DENVER, Colo., Nov 25, 2025 (247marketnews.com)- Lunai Bioworks (NASDAQ:LNAI) has moved a step closer to bringing its dendritic-cell–based immunotherapy into the clinic, securing its first Letter of Intent to license the technology just weeks after publishing data that drew unusually strong notice from researchers and industry observers. The agreement follows peer-reviewed results in Vaccines and a successful pre-IND meeting with the U.S. Food and Drug Administration, momentum the company is using to press toward a Phase I trial in high-need solid tumors such as pancreatic cancer.
The interest is centered on Lunai’s Dendritic Cell Combination Therapy (DCCT), an allogeneic, off-the-shelf platform designed to sidestep the cost and logistical burdens of patient-specific cell manufacturing. The company reports that DCCT induced complete regression of both primary and metastatic pancreatic tumors in humanized models, with no recurrence, suggesting robust multipathway immune activation. CEO David Weinstein said the company is seeing “accelerating validation from both researchers and industry partners,” adding that early licensing activity signals confidence in the platform’s scalability.
Outside experts have also highlighted the significance of the findings. In a widely shared LinkedIn post, biotech commentator Benjamin McLeod pointed to the study as a potential inflection point for cancer immunotherapy. The late Dr. Anahid Jewett of UCLA, a leading tumor immunologist, noted that two independent studies demonstrated an 80–90 percent reduction in tumor size and that much of the residual tissue consisted of immune cells rather than cancer cells—an observation she described as approaching the discipline’s long-sought goal.
Lunai is expanding the platform’s reach through collaborations with academic leaders, including Dr. Steven Dubinett at UCLA for non-small cell lung cancer and Dr. Xiaolin Zi at UC Irvine for prostate cancer. Dr. Dubinett has said Lunai’s dendritic-cell strategy has the potential to overcome entrenched barriers in solid-tumor treatment.
The company emphasizes that its donor-derived, ready-to-use cell product can be manufactured in days rather than weeks, potentially lowering treatment costs while enabling broader deployment. With licensing negotiations and further pre-IND activities planned for early 2026, Lunai Bioworks is positioning its DCCT platform as a contender in the next wave of scalable cell-based cancer therapies.
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