.
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