ImmuneOncia announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb.These results include updates on the Phase 1a clinical trial outcomes, along with biomarker findings achieved through collaboration with Lunit (CEO; Brandon Suh), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics.
The study, a dose escalation part of Phase 1, enrolled a total of 12 patients across four dose cohorts starting from May 2022. Each patient received IMC-002 at doses of 5, 10, 20, or 30 mg/kg every two weeks. Treatment outcomes revealed stable disease (SD) in 6 out of 12 evaluable patients, demonstrating a disease control rate (DCR) of 50%. Among these, 5 patients had hepatocellular carcinoma, and 1 had breast cancer. Furthermore, 4 patients maintained stable disease for over 6 months, resulting in a clinical benefit rate (CBR) of 33.3%.
AI-powered biomarker analysis, utilizing Lunit SCOPE IO, revealed that the density of CD47-positive macrophages was numerically higher in the CBR group compared to the non-CBR group (71.0/mm² vs. 44.3/mm²), while the density of CD47-positive tumour cells was similar between the two groups. These findings suggest a correlation between the density of CD47-positive macrophages and treatment response, underscoring the potential significance of targeting CD47 in future therapeutic strategies.
Principal investigator Dr. Ho Yeong Lim of Samsung Medical Center stated, "No dose-limiting toxicities (DLTs) were observed across all cohorts, and common adverse events associated with anti-CD47 therapy such as infusion-related reactions, haemolytic anaemia, thrombocytopenia, and neutropenia were not reported, confirming the high safety profile of IMC-002." He added, "Particularly noteworthy is the absence of long-term toxicity in a patient with hepatocellular carcinoma who has been on single-agent IMC-002 treatment for 15 months, demonstrating a favourable prognosis with stable disease and a 20% reduction in tumour size."
CEO Heung Tae Kim of ImmuneOncia commented, "We previously disclosed the high safety and tolerability of IMC-002, along with the recommended Phase 2 dose (RP2D) of 20 mg/kg every 3 weeks, based on interim results presented at the European Society for Medical Oncology (ESMO) in October 2023." He further stated, "With the Phase 1b trial for IMC-002 initiated last November, we anticipate additional efficacy confirmation for IMC-002 in specific solid tumours with high unmet needs."
About IMC-002
IMC-002 is an immune-checkpoint-inhibitor targeting the CD47 of macrophages, blocking the 'don't eat me' signal of CD47/SIRPα interaction between cancer cells and macrophages to enhance phagocytosis of cancer cells. IMC-002 is a potential first-in-class and second-generation anti-CD47 mAb demonstrating high safety with no commonly associated adverse events (hemagglutination, thrombocytopenia, neutrophilia, etc.) due to minimal binding to normal cells such as red blood cells.
