Lunai Bioworks lands first licensing deal for off-the-shelf cancer immunotherapy

27 November 2025

US biotech Lunai Bioworks (Nasdaq: LNAI) has signed its first letter of intent to license its off-the-shelf immune cell therapy after reporting complete tumor regression in preclinical pancreatic-cancer models. The company says the dendritic-cell combination therapy cleared both primary and metastatic disease with no recurrence.

The announcement follows a peer-reviewed publication and a successful pre-IND meeting with the US Food and Drug Administration. Lunai plans a Phase I study across several high-need solid tumors, including pancreatic cancer, where the five-year survival rate remains around 13%.

Chief executive David Weinstein said outside analyses have strengthened confidence in the platform, noting that early licensing activity shows interest in scalable cell therapies that could reach patients faster.

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