Liminatus Pharma (LIMN) Advances CD47 Immunotherapy with Enhanced Safety Profile and Korean Clinical Collaboration

Liminatus Pharma, Inc (NASDAQ:LIMN)

LA PALMA, CA, UNITED STATES, June 26, 2025 /EINPresswire.com/ -- Liminatus is advancing a second-generation CD47 antibody, IBA101, intended to improve the safety and performance profile of macrophage-based immunotherapy. Using strategic epitope targeting, IBA101 is designed to avoid red blood cell (RBC) and platelet binding, preventing the severe anemia and thrombocytopenia that halted earlier CD47 programs.

In a 4-week GLP toxicology study in cynomolgus monkeys at Charles River Laboratories, IBA101 was well tolerated at all dose levels, including the highest tested dose (100 mg/kg/week). No clinical or laboratory evidence of hemolysis, anemia, or thrombocytopenia were observed, and the NOAEL (No Observed Adverse Effect Level) was set at 100 mg/kg/week. These results contribute to a solid preclinical safety profile for a CD47-targeted therapy.

“The primate study results support our safety assumptions and inform our clinical dosing strategy” said Chris Kim, CEO of Liminatus Pharma.

Korean Clinical Collaboration: Preparing for Phase 1 studies in early 2027, Liminatus is partnering with Professor Se-Hoon Lee, a renowned lung cancer specialist at Samsung Medical Center in Seoul. Professor Lee’s team will play a central role in the Phase 1 dose-escalation and combination trial, which will incorporate advanced translational endpoints such as immune profiling, serial tumor biopsies, and multi-omics analysis.

During the initial monotherapy dose‐escalation phase, Liminatus is planning to characterize IBA101’s safety profile at each dose level. In the subsequent combination cohorts with PD-1/PD-L1 blockade, in-depth studies will be conducted with Professor Lee’s team on patients demonstrating meaningful anti-tumor responses. Those insights will inform patient selection for expanded cohorts—focusing on individuals most likely to derive high synergistic benefit from the IBA101 plus PD-1/PD-L1 regimen.

“Partnering with Professor Lee is not merely about ensuring smooth trial operations; as both a lung cancer specialist and a clinician with deep expertise in pulmonary oncology and cancer immunotherapies, he is the ideal collaborator to uncover the translational data essential for designing Phase 2 during the Phase 1 study,” said Chris Kim, CEO of Liminatus.

IBA101 blocks the CD47 ‘do-not-eat-me’ signal to promote macrophage-mediated clearance and reshapes the tumor environment to boost antigen presentation and T-cell activation. In mouse models, combining IBA101 with PD-1 blockade drove complete tumor regression without systemic toxicity. The antibody is engineered so it won’t stick to healthy red blood cells or platelets, allowing for higher, more reliable dosing and consistent activity in the body.

With its preclinical safety profile established and regulatory preparations underway in the U.S. and Korea, Liminatus plans to initiate its initial human studies in early 2027. Pending clinical outcomes, IBA101 may represent a more tolerable CD47 therapy option for combination immunotherapy regimens across multiple cancer types.

About Liminatus Pharma
Liminatus is a preclinical-stage immuno-oncology company advancing IBA101, a best-in-class CD47 inhibitor designed for safety, synergy, and durable tumor control. With operations in the U.S. and Korea, Liminatus is committed to bridging innate and adaptive immunity to deliver transformative outcomes in cancer and chronic inflammation.

About IBA101
IBA101 (Hu3A5) is a second-generation CD47 inhibitor licensed from Innobation Bio (Seoul). It is engineered to avoid red blood cell and platelet binding, aiming to eliminate severe cytopenias while promoting macrophage and T-cell-mediated anti-tumor activity.

Cautionary Note Regarding Forward-Looking Statements
Statements in this press release may constitute "forward-looking statements" under the Private Securities Litigation Reform Act of 1995. All statements, other than statements of present or historical fact, that address activities, events or developments that Liminatus Pharma, Inc. expects, believes or anticipates will or may occur in the future, including statements about results of operations and financial condition, expected future results, expected benefits from our investment and strategic plans and other initiatives, and expected future growth and profitability, are forward-looking statements. The words "will," "may," "believes," "anticipates," "thinks," "expects," "estimates," "plans," "intends" and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated by these forward-looking statements. In addition, statements which refer to expectations, projections or other characterizations of future events or circumstances, statements involving a discussion of strategy, plans or intentions, statements about management's assumptions, projections or predictions of future events or market outlook and any other statement other than a statement of present or historical fact are forward-looking statements.

Chris Kim
Liminatus Pharma, Inc
+1 213-273-5453
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