Lunai Bioworks (NASDAQ: LNAI) has launched a new oncology collaboration with a clinical-stage partner to apply artificial intelligence to data from a randomized Phase 2 trial in metastatic colorectal cancer.
The initiative aims to identify biologically relevant patient subgroups that could derive the greatest benefit from the investigational therapy. As part of the pilot agreement, Lunai will use its proprietary Augusta AI platform to assess de-identified patient-level data, including clinical variables, imaging results and longitudinal outcomes, with a particular emphasis on overall survival and disease progression.
By combining conventional clinical metrics with AI-extracted imaging features and time-based treatment response patterns, the company plans to develop data-driven enrichment strategies to support FDA trial design. These may include refined inclusion criteria, endpoint optimization and improved statistical powering.
“This collaboration reflects how AI can unlock hidden value in existing oncology datasets,” said David Weinstein, Chief Executive Officer of Lunai Bioworks. “Our platform is built to identify which patients derive the greatest survival benefit from a drug candidate, enabling smarter development decisions and potentially accelerating the path toward approval.”
The partnership begins as a targeted pilot but could expand into a broader, multi-study commercial program depending on results. If the analysis proves successful, both parties may explore applying the approach across additional tumor types, earlier treatment lines and adaptive trial frameworks such as basket or umbrella designs.
As drug developers increasingly turn to AI-based patient stratification tools to mitigate late-stage trial risk, Lunai’s model positions the company at the intersection of machine learning, precision oncology and clinical development optimization.
Patient stratification involves segmenting trial participants into defined subgroups based on factors such as biomarkers, genetic profiles or disease severity. This approach can enhance statistical power by reducing variability, lowering bias and improving the ability to detect treatment effects in patients most likely to respond.
Further details on the collaboration are expected to be included in a shareholder letter scheduled for release today.
More about Lunai Bioworks
Lunai Bioworks, listed on Nasdaq, is focused on AI-driven drug discovery and biodefense applications. The company leverages advanced machine learning models alongside proprietary phenotypic and neurotoxicity datasets to accelerate therapeutic development while promoting responsible use of generative biotechnology.