Lunai Bioworks Secures First Licensing LOI Following Landmark Breakthrough Showing Complete Tumor Regression in Humanized Cancer Models

Rhea-AI Summary

Lunai Bioworks (NASDAQ: LNAI) announced it has secured a first letter of intent (LOI) to license its next‑generation dendritic cell combination therapy (DCCT) after peer‑reviewed publication and independent expert review. In humanized mouse models of pancreatic cancer, the DCCT produced complete regression of primary and metastatic tumors with no recurrence and 80–90% tumor size reduction across two studies. Lunai also reported a successful pre‑IND meeting with the FDA and plans for formal licensing negotiations and pre‑IND activities in early 2026 toward a proposed Phase I trial for high‑need solid tumors.

Positive

• LOI secured for licensing the DCCT platform
• Peer‑reviewed publication in Vaccines
• Successful pre‑IND meeting with the FDA
• Complete tumor regression and no recurrence in humanized models; 80–90% reduction

Negative

• Results reported are preclinical only (humanized mouse models)
• LOI is non‑binding and not a completed license
• Formal clinical steps begin with pre‑IND activities in early 2026, so human trials not yet started

Insights

Translational Oncology Analyst

LOI and peer-reviewed complete regression in humanized models mark a materially positive preclinical advance toward clinical testing.

Lunai Bioworks reports a Letter of Intent to license its allogeneic dendritic cell combination therapy (DCCT) after peer-reviewed publication and independent expert review showing complete regression of primary and metastatic pancreatic tumors with no recurrence in humanized preclinical models. The company also completed a pre-IND meeting with the FDA and cites external recognition from the scientific community, creating a clear path from preclinical validation to regulatory engagement.

The business mechanism is straightforward: an off-the-shelf, donor-derived dendritic cell product aims to replace patient-specific manufacturing, which could materially shorten lead times and lower treatment cost if clinical results mirror preclinical efficacy. Key dependencies and risks are explicit in the disclosed facts: the results are preclinical (humanized mouse models), licensing remains at the LOI stage, and formal pre-IND and clinical milestones remain to be achieved. Independent expert commentary and a peer-reviewed publication strengthen credibility but do not change the preclinical status.

Concrete items to watch are the outcome of licensing negotiations and formal pre-IND activities planned for early 2026, confirmation of reproducibility in additional studies, and the initiation of the proposed Phase I clinical trial. Monitor regulatory feedback during the pre-IND process and any disclosed clinical trial design or safety data as the next decisive evidence; these will determine clinical translatability and commercial potential.

Following peer-reviewed publication and independent expert review of findings, the LOI advances Lunai's tumor-regressing immune-cell platform toward scalable therapies for aggressive cancers

SACRAMENTO, Calif., Nov. 25, 2025 /PRNewswire/ -- Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, today announced it has secured its first Letter of Intent (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 milestone follows Lunai's recent peer-reviewed publication in Vaccines, a successful pre-IND meeting with the U.S. Food and Drug Administration (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 (DCCT) across several high-need solid tumors, including pancreatic cancer, which currently has a five-year survival rate of just 13 percent.

"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 to unlock scalable, off-the-shelf treatments capable of reaching the patients who need them most."

In a widely circulated post on LinkedIn, Benjamin McLeod, Founder of Convey Bio and Co-Host of Bio2Bedside, highlighted the study as a potential breakthrough in cancer immunotherapy.

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. These results demonstrate potent, multi-pathway immune activation.

Additionally, the late Dr. Anahid Jewett, Professor at UCLA and a leading 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 percent 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 leading investigators, including Dr. Steven Dubinett (UCLA) for non-small cell lung cancer and Dr. Xiaolin Zi (UC Irvine) for prostate cancer.

"Lunai's dendritic cell approach has the potential to overcome longstanding barriers in solid tumor treatment," said Dr. Dubinett, Dean of the David Geffen School of Medicine at UCLA.

Lunai's DCCT introduces a first-in-class, allogeneic immunotherapy designed to scale:

• Lunai's DCCT leverages the natural antigen-presenting power of dendritic cells while eliminating the cost, time, and variability associated with patient-specific manufacturing.
• The DCCT is manufactured from healthy donor cells and stored ready-to-use. This off-the-shelf model reduces manufacturing timelines from weeks to days, lowering the overall treatment cost.
• In humanized mouse models of pancreatic cancer, one of the most lethal and treatment-resistant tumors, DCCT achieved complete regression of both primary and metastatic lesions with no recurrence.

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.

About Lunai Bioworks
Lunai Bioworks Inc. is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. With proprietary neurotoxicity datasets, advanced machine learning, and a focus on dual-use risk management, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more, visit https://lunaibioworks.com.

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SOURCE Lunai Bioworks Inc.

FAQ

What did Lunai Bioworks (LNAI) announce on November 25, 2025?

Lunai announced a first LOI to license its DCCT platform after peer‑reviewed results and a successful FDA pre‑IND meeting.

What were the DCCT preclinical results reported by Lunai (LNAI)?

In humanized mouse models, DCCT produced complete regression of primary and metastatic tumors with no recurrence and 80–90% tumor reduction across studies.

Does the LOI announced by Lunai (LNAI) mean a finalized license agreement?

No — the announcement describes a letter of intent (LOI), which is non‑binding and precedes formal licensing negotiations.

What regulatory progress did Lunai (LNAI) report toward clinical trials?

Lunai said it had a successful pre‑IND meeting with the FDA and plans pre‑IND activities and licensing talks in early 2026 ahead of a proposed Phase I trial.

Which cancers is Lunai planning to target with DCCT in the proposed Phase I trial?

The company proposed a Phase I evaluating DCCT across several high‑need solid tumors, including pancreatic cancer.

What does Lunai's DCCT off‑the‑shelf model claim to change for treatment delivery?

Lunai says DCCT is an allogeneic, ready‑to‑use dendritic cell therapy designed to shorten manufacturing from weeks to days and lower treatment cost.