danburstotug (IMC-001) / Immuneoncia Therap - LARVOL DELTA

Danburstotug, an anti-PD-L1 antibody, in relapsed/refractory extra-nodal natural killer/T-cell lymphoma: The phase 2 DISTINKT study. (PubMed, Br J Haematol) - P2 | "Danburstotug demonstrated robust, durable efficacy and manageable safety. PD-L1 MS showed potential as a predictive biomarker."

IO biomarker • Journal • P2 data • Hematological Malignancies • Hepatology • Liver Failure • Lymphoma • Natural Killer/T-cell Lymphoma • Ocular Inflammation • Oncology • Ophthalmology • T Cell Non-Hodgkin Lymphoma • Uveitis

Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study. (PubMed, NPJ Precis Oncol) - P2 | "Neoadjuvant danburstotug was safe, did not compromise surgical outcomes, and provided exploratory insights into treatment-induced immune microenvironment remodeling. ClinicalTrials.gov ID: NCT04196465, date of registration: August 28, 2019."

Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

IMC001 EpCAM: Phase I/IIa Clinical Trial of IMC001 in Patients With Advanced Epithelial Solid Tumors. (clinicaltrials.gov) - P1/2 | N=30 | Enrolling by invitation | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

New P1/2 trial • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

DISTINKT: A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Trial completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial primary completion date • Oncology • Solid Tumor • TMB

A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome. (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Phase classification: P2 ➔ P1

Phase classification • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • CRP

A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome. (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=30 ➔ 18 | Trial completion date: Jun 2026 ➔ Oct 2026 | Trial primary completion date: Jun 2026 ➔ Oct 2026

Enrollment change • Trial completion date • Trial primary completion date • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • CRP

ImmuneOncia Therapeutics has entered a manufacturing agreement with Swiss contract drugmaker Lonza to support late‑stage clinical production of Danburstotug, an experimental monoclonal antibody targeting PD‑L1 for relapsed or refractory NK/T‑cell lymphoma (Contract Pharma) - "Under the deal, Lonza will produce drug substance at its Slough, U.K., facility, while drug‑product development and clinical manufacturing will occur at sites in Basel and Stein, Switzerland. The South Korea–based biotech said it is leveraging Lonza’s end‑to‑end development and manufacturing capabilities as it positions the therapy for late‑stage clinical readiness and potential commercial rollout."

Licensing / partnership • Natural Killer/T-cell Lymphoma

ImmunOncia said Friday it presented phase 2 clinical trial results for its PD-L1 antibody Danburstotug (MC-001) at the Korean Society of Hematology International Congress (KSHIC 2026) (Korea Biomedical Review) - "In the phase 2 trial, Danburstotug monotherapy achieved an objective response rate (ORR) of 79 percent and a complete remission (CR) rate of 63 percent. The study reported a median progression-free survival (mPFS) of 29.4 months and a median overall survival (mOS) of 40.2 months. The two-year survival rate was 78 percent. Regarding safety, the company said 40 percent of patients completed two years of treatment without serious adverse events. Additionally, responses were observed even in patients with low PD-L1 expression."

P2 data • Natural Killer/T-cell Lymphoma

ImmuneOncia, a subsidiary of Yuhan Corporation, announced on the 5th that its new immune anticancer drug 'Danburstotug (development name IMC-001)' was designated as an orphan drug (ODD) by the Ministry of Food and Drug Safety (MFDS). [Google translation] (HIT News)

Orphan drug • Natural Killer/T-cell Lymphoma

Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: Mayo Clinic | Trial completion date: Jan 2026 ➔ Feb 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Feb 2025; low/slow accrual

Trial completion date • Trial primary completion date • Trial termination • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

ImmuneOncia reports 63% complete response with Danburstotug in NK/T-cell lymphoma (Korea Biomedical Review) - "According to the company, relapsed or refractory NK/T-cell lymphoma has extremely limited treatment options and a poor prognosis, with median progression-free survival (PFS) from conventional chemotherapy at just 4.1 months. In contrast, the phase 2 study of Danburstotug reported an objective response rate (ORR) of 79 percent, a complete response (CR) rate of 63 percent, a PFS of 29.4 months, an overall survival (OS) of 40.2 months, and a two-year survival rate of 78 percent with monotherapy."

P2 data • Extranodal Natural Killer/T-cell Lymphoma

Neoadjuvant anti-PD-L1 antibody therapy with IMC-001 in resectable gastric, esophageal, and hepatocellular carcinoma: A multicohort phase II trial (NeoChance study) (ESMO 2025) - P2 | "Conclusions Neoadjuvant IMC-001 demonstrated a favorable safety profile and drove profound immunologic remodeling and tumor regression across GC, ESCC, and HCC, even in PD-L1–negative, microsatellite-stable tumors. Distinct Immune response patterns by tumor type emphasize the need for rational combination strategies tailored to the immune contexture and functional balance."

Clinical • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Atherosclerotic Plaques in Patients With ACS. (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=14 ➔ 30 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

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

Preclinical development and a phase I trial of IMC001, an EpCAM-targeted CAR-T cell therapy, in patients with advanced gastric cancer. (PubMed, Mol Ther) - "One patient underwent conversion surgery at week 27 and remains alive 31.5 months post-infusion. These findings demonstrate an acceptable safety profile and promising efficacy of IMC001 in advanced GC, supporting further clinical development for refractory GC patients."

Journal • P1 data • Preclinical • Gastric Cancer • Oncology • Solid Tumor

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2027 ➔ Aug 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor

A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

NeoChance: Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Asan Medical Center | Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Enrollment closed • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Yuhan-backed ImmuneOncia locks in IPO to fast-track PD-L1 entry (Korea Biomedical Review) - "ImmuneOncia Therapeutics is gearing up for its Kosdaq debut, a move that could fast-track its flagship PD-L1 checkpoint inhibitor, IMC-001, toward commercialization....With Korea Investment & Securities as its lead underwriter, ImmuneOncia plans to submit its securities registration statement within the month and aims for final approval by mid-May....The company completed final patient enrollment for a phase 2 trial early last year, with all patient dosing expected to conclude in 2026. Clinical trials have shown an objective response rate of 79 percent and a complete response rate of 58 percent, positioning it for a biologics license application (BLA) submission in 2027 and potential approval by 2029."

FDA approval • FDA filing • Financing • Trial status • Oncology

A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov) - P2 | N=14 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P2 trial • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Mayo Clinic | N=40 ➔ 0 | Trial completion date: Nov 2025 ➔ Jul 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: Nov 2024 ➔ Jul 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Melanoma • Oncology • Solid Tumor

ImmuneOncia confirms excellent anticancer effect of PD-L1 antibody IMC-001 in phase 2 NKTCL clinical trial (BioTimes) - P2 | N=23 | DISTINKT (NCT04414163) | Sponsor: ImmuneOncia Therapeutics Inc. | "ImmuneOncia...announced the NK approval of IMC-001, a PD-L1 monoclonal antibody, at the European Hematology Association (EHA) held in Madrid, Spain on June 14, 2024 (local time). It was announced on the 17th that the results of the phase 2 clinical trial (DISTINKT Study) for T-cell lymphoma were announced....The treatment results showed an excellent anticancer effect with an overall response rate (ORR) of 79%, with 11 of the 19 patients for whom tumor evaluation was possible showing complete response (CR) and 4 showing partial response (PR). The median progression-free survival (PFS) was 30 months, and excellent long-term efficacy was also confirmed, with a 1-year OS rate of 84% and a 2-year OS rate of 72%."

P2 data • Lymphoma • T Cell Non-Hodgkin Lymphoma

ENHANCED EFFICACY AND SAFETY FROM PHASE 2 STUDY OF IMC-001, ANTI-PD-L1 ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY EXTRANODAL NK/T CELL LYMPHOMA (R/R ENKTL), NASAL TYPE: DISTINKT STUDY (EHA 2024) - "PD-L1 blockade with IMC-001 demonstrates remarkable effectiveness in patients with R/R ENKTL who havefailed L-asparaginase-containing regimens. Moreover, IMC-001 exhibits an outstanding safety profile, withoutlong-term toxicity."

Clinical • P2 data • Endocrine Disorders • Epstein-Barr Virus Infections • Fatigue • Hematological Malignancies • Hepatology • Liver Failure • Lymphoma • Ocular Inflammation • Oncology • Ophthalmology • T Cell Non-Hodgkin Lymphoma • Uveitis

Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers. (ASCO 2024) - "This phase I study in advanced gastric cancer resulted in durable response with a favorable safety and efficacy profile especially for the recommended dose of 1M/kg, demonstrate a promising of EpCAM CAR-T therapy in advanced GC pts. Further expanding of this dose with larger patient population and longer follow-up shall bring the hope to this unmet medical need."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EPCAM