IMC002 / Immuneoncia Therap, 3DMed - LARVOL DELTA

IMC-002 (IMM0306), a bispecific CD20×CD47 fusion protein, demonstrates improvements in active Systemic Lupus Erythematosus patients in a phase Ib/II study (ACR Convergence 2026) - P1/2 | "IMC-002 demonstrated a well-tolerated safety profile, and a promising efficacy for all dose cohorts across multiple organ systems in moderate to severe active SLE patients. Deep B cell depletion and subsequent B cell rebound indicated a balance of sustainable efficacy and safety (low infection risk). Figure 1."

Bispecific • Clinical • P1/2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD20

IMC-002-K102: A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - P1 | N=86 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | N=62 ➔ 86 | Trial completion date: Aug 2029 ➔ Aug 2030

Enrollment change • Trial completion date • B Cell Lymphoma • Biliary Tract Cancer • Breast Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hematological Malignancies • Oncology • Pancreatic Ductal Adenocarcinoma • Triple Negative Breast Cancer • CD20 • ER • HER-2 • PGR

ImmuneOncia Therapeutics said that on the 4th of last month it received approval from the Ministry of Food and Drug Safety to amend the phase 1b IND for ’IMC-002,’ a next-generation CD47 antibody drug candidate (Chosun Biz) - "The approval mainly adds a pancreatic ductal adenocarcinoma (PDAC) cohort to the 'ENBRIGHT' trial evaluating the safety and efficacy of IMC-002 in patients with advanced cancers who failed standard treatment."

Clinical protocol • Pancreatic Ductal Adenocarcinoma

Phase 1b dose-expansion study of IMC-002, a anti-CD47 monoclonal antibody, in patients with advanced triple negative breast cancer (TNBC). (ASCO 2026) - P1 | "IMC-002 in combination with gemcitabine plus carboplatin or paclitaxel demonstrated encouraging antitumor activity with a manageable safety profile in heavily pretreated patients with advanced TNBC. Exploratory baseline ctDNA analyses did not identify molecular features clearly associated with clinical benefit."

Clinical • Metastases • P1 data • Tumor mutational burden • Breast Cancer • Hepatocellular Cancer • Microsatellite Instability • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • MSI • TMB

IMC-002 (IMM0306), a bispecific CD20-CD47 fusion protein, demonstrates improvements in active Systemic Lupus Erythematosus (SLE) patients in a phase Ib/II study (EULAR 2026) - P1/2 | "Conclusions IMC-002 demonstrates a well-tolerable safety profile, and a promising efficacy for all dose cohort across multiple organ systems in moderate to severe active SLE patients. Deep B cell depletion and the followed B cell rebound indicate a balance of sustainable efficacy and safety (low infection risk)."

Bispecific • Clinical • P1/2 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD20

EGFR-TKI enhances anti-CD47 antibody-mediated macrophage phagocytosis in EGFR-mutant non-small cell lung cancer (AACR 2026) - "Lazertinib induces CD47 upregulation and synergizes with IMC-002 to enhance macrophage-mediated clearance of EGFR-mutant NSCLC cells. These findings provide a mechanistic rationale for clinical evaluation of EGFR-TKI and anti-CD47 combination strategies to improve therapeutic efficacy in EGFR-mutant lung cancer."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD47 • SIRPA • TGFB1

Cryo EM-based structural characterization of IMC-002, a next-generation anti-CD47 antibody with a unique binding site and biomarker candidates, supporting evidence of enhanced safety and efficacy (AACR 2026) - P1 | "Several factors identified through proteomics and AI-based IHC studies showed potential possibilities as predictive biomarker candidates. IMC-002 demonstrated excellent efficacy and safety in clinical trials through its unique binding mechanism, supporting its continued clinical development as a promising cancer therapy."

Biomarker • Clinical • IO biomarker • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD47 • SIRPA

Development of IMC-002, a next-generation anti-CD47 mAb: an affinity optimized antibody with enhanced safety and therapeutic efficacy in preclinical models (AACR 2025) - "These findings provide strong support for its clinical development as a cancer therapeutic. Phase 1a trials confirmed IMC-002's superior safety profile, and ongoing Phase 1b trials are evaluating its efficacy in combination with standard-of-care therapies in patients with HCC and TNBC."

IO biomarker • Preclinical • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD47 • SIRPA

Phase 1 Study of IMC-002, a Next-Generation Anti-CD47 Antibody, in Advanced Solid Tumors. (PubMed, Cancer Res Treat) - P1 | "RP2D was defined as 20 mg/kg every 3 weeks. Preliminary anti-tumor activity was observed, with a CBR of 33%."

Journal • P1 data • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

ImmuneOncia confirms safety and anticancer efficacy of antibody drugs in Korea (Chosun Biz) - "According to the company, excellent safety was confirmed in the phase 1 trial of IMC-002. It acts strongly on cancer cells while having little effect on normal cells such as red blood cells, minimizing blood-related side effects including anemia."

P1 data • Oncology

Enhanced safety profile of IMC-002, an affinity-optimized anti-CD47 antibody: Preclinical and phase Ia/Ib findings (ESMO 2025) - P1 | "Conclusions IMC-002 exhibited an excellent safety profile with minimal hematologic toxicity, no treatment-limiting anemia, and no infectious complications. These findings support continued clinical development at the recommended 20 mg/kg Q3W dosing regimen."

P1 data • Preclinical • Oncology

ImmuneOncia signs MOU with IMBDx to accelerate cancer drug and precision medicine development (Korea Biomedical Review) - "The company aims to enhance the development efficiency of its pipeline assets IMC-001 and IMC-002 while establishing an integrated system that connects diagnostics with treatment."

Licensing / partnership • Solid Tumor

Model-Informed Optimal Dosing of Anti-CD47 Antibody Using Target-Mediated Drug Disposition Model. (PubMed, Clin Transl Sci) - "The ideal regimen of 20 mg/kg every 3 weeks ensured that the mean plasma concentration remained above the MEC throughout the dosing interval. Our study developed a robust TMDD PK model for IMC-002, which provides the rationale for a dose regimen in a phase 1b study."

Journal • Oncology • Solid Tumor • SIRPA

A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - P1 | N=62 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Trial completion date: Dec 2026 ➔ Aug 2029 | Trial primary completion date: Jun 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Oncology

Phase 1b dose extension study of a next-generation anti-CD47 monoclonal antibody IMC-002 combined with lenvatinib in patients with advanced hepatocellular carcinoma (HCC). (ASCO 2025) - P1 | "IMC-002, when combined with Lenvatinib at a dose of 20 mg/kg Q3W, demonstrated a promising efficacy and safety profile. AI-driven biomarker analysis identified potential predictive value, supporting the need for further investigation in larger clinical trials. Tumor response by CD47 non-specific cell proportion.Cohort A: High proportion (≥15%) of 'non-specific' cells; Cohort B: Low proportion (<15%) of 'non-specific' cells."

Clinical • Metastases • P1 data • Anemia • Dermatology • Hepatocellular Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CD47

ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025 (PRNewswire) - P1b | N=49 | NCT05276310 | Sponsor: ImmuneOncia Therapeutics Inc. | "ImmuneOncia Therapeutics...announced interim results today from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC)....Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit. AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response."

Biomarker • P1 data • Hepatocellular Cancer

Next-gen Korean cancer fighters to showcase innovation at ASCO 2025 (Korea Biomedical Review) - "ImmuneOncia, a joint venture between Yuhan Corp. and Sorrento Therapeutics, will report interim data from a phase 1b trial of IMC-002, a CD47-targeting monoclonal antibody tested in combination with Lenvima (ingredient: lenvatinib) in patients with advanced liver cancer...The study showed an objective response rate of 30 percent and a disease control rate of 70 percent among 10 evaluable patients, with a median time to progression of 8.3 months."

P1 data • Hepatocellular Cancer

ImmuneOncia to Present Preclinical Results of CD47 Antibody at AACR 2025 [Google translation] (BioTimes) - "ImmuneOncia...announced on the 25th that it will present the results of a non-clinical study of its anti-CD47 immunotherapy IMC-002 at the American Association for Cancer Research (AACR), to be held in Chicago, USA from the 25th to the 30th....In this announcement, the mechanistic differentiation and excellent anticancer effect of IMC-002 were additionally confirmed, thereby reproving its clinical expandability and competitiveness....The ongoing phase 1b clinical trial has confirmed the efficacy of IMC-002 in patients with solid tumors, including hepatocellular carcinoma (HCC), which has a high unmet medical need. The efficacy results in the liver cancer patient group are scheduled to be announced at the American Society of Clinical Oncology (ASCO 2025) to be held at the end of May."

P1 data • Preclinical • Hepatocellular Cancer

Evaluating the Influence of IMC-002, a Novel Anti-CD47 Monoclonal Antibody, on Pretransfusion Compatibility Testing (AABB 2024) - "IMC-002 induced interference during ABO/RhD typing which could be mitigated by using washed RBCs and saline replacement. Plasma spiked with IMC-002 showed concentration-dependent panreactive results in antibody screening tests. However, it is presumed that these interferences are caused by mechanisms other than typical antigen-antibody reactions."

Oncology • CD47

Updated safety, efficacy, pharmacokinetics, and biomarkers from the phase 1 study of IMC-002, a novel anti-CD47 monoclonal antibody, in patients with advanced solid tumors. (ASCO 2024) - P1 | "IMC-002 has an excellent safety profile when administered intravenously at a dose of up to 30 mg/kg every 2 weeks intravenously for max 12 months treatment. IMC-002 monotherapy demonstrates meaningful clinical benefits in refractory HCC. The density of CD47+macrophages analyzed by AI is higher in CBR patients."

Biomarker • Clinical • Metastases • P1 data • PK/PD data • Anemia • Breast Cancer • Dermatology • Gallbladder Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • CD47

ImmuneOncia announces CD47 antibody phase 1 clinical trial biomarker results at ASCO [Google translation] (Newsmp) - P1 | N=12 | NCT04306224 | Sponsor: ImmuneOncia Therapeutics Inc. | "As a result of the analysis, 6 out of 12 patients with measurable lesions showed stable disease (SD), showing a disease control rate (DCR) of 50%....Of these, five were hepatocellular carcinoma patients and one was a breast cancer patient. In addition, stable response continued for more than 6 months in 4 patients, confirming a clinical benefit rate (CBR) of 33.3%....The researchers explained that the results of this study suggest a correlation between the density of CD47-positive macrophages and treatment response, and are expected to play an important role in the development of future treatment strategies targeting CD47."

P1 data • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Yuhan Corporation subsidiary Immune Oncia passes technology evaluation and begins full-fledged listing on KOSDAQ [Google translation] (Medifonews) - P2 | N=23 | NCT04414163 | Sponsor: ImmuneOncia Therapeutics Inc. | "Immune Onsia (CEO Kim Heung-tae) announced on the 17th that it passed the technology evaluation for KOSDAQ technology special listing...'Based on the results of this technology evaluation, we will challenge for KOSDAQ listing this year. Through this, we will accelerate the development of key pipelines currently in the clinical stage, non-clinical development of follow-up pipelines, and new candidates.'...IMC-001 (PD-L1 monoclonal antibody) demonstrated excellent efficacy and safety in phase 2 NK/T cell lymphoma (69%)....In addition, IMC-002, which is currently undergoing phase 1b clinical trials, will be selected as a poster at the 2024 ASCO Annual Meeting held in Chicago, USA on May 31 and will announce the results of phase 1a clinical trials."

Commercial • P1 data • P2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: ImmuneOncia Therapeutics Inc. | Recruiting ➔ Completed | N=24 ➔ 12

Enrollment change • Metastases • Trial completion • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - P1 | N=49 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | N=24 ➔ 49 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Jul 2024 ➔ Jun 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Oncology

Phase I dose escalation study of IMC-002, a novel anti-CD47 monoclonal antibody, in patients with advanced solid tumors (ESMO 2023) - P1 | "Conclusions IMC-002 demonstrated a favorable safety profile when administered intravenously every 2 weeks up to 30 mg/kg and showed preliminary efficacy in patients with advanced solid tumors. Based on safety and PK profile, we determined the recommended phase 2 dose as 20 mg/kg."

Clinical • Metastases • P1 data • Breast Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor