Lunai Bioworks Inc. (NASDAQ:LNAI) jumped 19.7% in Tuesday’s premarket session after the AI-driven biotech firm announced it has received its first Letter of Intent for licensing its next-generation immune cell therapy.
According to the company, its therapy produced complete regression of primary and metastatic pancreatic tumors in humanized preclinical studies, with no signs of return. This achievement comes shortly after Lunai published peer-reviewed results in Vaccines and completed a successful pre-IND meeting with the U.S. Food and Drug Administration.
The platform, known as Dendritic Cell Combination Therapy (DCCT), uses an allogeneic approach—manufacturing immune cell treatments from healthy donors and storing them as ready-to-use doses. Lunai says this “off-the-shelf” model drastically reduces production timelines from weeks to days and could significantly lower treatment costs.
“We are seeing accelerating validation from both researchers and industry partners,” said David Weinstein, CEO of Lunai Bioworks. “Independent expert analysis confirms the strength of our data, while early licensing activity reflects growing confidence in this platform’s potential.”
The company also noted the endorsement of the late Dr. Anahid Jewett, a respected UCLA tumor immunologist, who said: “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 said it is now preparing for formal licensing negotiations and additional pre-IND milestones in early 2026 as it continues moving its dendritic cell therapy platform toward clinical trials.