Liminatus Pharma Advances Immuno-Oncology Pipeline with Phase 1 Trial of IBA101

Liminatus Pharma has announced the planned initiation of a Phase 1 clinical trial for IBA101, a next-generation monoclonal antibody. This therapy is designed to block the CD47 “don’t-eat-me” signal, a common mechanism used by cancer cells to hide from the body’s innate immune system. By neutralizing this signal, IBA101 aims to enhance the ability of macrophages to identify and clear tumor cells, effectively “unmasking” the cancer for immune destruction.

Strategic Clinical Design and Initial Focus

The upcoming trial is structured as a seamless program that will first evaluate IBA101 as a monotherapy. This initial dose-escalation phase will focus on safety, tolerability, and how the drug moves through the body. Following this, the study will transition into combination cohorts, testing IBA101 alongside established PD-1/PD-L1 checkpoint inhibitors. This dual-action approach is intended to provide a more robust immune response than current standard treatments alone.

Lung cancer has been selected as the primary indication for this initial program. This choice is highly strategic, as PD-1/PD-L1 inhibitors are already the backbone of lung cancer care, yet many patients still require more durable and deeper responses. By integrating IBA101 into this existing paradigm, Liminatus hopes to provide a much-needed boost to long-term patient outcomes.

Expert Leadership and Translational Insights

The study will be conducted under the guidance of Dr. Se-Hoon Lee, a prominent expert in immuno-oncology research. A key feature of the protocol is the inclusion of real-time translational analyses. These benchmarks will help the research team characterize immune activity and identify specific biological markers that correlate with clinical success, allowing for more disciplined dose selection and targeted future development.

Liminatus is currently completing the necessary manufacturing and regulatory preparations to move the program forward. The company plans to engage closely with regulatory authorities to ensure the program is well-positioned for rapid advancement once the nonclinical requirements are finalized.

Source: BioSpace | March 17, 2026