IMC002 / Immuneoncia Therap, 3DMed - LARVOL DELTA

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

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

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

ImmuneOncia Announces Phase 1 Results of CD47 Antibody at ESMO 2023 (Businesswire) - P1a | N=24 | NCT05276310 | Sponsor: ImmuneOncia Therapeutics Inc. | "ImmuneOncia (CEO Heung Tae Kim) announced the results of its Phase 1a solid tumour clinical trial (IMC-002-K102 Study) of IMC-002, a CD47 monoclonal antibody, at the...ESMO 2023...From May 2022 to October 2023, a total of 12 patients were enrolled in four dose cohorts, each receiving IMC-002 at doses of 5, 10, 20, or 30 mg/kg every 2 weeks (Q2W). The clinical data showed no dose-limiting toxicities (DLT). 92% of treatment-related adverse events (TRAE) were of Grade 1-2, with 94% occurring during the first treatment cycle....The recommended Phase 2 dose of 20 mg/kg every 3 weeks (Q3W) was established. 6 out of 11 evaluable patients with measurable lesions also demonstrated stable disease (SD). 5 of the patients had liver cancer, and 1 had breast cancer."

P1 data • Breast Cancer • Hepatocellular Cancer

A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: ImmuneOncia Therapeutics Inc.

New P1 trial • Oncology • Solid Tumor

ImmuneOncia and 3D Medicines Signed Exclusive License Agreement to Develop, Manufacture and Commercialize IMC-002 in Greater China (PRNewswire) - “ImmuneOncia Therapeutics…announced an exclusive license agreement for the development, manufacture and commercialization of IMC-002, ImmuneOncia's monoclonal antibody against CD47…Under the terms of the agreement, ImmuneOncia will receive an upfront payment of $8 million from 3D Medicines. Additionally, ImmuneOncia is eligible to receive up to $462.5 million upon the achievements of all future development and commercial milestones, plus tiered royalties up to double-digits on annual net sales of IMC-002 in Greater China. In exchange, 3D Medicines will receive rights to develop, manufacture and commercialize IMC-002 in Greater China. 3D Medicines is planning to file IND to NMPA in China this year.”

Licensing / partnership • Non-US regulatory • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

[VIRTUAL] A preclinical study of IMC-002, a fully human therapeutic antibody safely targeting CD47 in cancer (SITC 2020) - "The purpose of the study is to assess the safety and tolerability of IMC-002 and determine the recommended Phase 2 dose (RP2D) of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas. Ethics Approval All experimental procedures were performed according to the guidelines of the Institutional Animal Care and Use Committee (IACUC) of the contract research organizations."

IO Biomarker • Preclinical • Breast Cancer • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD14 • CD8

[VIRTUAL] A preclinical study of IMC-002, a fully human therapeutic antibody safely targeting CD47 in cancer (SITC 2020) - "The purpose of the study is to assess the safety and tolerability of IMC-002 and determine the recommended Phase 2 dose (RP2D) of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas. Ethics Approval All experimental procedures were performed according to the guidelines of the Institutional Animal Care and Use Committee (IACUC) of the contract research organizations."

IO Biomarker • Preclinical • Breast Cancer • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD14 • CD8

Samsung Biologics, ImmuneOncia enter manufacturing development agreement (Biospectrumasia) - "South Korea based companies Samsung Biologics and ImmuneOncia Therapeutics held a signing ceremony for a contract to develop and manufacture five candidate molecules, expanding upon the two companies' existing CDO partnership first established in 2018…Under this extended deal with ImmuneOncia, Samsung Biologics will provide a full scope of CDO services from cell line development, process development, non-clinical and clinical material manufacturing, to IND submission support for global clinical trials of five candidates from ImmuneOncia's pipelines. ImmuneOncia's portfolio comprises diverse immune checkpoint antibodies including IMC-002, a CD47-targeting antibody that is currently undergoing a global phase 1 study based on the successful IND-filing approval obtained through the development and manufacturing partnership with Samsung Biologics."

Licensing / partnership • Oncology

[VIRTUAL] A PRECLINICAL STUDY OF IMC-002, A FULLY HUMAN THERAPEUTIC ANTIBODY SAFELY TARGETING CD47 IN CANCER (EHA 2020) - "The first-in-human (FIH) study of IMC-002 is planned to be initiated during the 1st half of 2020. The purpose of the study is to assess the safety and tolerability of IMC-002 and determine the recommended Phase 2 dose (RP2D) of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas."

IO Biomarker • Preclinical • Breast Cancer • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Oncology • CD14 • CD8 • CTLA4

A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: ImmuneOncia Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Samsung Biologics and ImmuneOncia Therapeutics Inc. development and manufacturing agreement accomplishes IND clearance of IMC-002 (anti-CD47 antibody) (PRNewswire) - "Samsung Biologics...and ImmuneOncia Therapeutics Inc. announced the successful FDA IND approval of IMC-002 under a development and manufacturing agreement with Samsung Biologics since 2018. As a result, ImmuneOncia will begin Phase 1 clinical trials of the pipeline product. IMC-002 is an immune checkpoint inhibitor antibody, which blocks CD47-SIRP- α interaction between tumor cells and macrophages. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas."

IND • New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

"#SamsungBiologics and #ImmuneOnciaTherapeutics Inc. Development and Manufacturing Agreement Accomplishes #InvestigationalNewDrug Clearance of #IMC002 (#AntiCD47Antibody) https://t.co/3ItuFriVWD" (@1stOncology)

IND

A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: ImmuneOncia Therapeutics Inc.

Clinical • New P1 trial

Aesop Onsia submits US FDA IND to suppress CD47 [Google translation] (Medical News) - "Aesop Onsia (CEO Song Yun-jeong) is the first Korean company to apply for approval of a phase 1 clinical trial plan to the US Food and Drug Administration (FDA) for IMC-002, a candidate for an immunosuppressive drug that inhibits CD47 ) On the 11th....This trial is a dose-escalation phase in patients with metastatic or locally advanced solid cancer and recurrent or refractory lymphoma."

New P1 trial • Non-US regulatory