ImmuneOncia Shares Phase 1 CD47 Antibody Biomarker Results at ASCO

ImmuneOncia, a biotechnology firm based in Seoul, South Korea, recently shared promising results from its Phase 1a clinical trial of IMC-002 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Led by CEO Heung Tae Kim, the company has been working on IMC-002, an anti-CD47 monoclonal antibody (mAb), to target solid tumors. The trial's findings also included biomarker data derived from a collaboration with Lunit, a company specializing in AI-driven cancer diagnostics and therapeutics.

Initiated in May 2022, the dose-escalation study involved 12 patients divided into four dosage groups, receiving IMC-002 at 5, 10, 20, or 30 mg/kg every two weeks. Clinical outcomes were positive, with 6 of the 12 evaluable patients exhibiting stable disease (SD), translating to a disease control rate (DCR) of 50%. The cohort included 5 patients with hepatocellular carcinoma and 1 with breast cancer. Notably, 4 patients maintained stable disease for over six months, yielding a clinical benefit rate (CBR) of 33.3%.

Lunit's AI-powered biomarker analysis, known as Lunit SCOPE IO, identified a higher density of CD47-positive macrophages in the CBR group compared to the non-CBR group (71.0/mm² vs. 44.3/mm²). However, the density of CD47-positive tumor cells was comparable between both groups. These insights suggest that the density of CD47-positive macrophages might be a key indicator of treatment response, highlighting the potential importance of targeting CD47 in cancer therapy.

Dr. Ho Yeong Lim, the principal investigator from Samsung Medical Center, noted that no dose-limiting toxicities (DLTs) were observed in any cohort. Furthermore, common adverse events linked to anti-CD47 therapies, such as infusion-related reactions, hemolytic anemia, thrombocytopenia, and neutropenia, were not reported, underscoring the high safety profile of IMC-002. Dr. Lim also mentioned a particularly significant case of a hepatocellular carcinoma patient who exhibited a favorable prognosis with stable disease and a 20% reduction in tumor size after 15 months of treatment with IMC-002.

CEO Heung Tae Kim highlighted that the company had previously reported the high safety and tolerability of IMC-002, along with the recommended Phase 2 dose (RP2D) of 20 mg/kg every three weeks, based on interim results from the European Society for Medical Oncology (ESMO) in October 2023. He added that with the initiation of the Phase 1b trial in November, they are optimistic about further confirming IMC-002's efficacy in specific solid tumors with significant unmet medical needs.

IMC-002 functions as an immune checkpoint inhibitor targeting CD47 on macrophages, which interferes with the CD47/SIRPα interaction—often referred to as the "don't eat me" signal between cancer cells and macrophages. By blocking this signal, IMC-002 enhances the phagocytosis of cancer cells. As a potential first-in-class and second-generation anti-CD47 mAb, IMC-002 exhibits a high safety profile with minimal binding to normal cells, such as red blood cells, thereby avoiding common side effects like hemagglutination and thrombocytopenia.

ImmuneOncia Therapeutics, Inc., founded in 2016, is a South Korean clinical-stage biotech company specializing in immuno-oncology. The company leverages its expertise in drug development and antibody engineering to provide innovative and safe immunotherapies for cancer patients globally. Their product portfolio includes various immune checkpoint antibodies targeting PD-L1, CD47, LAG3, along with bi-specific antibodies and ADC/AICs.