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

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

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 Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: ImmuneOncia Therapeutics Inc.

Metastases • New P2 trial • Oncology • Solid Tumor

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. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Feb 2026 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin 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 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | N=18 ➔ 3

Enrollment change • Enrollment closed • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Balance of CD36+ and CD16+ monocytes controls TLR-mediated cytokine release syndrome and MHC-dependent antitumor responses in EpCAM CAR T cell therapy for gastrointestinal cancers (ESMO 2023) - P1 | "Clinical trial identification The study had a classic 3+3 design for each indication trial, with separate EpCAM CAR-T cell (IMC001) dose escalations for monotherapy...Conclusions We present valuable insights into the pathophysiology of CRS and suggest that TLR4 on CD36+ monocytes is a promising target for managing CRS, which offers a new strategy for mitigating the side effects of CAR-T therapy. We also highlight the role of innate immune components, particularly CD16+ monocytes, in achieving optimal CAR-T treatment efficacy through antigen processing and presentation."

CAR T-Cell Therapy • Cytokine release syndrome • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD36 • EPCAM • TLR4

Intra-Lymphatic STI-3031 Using the Sofusa DoseConnect Device for Treatment of In-Transit Melanoma, The Sofusa-2 Study (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Jun 2024 ➔ Jan 2026 | Trial primary completion date: Jun 2023 ➔ Jan 2026

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

ImmuneOncia “more than half of the clinical subjects taking 'IMC-001' showed a 'complete remission' effect” [Google translation] (Health Korea News) - P2 | N=20 | DISTINKT (NCT04414163) | Sponsor: ImmuneOncia Therapeutics Inc. | "An immuno-oncology drug being developed by ImmuneOncia, a subsidiary of Yuhan Corporation, showed excellent effects in clinical trials. More than half of the subjects showed complete remission, and side effects were confirmed to be mild....According to the company, 7 out of 12 patients with measurable lesions in the clinical trial showed complete response (CR) and 1 partial response (PR). The overall response rate (ORR) was 66.7%, showing excellent anticancer effects. In addition, 8 of the patients who underwent follow-up showed a decrease in Epstein-Barr Virus (EBV) DNA levels after treatment, which is known to be highly associated with nasal type extranodal NK/T-cell lymphoma."

P2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Phase 2 study to investigate the efficacy and safety of IMC-001, anti-PD-L1 antibody, in patients with relapsed or refractory extranodal NK/T cell lymphoma, nasal type: DISTINKT Study (ICML 2023) - P2 | "PD-L1 blockade with IMC-001 is highly effective in patients with R/R ENKTL failing L-asparaginase containing regimens. IMC-001 has a good safety profile without long-term toxicity. We will present updated data for efficacy and safety."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

EpCAM CAR T (IMC001) for the treatment of advanced GI cancers. (ASCO 2023) - P1 | "This is the first CAR-T therapy ever tested in humans targeting the EpCAM. IMC001 showed a favorable safety profile and reasonable anti-tumor activities at the low and middle dosage levels in patients with advanced EpCAM+ GI cancers, especially in gastric cancer. In addition, our trial has successfully provided a surgical treatment opportunity after CAR-T therapy downstaging of unresectable gastric cancers."

IO biomarker • Metastases • Colorectal Cancer • Dermatology • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pruritus • EPCAM • IFNG • IL15 • IL6

A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=220 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Pan tumor • Trial withdrawal • Biliary Cancer • Biliary Tract Cancer • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma