LNAI News & Events

Lunai Bioworks completed a key commercial milestone under its NIH STTR-supported initiative, generating high-resolution, multidimensional behavioral signatures of ethanol exposure and alcohol withdrawal. Using high-throughput vertebrate screening, the company identified distinct, reproducible neurobehavioral phenotypes that are only partially addressed by currently approved therapies, highlighting previously underexplored biological mechanisms with strong translational potential. Based on these results, the company has initiated a new commercial drug discovery program targeting Alcohol Use Disorder, a condition affecting approximately 30 million individuals in the U.S. alone, with over 95% receiving no effective pharmacologic treatment. Lunai's AUD program is designed to advance differentiated, mechanism-informed therapeutic candidates toward clinical translation, while remaining strategically positioned for partnerships, licensing, and non-dilutive funding opportunities. With scalable screening infrastructure now operational, the company believes the program can rapidly progress toward candidate nomination and downstream development. The program is supported by a Small Business Technology Transfer grant from the National Institutes of Health and is being conducted in collaboration with Dr. Calum MacRae, Vice Chair, Scientific Innovation at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School.

Lunai Bioworks has secured its first Letter of Intent, or LOI, to license its next-generation immune cell therapy, which achieved complete regression of both primary and metastatic pancreatic tumors with no recurrence in humanized preclinical models. This follows Lunai's recent peer-reviewed publication in Vaccines, a successful pre-IND meeting with the FDA, and growing third-party recognition from the biotechnology and scientific communities. Lunai has proposed a Phase I clinical trial evaluating its Dendritic Cell Combination Therapy across several high-need solid tumors. In humanized mouse models of pancreatic cancer-one of the most lethal and treatment-resistant tumors-Lunai's DCCT achieved complete regression of both primary and metastatic lesions with no recurrence. The late Dr. Anahid Jewett, Professor at UCLA and an authority in tumor immunology, commented: "In our view, these results approach what could be called the 'holy grail' of cancer research. We observed an 80%-90% reduction in tumor size and volume across two independent studies, with most of the remaining tissue consisting of immune cells rather than cancer cells." Lunai is also advancing additional studies and expanding clinical reach for its DCCT platform through collaborations with investigators. Lunai Bioworks is preparing for formal licensing negotiations and pre-IND activities in early 2026, advancing toward clinical development of its dendritic cell therapy platform.